Pharma Times - COVID19 Special.pdf - Sri Adichunchanagiri ...

Pharma Times - Vol. 52 - No. 04 - April 2020 PB

Pharma Times Official Publication of: The Indian Pharmaceutical Association, Kalina, Santacruz (E), Mumbai 400098.

Single Copy Price ` 250ISSN 0031-6849

Vol. 52 No. 04 | April 2020Total Pages : 63

Official Monthly Newsmagazine of Indian Pharmaceutical AssociationIndexed by Scopus & Embase

Listed in journals approved by UGC for CAS & Appointment of University Teachers

Pharmaceutical Sector of India, Perspectives & its Journey During Covid-19: Recent Problems & Strategic Solutions –PPP Mode .................................................15Pharmacist the ‘Apostrophe’ of the Health profession ..... 20Covid-19: A Wake up Call for Pharma Stakeholders...........25Safety of Pharmaceutical Employees in Covid-19 Pandemic ........................................................................................26

ommitment to Public Health and Science will

go a long way in Defeating ‘Pandemics’ ... 22C

Pharma Times - Vol. 52 - No. 04 - April 2020 2 Pharma Times - Vol. 52 - No. 04 - April 2020 3Pharma Times - Vol. 52 - No. 04 - April 2020 2 Pharma Times - Vol. 52 - No. 04 - April 2020 3Pharma Times - Vol. 52 - No. 03 - March 2020 44 Pharma Times - Vol. 52 - No. 03 - March 2020 45Pharma Times - Vol. 52 - No. 03 - March 2020 44 Pharma Times - Vol. 52 - No. 03 - March 2020 45


COL

Pharma Times - Vol. 52 - No. 04 - April 2020 4 Pharma Times - Vol. 52 - No. 04 - April 2020 5Pharma Times - Vol. 52 - No. 04 - April 2020 4 Pharma Times - Vol. 52 - No. 04 - April 2020 5

Pharma Times - Vol. 51 - No. 09 - September 2019 4 Pharma Times - Vol. 51 - No. 09 - September 2019 5Pharma Times - Vol. 51 - No. 09 - September 2019 4 Pharma Times - Vol. 51 - No. 09 - September 2019 5

Contents

Regular Features

Copyright of Indian Pharmaceutical Association. All rights reserved throughout the world. Reproduction in any manner is prohibited.

Please send your communications to: The Editor, Pharma Times

The Indian Pharmaceutical Association, Kalina, Santacruz (E), Mumbai 400098. Tel: 91-22-2667 1072 E-mail: [email protected]

Printed by Dr. Alka Mukne, Published by Dr. Alka Mukne on behalf of The Indian Pharmaceutical Association and printed at Ebenezer Printing House,

Unit No. 5 & 11, 2nd Floor, Hind Services Industries, Veer Savarkar Marg, Dadar (West), Mumbai 400 028 and published at The Indian Pharmaceutical Association,

Kalina, Santacruz (E), Mumbai 400 098.

For Pharma Times Advertisements please contactTel. 022-26671072 / 26670744

[email protected] / [email protected]: www.ipapharma.org

Designed, Typeset & Printed at Ebenezer Printing House Unit No. 5 & 11, 2nd Floor, Hind Services Industries, Veer Savarkar Marg,

Dadar (West), Mumbai 28. Tel.: 2446 2632 / 3872 Fax: 2444 9765 E-mail: [email protected]

EDITOR Dr. Alka MukneEDITORIAL ASSISTANTSArjun JeswaniNeha DabholkarPooja Kulthe Rasika R. DharapRishab BabelSaee H. MisalSakshi Y. KasatSeline DantesShweta S.ShindeTamanna GidwaniVibhusha DubeADVISORY BOARD Dr. A. I. Mehta

Dr. B. Suresh Dr. C. Gopalakrishna Murty Dr. J. A. S. Giri Kaushik Desai Dr. Mukund Yelvigi Prafull Sheth Dr. Rao V.S.V. Vadlamudi Shashikant Joag Subodh PriolkarEDITORIAL BOARD Dr B.N. Sinha Dr. Divakar Goli Hemanta Kr. Sharma Dr. Jayant Dave Kalhan Bazaz M.P. George

Pharma TimesOfficial Publication of The Indian Pharmaceutical Association

Indexed by Scopus & EmbaseDr. N. Shivaprasad Dr. P. Khadgapathi Dr. Premnath Shenoy Puneet Gupta Dr. P.N. Murthy Raj Vaidya Rajesh Bhandari Dr. R.N. Gupta Sanjay Jain Dr. Shailendra Saraf Shyamal Kalani Sripati Singh Dr. Subhash Mandal Dr. S.P. Manek Prof. T.V. Narayana

2620

14

11

Lipid Excipients In Pharmaceutical Technologies .................................11Lipidic excipients in drug delivery for solubility and bioavailability enhancement .....................................................................................14From Exploration of Lipids to its Exploitation in Market: Pharmaceuticals, Nutraceuticals and Herbal .......................................20A snapshot of lipid excipients for Topical Formulations.......................26Processing technologies from Romaco Innojet GMP compliant hot melt device for applying pharmaceutical coatings .........................29Strategic Lipid-Based Delivery Interventions for Enhancing Oral Bioavailability of BCS II/IV Drugs .......................................................37Unleashing role of excipients in overcoming formulation challenges ....42Role of lipid excipients in oral sustained release drug delivery systems ..45

From the Editor’s Desk ............................................................................5President Speak ......................................................................................7Guest Editorial ......................................................................................8,9Advertisement Tariff .............................................................................13Book Review .........................................................................................25Letter to Editor ......................................................................................28Announcement ......................................................................30,41,55,57 IPA Building Progress Report .................................................................31Pharmexcil Updates ...............................................................................44Advertisement Index ..............................................................................47Minutes of CEC Meeting .......................................................................48Campus News .......................................................................................53Association News .................................................................................56Advocacy Corner ...................................................................................57

4237

5345

56

54 56


Contents

Regular Features















2620

14

11



4237

5345

56

54 56

Contents

Regular Features

Novel Coronavirus Pandemic- Stark Realities & New Lessons for Science & Humanity: Dr. Jayant B Dave, Adjunct Professor, L M College of Pharmacy, Ahmedabad .................................................................................9

Pharmaceutical Sector of India, Perspectives & its Journey During Covid-19 : Recent Problems & Strategic Solutions –PPP Mode: Dr. Dinesh Dua, Chief Executive Officer (CEO) & Whole Time Director, M/S Nectar Lifesciences Ltd. India & Chairman, Pharmexcil, Ministry of Commerce, Govt. of India .....................................................................................................15

Pharmacist the ‘Apostrophe’ of the Health profession Dr B Suresh, President, Pharmacy Council of India, New Delhi Pro Chancellor, JSS Academy of Higher Education and Research, Mysuru .....................................................................................20

Commitment to Public Health and Science will go a long way in defeating ‘Pandemics’: Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech ...................................................................................................22

Covid-19: A Wake up Call for Pharma Stakeholders: Dr. Ajit Dangi, President & CEO, Danssen Consulting ....................................................................................................................25

Safety of Pharmaceutical Employees in Covid-19 Pandemic: S. G. Belapure, Senior Technical Advisor, Indian Pharmaceutical Alliance ......................................................................................26

Pharmacy Experiences in India in SARS-Cov-2: Raj Vaidya, Community Pharmacist, Hindu Pharmacy, Panaji. ........................................................................................................30

Embracing 4.0 in Pharma Academics: Way Forward: Dr. Richa Dayaramani, Principal, Khyati College of Pharmacy ........................................................................................................36

An International Crisis: Long Term Impact of Covid-19 Pandemic on Health Care Scenario, Worldwide Pharmaceutical Growth and Global Economy: Anil Kharia*, Sapna Malviya1, Ankur Joshi1, *President, IPA MP State Branch, Indore, 1Indian Pharmaceutical Association, MP State Branch, Indore .....................................39

From The Editor’s Desk ........................................................................5

President Speak ...................................................................................7

"IPA in the News!!" ............................................................................8

Obitury .........................................................................................14,21

Letter To Editor .................................................................................33

Advertisement Tariff ..........................................................................42

Advertisement Index ..........................................................................42

Jumbo Covid Crossword ....................................................................43

Association News ..............................................................................44

Pharmascene .....................................................................................51


Indian pharma companies

have stepped up their act to

meet not just the domestic

requirement but also grateful

requests from neighbouring

countries and all major nations

of the world. All of this, with

skeletal work force, serious

supply chain disruptions and

cash flow issues!

Dear Readers,

These are difficult times! Mankind is in the grips of a pandemic that seems to be like a never seen before! As per the last count, 2.76 million people were infected worldwide, with 760K recovered and 194K

fatalities. The COVID-19 pandemic has caught the globe unawares and completely ill-equipped to tackle it. With no effective drug and no signs of any vaccines for the next year or so, nations after nations have imposed stringent lockdowns of a nature that none of us even remember hearing of! The virus itself seems to be behaving strangely within the human host. Whereas earlier, it was thought to be more lethal in older patients with pre-existing co-morbidities, doctors are now increasingly revisiting this presumption. Just a few days back, Washington Post (22nd April 2020) reported American doctors observing a clear pattern of unexplainable blood clotting, even in patients who were on anticoagulants. The post goes on to add that autopsies have revealed patients’ lungs filled with hundreds of microclots. So much so that medicos are seriously considering giving preventive anticoagulants to all covid-19 patients. Young American patients without any past medical history and seemingly mild symptoms have had life-threatening strokes requiring immediate hospitalization. The sudden lethality with which the virus strikes; how patients with mild symptoms have suddenly deteriorated and died, defying age and chronic conditions, has stumped doctors. As of now, it appears that India, like most ‘developing’ countries has had it slightly better; with all sorts of reasons being touted for this apparently greater resistance of its people to covid, right from genetic predisposition to greater preponderance of malaria to the BCG vaccine that most Indians have been administered for protection against tuberculosis.

During this period, India has more than justified its position as ‘pharmacy of the world’. Be it paracetamol tablets or hydroxychloroquine of which 70% of the global supplies come from India, Indian pharma companies have stepped up

their act to meet not just the domestic requirement but also grateful requests from neighbouring countries and all major nations of the world. Industry has been doing all of this, with skeletal work force, serious supply chain disruptions and cash flow issues! The regulators have responded with just as much alacrity; the recent notification by Department of Pharmaceuticals, Government of India constituting a technical committee led by Joint Drugs Controller (India) with industry representatives, for consolidating and recommending measures for revival of the fermentation industry and exploring latest technologies for API manufacture. It has been industry’s oft-repeated demand to incentivize API production in the country so that dependence on China for the vital starting materials, key intermediates and many of the APIs is reduced. The hospital pharmacists have been on the go along with doctors and nurses and the community pharmacists have also been doing their bit. Take a bow, all you fellow pharmacists, from the industry and other sectors! You are doing us all proud!!!

This special issue has leaders from the industry, academia and practice sectors writing for us, telling us about how the pandemic has impacted their respective fields and what long-term operational and other changes can be expected! We are sure you will find it hard to put down this issue till you have read it all through. Do let us know what you think about the write-ups. You can write in to me at [email protected]. Since this is going to be an e-issue, with no print copies being sent, we request you to kindly forward the copy to all pharma professionals in your circles.

Alka Mukne

Editorial Calendar for 2020 - 21Theme Based Special Issues Monthγ – scintigraphy in pharmaceuticals August ‘20Digitization in pharmaceutical industry November ‘20Nutraceuticals February ‘21

Our MissionThe Indian Pharmaceutical Association (IPA) is the national professional body of pharmacists engaged in various facets of the profession of Pharmacy. The IPA is committed to promote the highest professional and ethical standards of pharmacy, focus the image of pharmacists as competent healthcare professionals, sensitize the community, government and other on vital professional issues and support pharmaceuticals education and sciences in all aspects.

The information and opinions presented in the issue reflect the views of the authors and not of the Indian Pharmaceutical Association or the Editor Board. Publication does not constitute endorsement by IPA or Pharma Times. IPA, Pharma Times and/or its publisher cannot be held responsible for errors of for any consequences arising from the use of the information contained in this journal. The appearance of advertising or product information in the various section in the journal does not consitute an endorsement or approval by the Journal and/or its publisher of the quality or value of the said product or of claims made for it by its manufacturer.

From the Editor ’s Desk...


Contents

Regular Features















2620

14

11



4237

5345

56

54 56


Contents

Regular Features















2620

14

11



4237

5345

56

54 56

Contents

Regular Features

Novel Coronavirus Pandemic- Stark Realities & New Lessons for Science & Humanity: Dr. Jayant B Dave, Adjunct Professor, L M College of Pharmacy, Ahmedabad .................................................................................9

Pharmaceutical Sector of India, Perspectives & its Journey During Covid-19 : Recent Problems & Strategic Solutions –PPP Mode: Dr. Dinesh Dua, Chief Executive Officer (CEO) & Whole Time Director, M/S Nectar Lifesciences Ltd. India & Chairman, Pharmexcil, Ministry of Commerce, Govt. of India .....................................................................................................15

Pharmacist the ‘Apostrophe’ of the Health profession Dr B Suresh, President, Pharmacy Council of India, New Delhi Pro Chancellor, JSS Academy of Higher Education and Research, Mysuru .....................................................................................20

Commitment to Public Health and Science will go a long way in defeating ‘Pandemics’: Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech ...................................................................................................22

Covid-19: A Wake up Call for Pharma Stakeholders: Dr. Ajit Dangi, President & CEO, Danssen Consulting ....................................................................................................................25

Safety of Pharmaceutical Employees in Covid-19 Pandemic: S. G. Belapure, Senior Technical Advisor, Indian Pharmaceutical Alliance ......................................................................................26

Pharmacy Experiences in India in SARS-Cov-2: Raj Vaidya, Community Pharmacist, Hindu Pharmacy, Panaji. ........................................................................................................30

Embracing 4.0 in Pharma Academics: Way Forward: Dr. Richa Dayaramani, Principal, Khyati College of Pharmacy ........................................................................................................36

An International Crisis: Long Term Impact of Covid-19 Pandemic on Health Care Scenario, Worldwide Pharmaceutical Growth and Global Economy: Anil Kharia*, Sapna Malviya1, Ankur Joshi1, *President, IPA MP State Branch, Indore, 1Indian Pharmaceutical Association, MP State Branch, Indore .....................................39

From The Editor’s Desk ........................................................................5

President Speak ...................................................................................7

"IPA in the News!!" ............................................................................8

Obitury .........................................................................................14,21

Letter To Editor .................................................................................33

Advertisement Tariff ..........................................................................42

Advertisement Index ..........................................................................42

Jumbo Covid Crossword ....................................................................43

Association News ..............................................................................44

Pharmascene .....................................................................................51


COL

Pharma Times - Vol. 52 - No. 03 - March 2020 6 Pharma Times - Vol. 52 - No. 03 - March 2020 7Pharma Times - Vol. 52 - No. 03 - March 2020 6 Pharma Times - Vol. 52 - No. 03 - March 2020 7

COLCOL


President Speak...

Dear Readers,

“We must come to the aid of the ultra-vulnerable – millions upon millions of people who are least able to protect themselves. This is a matter of basic human solidarity. It is also crucial for combating the COVID-19 virus. This is the moment to step up for the vulnerable.”

The outbreak of coronavirus disease 2019 (COVID-19) has created a global health crisis that has had a deep impact on the way we perceive our Nation, world and our everyday lives. The COVID-19, which has been characterized as a pandemic by the WHO, is attacking societies at their core. More than a health crisis, it is a human, economic and social crisis. There are currently no approved treatments for COVID-19, the highly contagious respiratory illness caused by the novel coronavirus that has infected over 2.5 million people worldwide with more than 1.5 lac deaths as on today. The alarming acceleration in other countries with not only the rate of contagion and patterns of transmission, but the safety measures put in place to contain the spread of the virus. We anticipate severe hardship for already overstretched

health systems, particularly in rural areas, which normally lack the resources of those in cities. Every single person has a role to play in ending this pandemic. The outbreak affects all segments of the population and is particularly detrimental to members of those social groups in the most vulnerable situations, continues to affect populations, including people living in poverty situations, older persons, persons with disabilities, youth, and indigenous peoples. The pandemic and consequent lockdown have hit various sectors, including MSME, hospitality, civil aviation, agriculture, business and allied sectors. Ultimately, the behavior of each of us will determine the behavior of the virus. This will take perseverance and patience as there is no fast-track back to normal. It is imperative that we do not let down our guard. Physical distancing, lockdowns and other measures slow down and stop transmission though affecting lives and livelihoods. As we consider transition, we must acknowledge there are no ‘quick wins’. Complexity and uncertainty lie ahead, which means that we are entering a period where we may need to rapidly adjust measures, introduce and remove restrictions, and ease restrictions gradually, whilst constantly monitoring the effectiveness of these actions and the response of the public. 'Janata Curfew' is the beginning of a long battle against coronavirus outbreak and the countrymen have proved that together they can defeat any challenge. We all showed our unity, solidarity by lighting the lamps on 5th March at 9 pm for 9 minutes in response to the call given by Prime Minister Narendra Modi for the sake of the Nation. Let us all follow the guidelines given by Modiji with effective implementation of lockdown, the only alternative at present to prevent the COVID-19 pandemic.

I am happy to share the news with members that, IPA has been recognised at National level and got an opportunity to raise our voice through National TV channels and media. IPA has been contacted by various National TV Channels and National Media to give our input in various issues during COVID-19 crisis. I feel privileged to participate in the Panel discussion on “Challenges of Maintaining supply of essential commodities including medicines” conducted by Mirror Now on 25th and 26th March 2020 and also shared IPA views in the magazines: Out Look India, BBC- Asia, India Today on issues related to drugs used in Covid-19 and their exports. IPA also appealed to the Government and related agencies to engage PharmD students in COVID-19 control measures to reduce shortage of manpower.

I feel privileged to share that all the IPA State, local branches and Divisions are immensely contributing their services to the public and to the society at large. The COVID-19 material and posters prepared by Community Pharmacy division has been well received and my special appreciation to Manjiri Gharat for the contribution. My appreciation to IPA-MSB particularly Mr. Nitin Maniar and team for their charitable and societal activities in the most affected state of Maharashtra. My appreciation to IPA local branches Enikepadu, Rajahmundry, Ananthapur, Warangal City for their initiatives in creating awareness on COVID-19 with posters, other material. My compliments to Dr. G. Nagarjuna Reddy, Dr. K. Padmalatha, Dr. Sumalatha, Dr. J.V. Suresh, for preparing the awareness posters and also for distributing food to the migrant workers and transport people carrying essential commodities in Rajahmundry high way area. My special appreciation to Dr. Rao Vadlamudi and Dr. Ramalingam for sharing the COVID-19 updates of CPA and SEAR Pharm Forum regularly to IPA.

My compliments to Dr. Alka Mukne, Editor, Pharma Times for coming out with COVID-19 special issue featuring messages on COVID-19 from stalwarts of Pharmacy Profession and also briefing us all with the activities organised by state, local branches and divisions of IPA.

My sincere appreciation to Mr. P. D. Sheth, Returning Officer of IPA Elections 2020-22 for his timely decision to cancel the IPA elections due to COVID-19 Pandemic. My sincere thanks to all the CEC members for supporting the suggestion of Returning officer and consented to postpone the election process.

My thoughts and deepest sympathy are with those grieving from the loss of loved ones or who are seriously ill themselves. I send my heartfelt gratitude to those on the frontline - government Officials, in health care services, Technicians, Pharmacists, Pharma Industries, Police, Sanitary workers, Volunteers who are keeping services operating, working relentlessly to save lives.

“When all of us work together and start making our presence visible and demonstrate the value addition to the patients and community, the importance of the pharmacist in the society gets recognized by one and all. Let us make it possible by proving that pharmacist can contribute to a healthy society and thereby to “Swasth Bharat”.

Dr. T. V. Narayana

IPA has been recognised at National level and got an

opportunity to raise our voice through National TV channels

and media. IPA has been contacted by various National

TV Channels and National Media to give our input in

various issues during COVID-19 crisis.


"IPA in the News!!"

IPA President Dr. T. V. Narayana in a panel discussion on Mirror Now Television News Channel

IPA President Dr. T. V. Narayana's interview in India Today News

IPA President Dr. T. V. Narayana's interview in BBC- News


Novel CoroNavirus PaNdemiC- stark realities & New lessoNs For sCieNCe & HumaNityDr. Jayant B. DaveAdjunct Professor, L M College of Pharmacy, Ahmedabad

Abstract The article describes stark realities regarding origin and spread of novel Coronavirus SARS CoV-2 that has precipitated into global pandemic and most severe existential crisis since World War II. It touches upon scientific, sociological, international relations and philosophical aspects of the crisis. Due focus is laid on microbiology of virus, molecular basis of transmission and viral genome. The clinical presentation describes common symptoms, effects on lungs & cardiovascular outcomes. Importance of simple preventive measures is explained to ensure containment and prevention of mass communication. Diagnosis holds the key particularly in absence of any approved vaccine and drug therapy. ICMR has taken pragmatic stand on use of testing kits based on RT PCR for diagnosis and serological tests for surveillance. The article describes progress being made in development of vaccines, WHO global clinical trials and other evidence-based trials to find right therapeutic options. Last but not the least, authors delineate some ethical and innate lessons for science and humanity.

Keywords: Coronaviruses, SARS CoV-2, COVID 19, Global Pandemic, Transmission, Viral Genome, Hand sanitizer, Testing kit, Vaccine, WHO Global Clinical Trials, Antivirals, Immunomodulators, Hydroxychloroquine, Remdesivir, Plasma therapy, Ethical lessons

Article

IntroductionThe world is facing severe existential challenge as novel

Coronavirus disease (Covid-19) has turned out to be a psycho-physical and social crisis of unprecedented magnitude. The novel Coronavirus (CoV) like any other virus is not a complete living being and depends on cell machinery of host for its survival and yet it has gripped the whole planet barring a few isolated islands. WHO declared this as global pandemic on 12 March 2020 and with rising toll of precious human lives, United Nations Secretary General called this as humanity’s worst crisis since world war II. This is a new version of world war not among the nations but along the nations of world. Among several measures adopted by WHO, it has launched global mega trial of four most promising coronavirus treatment from existing drugs to find the right medicine.1 WHO Director General Tedros Adhanom Ghebreyesus said that India being a highly populous and responsible nation would determine trajectory of the disease and hoped that India would show the way to the world as it had done in the past in eradicating two silent killer disease, smallpox and polio.2 He recently hailed India’s collaboration with WHO in systematic engagement of Polio surveillance network across the country to fight against COVID. Ministry of Health official conveyed that its decision to join the global trial on 31 March to play

its part. The contagion is spreading much faster and statistics of infection & mortality worsening with every passing day. With 25.5 lakhs positive cases and 1.77 lakh deaths globally as on 22 April 2020 the mortality rate has shot up to near 7 percent from initial 1 percent worldwide. India on its part has done well in containing positive cases to around 20,000 and mortality rate to 3.2 percent. Shall we call the pandemic a mystery of nature or some sort of retaliation by nature against some ills of mankind?

Origin of Virus-Historical Background Coronaviruses are a large family of viruses that are common in

animals. Coronaviruses are named so due to crown-like spikes on their surface. There are four main sub-groupings known as alpha, beta, gamma, and delta. Human coronaviruses were first identified in the mid-1960s. The coronaviruses that evolved and caused three major epidemics of respiratory distress in humans in 21st century are- 1) Severe acute respiratory syndrome coronavirus (SARS-CoV) in 2003 with epicentre in China 2) Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012 in Saudi Arabia and 3) Epidemic of novel coronavirus (SARS CoV-2) or coronavirus disease (COVID-19) that started in Wuhan, China. Fatalities range from 10.35 & 5% respectively.3

Doctors in Wuhan noticed a surge in the number of pneumonia cases in December when tests for flu and other pathogens returned negative. A Chinese doctor treating COVID-19 patient in Beijing conveyed that numerous cases of mysterious pneumonia outbreaks had been reported by health professionals across several countries in later part of last year. Italian professor Giuseppe Remuzzi had pointed at “strange pneumonias” in Italy since November 2019.This implies that virus could have reached Europe before anyone knew about it.

While an unknown strain was isolated, a team from the Wuhan Institute of Virology led by Shi Zhengli traced its origin to a bat virus found in a mountain cave close to the China-Myanmar border. Shortly after the epidemic erupted, Chinese scientists sequenced the genome of SARS-CoV-2 and made the data available to researchers worldwide. The genomic sequence data showed that Chinese authorities detected the epidemic and that the number of cases were rising because of human to human transmission after introduction into the human population.

Dr. Jayant B. DaveDr. Jayant B. Dave Adjunct Professor in L M College of Pharmacy, Ahmedabad.Devoted to various facets of pharmacy profession, Jayant B Dave has gathered over three decades of valued industrial experience in several SMEs mainly in

areas of QC, QA, entrepreneurship and technical consul-tation services after distinguished academic career from M S University of Baroda. Natural inclination for teaching drew him to academic career for the last 15 years where he excelled in teaching & research in the fields of Pharma-ceutical quality assurance, Regulatory affairs and Clinical research. He was awarded Fellowship by IPA in 2012 and is presently serving as Adjunct professor at L M College of Pharmacy, Ahmedabad, partner of Apostle Remedies and as President of IPA Gujarat State Branch.


According to recent findings published in the journal Nature Medicine, the virus could have possibly been transmitted from animals to humans much before it was first detected in China. In fact, there are speculations that it could have been as long as a decade. Dr Francis Collins, director of the US National Institute of Health has conveyed that due to gradual evolutionary changes over the years, the virus gained the ability to spread from human to human and cause serious, often life-threatening disease.

A study conducted by an international team of scientists from Australia, Britain and the US released on March 17, compared the available genome sequence data for known coronavirus strains and confirmed that SARS-CoV-2 has originated through natural processes.4

However, many Western countries, US in particular are holding China guilty of negligence in proximately causing world pandemic and trying to demonstrate its prowess in identifying and combating the virus. Western countries and Japan are even accusing WHO DG guilty of going soft with China and not raising the alarm in a timely manner. China on its part has replied that it is the victim and not the culprit of the pandemic. It will take long time to reveal various dimensions of the most unfortunate tragedy. Fortunately, all nations are one in upholding the inevitable role of WHO as health keeper of the world.

Pandemic & World’s InterconnectednessA global pandemic calls for a global response, meaning, a

coordinated, multilateral response.5 India played a lead part in putting up a coordinated response by rejuvenated SAARC countries and made worthwhile contribution as seed money. The meeting of G20 nations convened at the initiative of Indian PM voiced coordinated response. India has shown its scientific potential as pharmacy of the world by supplying hydroxychloroquine tablets and supportive medication like paracetamol tablets to all in need of them. When China was struggling to cope with the epidemic, most countries did not quite realise the potential threat and that microbes do not recognise national or any man-made borders. China’s initial response was secretive, but it acted smartly later and earned both wrath & praise from WHO and some other countries. The worst appears to be over for China and South Korea with reporting minimal new cases of infection. China admitted to over 1000 deaths at a later date yielding to global pressure and attributed this to improper record keeping while it was busy combating the novel infection. Today China has great experience to share with the rest of the world in combating the disease and has transformed a major national crisis into an opportunity, both in terms of scientific research and economics. The Chinese health experts in Italy conveyed that Italy should not repeat the mistake made by China to advise home quarantine for patients exhibiting mild symptoms as they could easily transmit the virus to nearby people. Relatively small countries like Sudan & Turkey are extending aid in different forms to highly developed countries as a pragmatic humanitarian gesture and this is being accepted not just as a token of love but as much needed help. The global financial institutions like World Bank, IMF and RBI in India are playing their part to contain the disease and impending damage to world economy.

If the pandemic has a positive fallout, it is to underline the connected, interdependent nature of humanity today. Monitoring of the pandemic’s progress, the search for vaccines and cures, the sharing of containment and treatment protocols and potentially, of medical supplies are all multilateral. It is time world leaders realised this, and worked to reinforce weakened multilateral institutions,

including the World Trade Organisation. Globalised world requires global code of conduct to overcome the looming threat.

All nations are isolating themselves from foreign nationals but this is to ensure containment of the virus to so called hotspots with large outbreak/clusters and protection of locals and others at large. Each country has to put its house in order by further and further subdividing the task within itself. Today one third of human population is under lockdown in a desperate measure to contain the virus. All this is a part of united efforts to control the viral menace until science and/or some natural phenomenon is poised to tame the highly infectious virus.

Indian Leaders show the wayThe President of India, Ramnath Kovind conveyed in very early

phase that medically mandated and self-imposed quarantining is an opportunity for self-examination and evolution. He held sanitation and cleanliness personified by Mahatma Gandhi particularly during plague outbreak as humblest of civic virtues. He also held that major crisis has reassured our cultural ethos of ‘world as one family’- Vasudhaiva kutumbakam and quintessential equality and interdependence of mankind.6 The Prime Minister Narendra Modi initially gave mild exercise of Janata Curfew, mantra of resolve and restraint and later clamped 21 plus 19 days nationwide lockdown to tackle social emergency. United international response is vital under guidance of WHO. Wisdom lies in expressing solidarity and working for collective good in and through individual good. There are several aberrations and exceptions in the collective fight by the nation. In a recent message posted on social media, Prime Minister has brought out adaptability, inclusivity, opportunity and universalism as lessons emanating from COVID crisis.

Microbiology and Pathogenecity of Corona Viruses Coronaviruses have a single-stranded RNA genome (size

range between 26.2 and 31.7 kb, positive sense), covered by an enveloped structure. The shape is either pleomorphic or spherical, and it is characterized by bears club-shaped projections of glycoproteins on its surface (diameter 80–120 nm).7 Among all the RNA viruses, the RNA genome of CoV is one among the largest. The number of open reading frames (ORFs) in the CoV genome ranges from six to ten. CoV genetic material is susceptible to frequent recombination process, which can give rise to new strains with alteration in virulence.8 There are seven types of human Coronaviruses- 229E, NL63, OC43, HKU1, Middle East respiratory syndrome (MERS)-CoV, severe acute respiratory syndrome (SARS) CoV, and 2019 novel coronavirus (SARS-CoV-2) which are responsible for the infection with special reference to the involvement of the respiratory tract (both lower and upper respiratory tract), e.g., common cold, pneumonia, bronchiolitis, rhinitis, pharyngitis, sinusitis, and other system symptoms such as occasional watery diarrhea.9,10Among these seven types, three varieties (SARS-CoV, MERS-CoV, and 2019-nCoV) proved to be highly adaptive & pathogenic as described earlier and are classified as emerging viruses.10 The reservoir of SARS-CoV is unknown, but bats and subsequent spread to Himalayan palm civets are hypothesized. MERS-CoV also had a zoonotic origin in the Middle East, and the transmission was through camels.8. Knowledge about the structure, metabolic pathways of CoV, and pathophysiology of CoV-associated disease is important to identify possible drug targets. The most important structural proteins of CoV are spike (S) protein (trimeric), membrane (M) protein, envelop (E) protein, and the nucleocapsid (N) protein.


Transmission of Coronavirus and its molecular basisTransmission of virus occurs from persons who have the virus.

The disease can spread from person to person through small droplets from the nose or mouth which are spread when a person with COVID-19 coughs or exhales. These droplets land on objects and surfaces around the person. Other people then catch COVID-19 by touching these objects or surfaces, then touching their eyes, nose or mouth. People can also catch COVID-19 if they breathe in droplets from a person with COVID-19 who coughs out or exhales droplets. This is why it is important to stay more than 1 meter (3 feet) away from a person who is sick. Studies to date suggest that the virus that causes COVID-19 is mainly transmitted through contact with respiratory droplets rather than through the air. Aerosolization procedures are reported to enhance the spread of virus.

When virus enters into the body, it binds to the primary target cells such as enterocytes and pneumocytes thereby establishing a cycle of infection and replication. Other target cells of CoV are epithelial renal tubules, tubular epithelial cells of kidney, immune cells, and cerebral neuronal cells.11,12

CoV attaches to the target cells with the help of spike protein–host cell protein interaction (angiotensin converting enzyme-2 [ACE-2] interaction in SARS-CoV 2 13 and dipeptidyl peptidase-4 [DPP-4] in MERS-CoV14. After recognizing the receptor, the virus genome along with its nucleocapsid is released into the cytoplasm of the host cells. The virus produces two PPs- pp1a and pp1b due to ORF1a and ORF1b genes in its genome which enables it to take command over host ribosomes for their own translation process. After going through a series of changes including formation of mature viral particles called virions, form a vesicle, which fuses with the plasma membrane and releases the virus into the extracellular region. This cause a surge of pro-inflammatory cytokines and chemokines, which cause damage to lung tissue,18 deterioration of lung function, and then finally lung failure in some cases.8

Virus Genome Sequence Data The researchers across the world are working overtime to

understand evolution of the virus and they have identified eight strains of SARS-CoV-2 doing rounds globally. Over 2,000 genetic sequences of the virus submitted from laboratories across the world to the open-source project Nextstrain.org show how the virus is migrating into new subtypes. The report in National Geographic based on samples from all continents except Antarctica showed that the virus is taking on an average 15 days for mutating. These mutations are completely benign and useful as a puzzle piece to uncover how the virus is spreading. Looking at the evolution of the virus, scientists have debunked the conspiracy theory that the virus might have originated in laboratories and concluded that the novel SARS-CoV-2 is a product of natural evolution.15

The two independent research teams from National Institute for Infectious Diseases in Rome after comparative study of genome concluded that SARS CoV2 is a relatively slow-mutating pathogen. The scientists held that they would generally expect dozens of new mutations after so many infectious cycles in patients. The initial data showed that this is a very stable RNA virus, with only five novel variants. A virus with a stable genome is good news for vaccine development because it indicates that the effectiveness of vaccines could be more consistent, possibly over many years.16

FDA—in collaboration with the Centers for Disease Control and Prevention (CDC) and several other lead scientific institutes have

developed quality-controlled reference sequence data for the SARS-CoV-2 reference strain for the United States. Availability of traceable and quality-controlled data will help test developers and vaccine developers. The complete SARS-CoV-2 Reference Sequence Data is available on the FDA website.17

Recent work on genome sequence of CoV by Gujarat Biotechnology Research Centre found total nine mutants of the virus out of which six have been reported earlier and three were unique to sequencing here. This indicates that virus is mutating fast contrary to reports earlier and that mutation depends on several factors.18

Clinical presentation The “incubation period” means the time between catching the

virus and beginning to have symptoms ranges from 1-14 days, most commonly around five days.

The most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some patients may have aches and pains, nasal congestion, runny nose, sore throat or diarrhoea. Some people become infected but remain asymptomatic and don’t feel unwell. Most people (about 80%) recover from the disease without needing special treatment.1

Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Patients with COVID-19 pneumonia may progress to severe respiratory failure requiring supplemental oxygen and mechanical ventilation. One of the probable reasons is impaired surfactant production once virus enters via ACE2 on cells in the lungs. This acute lung injury, known as acute respiratory distress syndrome (ARDS) is associated with significant morbidity, mortality and healthcare resource utilization 19

Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness Patients with underlying heart conditions are at even greater risk for death due to COVID-19, and even those without underlying cardiac conditions can experience cardiac injury. While COVID-19 is most known for affecting the lungs, underlying cardiovascular disease or cardiac risk factors could worsen the outcomes. It was noted that the high inflammatory burden can induce severe cardiac-related problems such as vascular inflammation, myocarditis, and cardiac arrhythmias.20 Re-emergence of the disease in recovered patients reported in countries like South Korea, is a matter of great concern and investigation.

Persistence of Coronavirus on inanimate surface One meta-analysis comprising 22 studies revealed that human

coronaviruses can persist on inanimate surfaces like metal, glass or plastic for up to 9 days but can be efficiently inactivated by surface disinfection procedures with 62-71% ethanol, 0.5% hydrogen peroxide or 0.1% sodium hypochlorite within 1 minute. Other biocidal agents such as 0.05-0.2% benzalkonium chloride or 0.02% chlorhexidine digluconate are less effective. The authors expected similar effects against SARS-CoV-2 21.

Prevention, Diagnosis & Therapy Yet not in Sight Currently, there are no specific vaccines or treatments

for COVID-19. However, there are many ongoing clinical trials


evaluating potential vaccine and drug candidates. Until then early containment and prevention of further spread are the only viable potions to check the ongoing outbreak and to control the novel infectious disease.

Prevention of infection by Hand hygiene According to the Centers for Disease Control and Prevention

(CDC), hand hygiene encompasses the cleansing of hands by using hand washing with soap and water, antiseptic hand washes, antiseptic hand rubs such as alcohol-based hand sanitizers (ABHS) foams or gels. For many reasons, alcohol hand sanitizers are increasingly being used as disinfectants over hand washing with soap and water

A study published in 2017 in the Journal of Infectious Diseases evaluated the virucidal activity of alcohol based hand sanitizers against re-emerging viral pathogens, such as Ebola virus, Zika virus (ZIKV), severe acute respiratory syndrome coronavirus (SARS-CoV), and Middle East respiratory syndrome coronavirus (MERS-CoV) and determined that they and other enveloped viruses could be efficiently inactivated by both WHO ethanol and isopropanol based formulations I and II 22.

Office of CDER USFDA has recently issued Guidance for industry regarding Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency with immediate effect.23 Hand hygiene is an important part of the response to COVID-19. Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom, before eating, and after coughing, sneezing or blowing one’s nose. If soap and water are not readily available, the Centre for Disease Control and Prevention (CDC) recommends an alcohol-based hand sanitizer that contains at least 60 percent alcohol.

The hand sanitizer is compounded using only the following pharmacopeial grade ingredients in the preparation with percentage in final product consistent with World Health Organization (WHO) recommendationsa. Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous

solution duly denatured or Isopropyl Alcohol (75%, v/v) in an aqueous solution;

b. Glycerol (1.45% v/v); serves as humectant and prevents skin dryness

c. Hydrogen peroxide (0.125% v/v); d. Sterile distilled water or boiled cold water.

Diagnosis of COVID 19 infection is Key In the absence of approved vaccine or therapy isolating the

infected patients and quarantining the suspect is the only effective strategy to contain the virus and arrest the spread. South Korea and Germany stand out for mass testing which reduced fatalities and prevented health systems from breaking down. Like many other countries, it was important in India to prioritise the available testing kits for vulnerable sections like symptomatic foreign returnees and those coming in close contact with confirmed cases. With gradual increase in transmission, regularly testing of medical and healthcare personnel, people living in and around hotspots with large outbreak/cluster and those with symptoms resembling the flu and pneumonia have became the priority. The Government & ICMR have clarified that in view of positivity ratio of 1 in 24 tests, India has performed a greater number of tests than most developed

countries except Canada to register first 5000 & 10000 positive cases.24

This will also help in epidemiological data collection and taking further course of action. There are indications from ICMR that it will be possible to locally produce serological test kits in a couple of months. These are typically rapid diagnostic tests to detect the presence of antibodies, which can be used for preliminary screening of high-risk individuals and to identify so called safe individuals who contracted the virus but went undetected.

These rapid antibody tests as first line of diagnosis have thrown up false negatives, as many patients in the initial stages of transmission may not have developed antibodies. This has been reported by some States and ICMR is in the process of validating the kits (21 April 2020) Therefore, ICMR has insisted on Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) tests which take around six hours to give results besides the time taken to collect swab samples from nose or throat. The RT-PCR kit developed by Pune based Mylab Discovery approved by CDSCO claims it can deliver results in 2.5 hours. The most reliable RT-PCR test has 95 percent accuracy and gives 2-5 percent false negative or false positive results. Meanwhile, biotech companies in the US have devised new technologies to reduce testing time to a few minutes.25 Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram has developed confirmatory diagnostic test for N gene of SARS-CoV-2 using RT-L AMP technique that is simpler, faster & economical than RT PCR test and has applied for ICMR approval.26 A team of Indian medical scientists in Kyoto with support from IIT Roorki are developing diagnostic test based on X rays & AI based software. The Indian Government has developed popular mobile App Arogya Setu to find out possibility of contracting an infection by an individual based on his proximity to persons who have tested or would test positive for Coronavirus. The public health emergency has led to an unprecedented number of Emergency USE Authorizations (EUAs) for COVID19 diagnostic tests in USA.

Vaccine for COVID19 infection Prevention is better than cure and effective vaccine against

novel CoV is the long-term solution as achieved for viruses against Smallpox & Polio. The experts say it will take 12-18 months to bring a vaccine to market as one out of ten candidates fail in trials. As per WHO report, two candidate vaccines for COVID-19 have entered the first phase of human clinical trials and another 60 candidate vaccines are in pre-clinical studies. Vaccine jointly developed by CanSino Biological Inc (who developed Eloba Vaccine in 2017) and Beijing Institute of Biotechnology has entered human trial stage. They are using the non-replicating viral vector as the platform (same as that used for non-corona candidates like Ebola) to develop a vaccine with a ‘Adenovirus Type 5’ candidate. Adenoviruses are common viruses that cause pneumonia and can deliver potential antigens to stimulate the production of antibodies that work against the disease. India is also in the hot race with India’s Serum Institute, Zydus Cadila and Bharat Biotech working on vaccine development.27

COVID 19 Therapeutic options Until now, there is no approved vaccine or drug for management

of SARS-CoV-2 infection. However, from earlier experience of management of the Coronavirus, many agents are being used in


the treatment of SARS-CoV-2 in experimental settings with some success. WHO has initiated large scale global randomised trials called SOLIDARITY based on four existing drugs/combinations as under and provided guidelines that local physicians may consider when COVID 19 is suspected on clinical management of severe acute respiratory infection 28 • Local standard of care alone OR local standard of care plus one of: • Remdesivir (daily infusion for 10 days)• Chloroquine or Hydroxychloroquine (two oral loading doses,

then orally twice daily for 10 days)• Lopinavir with Ritonavir (orally twice daily for 14 days)• Lopinavir with Ritonavir (ditto) plus interferon (daily injection

for 6 days)

Prospective therapeutic options under trial can be broadly grouped into Antiviral, Immunomodulators and Host directed therapies.1. Antivirals-

• Nucleoside analogues- Ribavirin• Neuraminidase inhibitors- used in treatment of influenza• Protease inhibitors- Protease have important functions in

CoV life cycle. Liponavir & Ritonavir, antiretrovirals used for AIDS are part of WHO mega trials

2. Immunomodulators-• Corticosteroids- Corticosteroids were widely used for the

treatment of SARS-CoV and MERS-CoV and are also used in the management of the current epidemic of 2019-nCoV as Methylprednisolone. However, the interim guidelines by the WHO prohibit the use of routine corticosteroids unless indicated for other clinical ground

• Interferons-(IFNs): These are broad-spectrum antivirals, primarily used in the treatment of hepatitis B. In SARS-CoV patients, compared to Ribavirin or interferon (IFN) alone, the benefit was seen on IFN-α + high-dose corticosteroid group

• Immunoglobulins- In case of critically ill SARS, who show signs of deterioration, further escalation of immunomodulation is indicated and intravenous (IV) immunoglobulin may be considered

3. Host directed therapies- Target improvement of host immune response or factors associated with viral replication. Apart from immunomodulators, metformin, atorvastatin, fibrates, as well as nutritional supplements may help in treating acute respiratory distress syndrome (ARDS) by boosting immunity

4. Other therapies- Used rarely like siRNA, tumor necrosis factor-alpha inhibitors, neutralizing antibodies, pentoxifylline, etc. but evidence is quite poor

5. Recent advances in treatment- Chloroquine & Hydroxychloro-quine- Latter is the prodrug of chloroquine. It appears to block viral infection by increasing endosomal pH of the phagolyso-some needed for virus/cell fusion. It also interferes with ACE 2 glycosylation of CARS- Cov cellular receptors. The drug also has immune-modulating activity which is proposed to enhance its antiviral effect in vivo.

Remdesivir- A nucleoside inhibitor has potent activity against several families of RNA viruses. It incorporates into nascent viral RNA chains and causes premature termination of the viral RNA transcription.

Other Drugs being investigated- Umifenovir, Beloxavir, Favipiravir (Antiviral) and Irvemectin (Antiparasite)

6. Treatment evidence from China- Antiviral agents used so far include lopinavir, ritonavir, arbidol, oseltamivir, I.V. ganciclovir. Immunomodulators- commonly used agents are systematic corticosteroids and i.v. immunoglobulin in more serious cases. In one clinical study in China comprising 138 patients reported in JAMA most patients received Oseltamivir. The most commonly used antibiotics mostly for bacterial infections were Ceftriaxone, Moxifloxacin and Azithromycin. China also tried administering antibodies from COVID-19 recovered patients to impart passive immunity.

7. Convalescent plasma- USFDA has been working across across Government, academia and industry to expedite development of critical medical products to treat novel virus. Convalescent plasma is an antibody rich product made from blood donated by people who recovered from disease caused by virus. At home in India, Kerala, Maharashtra, Rajasthan & Delhi have nod of centre for conducting clinical trials of plasma enrichment techniques. The initial results are encouraging.

Limitations of current research- Lack of high-quality evidence by randomized controlled trials (RCTs) is the most important limitation of the current CoV research. As most of the CoV strains are genetically different and the outbreaks occur extremely randomly, conducting an RCT is extremely difficult, and reliance has to be done on observational studies.29,30,31,32

Ethical & Innate Lessons for science & humanityScience, ethics and philosophy are complementary to

our understanding of natural phenomena and corresponding wisdom filled action plan. There are some common and far reaching lessons for science, humanity and world at large.1. Change is inherent in nature and nature always fulfills the

change. 2. Cleanliness of body and psyche of all impurities are only

next to and means to Godliness. 3. We ought to realize uniqueness, interconnectedness and

equality of every individual & nation state. 4. Isolation is as important as socializing. Besides protecting

one’s own self and others from contracting/spreading infection, solitude has its own charm and helps discover one’s unconscious personality.

5. Science, profession, law, modern state, religion and all constituents have to contribute in establishment of righteousness and social order. Transparency, integrity and mutual cooperation are of paramount importance in this regard.

6. Collective religion aimed at welfare of human family also referred to as rashtradharma takes precedence over individual religion.

7. Modern system of medicines relies on several physical, biological, medical and other sciences for probing the cause and remedy of any disease. This indeed is helpful to mitigate and at times cure the disease. But science is not able to fully comprehend the complexities of natural phenomenon like antimicrobial resistance or strange behavior of a very tiny creature like novel coronavirus. More often than not, science brings restoration of some supreme orderliness and equilibrium prevailing in nature


at macro or micro level in different forms like regeneration of cells, autophagy or immunity in this case. Social ethics & faith in higher reality subtler than our mind and intellect needs to be interwoven in all human endeavors.

8. Faith in God, commitment to objective science, compassion for the world and hope for oneself, should be the way of life.

Influx of clinical data emerging on day to day basis encourages us to hope that COVID-19 will not be a virus without a known treatment for long.

AcknowledgementAuthor wishes to express sincere appreciation and thanks

to Mr. Shiv P Rathod, good friend & Associate Professor in Pharmacology (Retired), Faculty of Pharmacy, M S University of Baroda for valued inputs and necessary interaction

References1. https://www.who.int/health-topics/coronavirus2. Michael Ryan, Executive Director World Health Organisation through

economictimes.indiatimes.com (March 24,2020. 3. Indian Journal of Pharmacology - Editorial Volume 52, Issue 1, January-

February 20204. Coronavirus a product of evolution may have been in humans for years:

Study. The Indian Express 30 March 20205. Global disease call for global response through economictimes.

indiatimes.com, March27,2020 6. Ram Nath Kovind, COVID 19: What nature seems to be telling us, Times

of India March 20207. Yang H, Bartlam M, Rao Z. Drug design targeting the main protease, the

Achilles’ heel of coronaviruses. Curr Pharm Des 2006;12:4573-90. 8. Prajapat M, Sarma P, Shekhar N, Avti P, Sinha S, Kaur H, Kumar S,

Bhattacharyya A, Kumar H, Bansal S, Medhi B. Drug targets for corona virus: A systematic review. Indian J Pharmacol 2020;52 :56-65

9. Chang CK, Lo SC, Wang YS, Hou MH. Recent insights into the development of therapeutics against coronavirus diseases by targeting N protein. Drug Discov Today 2016;21:562-72.

10. Paules CI, Marston HD, Fauci AS. Coronavirus infections-More than just the common cold. JAMA 2020; 323:707.

11. Guo Y, Korteweg C, McNutt MA, Gu J. Pathogenetic mechanisms of severe acute respiratory syndrome. Virus Res 2008;133:4-

12. 12. Gu J, Korteweg C. Pathology and pathogenesis of severe acute respiratory syndrome. Am J Pathol 2007; 170:1136-47.

13. Li W, Moore MJ, Vasilieva N, Sui J, Wong SK, Berne MA, et al. Angiotensin-converting enzyme 2 is a functional receptor for the SARS coronavirus. Nature 2003; 426:450-4.

14. Mubarak A, Alturaiki W, Hemida MG. Middle East Respiratory Syndrome Coronavirus (MERS-CoV): Infection, Immunological Response, and Vaccine Development. J Immunol Res.2019;2019:1-11.

15. Scientists identify eight strains of Coronavirus, Economic Times Healthworld April1, 2020

16. Italian Researchers Identify New SARS CoV2 Gene Variants, American Pharmaceutical Review March 27, 2020

17. FDA releases SARS- COV-2 Reference Grade Sequence Data, American Pharmaceutical Review, April 2,2020

18. Gujarat: Genome sequence of coronavirus decoded, ET healthworld.com,April17,2020

19. Windtree to Pursue Clinical Study of Lung Injury Treatment in COVID-19 Patients ThroughAmerican Pharmaceutical Review March 24, 2020

20. Madjid M, Safavi-Naeini P, Solomon S, Vardeny O. Potential Effects of Coronaviruses on the Cardiovascular System. JAMA Cardiology; March 27, 2020

21. G. Kampf et al. / Journal of Hospital Infection 104 (2020) 246-25122. Alcohol sanitizer, Nina A Gold, ncbi.nlm.nih.gov/books/NBK513254,

Feb06,2020

23. Office of CDER USFDA ,Guidance for industry regarding Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, March 2020

24. Coronavirus Only 1in 24 samples positive Govt says, ET Healthworld.com. Sushmi Dey,April17.2020

25. Testing is key: Testing more will ease healthcare burden, Editorial- The Times of India, April 2, 2020

26. Kerala Institute says it has a faster & cheaper test for COVID19,ET Healthworld.com, Nidhi Sharma, April17,2020

27. Two Coronavirus vaccine candidates enter human trials,60 in preclinical stage:WHO, P B Jaykar, Business Today,April 5, 2020

28. Public Health emergency SOLIDARITY trial, WHO COVID-19 Core ProtocolVersion 10.0, march22,2020

29. Sarma P, Prajapat M, Avti P, Kaur H, Kumar S, Medhi B. Therapeutic options for the treatment of 2019-novel coronavirus: An evidence-based approach. Indian J Pharmacol 2020;52:1-5.

30. Pharmacy Times, USA 11 March 202031. www.fda.gov,COVID 19 update, FDA News Release, March 19, 202032. Delhi to start Plasma trials for COVID, www.timesofindia.indiatimes.

com,April 17,2020

IRF Lifetime Achievement Awardee Asit Ranjan Bhattacharya passes away

IRF Lifetime Achievement Awardee Asit Ranjan Bhattacharya breathed his last on 24th April 2020. Popularly known as ARB in pharmacy circles, Mr. Bhattacharya was a pharmaceutical technologist by profession, a philanthropist by heart, a great motivator, and superb human resource developer,

committed heart and soul to utilize his competencies for betterment of the pharmacy profession.

This visionary, settled in Kolkata, had a chequered career, being a prominent figure in the national pharmaceutical circuit and state level activities of IPA Bengal and U.P. branches. He had worked fervently for close to six decades, empowering the pharmaceutical industry and academics with his broad vista, his varied experience weaving a rich tapestry within the profession, down the years.

After completing his B. Sc. from Calcutta University he moved on to pursue B.Pharm. and M.Pharm. from L. M. College of Pharmacy, Ahmedabad, during 1954-1960. While at Benger Laboratories (Tata Fison), he was deputed for undergoing extensive training at Cheshire. U.K., with Benger Laboratories, in areas of Fermentation Technology, for technology transfer to its plant at India. Later, he moved on to be Production Manager at Life Pharmaceuticals, where he developed a unique haemostatic compound from pig lung extract, which is still marketed. Thereafter he worked as works manager of Dey’s Medical Stores (Mfg.) Ltd at Allahabad and retired from Pharmacia Ltd. Hyderabad as VP (Technical).

Mr. Bhattacharyya joined IPA during his student life since 1955 and continued his association till his last breath. He held leadership positions in celebration of first National Pharmacy Week (NPW) and several IPCs and was Executive Council Member of IPA Bengal Branch, President of Uttar Pradesh State Branch, Central Executive Council Member of IPA, Executive Council Member of IPCA. Mr. Bhattacharyya has received Pharma Achievement (Dr. Bakul Bhaduri Memorial) Award from IPA, Bengal Branch in 2007, IPA fellowship Award in 1998 and IRF Lifetime Achievement Award in 2016. We at IPA, condole his sad demise.


PHarmaCeutiCal seCtor oF iNdia,PersPeCtives & its JourNey duriNG Covid 19 : reCeNt ProBlems & strateGiC solutioNs –PPP modeDr. Dinesh Dua Chief Executive Officer (CEO) & Whole Time Director, M/S Nectar Lifesciences Ltd. India & Chairman, Pharmexcil, Ministry of Com-merce, Govt. of India

Article

India in the field of pharmaceuticals has made its presence significantly in the global market by the turn of the century after becoming self-sufficient in the previous century. The Indian Pharmaceutical industry through robust quality management system and being sensitive to provide medicines at an affordable price has acquired reputation as the provider of standard, safe and efficacious medicines across the globe and evolved as “Pharmacy of the World” with supplies over 206 countries.

India is 3rd largest formulations exporter by volume and 10th largest by value in the world, besides being the largest exclusive generic exporter by value and is having 8 out of top 20 global generic companies. Apart from generics, India is the major supplier of Vaccines & APIs globally. 90% of WHO Prequalified API’s are sourced from India and India Produces 65% of WHO demand for DPT & BCG and 90% of Measles vaccines. India has the distinction of saving hundreds of millions of populations from the dreaded diseases like HIV, Malaria & Tuberculosis and known for its quality & affordable medicines.

Over 55% of our Pharma exports of US $21 Billion, are to the highly regulated global markets in the world & conventionally Indian exporters are focusing more on the USA & Europe and on the Global procurement agencies. In recent years huge market opportunity is emerging for Indian manufacturers in the untapped but potential markets of LAC, Africa CIS and Asia.

Indian Pharma, being knowledge-based industry, plays an important role in the Indian economy and it has been an excellent export performer over the years. Pharma is one of the few sectors in India that have consistently showed a growth rate, despite economic slowdown globally.India exported 19.13 billion USD worth pharmaceuticals with 10.72% growth in FY-19 and in the first 11 months of this year (April to Feb) recorded 10.70% growth with the export value of US$ 18.97 billion over corresponding period

FY-19. Because of supply chain disruption in the wake of COVID-19 pandemic and the lockdown in the country, pharma exports were affected to certain extent and we have recorded 1545 mn USD in March 2020 with -26.42% negative growth compared to March 2019 exports of 2100 mn USD. Thus, the total exports in FY 2020 are 20.52 BN USD with7.2% growth.

Supply chain disruption in the wake of COVID-19 outbreak in China

In view of grim Coronavirus situation, supply chains originating from China have been significantly disrupted globally and consequent shutdown of vast segments of Chinese industry in the Month of January and February 2020, it was expected that Indian pharma market especially exports could have negative impact as we are relying majorly on China for Key Starting Materials and Active Pharmaceutical Ingredients.

Fortunately, it didn’t affect Indian industry much in the month of January as most of the enterprises stockpiled the inventory required for 03 months in view of the Chinese New Year holidays and also to meet export obligations.

Restrictions on exports of few pharmaceuticals imposed by DGFT, Notification NO: 50/ 2015-2020, dt:03rd Mar & Industry’s concerns

With supply chain disruption in pharmaceuticals as a result of COVID-19 outbreak in China and the increasing no.of positive cases in India, a committee constituted by the Dept. of Pharmaceuticals had recommended restricting the exports of certain pharmaceuticals to tackle the possible domestic shortages of medicine during the outbreak. Accordingly, Director-General of Foreign Trade issued a Notification No:50/2015-20 on March 3, amending the export policy of 13 APIs and formulations made from these APIs from “Free” to “Restricted” with Immediate effect. The list includes paracetamol, Tinidazole, Metronidazole, Acyclovir, Vitamins B1, B6, B12, Progesterone, Chloramphenicol, Erythromycin Salts, Neomycin, Clindamycin salts and Ornidazole.

DGFT Notification-50 had created lot of inconvenience and hardships to the exporters and Industry bodies worried that the notification would affect the nations export performance, since most of the industries have manufactured the restricted items before the outbreak of COVID-19 and have planned and committed to ship the consignments to their customers in agreed timelines.

Pharmexcil has represented the issued faced by the industry to the Government and requested to revisit the effective date of the notification and to allow the free export of drugs manufactured before the date of issue of the notification i.e 03/03/2020 as most of these listed drugs (eg: Vitamins & hormones) have limited shelf life of 18-24 months and if the restrictions prolongs, buyers would not accept the material and the same formulations cannot be utilized for domestic consumption because of national

Dr. Dinesh DuaDr. Dinesh Dua is currently the Chief Execu-tive Officer & Whole Time Director of M/S Nectar Life sciences Ltd. Prior to this, he was he was Managing Director of Akorn In-dia Pvt. Ltd.,a 100% subsidiary of US MNC, Akorn Inc. With over 4 decades of profes-

sional experience across varied industries, Dr. Dua is also Chairman, CII Regional Committee on Lifesciences - North, Chairman, CII Regional Committee on Startups & Entrepre-neurship - North, Past Chairman of Confederation of Indian Industry (CII), Chandigarh Council, Member Executive Council, FOPE, North India Chairman for Startups & Entrepreneurship for Confederation of Indian Industry (CII) & is also Past Chair-man of CII, Chandigarh Council, Member Executive Council, BDMA.


regulatory requirements of IP specification for domestic sale. Further, Pharmexcil had requested to examine the feasibility of exempting the “Drugs Manufactured for Export purpose only” from the restrictions.

Pharmexcil further guided the industry about the Para 1.05 (b) of Foreign Trade Policy 2015-2020, giving the exporter provision of clearing the shipments with Irrevocable Commercial Letter of Credit (ICLC) and instructed the industry to apply for license “under the Restricted Export Item (Non SCOMET)” with DGFT for continue their exports.

Para 1.05 (b) reads as

“Item wise Import/Export Policy is delineated in the ITC (HS) Schedule I and Schedule II respectively. The importability/ exportability of a particular item is governed by the policy as on the date of import/export. The date of import/ export is defined in para 2.17 of HBP, 2015-20. Bill of Lading and Shipping Bill are the key documents for deciding the date of import and export respectively. In case of change of policy from free’ to ‘restricted/prohibited/state trading’ or ‘otherwise regulated’, the import/export already made before the date of such regulation/restriction will not be affected. However, the import through High Sea sales will not be covered under this facility

Further, the import/export on or after the date of such regulation/restriction will be allowed for importer/exporter has a commitment through Irrevocable Commercial Letter of Credit (ICLC) before the date of imposition of such restriction/ regulation and shall be limited to the balance quantity, value and period available in the ICLC. For operationalising such ICLC, the applicant shall have to register the ICLC with jurisdictional RA against computerized receipt within 15 days of imposition of any such restriction/regulation.

Whenever, Government brings out a policy change of a particular item, the change will be applicable prospectively (from the date of Notification) unless otherwise provided for”

The Industry bodies viz IDMA, BDMA, IPA, OPPI, & Pharmexcil had collectively represented the issues to the Hon’ble Minister of Chemicals and Fertilizers during CEOs round table held on 5th March during India Pharma 2020, in the presence of Secretary-DoP, Chairperson- NPPPA & DCGI. The issues have also been brought to the notice of the Hon’ble Minister of State, Commerce & Industry on 12th March 2020 through DVC.

Industry bodies represented that most of the listed products in Notification No: 50 are not related to COVID 19- treatment as critical therapy and assured the government that they have enough quantities of stock required for domestic market as well as exports. The associations have put forth the following for consideration.• APIs already manufactured as per importing country standards

(BP/USP/JP) are not permitted to be sold in the domestic markets.

• Restrictions will lead to many Indian pharma companies getting blacklisted from global tenders/contracts. This could have a negative effect on the economy and our companies will also lose opportunity to participate in future contracts/ tenders, besides loss of credibility.

• The finished dosage formulations of the affected APIs that are meant for exports are manufactured and packed as per the specifications, standards and labeling as per the regulations of the importing countries. Hence even if their export is restricted,

these products cannot be diverted to Indian market and would be colossal national loss and wastage of good quality medicines. Moreover, the growth of exports would decline and the threat of losing market share in prominent destinations is imminent and real.

• India has net surplus of formulations to meet global demand. Hence restricting a product that is in surplus wouldn’t address the issue at hand.

• Restricting exports of Finished Dosage Forms will adversely affect the global brand image created by India over decades, that too when several countries of Europe, Africa, South East Asia and USA are reporting increasing number of positive cases day by day, and rely largely on India for supply of generic medicines and APIs. This could force certain countries to shift their requirements in the long run, either to local industries or to other emerging suppliers and may even be detrimental to India’s image as Pharmacy of the world.

• Due to the notification being issued without any prior intimation, medicines worth crores of rupees are lying at various locations of supply chain and the ports. Many of those medicines will have to be piled up in warehouses for want of approvals/ clearances with no additional benefits and besides, have limited shelf life.

• Chinese government succeeded in containing the further spread of the COVID-19 and the position of China has substantially improved during the past few weeks with restoration of manufacturing activities in most of the provinces. The Indian industries started receiving the few supplies from China and is expecting more supplies in coming weeks.

• Industries assured that they have adequate stocks of active pharmaceutical ingredients & finished formulations to serve the domestic requirements and also the exports and reiterated that industry will maintain sufficient stocks required for 2/4 months

India’s export restrictions of Pharmaceuticals have created panic state in those countries who are depending on Indian generics and it was reported that there was national shortage of certain listed medicines especially Paracetamol in some countries including Unite Kingdom.

DGFT Clarifications w.r.t Notification No:50 dated 3rd March2020

Considering the representations of industry bodies, on 20th March, DGFT has given some relaxations to the listed products manufactured against the advance licenses as well as to those manufactured in SEZ units.• DGFT had given clarification vide Policy circular No: 33/2015-20

that, Restrictions on exports do not apply to SEZs as per SEZ rules and hence exports of restricted products are allowed from SEZ units and further clarified that all other items under the ITC (HS) in the notification other than ones falling under item description specified are allowed for exports.

• DGFT Policy circular No: 34/2015-20, dt: 20/03/2020, stated that all formulations of listed products in the Notification No: 50 are allowed to be exported under Advance licenses issued on or before the date of issue of notification (i.e.03/03/2020).

Unresolved issues even after the DGFT clarificationsDespite the relaxations given for products manufactured in

SEZ units & for those manufactured against Advance licenses, huge shipments of listed products manufactured for export were


lying in ports for customs clearances resulted in exporters paying huge demurrages.

Exporters were struggled with logistics issues as Air cargo services were deeply impacted & freight charges have shot up badly affecting Imports and exports. This can be a major bottleneck going forward unless proper measures taken by Govt on top priority with concerned ministries by allocating reserve space for medicine in both inward & outward cargo along with faster clearances. The restrictions on exports coupled with the logistic issues have brought the exporters in a disadvantageous position of losing their valued importers, loss of credibility, penalties for delayed supplies, huge demurrages and they were much distressed.

Pharmexcil & other bodies requested the Government to take up these issues with concerned ministries by allocating reserve space for medicines in both inward & outward cargo along with faster clearances.

Concerns on Exports from EOUs Though the DGFT has clarified that SEZ units are exempted

from the restrictions, DGFT still silent on EOUs. On 23.3.2020 Pharmexcil submitted representation to DGFT to exempt the EOUs from Notification No:50 on consideration of the following.• The products have been manufactured against confirmed

order received couple of months ago before the restriction was imposed and hence, they may be allowed to export the same.

• Products manufactured by EoUs are meant for export markets only, (approved as per FDA guidelines), and these cannot be used in domestic markets because of the regulatory technicalities. EOUs import the key starting materials /API's of USP/EP/BP specifications and manufactures the finished drugs as per the specification, labelling & printing requirements of the exported country. Since the drugs manufactured by EOUs are not as per Indian Pharmacopeia (IP) specification (the basic & major regulatory requirement to sell the drugs in India) these drugs cannot be utilized for domestic sale as per the law currently prevailing. Thus, the restrictions on exports of listed drugs are causing the loss of shelf life of the manufactured goods by the EOUs with ultimate wastage of the drugs without serving the prime objective of the export restrictions to protect the national rug security.

Prohibition of the export of Hydroxychloroquine and its Formulations - DGFT Notification No. 54/2015-2020, 25th March 2020

The Government of India on 25th March prohibited the export of anti-malarial drug Hydroxychloroquine, with immediate effect to ensure enough availability of the medicine in the domestic market vide DGFT notification no: 54/2015-2020. It, however, said the exports of Hydroxychloroquine are allowed in following cases. a) From the SEZ/EOU units and in cases where export is made to

fulfill export obligation under any Advance license issued on or before 25th March 2020 being the date of the notification

b) Exports will be allowed also in the case of shipments where Irrevocable letter of credit (ICLC) has been issued before the date of the notification or in case where in full advance payment has been received by the exporter in India against specific shipment subject to documentary evidence.

c) Exports will be allowed by Govt of India to other countries on humanitarian grounds on case-to-case basis on the recommendation of Ministry of External Affairs.

Removal of exemptions given for HCQ exports:International demand for Hydroxychloroquine has spiked after

a small-scale test indicated that the drug showed promising results against COVID-19. Govt of India & the industries got many requests for supply of HCQ.

On 4th Apr, the Govt had removed all the exemptions given in earlier Notification-54 and imposed complete ban on exports of HCQ & its formulations vide DGFT notification No: 01/2015-20.

Government allows exports of 12 APIs & Its formulations (DGFT Notification NO: 02/2015-2020, dt:06th Apr 2020)

Almost after a month of imposing export restrictions on 26 pharmaceuticals on 3rd March, the Government of India has removed these restrictions for 24 products (12 APIs & its formulations) except for Paracetamol & its formulations on 6th Apr 2020 considering the no.of representations received from Pharmexcil, IDMA, IPA & other industry bodies and the DGFT issued notification (No:02/ 2015-20, dt:06th Apr 20) in this regard.

Status of Paracetamol & HydroxychloroquineParacetamol:

Paracetamol, being a drug used as front-line treatment for various epidemics because of its dual action as analgesic and as anti-pyretic with minimum side effects after prolonged use has become the drug of choice in many countries in the COVID-19 pandemic. India is the second largest producer of Paracetamol with manufacturing capacity of more than 6350 MT/month and can be scaled up further by 20%. Leading manufacturers are Farmson Pharmaceuticals Gujarat Pvt Ltd, Granules India Ltd, Meghamani Unichem & Sri Krishna Pharmaceuticals Ltd.

Among the total production, about 2500 MT/month is utilized by domestic industries either for domestic consumption for about 700 MT and balance 1800 MT’s for conversion of the Paracetamol by companies into Formulations for exports. It was assured by the industry that they will maintain enough stock of about 40% of production at any given time.

Hydroxychloroquine:India being the world’s largest producer of Hydroxychloroquine

(HCQ), exports almost 80-85 % of the production to all parts of the world. India’s total exports of HCQ and its formulations during financial year 2019 was US$ 51.6 million and in FY 20, it was US$36.41 million during April-February.

Leading manufacturers of HCQ tablets are IPCA Laboratories, Zydus Cadila Healthcare, INTAS Pharmaceuticals and Laurus Labs Ltd. The global demand for this product has increased manifold and countries like USA, Brazil had requested India for supply of this medicine. The domestic production capacity of API is 38MT/month and it can be scaled up to 58MT.

Governments decision to supply HCQ & Paracetamol to affected Nations:

Upon review of the status of the Indian manufacturers’ capabilities in fulfilling the needs of the nation, the government has taken a call to release the exports of HCQ & Paracetamol to countries which needed it the most and made an official announcement on 7th April that Government would license Paracetamol and Hydroxychloroquine (HCQ) in appropriate quantities to all our neighboring countries who are dependent on


our capabilities and the will supply these essential drugs to nations who have been badly affected by the pandemic.

India supplied HCQ tablets to over 50 countries including USA, Spain, Brazil, Germany, Russia, Bahrain, Nepal, Bhutan, Bangladesh, Afghanistan, Maldives, South Africa, Seychelles, Mauritius, Dominican Republic, Kuwait, Antigua & Barbuda & Palau etc.

Pharmexcil’s Advisory to Exporters of HCQ & Paracetamol:Basing on the experiences of the companies exported HCQ,

Pharmexcil has released advisory on the procedural formalities for obtaining license/permission to export these drugs for the benefit of the industry. • In principle the communique between the Government to

Government for supply of HCQ & Paracetamol will be considered and export will be allowed after examination on case to case basis.

• The request received by the Indian External Affairs Ministry from the other country will be examined by the team of officials nominated to monitor the National Drug Security led by the Dept of Pharmaceuticals. Having assured the obligation of meeting the domestic requirement, export is being allowed by the Government.

Removal of export restriction on Paracetamol Formulations- DGFT Notification No: 03/2015-20, dt:17th Apr 2020

Having assurance from the industry about the availability of Paracetamol stock for domestic need, Government on 17th April lifted the restrictions on exports of Paracetamol Formulations. However, restrictions on exports of Paracetamol API remains continued.

All the industry associations have requested the Government to consider the relaxation of export restrictions of Paracetamol API as well.

Other Issues faced by Pharma Industry during Lockdown period & Request made to Government by Industry associations• Members are struggling with logistics issues as Air cargo

services are deeply impacted & freight charges have shot up badly affecting Imports and exports. This can be a major bottleneck going forward unless proper measures taken by Govt on top priority with concerned ministries by allocating reserve space for medicine in both inward & outward cargo along with faster clearances.

• The restrictions on exports coupled with the logistic issues are making the exporters in a disadvantageous position of losing their valued importers, loss of credibility, penalties for delayed supplies, huge demurrages and thus making them much distress as they left with only 4-5 working days in this current financial year.

• There is a drastic fall in the business activities vis a vis lower domestic and international sales at this juncture, the working capital requirement of the businesses should be automatically made double without any collateral and no new application. The reason for this request is that the prices of major APIs have doubled and in addition to this, China is asking for advance payment or payment against delivery. This additional increase in working capital extended for one year with a provision of 3 years repayment period.

• Lock down period should be declared Zero financial period i.e. No interest on borrowing, No GST or Excise liabilities, No time barred cases, for a period of 6 months or so. Previous payment should be deferred for three months after the lockdown period is over.

• EMIs on all term loans should be deferred by six months to support the functioning of companies. The extended period should be added in the remaining maturity period of the loans and the same should be also back ended in six months installments.

• Local police authorities manning the nakas /toll posts/check posts in the states of Haryana, Himachal Pradesh and Rajasthan are not permitting the employees of Pharmaceutical companies to pass through. This is creating difficulties in carrying out manufacturing of vital medicines and drugs by the Pharma Companies. Industry bodies has requested that the concerned State Govts may issue passes/permits subject to compliance to safety procedures stipulated so as to enable the employees of Pharma Companies to report to duties so that the production facilities can carry on their work and production chains are not disrupted.

• It is requested that the matter may please be taken up with concerned authorities of the said state governments in the interest of ensuring that the Pharma companies can carry out their production activities so that there is no shortage of medicines supply in this hour of crisis.

Baddi Issues:For a long time since the lock down Formulations plant which

manufactures Lifesaving high technology medicines supplied to India as well as other countries of the world are closed for finished goods lying in the Warehouse losing both potency & expiry of month or thereabouts. • Similarly, raw materials & packaging materials are not being

let in as these industries are not essential & entry is not being allowed for both the industries.

• Highly skilled manpower is predominantly located in Panchkula, Pinjore in Haryana & Mohali in Punjab. These employees had not been allowed to enter Baddi & therefore industry is forced to close operations. Subsequently industry was allowed to move personnel only once & staying arrangements were supposed to be done in the plants which in majority of the units is infeasible.

In view of the foregoing & so as to ensure there are not drug shortages in the country, industry bodies appeal to D.C., Baddi to take proactive & pragmatic view & allow:

- Interstate & district manpower movement.- Interstate & district transportation

This will help vital & critical pharma industry as well as 700 Units in Baddi to continue to supply to the entire country where the market share of Baddi alone is 40% in domestic & 20% of the exports share.

Governments initiatives to ensure Smooth functioning of Pharma industry & to see the availability of Essential medicines• On 21st March 2020, Cabinet approved “Promotion of

Domestic manufacturing of critical Key starting Materials/ Drug Intermediates and Active pharmaceutical Ingredients in the country”, basing on the recommendations of the Dept


of Commerce commissioned study report “Strategies to Reduce Import Dependence of APIs, KSMs and Intermediates” conducted by Pharmexcil.

The sanctioned schemes area) Promotion of Bulk Drug Parks- Decision to develop 03 mega

bulk drug parks in partnership with states. GoI will give grant in aid to states with 1000 Cr for each bulk drug park, thus a sum of Rs.3000 Cr approved for this scheme for next 5 yrs.

b) Production Linked Incentive Scheme: Financial incentive for eligible manufacturers of 53 critical bulk drugs (26 Fermentation based & 27 chemical synthesis based bulk drugs) on their incremental sales over base year 2019-20 for period of 06 yrs. A sum of Rs.6,940 Cr approved for next 8 yrs.

• On 26th March 2020, Chairman, National Pharmaceutical Pricing Authority has directed all the Chief secretaries of the states to ensure unobstructed movement of raw material, packing materials, finished products and manpower related to manufacturing & distribution of drugs & medical devices.

• On 26th March 2020, Ministry of Health & Family welfare has allowed the doorstep delivery of medicines.

• On 27th March 2020, HCQ notified under Schedule H1: In view of the recommendation of Hydroxychloroquine for prophylactic use in high risk contacts of COVID-19 by ICMR, the Ministry of Health & Family welfare has notified Hydroxychloroquine under Schedule H1 on 27th Mar, restricting sale only based on prescription to prevent the self-medication and misuse of medicines by general public.

• On 27th March 2020, Ministry of Environment, Forest & Climate Change has appraised all the projects or activities in respect of bulk drugs, intermediates manufactured for addressing ailments such as COVID-19 and those with similar symptoms are categorized as B2 for a period up to 30th Sep 2020 as an interim measure to expedite the prior environmental clearance.

• On 28th March 2020, Department of Pharmaceuticals has set up Control Room to coordinate transportation & other logistic services for essential supplies in the country.

• On 31st March 2020, DGFT extends Current Foreign Trade Policy for one (01) year i.e upto 31.03.2021 vide Notification No:57/ 2015-2020. Further DGFT stated that the regional authorities will not insist on valid RCMCs till 30th September, 2020.

• On 31st March 2020, Director General of Shipping has issued advisory on non-charging of any demurrage, ground rent beyond the allowed free period or any performance related penalty on non-containerized cargo during the period of effect of COVID-19 pandemic.

• On 1st April 2020, Directorate General of Civil Aviation (DGCA), has relaxed norms and given special permission to conduct cargo operations using passenger aircraft during lockdown period.

• On 1st April 2020, Publication of List of Nodal officers of CBIC all over India for facilitating customs clearance amidst COVID-19 crisis.

• On 4th Apri l 2020, The Government ordered 10 Cr Hydroxychloroquine tablets from leading manufacturers to maintain the stockpile required for the domestic needs.

• On 6th April 2020, The Government directed the NPPA to exercise the functions under Paragraph 3 of DPCO 2013 “Directions to Manufacturers of Active Pharmaceutical Ingredients or

Bulk drugs or Formulations with a view to achieve adequate availability of medicines to the public.

• On 9th April 2020, Dept of Pharmaceuticals suggested ministry of Home Affairs to take effective measures to continue pharma and allied industries operations smoothly especially w.r.t movement of contact labourers, vehicle drivers & courier services etc.

Production of API guaranteed is about 40-50% and hopefully in the fortnight it will go up to 60-70%. Formulations production is at about 50-60% and it will go upto 70-80%. Huge amount of support has given by the state Governments especially Telangana, Andhra Pradesh & Gujarat besides the Centre. Despite the challenges faced by the industry either in terms of export restrictions or operational challenges viz logistic concerns w.r.t ports, air lines, customs clearances and labor movement restriction, Indian pharma industry has performed amazingly well until third week of March. Only towards end of March our exports are suffered, and exports are at a very slow place even in April. Salutations to the entrepreneurship of Indian! As soon as COVID-19 gets flattened out and the transportation is eased out, we will start exporting significantly to all the countries which are very short of medicines.

Pharma industry has risen to the occasion in spite of all the difficulties of interstate movement, restrictions on transportation as well as on man power movement and migration of workers to their hometowns, due credits to the domestic industries as well as to the all the industry associations, Pharmexcil, IDMA, BDMA, IPA & OPPI! Special thanks to the efforts of Ministry of Commerce, Ministry of Health, Ministry of External Affairs, Ministry of Home Affairs and Department of Pharmaceuticals in particular.

The government, the regulatory agencies and the rest of the stakeholders including all the industry associations are paying in this very crucial & critical time which is laudable and deserves pat on back of all stakeholders.

Pharmexcil is representing the issues continuously to the Commerce Ministry on the issues being faced by the member companies due to the outbreak of COVID-19 and lock down. In this context, Pharmexcil hereby requests you to submit the problems being faced by your company currently, in the format given below to enable Pharmexcil to consolidate the issues and represent to the Commerce Ministry for taking up with concerned Ministry/Department .

Problem Type & Required Clearances Please mention your State/Region and describe

the problem in brief Issues related to DGFT Logistics/transport availabilityAvailability of Airliners for Cargo movement Availability of Shipping Lines for Cargo movement

Permission/Passes for manpower movement

Manpower availability at Ports & Loading and unloading of Materials at ports/ICD

Interstate Raw material Moment Issues related to CDCSO

Member companies are requested to share their problems in the format ASAP by email to [email protected] with a copy to [email protected]. On receipt of the inputs from member companies, Pharmexcil will represent these issues with the Commerce Ministry for taking up the matter with the concerned Ministry/Department.


PHarmaCist tHe ‘aPostroPHe’ oF tHe HealtH ProFessioNDr. B. Suresh President, Pharmacy Council of India, New DelhiPro Chancellor, JSS Academy of Higher Education and Research, Mysuru

Article

The apostrophe character is a punctuation mark, and sometimes a diacritical mark, and serves two basic functions; they show possession and indicate letters have been removed to form a contraction. The apostrophe probably causes more grief than all the other punctuation marks put together! The problem nearly always seems to stem from not understanding that the apostrophe has two very different (and very important) uses in English: possession and contractions.

The Pharmacist unfortunately has become the apostrophe of the health profession in the manner that he is the missing letter between the Physician and the Patient and all the time playing that missing role without being visible to either provider or the user. On the other hand, the Pharmacist also plays the role of ‘possession’ where his role is highly important in the healthcare conundrum as the guardian of medicines. Here too the problem stems from not understanding that pharmacist plays two different roles, one that of the invisible healthcare provider and the visible manufacturer of medicines. While we seek the recognition stemming out of a healthcare provider, the society gives us the recognition that of a provider of medicines (be it manufacture or sale). If the Pharmacy profession in India really needs to get its recognition in the healthcare team then we must play the visible role in being the bridge between the Physician and Patient.

In the present COVID Pandemic the pharmacists not only in India but even globally felt that they were not being recognised as an important ‘Frontline Warrior’ in the fight against coronavirus. The International Pharmaceutical federation (FIP) too, had to bring out a statement supporting the role of Pharmacists as Corona warriors. The Pharmacy Council of India too had conveyed to the Ministry of Health and Family Welfare, Government of India that the services of the pharmacist in the fight against the pandemic would be valuable to the nation and the Government of India in their ‘Covid warriors’ database has listed Pharmacists available state-wise whose services can be utilised by the governments and administrators at the time of need.

The Indian Pharmaceutical Industry and the Pharma sector was the cynosure of the world, for a change, for all good

reasons. The Pharmaceutical industry clearly established its position as the reliable partner in healthcare needs and even went ahead and stated that the service to humanity is more important than the pricing of medications. They could easily connect with the vision of nation and its leader and strategized and raised to the occasion be it the manufacture of large volumes of Hydroxychloroquine and other antivirals or the efforts in the direction of development of vaccines and other immunomodulating therapies. The world strongly believes that perhaps India would be first to come out with an affordable vaccine against Coronavirus and towards that many industries have been driving their research as early as January 2020. The Pharmacists and Pharmaceutical scientists in the industry have kept the pride of the Indian pharma sector flying high all the time and have been getting the recognition as scientists and technocrats.

The ‘missing pharmacist’ in community pharmacy identified themselves as ‘chemists and traders’ and sought recognition from the government that the ‘chemists’ also be recognised as healthcare workers and be eligible for insurance. They also expressed concern about the medicines being delivered by ‘online Pharmacies’ through a tie up with shared platform of transport services such as Uber and Ola, as the ‘chemists’ are already doing home delivery of medicines as per the government orders. When ‘chemists’ are doing this wonderful job and the association of chemists is asking respect for ‘Pharma trade’, I don’t understand that how we expect the health profession or the government or the patient to recognise us healthcare provider. If truly we seek recognition as health care provider, we the ‘Pharmacists of India’ shed the shadow of ‘Chemist’ and ‘trader’ and make our presence visible in the community pharmacies as ‘Pharmacists’ rendering professional service in the healthcare conundrum.

The great comfort to the Pharmacy profession is the stellar role played by the regulatory officers of the country be it the CDSCO or the state drug control departments in working closely with all stakeholders and recommending to the government policies that decrease the degree of difficulty and ensure the continuous available of medicines for national and international appreciation and they truly deserve our appreciation. Similarly, the Hospital Pharmacists be it the Government sector or the private sector continued to provide their selfless services and where truly the pharmacists with their ‘white coats’ bringing respectability amongst the society about the role of Pharmacists in healthcare. The new generation pharmacists, the clinical pharmacists, were full of passion to raise to the occasion and use their clinical expertise in reaching out to the patients and creating awareness on the health advisory of the government and was recognised by the health profession and the community at large.

The unprecedented challenge was most for the academia in the pharmacy field. Unlike the other segments it was not slowdown that bothered them, but to suddenly transition from didactic

Dr. B. Suresh Prof. Suresh Bhojraj is President, Pharmacy Council of India, New Delhi. He is Pro Chan-cellor, JSS Academy of Higher Education and Research, Mysuru, for the past thirty years has been actively involved in uplifting the standards of pharmacy education and pro-

fession in India. He was elected in 2003 as the President of Pharmacy Council of India, the statutory body regulating the pharmacy education and profession in India. He was once again re-elected as the President of Pharmacy Council of India in August 2008 and August 2013. Dr. Suresh is also the del-egate member of the United States Pharmacopeia Convention and also the member of the Council of Convention of the USP. Prof. Suresh has also been President of IPA from 2008 - 2010.


teaching to digital teaching overnight. Though there was lots of scepticism associated with this, they responded remarkably well and made the disruption least felt by the students and continued to engage the students with their academics and also prevented them from their movements by holding them captive through their online classes, seminars, webinars and so on. Perhaps the productivity from the academia was the highest during this pandemic period. This clearly shows that ‘forced experimentation’ does yield good outcomes. My congratulations to all my academic colleagues for their wonderful response.

Perhaps it is time for us to resolve that –

We the Pharmacists of India having qualified ourselves as the “Pharmacist” under the Pharmacy Act, 1948 and practising the profession of Pharmacy resolve to

Serve the citizens of India with our knowledge, skill and expertise on medicines

Deliver Pharmaceutical care that ensures the efficacy and safety of medicines, besides

Promote among the pharmacist fraternity through selfless service and get due recognition

Uphold the dignity of the profession through our action, deed and words.

The Pharmacists of India declare that as a registered professional practitioner they will assure the health of people of India by manufacturing quality medicines , dispensing right medicines and the right dose and counselling the patients on the safety of the medicine and it’s use and through this endeavour promote the dignity of the pharmacy profession and earn the respect of community.’

It is time now for us to shed the identity of ‘apostrophe’ and come to the fore to be visible and be aware of our roles.

A Proud Pharmacist – even in unprecedented times!

A Tribute to Pharma Legend, Padma Shri Prof. Harkishan Singh

Revered Professor Harkishan Singh ji, Emeritus Professor, University Institute of Pharmaceutical Sciences (UIPS), Panjab University, a globally renowned pharmaceutical scientist and science historian, bid adieu to his wonderful life sojourn of 91 years, Friday morning i.e. 20th March 2020.

Born in November 1928, Professor Singh completed his graduation in year 1950, ranking first from UIPS, Panjab University, and postgraduation and Ph.D from Banaras Hindu University in 1952 and 1956, respectively. With a total experience of over 40 years in teaching and research in medicinal and pharmaceutical chemistry,

over 50 doctoral and master’s theses had been completed under his supervision in the research areas of heterosteroids and natural products for the pharmaceutical developments in India. Professor Singh’s unparalleled achievements and contributions to the profession of Pharmacy have been documented in large number of publications and books and is also evident by his over 330 publications include 21 books, 9 history monographs; 6 book chapters, 16 other review papers; 125 original research papers; 65 research papers on pharmaceutical history; over hundred articles on pharmaceutical education, professional issues and other topics. There are as many as fourteen patents obtained on his name in the area of heterosteroids. Professor Harkishan Singh delivered several invited lectures at institutions and conferences within the country, United States of America, United Kingdom, Canada, and China, including the one at the Harvard Medical School and at the International Symposium on Molecular Structure (1986) sponsored by the International Union of Crystallography, at Beijing.

One of the rarest accomplishments to the credit of Professor Singh and of Panjab University, per se, was the discovery of a clinically useful drug Chandonium Iodide (HS-310) which was later named by World Health Organisation (WHO) as Candocuronium Iodide. This is highly pertinent to add that Candocuronium is the only drug discovered from any Indian University till date.

In recognition of his illustrious contribution for the development of medicinal and pharmaceutical chemistry, the Panjab University conferred the prestigious Professor Emeritus title upon Professor Singh in the year 2003 and Doctor of Science (Honoris Causa) in the year 2016. Other international recognitions include, D.Sc. (Hons. Causa) by University of the Sciences in Philadelphia, USA in 2014 in recognition of his distinguished academic career and outstanding contributions to scientific research in organic and medicinal chemistry and history of Pharmacy; his standing as a Historian recognized by his election to “the Academie Internationale d’Histoire de la Pharmacie” in 1995. Prof. Harkishan Singh, was conferred the prestigious “Padma Shri” by the Honorable President of India in 2017. We at IPA, condole the sad demise of the stalwart & thespian Prof. Harkishan Singh.

Conferment of the Padma Shri by the then President Pranab Mukherjee


CommitmeNt to PuBliC HealtH aNd sCieNCe will Go a loNG way iN deFeatiNG ‘PaNdemiCs’Dr. Krishna EllaChairman & Managing Director, Bharat Biotech

Article

History shows that infectious diseases are a recurrent problem resulting in sheer devastation, to human lives, and on the economic front. The world is mindful that the Spanish flu of 1918 resulted in the death of nearly 50 million people worldwide, and resulted in a severe economic depression. Even during the influenza pandemics of 1957 and 1968 the development of vaccines, were delayed, failing to provide effective mitigation during the severe phases of the pandemics.

Pandemics have led to large-scale outbreaks of infectious disease that can greatly increase morbidity and mortality over a wide geographic area and cause significant economic, social and dogmatic disruption, and an effective vaccine can halt the spread of the infection.

There is wide acceptance, and data demonstrate vaccines are the most effective and affordable strategy to fight infectious and pandemic diseases all over the world. Despite this, preventive health measures especially in the form of vaccines have unfortunately not always been an area of priority and at best only a reactionary response to deadly outbreaks like H1N1, Ebola, Zika and most recently COVID-19.

Challenges Faced:Large parts of the scientific fraternity over the decades have

advocated the need for better awareness towards medical research

and regulatory support which will help to build the necessary robust infrastructure for better disease preparedness and support vaccine development in the long term.

The goal of the biotech and vaccine industry must be to commit, invest and innovate technologies to address the healthcare concerns of a developing world and provide affordable, efficacious and high-quality vaccines and biotherapeutics.

In times of duress, it is invariably the scientists and companies engaged in research, development, and manufacturing of vaccines who are urged to find a solution with the shortest timeline possible.

In a pandemic situation, international sharing of data and surveillance will be vital in drawing a road-map to assess the risks and determine what vaccination policies each nation needs to adapt to ensure their population is safe and stays protected.

Comprehensive research should be undertaken to gain knowledge about the virus. Clinical research should start at an optimal speed to understand the molecular and immune pathogenesis of the disease. This will help to understand and overcome initial vaccine development challenges.

Public funding for the development of pandemic vaccines is a pressing need as these are extraordinarily high-risk investments and helps to diminish the risk as well as incentivize vaccine manufacturers. Intellectual property issues and regulatory concerns shouldn’t hinder the quick development of the vaccines.

In the pursuit of vaccine development, companies all over the world are met with their own distinctive challenges. For example, in India, we face a few hurdles with regards to the import of ‘knockout mice’ which are critical in clinical animal trials. Regulatory approvals often take one year to be granted thereby slowing down vaccine development especially in crucial times such as these.

We must also take immense pride in knowing that 70% of the world’s vaccines are supplied by India. These vaccines are manufactured with the highest safety and efficacy and are highly affordable being delivered to countries with lower resources.

The Way Forward:Work towards developing a vaccine for COVID-19, the deadly

virus that has crippled even the most prepared and healthcare advanced nations, is underway in many countries. An effective vaccine will help in reducing the rate of infection thereby decreasing the number of deaths. It can also decrease the chance of resurgence of infections to a pandemic portion at the national and global levels.

The goal of the vaccine industry should be to start working as soon as the first report of an infectious outbreak is reported. There should be a selection of vaccine targets and candidates much before the establishment of an epidemic/pandemic. Individual governments and regulators must consider devising a 'Pandemic Paradigm' vaccine development plan and approve vaccine trials on a fast-track basis during crucial times.

Dr. Krishna EllaDr. Krishna Ella is the Chairman & Man-aging Director of Bharat Biotech incor-porated in 1996. A gold medallist at university, Dr. Ella worked as a research faculty at the Medical University of South Carolina, Charleston after earning his Ph.D. from the University of Wiscon-sin-Madison. A research scientist in Mo-lecular Biology, Dr. Ella strongly believes that innovative technology in vaccine development is essential to solve public healthcare problems caused by infec-tious diseases. Under Dr. Ella’s lead-

ership, Bharat Biotech has grown to become a global leader in innovative vaccines. A serial entrepreneur with a passion for innovative ideas, Dr. Ella has also ventured into veterinary vaccines, food processing, and developing biotechnology in-frastructure in the country. Dr. Ella is also involved in shaping India’s science education and policy through his association with several committees such as:

Scientific Advisory Committee to the Union Cabinet, CSIR Gov-erning Council, CCMB Governing Council, Research Council for CSIR National Laboratories, Board of Visitors – Global Health Institute, University of Wisconsin-Madison.

Several awards have been conferred on Dr. Ella including the ET Now Special Recognition for Healthcare Industry Award, J R D Tata—Best Entrepreneur of the Year Award, Marico In-novation Award and University of Southern California—Asia-Pacific Leadership Award.


While developed nations have access to advanced treatment and medicine, the challenge is to provide the greater populated developing nations cost-effective vaccines that can be administered with ease by grass-root health care workers.

Apart from being safe and highly efficacious, for a vaccine to have a greater impact, they have to be available quickly and in large quantities. The vaccine developed must have high production scalabilities, should facilitate rapid and easy transportation to remote villages under minimal cold storage facilities. The foremost factor is to adopt a proven safety platform that allows ease of production.

The vaccine, CoroFlu® which Bharat Biotech is developing in collaboration with a team of international virologists and leading Influenza expert Dr. Yoshihiro Kawaoka. CoroFlu® will be built on the backbone of FluGen‘s flu vaccine candidate known as M2SR. Based on an invention by UW–Madison virologists and FluGen co-founders and Gabriele Neumann, M2SR is a self-limiting version of the influenza virus that induces an immune response against the flu.

The underlying flu vaccine backbone has been tested in humans already and has demonstrated a good safety profile in four clinical trials on hundreds of human patients. This could probably ease the regulatory pathway for future trials. It also will potentially address two pressing health issues at the same time, coronavirus and influenza (common flu).

Bharat Biotech is committed to manufacture the vaccine, conduct clinical trials, and prepare to produce almost 300 million doses of vaccine for global distribution. Development of the

vaccine and testing in laboratory animal models at UW–Madison is expected to take four to six months. The animal trials are crucial and once the safety, efficacy is established, we will move on to human clinical trials. Our expectations and hope are CoroFlu® to be available in mid-2021.

As a vaccine leader, Bharat Biotech has commercialized 16 vaccines, including a vaccine developed against the H1N1 flu that caused the 2009 pandemic and has developed a vaccine for the Zika virus which is currently under clinical trials.

The Future :Global pandemics may become the primary public health

concern in the times ahead. Modern-day travel has reduced the world to become a global village and pandemics which were considered once in a lifetime events can no longer be ignored and may become more frequent.

COVID-19 paralyzed even the most developed and prepared nations’ healthcare systems, leaving many infected with the virus, and causing loss of several human lives. It has changed our norm of daily lives by confining us to our homes, putting a mask over our face, and made us practice social distancing.

COVID-19 has become the most destructive respiratory disease mankind will face in the modern era and must not be underestimated.

With many promising treatments being studied all over the world, only a vaccine can be considered as a long-term strategy to combat COVID-19 and other pandemics.


Pharma Times - Vol. 52 - No. 04 - April 2020 24 Pharma Times - Vol. 52 - No. 04 - April 2020 25Pharma Times - Vol. 52 - No. 04 - April 2020 24 Pharma Times - Vol. 52 - No. 04 - April 2020 25Pharma Times - Vol. 51 - No. 09 - September 2019 54 Pharma Times - Vol. 51 - No. 09 - September 2019 55Pharma Times - Vol. 51 - No. 09 - September 2019 54 Pharma Times - Vol. 51 - No. 09 - September 2019 55

Pharma Times now delivers you even more benefits & exposure to Pharma Industry

With over 50000+ readership Pharma Times helps you to maximize your business potential & brings you ahead of competition

Pharma Times is leading monthly newsmagazine of Indian Pharmaceutical Association.

• Indexed by the search engines - Scopus & Embase of the premier scientific publication house Elsevier, Pharma Times is not only referred by domestic market but also well sought after among the global Pharmaceutical hub.

• The one of the few journals being referred by the students to CEOs of Pharmaceutical industry.

• Series of Quarterly Special issues focus on the key aspects & highlights new technologies and innovation in Indian Pharmaceutical Industry.

• One of the most authentic information source for Regulatory Issues

• Reach to the remotest location of Indian Pharmaceutical Industry.

Editorial Calendar for 2018 - 19

Pharma Times - Vol. 51 - No. 08 - August 2019 PB

Pharma TimesSingle Copy Price ` 250ISSN 0031-6849

Vol. 51 No. 08 | August 2019Total Pages : 40




Anticipation of Pharma Industries from Pharma Academics: What to Instill in Fresh Breeds? .......................................................... 12

Role of Pharmacist in Personalized Medicine ............ 23

Good Laboratory Practices: Need of the hour ...9

GLP

Pharma TimesSingle Copy Price ` 250

ISSN 0031-6849

Vol. 51 No. 05 | May 2019

Total Pages : 48

Official Monthly Newsmagazine of Indian Pharmaceutical Association

Indexed by Scopus & Embase


Pharma Times Official Publication of:

The Indian Pharmaceutical Association,

Kalina, Santacruz (E), Mumbai 400098.

Lean Six Sigma: A pristine tool for

quality in pharmaceuticals ...........................13

Minutes of CEC Meeting .............................31

Hydrogels: A promising drug delivery carrier

for ophthalmic applications.................9

Capsid Protein: Potential Target for Treatment of HIV...9

Pharma TimesSingle Copy Price ` 250ISSN 0031-6849 Vol. 51 No. 07 | July 2019

Total Pages : 40




From Patient-Centricity to Personalization A paradigm shift: ......................................................12FARM Notes: A systematic Review ...........................23


Theme Based Special Issues Month

Project Management November 2019

For Opportunities, Contact us at [email protected] / [email protected]

Tel. 022-26671072 / 26670744 Mob.: 9594745412Website: www.ipapharma.org

Pharma Times - Vol. 51 - No. 12 - December 2019 PB

Pharma Times Official Publication of:

The Indian Pharmaceutical Association,

Kalina, Santacruz (E), Mumbai 400098.

Report: IPA Team at 79th FIP World

Congress, Abu Dhabi ...........................................8

Sustainable Pharmacy ........................................ 13

National Board of Accreditation ..................... 15

Nutraceuticals as a Personalised Medicine:

In the prevention and treatment of cancer ...9

Single Copy Price ` 250

ISSN 0031-6849

Vol. 51 No. 12 | December 2019

Total Pages : 44


Indexed by Scopus & EmbasePharma Times


Pharma Times - Vol. 52 - No. 02 - February 2020 PB


Single Copy Price ` 250ISSN 0031-6849Vol. 52 No. 02 | February 2020Total Pages : 44




Report: IPA Awards Function and Fellows’ Dinner 2019: ..............................................................8OOS/OOT Investigations– USFDA Vs. MHRA perspective - An Analysis & way ahead for Pharmaceutical Industries............................................ 14An Overview of Recent Trends in Medical Device Pharmacovigilance Regulations .......................................... 27

Challenging Protection for Geographical Indications: The Distinct Intellectual Property Right Based on Local Knowledge and Reputation ...11

Pharma Times - Vol. 52 - No. 03 - March 2020 PB


Single Copy Price ` 250ISSN 0031-6849

Vol. 52 No. 03 | March 2020Total Pages : 48



Current Practice amongst Patients, Pharmacists and Distributors .......9

Disposal of Unused and Expired Medications:

How the advanced technologies are becoming the first choice for Pharmaceutical competitors: A review on Multi-layered Tablet dosage forms.............. 13

Importance of ISO Standards 45001:2018 (OHSMS), In Pharmaceutical Industry [OHSMS = (Occupational Health and Safety Management Systems)] ....................... 27

Editorial Calendar for 2020 - 21

Theme Based Special Issues Monthγ – scintigraphy in pharmaceuticals August ‘20Digitization in pharmaceutical industry November ‘20Nutraceuticals February ‘21


Covid-19: a wake uP Call For PHarma stakeHoldersDr. Ajit Dangi President & CEO, Danssen Consulting

There is no industry in the world which has not been impacted by COVID 19 and the pharma industry is no exception. Firstly, we must acknowledge the excellent work our pharma manufacturers and healthcare professionals are doing by working 24×7 to ensure that patients not only in India but all over the world get their medicines on time. While words like carnage, catastrophe etc. are being used to describe this pandemic, it is also a wake-up call to the industry and the policymakers to learn from this crisis and draw out an action plan to make the industry future-ready and insulate ourselves from such calamities. Following are a few suggestions:

1. API imports– It is now well recognised that our overdependence on imports for APIs and drug intermediates is a major geopolitical risk. While this issue is being discussed for almost a decade, the action plan has been missing. We declared the year 2015 as a ‘ Year of Bulk Drugs’, however, the government announced a package of Rs 14,000 crores to manufacture key APIs indigenously only on March 30, 2020. More than 53 critical bulk drugs covering major therapeutic classes have been identified for domestic manufacture, of which 26 are fermentation-based and 27 are based on chemical synthesis, roping in expertise from National Chemical Laboratory, Pune. DoP has also formulated a scheme namely ‘Assistance to Bulk Drug Industry for Common Facility Center (CFC)’ in any upcoming bulk drug park promoted by the state governments.We now urgently need to do three things.One, develop more vendors globally for APIs required for manufacturing essential medicines rather than depending only on one country and second, draw out a plan to incentivise industry to do backward integration for their major brands by putting such projects on the fast track. Apart from giving monetary incentives, accelerating regulatory approvals such as environmental clearance, land acquisition, FDA licences, and amendment of restrictive labour laws and generally improving ease of doing business is also necessary. Needless to mention, states must ensure uninterrupted electricity and water supply and good infrastructure for the smooth functioning of such plants. Thirdly, we need to activate some of our moribund pharma PSUs like IDPL, HAL, BCPL etc. by bringing in newer manufacturing technologies and more dynamic management. While Bureau of Pharma PSUs was established in 2008, it has little progress to show. Similarly, fine institutes like Haffkine Institute, Mumbai which is the oldest biomedical research institute in the country established way back in 1899, can contribute immensely in times like this with their wealth of knowledge in vaccine technologies. They need to be activated.2. Digitalisation – India rightfully chose the path of digitalisation

by announcing its flagship programme ‘Digital India’ in 2015. COVID 19 has given it a spurt as more and more people have started doing transactions online improving efficiency and speed. It is estimated that the E-way billing system for truckers who transport goods like pharma supplies and other goods on national highways across the country has reduced transport time by almost 30 per cent and has also improved GST tax compliance. Similar is the case with fast tag system for tolls. Efficient logistics and supply chain is the lifeline of pharma industry, particularly for temperature-sensitive products and digitalisation will bring speed and efficiency in warehousing, forecasting, planning etc., thereby improving productivity.While the policy on online pharmacies has been incubating for over two years, very little progress has been made. One of the reasons being resistance from vested interests and fear of counterfeits entering the supply chain. Some of these issues can be addressed effectively by putting appropriate legislations in place. Online pharmacy can also reduce price to patients by cutting down intermediaries.Another positive development is that Niti Aayog and MCI have just come out with guidelines on telemedicine. They help physicians and encourage them to consider telemedicine as a part of their normal practice using videos, internet-based platforms like web chat, apps etc. without carrying out a physical examination. This fulfils a major gap as until now there were no official guidelines or legislations for the practice of telemedicine. Hopefully, product detailing through medical reps will also undergo a major change.3. Healthcare spends – Our government’s healthcare spend is just over one per cent of GDP. For a country of 1.3 billion people, this is quite miniscule. While we have been talking about doubling this for quite some time, with the impending economic slump and a probable recession, this is going to be a major challenge. Policies like OTC legislation need to be enacted speedily to reduce the burden on scarce resources like access to medical consultation etc., at least for minor ailments.4. Impact on industry growth – The Indian pharma industry was expected to grow by 10- 13 per cent in 20 – 21. Fortunately, following representation from Pharmexcil, Government has just lifted the ban on exports of certain essential drugs. However, many manufacturing plants are working at suboptimal capacity due to the absence of workforce, hence this growth rate is unlikely to be achieved. For instance, plants in Uttarakhand which produce about 15 per cent of total formulations in the country, are unable to work to full capacity as only about 15- 20 per cent workforce is reporting to work either because of fear of COVID-19 infection or because the state government has announced full pay even if one is absent from work. Looks like we are likely to end up FY 21 with single-digit growth.5. Change in human behaviour – WHO has recognised the role of positive change in human behaviour in addressing a crisis of this nature. Good practices like frequent hand washing, social distancing, personal hygiene and good sanitation practices should be continued even when this crisis is over. Drugs and vaccines are not substitutes for good hygiene, sanitation and adoption healthy lifestyles.

Sourced from: Express Pharma, https://www.expresspharma.in/covid19-updates/covid-19-a-wake-up-call-for-pharma-stakeholders/,

Article

Dr. Ajit Dangi Dr. Ajit Dangi is President & CEO of Danssen Consulting, a strategy firm specialising in life sciences & Health-care. He has been Director General of Organization of Pharmaceutical Pro-ducers of India (OPPI) for seven years

before this. Dr. Dangi has served as Chairman of the Board of Fulford India Ltd. ( subsidiary of Merck & Co. Inc. USA ) for ten years and also currently serves on the Board of Atul Bioscience Ltd. He is former President & Executive Director of Johnson & Johnson India Ltd. where he served for 20 years in various capacities.


saFety oF PHarmaCeutiCal emPloyees iN Covid 19 PaNdemiCS. G. BelapureSenior Technical Advisor, Indian Pharmaceutical Alliance

INTRODUCTIONCOVID-19 is, first and foremost, a new challenge to mankind.

Thousands of health professionals are heroically battling the virus, putting their own lives at risk. Governments and industry are working together to understand and address the challenge, support victims and their families and communities, and search for treatments and vaccines.

As this global crisis plays out, Pharmaceuticals manufacturing has been enlisted as an ‘essential service’ by the Government of India, and hence the need to act swiftly and promptly – both to ensure continuity of medicine supplies to avoid drug shortages, and at the same time, ensure the safety of the workforce in manufacturing facilities during the crisis.

The objective is to share the best practices for safety of employees engaged in manufacturing of pharmaceutical products, and provide a comprehensive set of practices across Indian and global pharmaceutical manufacturing companies in response to the COVID-19 crisis. This article is based on Indian Pharmaceutical Alliance document on “Employee Safety in Pharmaceutical manufacturing - Covid19 “This is condensed version of the best practices.

Close coordination and liaison with the local health authorities / Government functionaries involved in fight against COVID-19 is necessary. The local authorities would have to be contacted and permission sought for continued manufacturing operations during lockdown as also to seek their approval and support for smooth operations and movement of goods and people. Employees would have to be issued passes to ensure travel during lockdown / curfew situations.

It is recommended to inform local public health authority the plan developed by the company for protecting the employees and seek their inputs and recommendation.

COMMUNICATION ACROSS MANUFACTURING NETWORK To enable effective two-way communication across the

manufacturing network, companies need to setup two teams to drive the communication network– (a) Central Crisis Team at corporate / head office, closely connected with (b) Local Crisis Teams at each manufacturing location.

Following are some of the best practices for communication• Requests to adhere to general hygiene & other COVID-19

safety norms, such as following (local and central) government notifications, frequent and adequate hand wash procedures, keeping social distancing

• Bulletins from central team to all sites with updated policies, guidelines and mechanisms to deal with the evolving situation Regular updates from leadership on organization’s response to the crisis

• Information on current sentiment of employees overall, including sharing positive news / developments for boosting moral of the employees. Emergency notification system to keep employees up to date with immediate news and actions (e.g. through centralized text messages or messages thru smart screens) Hold regular company-wide townhalls (virtual) to share best practices, discuss potential issues / risks, answer key questions around the crisis

EMPLOYEE SEGREGATION AND REMOTE WORKING FOR NON-ESSENTIAL WORKFORCE

Segregate entire workforce into two categories: (a) essential workforce needed on-site, and (b) non-essential workforce • List of essential resources to be made based on production

plan for the month / week. All personnel directly required for in-person activities can be categorized as essential (such as manufacturing shop floor personnel, QC analyst, engineering).

• All other personnel to be identified as non-essential for on-site presence (e.g. planning team, transformation teams, project teams, audit team, supply chain coordination team etc.).

• People with conditions such as diabetes, heart and lung disease are also more vulnerable to serious illness. It would be ideal to restrict such high-risk profile employees from on-site

• If any of the employee has even a mild cough or low-grade fever, he should be advised to stay at home. Advise employees in advance that if they have any symptoms or feel unwell, they should not attend.

Define working norms, rules and guidelines for all personnel and contractors belonging to each category:

• Essential workforce: Ensure safety of essential workforce through implementation of on-site personnel & material movement norms (Additionally, segregate these essential resources into “work-teams” to minimize risk of contamination between different sub-teams.

• Non-essential workforce: discourage (to the extent possible) all non-essential personnel (employees, contractors, visitors) from entering site. Provide for remote working options for such workforce.

ON-SITE PERSONNEL-MOVEMENT NORMS Transportation of employees and contractors:

S. G. BelapureShirish Belapure is currently with Indian Pharmaceutical Alliance as senior technical Advisor & coordinates the activities of Qual-ity Forum. With more than 42 years experi-ence in various capacities in pharmaceuti-cal manufacturing, his last position was

Manaaging Director of Zydus Hospira Oncology Pvt. Ltd. & has worked with Zydus, Sunpharma, Cipla to name a few.

Article


Transportation of key personnel to and from manufacturing location is very critical to avoid contamination from external surrounding. It should be ensured that employees wear facemasks and take care of their personal safety & hygiene during traveling. Below are recommended key considerations for employee safety:• One person per seat, employees occupying alternate seats,

sitting diagonally from each other. It would be ideal to identify the seats that should not be occupied. Clear advisory can be issued to employees as under: The seats marked as ‘do not sit here’ should not be

occupied. Kindly maintain 1-meter distance while boarding and de

boarding the bus. Avoid standing while in transit. In case you find the bus fully occupied, please avoid

boarding in such circumstances. Wait for the next bus.• Cleaning & sanitization of pick up vehicles & buses before every

trip: The vehicles should also be regularly surface-sanitized; e.g. seats, windows, floors, railings etc. after every use. The vehicles should be 'deep-cleaned' at the most frequent interval possible, but at least daily

• Distancing protocols and respiratory hygiene should be ensured during travel: Articles like tissues, no-touch dust bins (foot operated) and alcohol-based hand rubs should be abundantly provided and encouraged at all identified places, which are ear marked.

Common area norms Entry & exit from plant premises should be monitored.

• Safe distance of minimum 1 meter should be maintained between employees during entry to the site.

• Body temperature for all employees should be checked and recorded with infrared thermometer or thermal camera before entering and exiting the facility at security main gate.

• Hand wash with soap / sanitization should be carried out by all employees before / during entry to the plant.

• Biometric attendance system should be avoided. Widespread usage of other shared items (e.g. pens, registers) should also be avoided;

• Enough PPEs should be provided and encouraged to be used at all points by working staff

• It is recommended to take an explicit health self-declaration from employees / contractors / visitors at entry points

Canteens / cafeterias• Access to canteens / cafeteria

should be restricted to the extent possible; e.g. employees getting their lunch packed from home, if possible

• Zones should be established within the common areas through physical segregation or by staggering timings to avoid mix up of employees from different work places or defined ‘Work-teams’

• Distancing protocols should be established within the canteen, such as having only 2 people per table instead of 4+ (to ensure minimum distance between employees)

• Disposable cutlery should be used (to the extent possible). Alternatively, if stainless steel plates, cutlery & utensils are used, they should be washed with soap/detergent & hot water using an approved procedure.

• Multiple touchpoints to be avoided to the extent possible, by enforcing norms such as food to be served only by canteen personnel wearing protective gears, single-touchpoint plate dispensing

• All areas should be sanitized and disinfected between every staggered meal timing, to the extent possible

• Physical transactions such as cash or coupons to be avoided to the extent possible

(Exhibit 2: illustrative markings to enforce distancing norms in canteen areas)

Change rooms / Washrooms• Limit number of employees entering the change rooms and

washrooms at a time to maintain distancing protocol • Access to change rooms and washrooms should be staggered

i.e. employees from the same ‘Work-team’ should enter change-rooms together, to avoid contamination between different groups of employees. Frequent sanitation is needed

• Garments should be handled carefully to ensure no risk of contamination:o Used garments should be removed on the same day for

washing and not stored in locker overnighto Used garments should be soaked in hot water & disinfectant

solution after use• Areas that are frequently touched by employees should be

cleaned regularly, such as phones, lockers, door handles, taps, bins, hangers, cross over benches at change room

• Ensure door handles, knobs, elevator keys, handles etc. are covered with cling film to facilitate easy cleaning and sanitization

Service areas – utilities, water system, HVAC floors, engineering & maintenance• Dedicated personnel should be identified for each service area.

Every maintenance personnel should use their own tools (not to be shared)

• Tools used for maintenance should be sanitized before and after use

• Entry of maintenance personnel in the manufacturing / QC area should be deferred (to the extent possible) for all non-essential maintenance activities; e.g. instrument calibration, preventive maintenance

• Maintenance personnel should enter manufacturing area only during critical breakdowns that cannot be resolved remotely

• Visitor entry – such as vendors, technicians – should be avoided

(Fig. 1: illustrative entry and exit practices on safe distancing in

plant premises)


to the extent possible. If visitor entry is unavoidable, a guidance for entry and exit should be issued to vendors / visitors prior to coming to the facility. All procedures defined for employees should be followed (at minimum) for vendors / visitors as well

Use of conference rooms and training rooms• Gathering of employees should be avoided in conference rooms

/ training rooms to the extent possible• Meetings should be conducted through virtual platforms such as

Microsoft Teams, Zoom, Skype, Teleconference (these are just illustrative, and can vary based on organizations’ preference / policies)

• If a meeting or training cannot be avoided, social distancing protocols should be maintained in conference rooms and training rooms

• Retain the names and contact details of all participants for at least one month. This will help public health authorities trace people who may have been exposed to COVID-19 if one or more participants become ill shortly after the event

MANUFACTURING AREA & QC LAB WORKING NORMSEssential and non-essential personnel mapping • Minimum manning to be followed on the shop floor and in QC

lab (to the extent possible), and employees should be dedicated by unit operations or manufacturing areas / rooms. To be done by creating segregated ‘Work-teams’ of employees

• Creation of smaller ‘Work-teams’ of essential employees (sub-teams) to be done to ensure minimum contact between different groups of employees

• If non-essential personnel are required to be on site, it must be ensured that they do not come in physical contact with essential personnel, else be explicitly tagged to ‘work-teams’

Behavior within the plant premises• Employees should follow distancing norms even after changing

into clean room garments, such as always remaining at least 1m apart, not filling documents together, avoiding sharing equipment or tools

• Hands should be disinfected after touching any external object, such as equipment, doors, documents

• Air-lock mechanism should be used while transferring samples from manufacturing area to QC lab. Samples should be preferably packed into an additional cover / polybag which should be removed in the air lock

• Documents should not be handled with bare hands; QA personnel should also wear gloves while reviewing documents

• Use of telephone receivers should be avoided; speaker phone should be used to the extent possible

• Microbiological monitoring of the manufacturing area should be done regularly and any change in microbiological flora should be reported

• Ensure personnel cell phones are also sanitized as appropriate, regularly (potentially daily)

Shift handover• Handovers should happen remotely and not in-person; i.e.

employees working in one shift should exit the facility before employees from next shift enter the change room

• Key messages during handover should be written using personal / shift-specific pens on defined sheets of paper and stored at

a defined location (such as on performance dialogue boards, shift huddle areas)

Adaptation for unions & contractors• Essential union workers and contractors should be identified in

advance, and all safety measures should be extended to them as well (i.e. same safety protocols as permanent employees)

• Workers and contractors should be dedicated to the same set of employees (i.e. ‘work-teams’) coming to the plant in a shift.

• A record should be maintained for every worker contractor coming in contact with employee other than the defined matrix / ‘work-team’

ON-SITE MATERIAL-MOVEMENT NORMS Overall material-movement across receipt, testing & release,

dispensing & issuance, finished goods movement, should be carried out in line with existing site procedures. In addition, there are a few select safety practices that may be adopted, mentioned below:

Receipt of raw material & packing material • Once the materials are received at the receipt bay, surface

sanitization (preferably with 70% isopropyl alcohol) should be performed in addition to dedusting (if not already a part of existing procedure). Dedusting should be done without use of pneumatic blower

• Both materials & sampling tools need to be surface-sanitized. Keep materials sanitized for at least 5 minutes before use

Testing and release of material • External surface sanitization should be done for both material

and tools before and after sampling process. o Polybags containing the material / tools should ideally be

single use o Sanitized materials / tools should be left idle for at least 5

minutes before use

Dispensing & issuance of raw material & packing material • The dispensed material should be dropped off at material

airlock of manufacturing / packing area• Surface sanitization should be done (preferably with 70%

isopropyl alcohol) before accepting the material into the manufacturing / packing area

Shifting of Finished Goods / Semi Finished Goods to warehouse & dispatch of finished goods• All equipment (fork lift, hand pallet etc.) should be cleaned and

sanitized before and after every use, in line with existing plant procedures

WORKPLACE INFRASTRUCTURE & MECHANISMS TO AVOID CONTAMINATIONPhysical mechanisms to reduce transmission • Physical barriers should be provided where personnel might

come in contact with each other; e.g. different areas within the manufacturing floor and QC lab, during material movement, areas within the cafeteria. If provision of physical barriers is not possible, distancing protocols should be enforced

• Identify a room or area where someone who is feeling unwell or has symptoms can be safely isolated. In terms of the contingency plan, transfer to the identified health facility.

• Where feasible open windows and doors whenever possible to make sure the venue is well ventilated.


Cleaning & sanitization procedures• For common areas, the frequency of cleaning and sanitization

should be increased, especially for areas with highest risk of transmission (i.e. areas with maximum personnel movement), such as corridors, change rooms, cafeteria, wash rooms

• All materials used in production processes should either be sterilized or surface disinfected while transferring in from outside areas

• 'Deep-cleaning' procedures should be established for critical areas in case any contamination / infection is suspected or observed.

Tracking employees’ health & contact with other employees• All essential and non-essential employees and contractors

entering the premises should be explicitly tracked and recorded

• Basic monitoring data e.g. body temperature should be regularly logged and recorded. Any deviations should be reported, and appropriate action should be taken

• Tracking of personnel gathering at common places should be carried out separately at respective areas, such as in canteens, change rooms.

• All employees are to log at least daily if close contact has taken place between different employees from different work-teams so in case of a potential infection, it is possible to identify who to quarantine

• Details of all external personnel (such as community stakeholders, government representatives, personnel from the media) with whom employees may come in contact with, must be appropriately recorded and shared with leadership and relevant stakeholders

• A dedicated quarantine / isolation room should be provided at each site to isolate suspect cases until they are transferred to home quarantine / hospital

Assess risk and response from official health authority channels regularly • Employers should routinely monitor updates on risk and

response on official channels of health authorities (e.g. MOH, WHO, CDC, local health authorities etc.).

• Additionally, local site leadership to collaborate with these agencies to ensure employee safety at plant and during travel (e.g. support in creating curfew passes for relevant employees)

Update policy and communicate with all personnel • Situation should be monitored on official channels at least on a

daily basis and governance mechanism should be put in place for quick reaction to emerging situation on plant operations

• Communicate the change in policy with all employees through an emergency notification system to keep employees on top of latest news (e.g. through text Messages or emails)

COLLABORATE WITH LOCAL HEALTHCARE PROVIDERS FOR EMPLOYEE CARE

Agreements / arrangements should be put in place with local healthcare providers - physicians, hospitals for immediate action to be put in place if employees need assistance or indicate symptoms for COVID-19. Take updates from verified media & adhere to guidelines/notification from local authorities. Facilities should be put in place for incident reporting, quarantine, health plan hotline etc. to provide access and support to employees



PHarmaCy exPerieNCes iN iNdia iN sars-Cov-2Raj VaidyaCommunity Pharmacist, Hindu Pharmacy, Panaji.

In India, pharmacies and pharmacists have hardly ever been projected/included as part of disaster management plans or teams. The preparation for a COVID-19 pandemic was certainly beyond anyone’s disaster management plans and dreams. And so was the pharmacy profession and trade in India. Formal induction and training of retail pharmacists and their staff in disaster management has never been heard of in the country.

Living with the pandemic is no doubt an eye opener for all, and I shall try to pen down some of things which affected the community pharmacy. Media and social media has allowed me to get in a lot of insight into the happenings and situations and this article is based on these readings as well personal experiences in my battle zone – my community pharmacy. And of course, India being a huge country, a lot more a lot more experiences may have been missed.

Pre-lockdown (India) – disruptions and anxieties:While we all eagerly watched how China was affected, and how

day by day the cases popped up in different countries, and numbers rose, the hope was that it should not affect our country, our state, our city/village. Did the low number of cases in the country make us complacent - “we won’t be affected”? A variety of opinions, theories mixed with rumours of hot climates, good immunity of Indians, BCG vaccination, preventive homeopathy, mystic powers, etc. flooded the social media, and left everyone into a tizzy and a state of confusion. A strong sense of reality hit as numbers started to slowly creep up in India too, and then came the announcement of the one day “National Lockdown”, shortly followed by the 21 day, and then extended to 40 days.

Information started spurting on social media that the disruption in China was likely to affect the availability of medicines in India - since we depend heavily on China for imports of APIs. This created anxieties amongst many patients, especially those who were on medicines for chronic illnesses – and a common query to the pharmacy staff was whether they should buy adequate stocks and keep – just in case there were shortages in the coming days. Pharmacy staff had no concrete answer, but did their best to soothe the anxieties of patients.

There was information flowing around that pharmacies have started stocking up, but there is no study or concrete evidence or documentation of this. Since there is no system built up by which

even the authorities can track or have a quick overview of the stock positions in the supply chains in the country. Doing this for 8 Lakh + stores for the huge number of medicines (unknown number of drugs and FDCs), is presently next to impossible.

During lockdown (India) – disruptions and anxieties:The lockdown announcement was quite sudden, and brought

with it multiple challenges for both pharma distributors and pharmacies:1. Public transport halted: The biggest impact of this was on the

staff working in pharmacies and pharma stockists. Those who were solely dependent on public transport could not report to work. Getting transit (curfew) passes was a new thing for most people, and there were hurdles in getting it done. Many of them were refused from proceeding to work (and in some cases assaulted), even though they were eligible to travel to work. AIOCD had to resort to writing letters to authorities of various states to ensure that this does not happen again and pharma staff are permitted to proceed to work.

2. Fear of COVID-19: Some of the staff did not report to work for other reasons - worried that they would afflicted, family members did not permit to go to work, or they had young kids or elderly/sick at their homes. The Govt. also had made a clear announcement when going into lockdown that the owners cannot terminate or stop salaries to those who could not report to work.

3. This put a heavy burden on those staff reported to duty: Those who stayed nearby and could walk to work, or were having their own vehicles joined work. Same came along with their colleague on 2 wheelers, while some were dropped to work by their family member and then collected after working hours. It is indeed commendable that these workers in the pharmacy and pharma wholesalers came to work in spite of knowing all the risks, and especially with positive cases being found in their state/city/locality. And especially those in the hot spots. Some pharmacies in some pockets remained closed for varying number of days, because of their personal difficulties in doing so – age factor, co-morbidities, reliance on staff to operate, etc.

Shortage of manpower: This meant various things for the pharmacy staff:1. Less staff had to handle the heavy load of rush, especially

for the 1st few days of lockdown as patients rushed to get their medical supplies. The timing of the announcement for lockdown was such that it did not give any time to patients to get their stock of medicines beforehand. Of course the announcement said that pharmacies will remain open, but nevertheless, there was panic to buy their supplies for at least a month, and some tried to buy for 2 or 3 months.

2. Most pharmacies usually try and keep inventories in control to manage their business, and increased demand in medicines was not easy to cater immediately for all. Many pharmacies depend on daily ordering and purchases, especially for

Raj VaidyaRaj Vaidya is Practising Community Phar-macist for past 30 years at Hindu Phar-macy, Panaji. Currently Editor of E-Times, a bi-monthly publication of IPA – Community Pharmacy Division (CPD), he has been Vice President & Chairman, IPA-CPD (2006-12)

& Fellow of IPA. Raj Vaidya has been proactively involved in up-gradation of pharmacy practice in India through writing, train-ing and advocacy.

Article


certain products. There being a large number of brands in the Indian market (some estimates say 1.5Lakh+?), and heavy competition amongst the marketing by companies, it is not easy to predict stocking quantities many times.

3. Pharmacies have multiple functions which cannot stop even when there are staff shortages – dispensing process (including billing, packing and taking cash), daily stock ordering, receiving and checking goods, feeding of invoice in the software, putting goods in place, basic cleaning, answering queries of patients in-person and over telephone, etc.

4. In the mad rush, ordering took a back seat. Besides, many stockists themselves were also working below capacity because of staff shortages. Deliveries to pharmacies were thus hampered, and pharmacies could not always move out to bring supplies from stockists. Stockists generally compete with each to provide services to retail pharmacies, which includes door deliveries, immediate deliveries. In this hour of crises, all that was hampered. Some stockists were closed, some operated only for few hours every day, some could not offer deliveries for a few to many days.

5. There was sudden additional demand for other items - sanitizers, masks, disinfectants, hand washes, soaps, toilet paper, etc. In addition, there was unexpected demand in pharmacies for oats, powders for health drinks, milk powder, sanitary pads, biscuits, shaving aids, etc. – because in certain pockets of the country the groceries or super markets were either closed or had huge queues for buying. In addition, since the immune system was what the new virus attacked, there was lots of advice floating around on social media to boost one’s immune system. This also included promotion of ayurvedic and homeopathic products. This resulted in additional demands for Vitamin C tablets, Chyavanprash, Guduchi, Amla, ayurvedic immunity booster proprietary products, etc. This also increased the burden and workload in the pharmacy, and sales as well.

6. Demand for pet foods increased, and the stocks in pharmacies disappeared in no time.

7. Pharmacies soon noticed shortages of various stocks with the stockists. Perhaps for various reasons - probably because some retailers had bought extra, which in turn could be because patients had bought extra (Appeals were subsequently sent out by chemist associations asking pharmacies to limit to one month supplies to patients). And at the same time, supplies to stockists were hampered because of lockdown, transportation delays and blockades, closure of some transportation godowns. Yet, it is hats off to the supply chain to do its best in challenging times, with so many hurdles, to keep the supply chain unbroken. Family members of the owners of both stockists and retailers too joined hands in covering up for the staff shortages.

8. There were incidences of pharma manufacturers working below capacity, as they too had staff shortages. In some places, pharma manufacture was permitted, in some places it was not. In some places, pharma units were shut down because positive cases were found amongst workers. The medicine shortages issue is likely to trouble us on and off.

Home deliveries of medicines:The Ministry of Health, on 26th March, 2020, issued a

notification by which a pharmacy retailer could sell and do home delivery of medicines, including those under Sch H, but subject to conditions: a. Sale of Sch H shall be against receipt of hard copy or email of

a prescription. b. Register your Email id with the licensing authority if prescriptions

are to be received by email.c. The drug delivery can only be done within the same districtd. In case of chronic diseases, the prescription shall be dispensed

only if it is less than 30 days old, and in acute cases, if it is less than 7 days old.

e. The bill or cash memo shall be sent by email to licensing authority and records of all such transactions shall be maintained by the licensee

f. Home delivery of medicines was not permitted for medicines in Sch H1, or Sch X, or controlled substances.

The above order, taken out as part of the strategy to keep people at home, and reach medicines to those who cannot come out. It is known that prescription medicines are often available without a prescription. In addition, in India, home deliveries of medicines have been very commonly happening. The above order gave some legal sanctity to it. However, many pharmacists raised several questions relating to online pharmacies, who, in spite of no regulation in place for the past 3 years were allowed to carry on, and now, while allowing home deliveries for brick and mortar pharmacies, rules are being put down…

Since many doctors are not practising, patients would have difficulty getting prescriptions for their chronic conditions, if their earlier prescriptions are already beyond 30 days? The content, format for a prescription has not been modified for decades. There is no legal format for telemedicine in the country, there is no format or guidelines in place for sending a prescription by a doctor to the patient or the pharmacy directly, or to both.

The legal sanctity of the order allowed the drug regulators of various states to encourage the pharmacies to do home deliveries in this hour of crises, and regulators worked in tandem with the chemists association in various regions in this hour of crises to give sufficient publicity of this activity to the public so that they do not panic, and are able to receive their medicines without moving out of the safety of their homes.

Challenges faced by patients: a. Many patients, elderly or their family members could not go

out. They had to depend on someone else or on home delivery of medicines. At times, certain medicines are not available in some neighbourhood pharmacies, so they have to be procured from pharmacies who are at a distance. Many pharmacies could not do home deliveries, especially in the initial stages, because they were short staffed.

b. In the initial few days of the lockdown, there was a lot of panic amongst patients as they were worried for their medicines. Many rushed or sent their family members/friends/acquaintance who could move out during lockdown to bring their quota of medicines.


c. The queues were big because the many/most pharmacies were short staffed, and also in came the new norm of social (physical) distancing.

d. Many patients on chronic diseases s get their free medications from public health centres. Medicines of many patients are available only in specific localities or pharmacies. Many such patients had a, because they could not get the same “brand” of medicines. Many were convinced and many were not convinced to buy alternate brands. A lot of precious time, and energy, was spent in the bargain of all those involved. And anxiety of course – including of the lockdown restrictions.

Protection and safety of Pharmacy staff:News kept flashing on media how the numbers were increasing

in other countries. And how the frontline workers were affected, how there were casualties. How badly Italy and Spain were hit, and then the USA. Soon news came in that pharmacies in few countries were effected, a few passed away too, due to COVID-19. All this created a sense of insecurity, panic amongst pharmacy staff back home in India, especially in those cities, areas, where the numbers of patients were steadily rising. Soon we heard news of some cities, or locations in India being completely cordoned off, due to rising cases. The pharmacy staff working these areas were also fearful.

Pharmacy staff in various countries innovated, and started taking various measures to protect themselves: wearing a mask, and in addition, some used hoods/shields of transparent acrylic to further protect their eyes and face, hair cover, gloves. Some innovated by putting plastic sheets in front of their pharmacy counters to protect themselves. Some directives stated to disinfect the supplies received from stockists before the supplies were taken in the pharmacy.

Pharmacies in India too took various safety measures, some indigenous ones: Besides wearing masks, some starting wearing aprons, and some began using hair covers. Since many pharmacies are small, some of them did not allow clients inside, and made them queue outside the pharmacy, maintaining physical distancing (1 metre). Some of them put barricades in front of the counter to keep the clients at a distance, while some used strings to make such a barrier. Many of them drew squares or circles 1 metre apart, on the floor/footpath to indicate where clients should stand in a queue. Medicines were dispensed through a dispensing window or by keeping a distance from the client. Facilities to use hand sanitizers was provided to clients visiting the pharmacy – to use them before entering and after leaving. Pharmacies put up their own handmade or computer printout posters to educate, guide their clients to follow the new set of norms which cropped up under the new circumstances. Besides, basic in-house training was provided to their staff.

Battling unexpected situations:Hydroxychloroquine (HCQ): As the numbers of suspect and

confirmed slowly started inching up, the first to be alerted to use HCQ as a preventive were the medical professionals. By then the ICMR had issued guidelines for its preventive use for frontline workers. There was quite a rush by doctors in public hospitals to acquire the 400mg tablets of the drug. The respective departments managing the public hospitals procured their stock of HCQ directly from the wholesalers

to give it to their frontline workers. Those who did not get it resorted to picking it up from the private pharmacies. All this created temporary shortages with the stockists and pharmacies.

Many consumers got hold of information through social media that HCQ could be used for prevention, treatment of COVID-19. Pharmacies received phone calls and queries across the counter asking for HCQ. There were understanding, and the not-so-understanding clients, when pharmacists explained the real position about the use of HCQ.

And there were many patients who were on HCQ for their RA (and lupus, etc.) and using it regularly to keep their symptoms in control. This sudden shortage of HCQ made them panic. Some of the patients complained that while earlier they could buy refills for their HCQ without a prescription, some pharmacies were giving them now and insisting on a fresh, hard copy of a doctor’s prescription. This is because the CDSCO had come out with a notification on 25th March, 2020, and shifted HCQ from Schedule H to H1 category. While the intention of the CDSCO order was good, and it gave a stern message (which was further endorsed and circulated to respective pharmacies by state drug control departments), the order did not consider the following aspects:1. It did not give any guidance of what was to be done for patients

who have been on HCQ for some time now for their RA, lupus, etc. Whether any discretion was to be used by pharmacists in dispensing them to patients was not specified

2. Patients were not aware of this change, and it worked up their anxiety and anger on pharmacies who did not dispense. Many patients were not able to produce fresh prescriptions, and also stated that their doctors were not accessible in this lockdown time.

3. Different pharmacies may have used different yardsticks, because there was no sure shot solution to such a problem. Pharmacies used their own discretion in giving or refusing patients of their regular supply of HCQ.

Availability of drugs for ICU Management of COVID-19: As the country further planned its emergency preparedness a new order was issued by the CDSCO, in mid-April 2020. It asked all drug regulators to ensure that a list of 55 drugs needed for ICU management of COVID-19 were available, in sufficient numbers across the country. This list included vasopressors, emergency cardiac drugs, injectable sedatives/muscle relaxants, injectable antimicrobials, injectable anti-epileptics, IV fluids, and some other drugs. Some of the drug regulators forwarded the list to all the pharmacies in their region and requested for a weekly information by Email of how much of these medicines they were holding.

The media reported the next day about this, and it read that the Govt has asked all the pharmacies in the country to stock all of these 55 drugs in sufficient quantities. The reality is that many pharmacies even in the cities and metros do not stock most of these medicines. That is because most of such medicines are either stocked by hospitals or their pharmacies, or at the most by pharmacies close to hospitals. Making all these medicines available in all the pharmacies in the country is next to impossible. This is just an example of the chaos that the pandemic has created.


Restrictions to sell medicines for fever, cough and cold: In certain hotspots (in different parts of the country), with high positive cases of SARS-CoV2, the District Collectors, the police or the drug administration issued guidelines (and then orders in certain locations) to pharmacies in their jurisdiction to dispense medicines for cough, cold and fever strictly, only against the prescription of a doctor (The names of the medicines were not listed by the authorities). Pharmacies are also been asked to send a daily report to the local drug regulator and the police on Email/WhatsApp of the details of the medicines sold, the details of the patient and details of the doctor who prescribed. And further, to take down and send the details of any patient who comes to the pharmacy asking for medicines for cough, cold or fever, or who shows any signs or symptoms of these – to the police, and FDA, and also direct the patient to visit the nearest flu clinics/govt clinic/hospitals in the locality.

The reason behind the move was that patients were hesitant to self-report of COVID-19 symptoms, and were not going to hospital clinics – and could try to self-medicate. These were stringent measures put in place by the various administrative heads to try and trace as many suspects of COVID-19 to stop the spread of the virus.

In addition, various Guidelines/directives were issued in various locations/hotspots, in specific areas where there strict curfews, to restrict the moving out of people from their homes. The administration restricted/reduced the timings of opening of pharmacies, so that with shortened duration, there would lesser movement of people, and reduce the risk of spread.

Recognition of COVID warriors: Of course, in India too, there was a lot of praise for the frontline workers in the battle against COVID-19 – the doctors and nurses. And those working in the hospitals, and the policemen, and sanitary workers, and so on. However, pharmacists, and those in the medicine supply chain staff are no less of COVID warriors. They too have played a very big role in ensuring that patients gets their medicines, guidance with the touch of care and concern.

In the pharmacy world also have to come to terms with the huge new changes the pandemic will bring about, and should do a massive rethink on various aspects. The pharmacy profession in India has to change gears and surge ahead – to improve the knowledge and skill levels of pharmacists on the front line, use of technology, and also equip them with disaster management skills.

Awareness of Pharmacy services and PharmacistsNow a days we all are fighting against the COVID-19 pandemic. Pharmacists are engaged in different sectors of pharmacy profession and are playing their crucial role in different capacities. Particularly hospital pharmacists are working in hospitals with doctors and nurses & other health care members and also community pharmacists are supplying medicines to masses through their pharmacies in this crisis. Also manufacturing, QA & QC pharmacists are producing medicines in drug industry even in this crisis to ensure availability of medicines in market. Regulatory (Drugs Control) pharmacists are ensuring legal compliance and availability of quality and standard medicines and medical devices in market. Further, few of our research pharmacists are engaged in searching medicines to fight COVID. It is also remarkable that two hospital pharmacists were in the team with Doctors who were subjected to stone pelting in Moradabad in UP in 3rd week of April.Hope we would get success in fighting against the COVID-19 pandemic. But it is surprising to note that our pharmacy services and pharmacists are not popularized /recognized among masses as it should be. In television discussions or even our Hon'ble PM and many CMs and many leaders are not aware of our services. Our community pharmacists’ services are referred to as ‘dawa dukandar’. The name of hospital pharmacists is not uttered where as they are engaged in hospital with physicians too and they are working day and night without recognition of their work.On introspection, it is noted that we could not establish our image among masses and leaders and government officials though we the Pharmacists are engaged in such vital services of health care. We have celebrated NPW more than 50 years, our pharmacy education is more than 85 years old. Hence once again we have to take following measures after winning the COVID fight:

1. Promotion of Pharmacists Qualifications Availability of different categories of qualified Pharmacists i. e. D.Pharm., B.Pharm., M.Pharm., Pharm.D. and Ph.D. in pharmacy .

2. Amendment in Drugs and Cosmetics Rules for retaining only one category of retail Drugs Store 'Pharmacy' having presence of qualified pharmacist only. All other categories need to be deleted. For villages, restricted licence may be permitted on seeing village conditions

3. In community pharmacy actually we are not playing professional role. It is a fact that Community pharmacy is a profession and not a trade but it is totally in the hands of traders. We community pharmacists, have to work as pharmacy professionals and to provide pharmacy services at pharmacies. All should start pharmacy practice as provided to us legally by PPR 2015.

4. All Community and Hospital pharmacists should wear apron with nameplate designated as Pharmacist with name and emblem.

5. Patient Counselling is to be started in each hospital and pharmacy.

6. Celebration of NPW is to be reformulated. It should be celebrated in each hospital inviting all doctors, dignitaries of that area, media and display of posters in hospital. Also posters are to displayed in each pharmacy and some special services may be provided during NPW to patients/customers to popularise us.

At State level we should invite Minister, Health official, media, HOD of all Medical Colleges /hospitals Principal of all schools and colleges etc to actually popularise the profession.Dr. R. N. Gupta, Fellow IPA, Eminent Pharmacist Chairman- IPA HPD & Vice President, IPA

Letter to Editor


emBraCiNG 4.0 iN PHarma aCademiCs: way ForwardDr. Richa DayaramaniPrincipal, Khyati College of Pharmacy

The recent global scenario in the wake of COVID – 19 outbreak has brought a sea of opportunities clad in the form of challenges for pharmaceutical industry requiring healthcare concerns in terms of both service as well as manufacturing sector. It drew our attention towards the fact that this is high time we come out of our comfort zones and prepare ourselves to address and foster futuristic needs of healthcare both for goods as well as for service industry. The technical and professional pharma education sector stands on the fact that we have to cater the needs of the industry by providing them trained and qualified manpower to suit their dynamic requirements. The focus of pharmaceutical education outcome is more placements oriented unlike humanities and other academic sectors. As the demands of industry are not static hence it implies that the academic deliberations are bound to be dynamic in nature. Of late, we are experiencing an interdisciplinary and multidisciplinary approach involving basic sciences and application sciences to come up with innovations and breakthrough in research and technology together. On a global level there is a change being witnessed which is forcing our academic fraternity to update, review and revise itself to keep pace with the current industrial needs. This communication is aimed at reviewing the present status of pharma education with respect to industry 4.0 scenario and way forward to overcome the challenges of outcome based learning via academics 4.0.

CONCepT OF 4.0 FOR bOTh iNDUSTRy AND eDUCATiONIndustry 1.0 refers to first industrial revolution comprising of use

of steam and hydropower based machines to produce goods and commodities that were prepared by hand or manual operations. The machines were simple and there was a requirement of manpower or labour to operate them and carry out other operations. Industry 2.0 was marked by usage of modern production lines comprising of electrically operated machines. The requirement of labour was less but there was a need of trained manpower to operate them and handle the operations. The production scales were massive and it was a period of great economic growth. Industry 3.0 dawned in the late 20th century and is often known as 'Digital Revolution'. With extensive use of computers and immense industrialization along with technological advancements, there was a significant growth in communication technologies with the supercomputer. Machines started to abrogate the need for human power in life although productivity, consumerism and technological advancements were in the peak levels.

The term Industry 4.0 or simply I4, originated in 2011 from a project in the high-tech strategy of the German government, which promotes the computerization of manufacturing. The basic four components of the fourth industrial revolution are interconnection, information transparency, technical assistance

and decentralised decision ability of cyber physical systems to perform their tasks almost autonomously. To summarize, the I4 comprises of technologies like IoT, mobile devices, location detection technologies, advanced human machine interfaces, 3D printers, smart sensors, augmented reality, big data analytics and advanced algorithms, multilevel customer interaction and customer profiling, cloud computing, cognitive computing etc. The fourth industrial revolution is changing the world around us. Artificial intelligence (AI), robotics, big data and the internet of things (IoT) will combine to impact on jobs and industry. From diagnostics to patient care optimization and security automation AI is changing the world and the way we live. In order to make healthcare more cost-effective, accurate and rapid latest machine learning technologies are being used by the industry. Albert Einstein said that “Education needs to be aligned with the fundamental changes in the nature of work and address the issue of employability.”

With ever changing times the concept of how a university should be and how it should function has also changed especially in the last 30 years after the introduction of privatisation in education.

'Knowledge Economy' a term coined by Peter Drucker (1969) in his book 'The Age of Discontinuity', discerns four major areas of discontinuity –(1) The impact of the new technology on the industrial structure(2) The shift from an 'international economy,' to a 'world economy'

which as yet lacks policy, theory, or institutions(3) A new socio-political reality, embracing business, government

and other pluralistic institutions, which poses drastic political, philosophical and spiritual challenges

(4) The rising importance of knowledge and of formal education, with resulting implications for work, life, leisure and leadership.

The education system in India has evolved from Education 1.0. (home schooling and primary methods of teaching), Education 2.0 (providing education on mass scale with the teacher as the knowledge provider and the student as the passive recipient), Education 3.0 (use of computers and internet in teaching and learning, which helped in increasing access and equity) and Education 4.0 (high-speed internet, mobile technology, social media platforms etc. facilitating personalized learning anytime anywhere and redefining the role of teachers as facilitators and mentors). Currently we are in a state of massive transformation from Education 3.0 to Education 4.0, where the focus is on student’s learning outcomes. The primary focus areas of delivery are employability, student engagement and experience, research excellence and society including industry responsibility.

Dr. Richa DayaramaniDr. Richa Dayaramani (M.Pharm., PhD) is currently Principal at Khyati College of Pharmacy, Ahmedabad. She has 15 years of teaching along with 5 years of industry experience and was awarded the 2019 PC Kharia APTI Best Principal Award.

Article


PRESENT SITUATIONAccording to a survey report by the British Chambers of

Commerce in April 2018, it was realised that 75% of the businesses were facing a shortage of digital skills in their workforce. Now this is the realisation of business firms in one of the most advanced countries so India can also anticipate the same by now. As defined by Cornell University, digital skills is the ability to find, evaluate, utilize, share and create content using information technologies and internet. The industrial requirements are changing at a faster pace than what we educators perceive. The recruitment models have changed from 'Hire, Train, Deploy' to 'Train, Hire and Deploy' and work outsourcing or contract employment which drastically reduced the deployment time from 6-8 months to 15-30 days.

According to a study by Mc Kinsey Global Institute, out of 750 occupations, nearly 75% are highly susceptible to automation. This means that in near future several skills will become futile and dead along with mass unemployment if newer skills are not embraced by the job seekers and the educators.

In present times universities need to think about more evolved forms of brick and mortar universities. They should offer courses with technological disruptions, learning freedom with respect to subject, content, time and place. The courses should enhance the learning experience of the students. This need of near future is raising a big question upon all of us as educators: Whether we are ready and what is our readiness to prepare the future generations to thrive in this changing landscape? The future work generation requires skills such as problem solving abilities, creative thinking, digital skills, team work and leadership by example and not by authority. The present education system of teaching – learning hardly has any emphasis on imparting these. Students are exposed to such abilities only during their professional journey or professional studies but by that time their attitude belief system becomes cemented and there is not much room for new adaptations.

It is high time we focus and revamp the pharma education system right from delivery techniques, mentoring techniques, futuristic subjects and content to make it future ready so that our students are suitable to the demands of industry 4.0 and beyond.

TWiNiNG phARMA ACADeMiA WiTh phARMA iNDUSTRy 4.0India’s re-skilling challenge can be met through an evolved

understanding between the three links of this chain: the industry, the jobseekers and the universities. With the right learning environment, professionals in this country will always find themselves equipped enough to handle the jobs of the future. To take full advantage of the opportunity created by advanced technology we need a similar revolution in education – not just to meet the needs of industry, but also to ensure the best possible student experience, use of staff time and investment in infrastructure and facilities. Students look after a combination of instructor-led educational model and learning from own resources at own pace. They want enhancement of employability skills along with academic excellence. There is an urgent need for collaborations of industry and universities / institutions. The curricula have to be dynamic in nature (that changes with the changing requirements of industry or employer). We have to work with universities to design and deliver the technological solutions for a future-proof student experience that can also help tackle the big challenges in higher education. Choice based credit system (CBCS) enables students to choose courses even outside their program but it is yet to enter into Indian education system in true sense as there are too many regulatory and governing limitations. It is no longer a

one-time course/degree that can ensure life-long employment, but a continuous endeavour towards up-skilling that can achieve it. The responsibility of universities today is to ensure two things: 1. Students should possess hard and soft-skills to be ready for

their jobs. 2. The students must have necessary attitude to become a lifelong

learner.

This can be achieved by universities offering a continuous, comprehensive learning system, which, besides offering programmes to provide the right skills for the start of a career, also provides for re-skilling students while they are on the job.

Research is an important vertical in pharmaceutical academia and industry and inducing the right skills for creating a competent research workforce is the need of the hour. Such content will enable switching between online, blended, or on-campus courses that can suit various learning styles and learner preferences. These can then be offered as learning credits be it for award of a degree, or for shorter certifications. Focus shift from 'learn and do' to 'learn by doing' in a manner that makes the students to work on industry projects supported by learning resources content, courses and faculty as mentors. Such self-paced, credit-based, and on-demand education will promote a pool of professionals, eager to invest in learning. This model can create a viable ground for academia-industries partnership.

WAY FORWARD The good news is that Industry 4.0 cannot exist without

academics 4.0. Modern learning cannot take place without modernizing the delivery. Faculty 4.0 needs to be updated with curriculum 4.0. Teachers should focus their efforts on using technological applications that support and enhance cognitive learning abilities. Learning outcomes should be based on personalized adaptive learning techniques. Intelligent digital assets and teacher – student interaction should guide teaching concepts. Teacher – student interaction should be based on a smart approach to make the whole experience engaging and interesting. There has to be a greater flexibility in choosing their mode of engagement. This would be supported and enabled with the help of technology. Such newer forms of learning models would become important to develop a holistic view of learners’ engagement and progress.

Indian education system is no exception to equip itself with futuristic education delivery and assessment techniques to build a workforce for enterprise 4.0 by preparing a robust professional framework. Career planning in a rapidly changing world will be based on inter disciplines that are more advanced and futuristic.

Some examples of inculcating technology based delivery are:1. Modern techniques such as Machine Learning (ML) can be

used for granular assessment of student progress and provide valuable insights into a student’s strengths and weaknesses. Fair and transparent student evaluation using different machine learning algorithms can be utilised by mentors. The final grades of the student can be predicted and the prediction results can be utilised to mentor the students to achieve better grades.

2. Transformed teaching – extensive use of Artificial intelligence (AI) models and augmented reality based demonstrations (AR) in Program Educational Objectives and Program outcomes

3. Mixing campus-based and distance learning on a module-by-module basis

4. Using learning analytics as a tool for tutors to develop a holistic view of learners’ engagement and progress


5. Faculty of the future needs to have a blend of academics and practice. So, merely an academic qualification like PhD or being an all throughout practitioner will not help. The future faculty has to have a blend of both in order to develop their own learning and teaching pedagogy

6. Inculcating technology and innovation in research - Novel ideas in the development of drug delivery till the level of proof of concept can be initiated that are developed in the academia and later can be taken up by the interested industry partners

7. More Train the Teachers programs for preparing the task force to deliver the curricula 4.0

8. Like evidence based medicine, concept of evidence based learning can be initiated

9. The industry lacks the cognitive workforce but has a huge investment and ready research infrastructure where as the academic institutions lack the latest research infrastructure. Thus more research collaborations and twining projects can be taken up to have an efficient delivery and a win-win situation for both stakeholders. This will also ensure that the students are exposed to real research environment.

As put forth by Bill Gates “The first rule of any technology used in a business is that automation applied to an efficient operation will magnify the efficiency. The second is that automation applied to an inefficient operation will magnify the inefficiency.” We should also not forget the risks associated as technology can sometimes create perverse incentives, such as the reduced student engagement seen when lecture capture is made available online and it is no longer necessary to attend lectures in person. Having a 100% digital education is not an all-inclusive solution, nor should it be the only method of teaching in use. However, benefitting from ‘hybrid education’ can only happen if teachers’ digital skills are encouraged and implemented through experimental collaborations and partnerships with tech industries.

Government’s initiativesFortunately, recognising the need for an overhaul in the

education system and build a talent pool, the government too is introducing measures to meet this goal. For instance, the Life Sciences Sector Skill Development Council (LSSSDC) has been established by and for the life sciences sector in India, to address the skill gaps across functional areas and levels in the sector, by helping to generate a sustained stream of high quality skilled individuals. Pharmacy Council of India (PCI) has collaborated with LSSSDC and constituted a working committee to develop electives oriented to nurture the learners according to current industrial requirements. Many Universities are now adopting the MOOCs (Massive Open Online Courses) – for example 'SWAYAM' initiated by the Government of India to provide online teaching and learning resource to all. Academic research, Management Development Programs and Consulting are of paramount importance for the future Universities. USFDA in 2018 permitted the marketing of first AI based medical screening device which does not require a clinician to analyse the findings.

exAMpleS OF eDUCATiON 4.0 iN ACTiONSome of the following trends are being used around the world

in futuristic and progressive universities: • Teaching transformed – How should human teachers focus

their efforts if AI and other technologies become used to their full potential in the university experience?

• Personalised adaptive learning – An individualised approach that takes learner diversity, performance and behaviour into account

• Assessment re-imagined – Can AI, digital experiential learning and micro-credentials replace high stakes summative tests?

• Intelligent digital and physical estates – This concept is responsive to student journeys and interactions, helping universities deliver efficiencies and a smart approach to campus design

• An award-winning Chatbot in Leeds where by using AI and Chatbot technology, a Chatboat named Becky provides an instantaneous response and information to prospective students going through clearing

• Northampton’s blended learning where Active Blended Learning provides a learning environment where students play an active role and are given the opportunity to engage in a variety of ways in and outside the classroom, in the field, in the lab, in the studio and in the workplace. Those study modes are fully integrated into a proper blend, not different strands of a course running in parallel

• A reason to be proud of is provided by Indus International School of Bangalore where Eagle 2.0, a humanoid teacher assistant is working along with teacher (human mentors) to deliver the lessons

• With the COVID – 19 outbreak online teaching is introduced and utilised as a tool of crisis management in school and higher education with the help of various platforms like Google classroom, Zoom cloud meeting, A-VIEW, GoToWebinar, Facebook live etc. Teachers and students have started exposing themselves to online videos, online submission of assignments and assessment systems

CONCLUDING REMARKSPharma education 4.0 is in response to the Industry 4.0

and shall define the University of the Future. Industry model is based on sound authentic delivery and not mere lip service. In pharmaceutical education, building a robust industry interface is the most critical differentiator criterion.

The critical indicators of the level of industry institute interface are the number of joint research projects taken up in association with industry, the number of field cases authored by faculty, the number of live cases that students take up with industry, the number of open management development programmes (MDPs) conducted, the number of consulting projects taken up by faculty and the revenue generated from them, and the frequency of revamping the curriculum and periodic assessment of its relevance apart from the existing practices of mere public relations work done by organising guest lectures and seminars. The scope of involving and integrating tools of artificial intelligence, augmented reality, robotics and mechatronics with the practical deliverables need to be assessed and opportunities to be created for the same. Universities and institutions should explore the opportunities for collaboration with other institutions and industry to satisfy this requirement. The wealth of knowledge too has to be not weak or superficial and the world needs distils of reliable knowledge, not mountains of unemployable research and casuistry-laden publications. Governance and politician’s control have to become honest enough, only then looming societal challenges shall face redemption. Although the present situation has exposed the teachers and learners towards use of technology but these are just baby steps towards a bright and futuristic pharma education.


aN iNterNatioNal Crisis: loNG term imPaCt oF Covid-19 PaNdemiC oN HealtH Care sCeNario, worldwide PHar-maCeutiCal GrowtH aNd GloBal eCoNomyAnil Kharia*, Sapna Malviya1, Ankur Joshi1

*President, IPA MP State Branch, Indore1Indian Pharmaceutical Association, MP State Branch, Indore

ABSTRACTCOVID-19 is a disease caused by the new coronavirus, initially called 2019-nCoV, which is then experts from the International Virus Taxonomy Committee called it SARS-CoV-2. The World Health Organization had previously declared COVID-19 an international emergency as the disease is spreading at an alarming level affecting 199 countries and territories around the world.

The impact of Covid-19 has blocked down the United States, India and other countries, as well as increased the chances of rising costs of raw materials and drugs. 13% of branded and generic manufacturers are based in China. According to the FDA, as of 2018, 24% of the drugs and 31% of the medical ingredients have been imported from India. If the current situation continues, the cost of essential medicines could rise in the United States and other countries as well. This review document will emphasize the impact of COVID 19 on the pharmaceutical industry, education and the community.

KEYWORDS: COVID-19, Pharmaceutical Industry, Education, Community

INTRODUCTION Coronaviruses are important human and animal pathogens.

Identified in late 2019 as the cause of a group of pneumonia cases in Wuhan, a city in the Chinese province of Hubei. It spread rapidly, causing an epidemic in China, followed by an increasing number of cases in other countries of the world. WHO has officially designated COVID-19 as a pandemic belonging to β coronavirus, a large class of viruses prevalent in nature. Like other viruses, COVID-19 has many potential natural hosts, intermediate hosts and end hosts. In recent decades, India has become the world's pharmaceutical center, being the largest supplier of generic drugs worldwide with a 20% share in the volume of the global supply and 50% of the world demand for vaccines. The COVID-19 crisis has highlighted the contribution of the Indian pharmaceutical industry as a major exporter of hydroxychloroquine in several countries that can help save thousands of lives. COVID-19 is a health threat and is rapidly proving an economic threat. It could cripple several economies starting with employees and industries affected by stock market crashes and the closure of workplaces due to the inability of the workforce function. In India, the impact has not been fully anticipated, but as the Chinese economy stagnates, we can expect some sectors to be hit almost immediately. The COVID- 19 has impact on the economy affecting all sectors-Education, Manufacturing, Health Sectors, Trade and Transport and entire services (Fig No.1).

Fig No. 1: Impact of COVID 19 on Indian Economy

iMpACT ON The phARMACy iNDUSTRy [1,2,3]Escalation in cost of Pharmaceutical Raw material: The impact

that COVID-19 has created in China and cause lock down in India, the United States and other countries further raise the chances of increasing the cost of raw materials and drugs. 13% of brand and generic manufacturers are based in China. According to the FDA, as of 2018, 24% of the drugs and 31% of the medical ingredients have been imported from India. For example, the cost of acetaminophen in India has increased to Rs 400-450 per kilogram from Rs 250-300 per kilogram and the price of vitamins and penicillin has increased by 40-50% in India. If the current situation continues, the cost of essential drugs could also rise in the India as well as in other countries.

FDA policies: The impact of COVID, drug demand and lock down in several countries may force the FDA to allow relaxation in some areas, as the generic drug review process is long, the demand and shortcomings created can also force change minors. The Federal law requires the manufacturers to notify the FDA about shortages

Mr. Anil KhariaMr. Anil Kharia is President, IPA MP State Branch, Chairman of Modern Group of Insti-tutes & MD, Modern Laboratories and Nan-dani Medical Laboratories Pvt. Ltd., Indore. With B. Pharm and M. Pharm from Dr. Hari Singh Gour University, Sagar & M.B.A. from

Devi Ahilya Vishvidhalaya Indore (M.P), Mr. Kharia has been leading various other organizations.

Article


when the circumstance arises. The rules do not apply to medical devices since they are manufactured in multiple plants. The shortage of devices during the pandemic could force the FDA to rethink on device regulations. For example, to maximize the number of respirators available, the FDA and CDC recently announced that some respirators regulated by the CDC, but not by the FDA, may also be used.

Pharmaceutical Data and Analytics: Pharma industry has an enormous amount of data, which also brings in various challenges like Integrating Big Data, leveraging unstructured data, advance insights from clinical trials, data privacy, social listening. The cost of developing a drug is skyrocketing and the time required to launch a drug is also high. The industry has been using data for years, but the challenge lies in leveraging its full potential. Numerous clinical and molecular data available over the years can aid in predictive analysis, which can be used to accelerate the clinical trial process and drug development. Companies are leveraging data and analysis, but the current situation may want them to use the data even more efficiently for clinical trials, forecasts and marketing. Big data infrastructure and social listening will also play a key role. In addition to costs, the time required for development and clinical trials could draw more attention to real-world data (RWD). Almost 95% of companies are using RWD or will be using it by 2021. Data accessibility and security concerns are some of the challenges of using RWD, but they can be solved and will gain greater popularity as companies and regulatory agencies they can, from now on, try to introduce innovative measures in clinical trials. Clinical trials are gold dust for the pharmaceutical industry, but in the past, there have been cases where the drugs have been recalled even after FDA approval. The main problem with the clinical trial is that it observes a homogeneous population. To address this, FDA might relax the regulations on RWD.

Digital health is a cultural transformation of traditional healthcare: Digital health may be the next big news, as telemedicine/video consultations, videos and health-related apps are gaining popularity. Investments in online portals that help doctor-patient interaction will increase. For example, Wellmind Health (which offers online courses for awareness-based cognitive therapy) has seen a recent trend of increasing purchases and demands. Due to the current pandemic situation, NHS England has instructed UK hospitals to increase consultations on telemedicine / video. Meditation apps for calm and headspace have launched free digital offers to help people cope with panic and anxiety.

Import substitution centre and government measures to increase API production: The global COVID-19 pandemic has revealed the intricate interdependencies that exist in the international pharmaceutical market. China, the epicenter of the global epidemic, is also the world's largest supplier of active pharmaceutical ingredients (APIs), also known as bulk drugs. India, which is a major exporter of generic drugs worldwide, depends on China for over two thirds of its drug needs.

Estimates indicate that India provides up to 50% of the generic drug needs and vulnerabilities in the United States caused by COVID-19 causing disruptions in global pharmaceutical supply chains. Perhaps this is also a good opportunity for India to revaluate dependencies and plan for the future.

According to Indian government estimates, India ranks third in pharmaceutical production by volume and 13 in value. It represents around 10% of world production in volume and 1.5% in value.

This obvious discrepancy indicates the relatively lower price of Indian pharmaceutical products and the strong demand enjoyed in the global market. As a leading supplier of affordable low-cost medicines worldwide, India's role as a "global pharmacy" is well recognized by experts. So that the government can plan the import substitution industrialization to increase API production. The import substitution industrialization (ISI) industrial policy is premised on the realisation that economic development and more specifically, industrialisation can only be achieved by developing local capacity that is capable of substituting imports in order to reduce or possibly eliminate economic leakages.

Moreover, the import substitution industrialization is seen as a promoter to achieve economic diversification. In that, the mechanisms deployed in the implementation of this policy (reduction of tariffs on input resources, high import duties or locally manufactured goods, exchange rates differential, and eventual abolition of export duties) help the developing economies to garner the requisite industrial know-how to embark on competitive exportation of manufactured goods.

Indian Pharma to focus on import substitution: Indian pharmaceuticals industry is on path to improve its infrastructure and technical capabilities. The industry is now actively making efforts to work towards import substitution through a task force constituting various stakeholders that include government officials, Pharmexcil, manufacturers, CSIR (Council of Scientific and Industrial Research) labs and others. The task force is identifying top 100 imported raw materials and products. These products could be individually or jointly developed.

The Government should focus more on the idea of import substitution and lay the guideline for manufacturers regarding infrastructure, plant layout, economic viability, project reports and other associated know-how of the pharmaceutical industries.

The industry is expecting a healthy growth of 12-15 per cent CAGR in value terms and 10 per cent year-on-year growth in pharmaceutical exports this year, said, Pharmexcil chairman Madan Mohan Reddy, in Pharma Lytica Summit in Hyderabad on 20th April 2020.

As patents are expiring, India has a great opportunity. Indian industry can meet the global regulations and this offers substantial growth to almost about 15-20% growth annually in the coming years. Government is pushing for manufacturing that will help sustainability and address the import burden.

Government help for firms making import substitute products and Bulk Drugs [5]: India is far ahead of the world in drug production. However, the country still imports key raw materials, largely 53 active pharmaceutical ingredients (APIs) and basic materials (KSM) or intermediaries. To meet the Prime Minister's vision of ensuring national drug safety, the Ministry attributed Rs. 13.76 billion program to increase the production of medical and bulk devices.• The first scheme is helping states create three bulk drug parks

spread over at least 1,000 acres. The Center will provide aid through grants of up to 1 Crores. This amount will be allocated to various common structures such as solvent recovery plants, power and steam plants, distillation plants and effluent treatment plants. These structures are individually expensive, making internal production impossible. Common structures will help Indian companies keep production costs on par.


• The second scheme aims to provide incentives for incremental production during the base year of critical drugs. The government has identified 26 fermentation and 27 chemical based raw materials, on which India relies heavily for imports and has formulated a scheme to incentivize 20% for the first four years, 15% for the fifth year and 5% for the sixth year in incremental production. They have also identified 27 key chemical based raw materials for which an incentive rate of 10% will be provided during the six-year period of the scheme. These APIs largely contain anticancer drugs, antibiotics, anti-inflammatories and antidiabetic agents.

• The third scheme focuses on promoting the national manufacture of medical devices. It offers grants in aid to state governments to set up four medical device parks, at the cost of Rs. 100 million rupees each. The parks will have common facilities such as a test center, an electromagnetic interference laboratory, a medical-grade low vacuum modulation, a sterilization centre and electricity testing.

• The fourth scheme is to help medical device manufacturers. A manufacturing-related incentive scheme has been formulated to provide 5% incentives for six years to medical device manufacturers. An incentive scheme linked to production has been formulated to provide a 5% incentive in six years to manufacturers of medical devices in four categories: cancer treatment / radiotherapy, aesthetic and cardiorespiratory medicine, radiology and nuclear and all implants such as cochlear and pacemaker. During these years, Rs. 3.42 billion will be distributed as incentives to producers under the scheme. The government is also looking for additional production of medical devices worth Rs. 68,437 crores in the first five years and nearly Rs 19 billion of import substitutions per year, which will also help us export medical devices. Similarly, it is targeting an incremental API production of Rs 46.8 billion over the next five years and replacing imports of Rs 19 billion per year. These efforts will promote Make in India, the replacement of imports, exports and guarantee the safety of medicines.

iMpACT OF COViD-19 ON The COMMUNiTy [6,7]The coronavirus epidemic in China and other parts of the world

can have a direct and indirect impact on the Indian economy. Coronavirus spread across India in March and since then, India has over 2000 cases of COVID-19. After the outbreak of the most affected countries such as China, Iran and Italy in Spain, Germany, South Korea, the United States and the United Kingdom, the World Health Organization has declared that COVID-19 is a global pandemic. The rapidly spreading virus has a huge human cost with over 20 lakh patients who tested positive and a number of deaths that has crossed 1,36,000 since April 15, 2020. Maintaining the resources is necessary to fight the epidemic and flatten the growth curve, of the world. The economy is about to face a setback. China is an important player in the world market and, due to the way India integrates with the Chinese economy, will have a significant impact on the Indian economy. According to UNCTAD, the cost of the pandemic is $ 2 trillion. COVID-19 is a health threat and is rapidly proving an economic threat. It could cripple several economies starting with employees and industries affected by stock market crashes and the closure of workplaces due to the inability of the workforce function. In India, the impact has not been fully anticipated, but as the Chinese economy stagnates, we can expect some sectors to be hit almost immediately. On the contrast the opportunities for India in COVID-19 are stated below (Fig No. 2).

Fig No. 2: Opportunities for India in COVID 19

Mouth masks, disinfectants and hygiene products have become expensive: This is a direct effect of coronavirus outbreak in India. While the WHO discourages the accumulation of masks and disinfectants against pollution, the market may face strong demand that has already started as India reports cases in Rajasthan, Delhi, Telangana and Maharashtra. Currently, the principles in the N95 masks have been shot online. Sellers like Amazon and Flipkart are listing skins ranging from INR 499 to over INR 1,000. Some products are no longer available and some have 9,999 original prices with a significant discount. As companies rush to raise prices due to demand and healthcare sectors suffer from unavailability, it is not difficult to predict the scarcity of masks as people make their way to local pharmacies and shopping online to get their supplies. Likewise, hand sanitizers are installed in most stores,

The costs of medicines and medical treatment are expected to increase: The Indian pharmaceutical sector depends on Chinese raw materials. With the blockades in China, the supply route has been largely interrupted. The stock of raw materials for medicines will have difficulty reaching the Indian pharmaceutical industry. This is already affecting drug prices. According to CRISIL reports (via Business Today), the cost of common medicines like paracetamol, which is a common pain reliever, has increased by a whopping 40%, while 69% of Indian medicines come from China in bulk purchases. In addition to relying on the offer of the sector, we have not yet received concrete updates on the costs of treatment, testing and prevention of the spread of the virus.

Industries that depend on cheap labour could suffer a blow: As the Ministry of Family Health and Welfare prepares for a health emergency, Union Minister Harsh Vardhan announced a multi-step strategy to combat COVID-19. The plan calls for India to be quarantined by the rest of the world in terms of air travel. Returning foreign or Indian citizens will have to specify a compelling reason to enter the country if they are not on the diplomatic mission of the United Nations and WHO. At the state level, the government has been trying to curb community broadcasts since Section 2 of the Emergency Illness Act was issued by the Ministry of Health and Family. While immigration will be controlled, there are several parts of India that the government cannot even begin to evaluate. Cheap labor is a large part of the Indian economy. As the virus travels through the populated country, local broadcasts could increase the number of cases. Workers do not receive health care and employment benefits to treat the viral epidemic. Poor health is very likely to be affected by the workforce, which could result in a lack of assistance, which would further paralyze sectors that


are dependent on cheap labor. Containment becomes a difficult task.

CONCLUSIONCoronavirus spread across India in March and since then, India

has more than 12,799 cases of COVID-19. After the outbreak in the most affected countries such as China, Iran, Italy, Spain, Germany, South Korea, the United States and the United Kingdom, the World Health Organization declared that COVID-19 is a global pandemic. The rapidly spreading virus has a huge human cost with over 23 lakh patients who tested positive and a death toll that crossed 161,191 through April 19, 2020. Maintaining the resources needed to fight the epidemic and flatten the growth curve. The global economy will face a setback in the midst of a global emergency.

Despite being the main player in the pharmaceutical industry, a large gap that has developed over the years in the Indian industry is the excessive d e p e n d e n c e o n Chinese APIs (bulk drugs), in particular fermentation-based products such as Penic i l l in G and many intermediate materials (KSM or key start for API).

Therefore, the great opportunity fo r I n d i a i s t o internalize the entire supply chain for our sake, in addition to presenting ourselves

as an end-to-end giant in the pharmaceutical supply chain. A strong pharmaceutical industry has always been a pillar of affordable health care in India and this trend can be expected to be further strengthened now.

Current crisis of fans, PPE, masks, diagnostic kits: Almost all navigation equipment arrives in China. In India, several non-medical equipment companies took the opportunity and transformed their production to produce fans and other equipment that is currently needed. The pandemic will eventually disappear, but the team will remain. A push through Make-in-India for medical equipment can further strengthen this trend. The General Information and Precautionary Measures On the Public Health by World Health Organization is stated in figure number 4.

REFERENCE1. https://www.expresshealthcare.in/blogs/covid-19-pandemic-long-

term-impact-on-indian-healthcare/418670/(Consulted April 15, 2020)

2. https://www.abpi.org.uk/medicine-discovery/covid-19/what-are-pharmaceutical-companies-doing-to-tackle-the-disease/(Consulted April 15, 2020)

3. h t tps ://www.ameexusa .com/blogs/cov id -19- impact -on -pharmaceutical-industry (Consulted April 15, 2020)

4. https://qz.com/india/1830849/coronavirus-could-be-indian-pharmas-big-opportunity-in-africa/(Consulted April 16, 2020)

5. https://economictimes.indiatimes.com/news/economy/policy/covid-19-centre-chalks-out-four-schemes-to-boost-production-of-bulk-drugs-and-medicaldevices/articleshow/74867468. CMS? utm_source = contentofinterest & utm_medium = text & utm_campaign = cppst (consulted April 18, 2020)

6. https://www.business-standard.com/article/economy-policy/govt-approves-rs-13k-crore-package-to-boost-bulk-drugs-manufacture-120032101140_1.html (access April 18, 2020)

7. https://economictimes.indiatimes.com/https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/remove-policy-hurdles-grant-infrastructure-status-to-bulk-drug-industry-cii- kpmg-report / articleshow / 75208267.cms? utm_source = contentofinterest & utm_medium = text & utm_campaign = cppst (Consulted April 18, 2020)

Fig No.4: General Information On the Public Health of the World Health Organization

Note: From 1st July, 2017 GST 5% will be applicable for advertisements.For Advertisements: Contact us at Tel. 022-26671072 / 26670744

[email protected]/[email protected]: www.ipapharma.org

Advertisement Tariff for Pharma TimesPositions For Color

page (Rs.) Per insertion

For b/W page (Rs.)

Per InsertionFront Cover Gate Fold 50,000.00 -Back Cover 44,000.00 -Inside Front 30,000.00 -Inside Back 28,000.00 -First Page (Page 3) 30,000.00 -Last Page (Opp. Inside Back) 20,000.00 -Page Facing Content & Editorial Note

20,000.00 -

Double Spread (Or Centre Spread)

35,000.00 -

Full Page 16,000.00 10,000.00Half Page 9,000.00 6,000.00Discount for 1 to 3 insertions - 10%

Discount for 4 to 6 insertions - 15%

Discount for 7 to 12 insertions - 20%

Sr. No. Company Name Pg. No.Advertisement Index

Aczet Pvt. Ltd.1. ............................................... 60Ami Polymer Pvt. Ltd.2. .................................... 23Brothers Pharmamach (I) Pvt. Ltd.3. .................6CONDOT4. ......................................................... 62Elmach Packages (India) Pvt. Ltd.5. ....34,35,63Fourrts (India) Laboratories Pvt. Ltd. 6. ......... 61Gattefosse (India) Pvt. Ltd7. ...............................2J.S.S. College of Pharmacy8. ..............................3SRICO9. ............................................................ 29


JUMBO COVID CROSSWORD

Read the Next issue for the quiz results & the names of the winners !!

1 2 3 4 5 6 7 8

9 10 11

12 13

14 15 16 17 18

19

20 21 22

23 24

25 26 27 28 29

30 31

32 33 34

35 36 37

38 39

40

41 42

CLUESACROSS1 . New norm for keeping away from others [6, 1st 9 of 10 letters] (6,

9) 9. The highest number of Covid19 cases are __ ___ [in reverse order]

(2,1,1,1)10. From here a swab could be taken to check for CoV-2 [1st 3 of 4 letters,

read backwards] (3)11. The tiniest being that shook the high and mighty the world over [read

backwards] (5)12. Machine learning - will this application help in the fight against

Covid-19? (1,1)13. This type of cat could be an intermediate host for the new corona ?

[middle 3 of 5 letters] (3)14. From RA to Covid19 prophylaxis limelight (1,1,1)16. You must compulsorily report a Covid-19 diseases case to the

authorities. Because it is now _______ [1st 3 of 10 letters] (3)17. Homemade masks qualify as ___ - medical ones (3)19. The prime flying suspect for transmission of nCoV (3)20. Could this climatic temperature kill the nCoV ? (3)21. If you took the current pandemic’s most discussed drug, you could

get ___________ as a rare side effect (1,7)23. This gun at your forehead – measures how hot you are [in reverse

order] (1,1)24. Crucial shielding kit, for COVID-19 frontline warriors. But in short

supply across the world [in reverse order](1,1,1)25. Another frontline cover-up warrior on the face (4)27. In the lockdown period, non-essential ________ are not permitted to

open for business (6)30. Settling of RBCs – a strong factor to predict disease progression in

COVID-19 ? (1,1,1)31. Birthplace of current pandemic (5)32. This HIV treatment could help in getting the better of SARS-CoV2 ?

(1,1,1)34. Intermediary host for MERS-CoV. Water storer? [1st 2 of 5 letters]

(2)37. In the Covid and post era the warm _____ with friends and colleagues

could be a strict No No (4)38. Mechanical breather. Costly, heavy shortages in the pandemic (10)

41. Covid19 protective gear for your eyes (7)42. Disease spread across the world (1st 7 of 8 letters) (7)

DOWN1 . In lockdown, don’t go out [4, 2, 1st 3 of 4 letters] (4,2,3)2 . One of the ‘symptoms’ you hear to be alert of a Covid19 suspect (5)3 Zydus, ICPA make the ___ of this tablet currently in hot demand

(1,1,1) 4. Kill the microbes on the non-living substance (9)5. The “handy” thing that went off the shelves in a mad rush for cleaning

(9)6. Homeopathic preventive remedy for Corona, suggested by AYUSH. Not

a poison in the album (1st 5 of 8 letters) (5) 7. The new worldwide buzzword with a genetic strand and crowns (6)8. A strain not known before, so the new name (5)18. Fruit bats hosted this virus in West Africa[1st 3 of 5 letters, in reverse

order] (3)15. Isolate for 14 or 28 days (1st 4 of 10 letters) (4)22. It ‘flu’ in a century ago (7)23. The world eagerly watched every day for any ‘sudden’ rise of nCoV

cases [last 3 of 5 letter word] (3)26. The single strand in nCoV [in reverse order] (1,1,1)27. Something similar to nCoV struck in the middle-east in 2000 [2nd,

3rd, 4th initialism of 4 letters, in reverse order) (1,1,1)28. When you detect a CoV-2 positive patient, you ___________ him/her?

[1st 3 of 7 letters, in reverse direction) (3)29. Manoeuvre it in the throat, take a sample and test for CoV-2 (1st 3

of 4 letters) (3)32. LPV/R are _____, being tried out in COVID-19 (1,1,1)33. These changes made the coronavirus deadly (1st 5 of 7 letters in

reverse direction) (5)35. Version 1 (2003) of COVID-19 (1,1,1,1) 36. Simple and cheap CoV-2 killer. Use with water for 20+ seconds (4)37. The UK wanted its population to get CoV-2 infected to get this

immunity (4) 39. If you are ___, strictly do not report to work (3)40. New evidence in this animal showing that Remdesivir could help in

Covid? Shares 93% DNA sequence with humans. (1,1)

- Raj Vaidya


customers and for the pharmacists. Posters for pharmacists were especially made to salute the dedicated services of the pharmacists and pharmacy team during this pandemic and to give recommendations for personal safety and care. Both of these posters were made in English as well as in Hindi and were widely circulated to all the pharmacists across the country through social media and IPA website.

IPA Industrial Pharmacy DivisionIPA Industrial Pharmacy Division (IPD) under the leadership of IPD Chairperson, Dr. J. Jayaseelan has been involved in public service programs during the COVID-19 pandemic and distributed total 1000 litres of alcohol- based sanitizer and 500 units of N95

IPA National Vice Chairman, Industry Division Mr. J. Jayaseelan has handed over 1000 Ltrs of Hand Sanitizers and 500 N 95 Masks to

Tamilnadu Health Minister Dr. C. Vijayabaskar along with Mr. S V P S Sivanandhan

facemasks to 4 medical colleges of Tamilnadu. This support was also gratefully acknowledged by the Minister of Health & Family Welfare, Tamilnadu, Dr. C. Vijayabaskar.

IPA Hospital Pharmacy DivisionIPA Hospital Pharmacy Division (HPD) Executive Committee member, Dr. Suresh Saravdekar engaged a webinar on 'Patient Centric Hospital Pharmacy Services', on 17th April, 2020. The webinar was supported by Cipla. The 10 salient learnings for hospital pharmacists from the webinar are as follows : 1. Hospital Health Care Services is most important and essential

services of patient care and Hospital Pharmacy Services plays a key role in Safe and Effective Medication Management in the hospitals

2. World over, use of medicines is essential and basic aspect of in all health care services.

3. World over, medicines are used by the people as a consumer good for Self Care as well medicines are used by health care providers for Sick Care.

IPA Community Pharmacy Division IPA CPD prepared special informative posters for the pharmacy


4. Irrespective of who uses medicines, all medicines have two fundamental and basic characteristics. Firstly, all medicines including natural ones are foreign to the body and secondly, currently used medicines cannot be selective and targeted only to effected organ or system.

5. Consequently, being foreign to body when medicines are consumed or administered in the body, the body tries to throw these foreign substances outside body.

6. Body does this mainly through two organs; first liver converts the medicines in urine soluble form and then kidneys throws it outside body through urine. Subsequently, these two organs liver and kidneys are overburdened after habitual and chronic use of medicines.

7. Further, because medicine is non-specific and cannot be targeted for its action, when consumed or administered into body, medicine gets absorbed into the blood and travels all over body including desired site of its action in the body as well undesired sites. This undesired effects on the untargeted organs produce undesired effects. These unavoidable effects are called as Untoward / Side Effects and Adverse Drugs Reactions.

8. Therefore, it should clear that the consumption of Medicine is not as simple and similar to the consumption food, which is a natural to the body. Use of medicines involves various complex and different systems of the body.

9. Hospital Pharmacist who is well equipped with the knowledge and experience about the intricacies and details about medicine use which occur during use of medicines either for Self Care and for Sick Care, can play a crucial role in safe and effective Medication Management in the hospital health care services.

10. The Hospital Pharmacist should use the knowledge of safe use of medicines to educate the patients and also to empower him/herself. This would help in evolving and designing a health care system which would be 'Patient Centric rather than Product Centric.'

IPA Assam State Branch The members of IPA Assam State branch and the Department of Pharmaceutical Sciences, Dibrugarh University prepared

Research Scholars handing over the consignment to AMCH Officials

IPA Delhi State Branch1. Dr. Gaurav Kumar Jain, Secretary, IPA Delhi branch, along with

Shri Balaji Sewarth has run campaign for providing food and groceries to poor and needy people during COVID-19 lockdown. The campaign was run throughout country and Dr. Jain was incharge for Haryana State.

2. Team of IPA Delhi Branch Students’ Forum under leadership of Dr. Gaurav Jain distributed free of cost hand sanitizers to Delhi Police and common people for best hygiene practice. The hand sanitizers were prepared in Nanomedicine Laboratory, Jamia Hamdard, New Delhi under guidance of Dr. Farhan Jalees Ahmad.

Dr. Gaurav providing free hand sanitizer to police person and health worker

3. IPA Delhi branch team sensitized people 'to stay home and follow lock-down' through a collage circulated via Facebook, Instagram and various other social media.

IPA Delhi Branch Team awareness campaign for Support of Lockdown

4. Dr. Gaurav Kumar Jain was invited as a Speaker for a COVID-19 related webinar titled 'The Upside Down World- The Changed Paragon of Education and Research' jointly organized by ICT Mumbai and NIPER, Mohali on 15th April, 2020. Dr. Gaurav Jain emphasized on the topic 'New Considerations and Challenges for Student Under COVID-19- How to be prepared for the after effects'. The lecture was well appreciated and was found to be very relevant by most of the attendees.

5. Dr. Sushma Talegaonkar, EC Member of IPA Delhi branch and Isha Aggarwal, IPA-SF Member organized E-article competition and E-poster competition on Theme 'COVID-19 impact on Global Pharmaceutical Industry.' The competition had over 500 participants.

30 liters of liquid sanitizer and 40 l i ters of l iquid hand wash and had distributed to Assam Medical C o l l e g e a n d Hospital (AMCH). Another lot of liquid hand wash was also provided to the Indian Bank, Dibrugarh Branch. M o r e ove r t h e faculty members

of the Dept. of Pharmaceutical Sciences along with all the teaching and non-teaching staff of Dibrugarh University have donated one day salary of Rs. 15 lakhs to the Chief Minister Relief Fund, Assam Arogya Nidhi.


IPA Gujarat State Branch Gujarat State Pharmacy Council, in co-operation with IPA Gujarat State Branch and other organizations, has taken several initiatives to display professional role of pharmacists in testing times like

Gujarat and offered donation of Rs. two lakhs towards CM Relief Fund. Equally important, the Council offered Pharmacist warriors

List containing 3000 plus members willing to render any necessary service. The pharmacists rendered services in home quarantine and screening of labourers. The Council has prepared e-link that enables any one to locate nearby Chemist & Druggist store/Pharmacy and inquire about availability of any particular medicine during lockdown. The Council jointly with other institutes have set up a platform United for humanity to serve as a bridge between volunteers who are willing to serve and all in need of service like residence/food/health/security etc. Mr. Montu Patel, President of GSPC has been appointed as State nodal officer for Gujarat. NIC has appointed 58 nodal officers in all in different states as part of empowered group 4 on COVID 19 for augmenting human resources & capacity building.Graduate School of Pharmacy, Gujarat Technological University in association with IPA Gujarat State Branch prepared alcohol-based hand sanitizer as per WHO recommended formula and distributed to cops and all staff on official duty.

IPA Jharkhand State BranchIPA Jharkhand state branch has taken some steps to fight COVID-19 under the guidance of IPA President, Dr. R. N. Gupta. The branch arranged awareness programme among nearby villagers and local people to fight coronavirus pandemic by distribution of pamphlet and orally through nukkad sabhas. They were informed about use of mask, hand washing, safety precautions and also the importance of maintaining social distancing while going out for emergency work only. Dr. M. P. Chopra, Secretary of branch and Secretary of Lions Club International, Ranchi joined hands with Ramakrishna Ashram, Ranchi, and distributed raw foods to around 300 needy family in different parts of Ranchi. Dr. Abhimanyu Dev, Dr. Venketash and Dr. K. K. Pradhan, IPA member and faculty member of Department of Pharmacy, Birla Institute of Technology, Mesra, Ranchi, have started research work to select drug from existing molecules to fight COVID-19 using different techniques.

IPA Madhya Pradesh State Branch1. Sanitizer distribution campaign to Nagar Nigam Indore: Mr. Anil Kharia, President, IPA MP State branch prepared

sanitizer and distributed approximately 1700+ sanitizer bottles to the government authorities of the Madhya Pradesh to prevent viral infection amongst the community. Awareness about measures to prevent getting infected were also given.

2. Pharma student awareness in society regarding corona virus: Students of the Modern Institute of Pharmaceutical Sciences under

the aegis of the IPA MP State Branch prepared various slogans and video for the awareness of the corona virus in society.

COVID crisis. To begin with, President and members of State Pharmacy Council met Mr. Nitin Patel, Deputy Chief Minister of


3. Online interactive session for awareness of COViD-19

Dr. Sapna Malviya, Professor and Head, Modern Institute of Pharmaceutical Sciences under the aegis of IPA MP state Branch addressed students and faculties on COVID-19 precautionary measures and Ayurveda – based diet, yoga and meditation that can boost immunity.

4. preparation of the hand rub sanitizer as per WhO

Mr. Ankur Joshi, Assistant Professor of the Modern Institute of Pharmaceutical Sciences under the aegis of IPA MP state Branch prepared hand rub sanitizer as per WHO (World health Organization). The hand rub formulation contained Ethanol 96%, Hydrogen peroxide 3 %, Glycerol 98% and Sterile distilled water. The prepared hand rub sanitizer was distributed in various department of the institute for the purpose of safety from COVID-19.

IPA Maharashtra State BranchTo support the ongoing battle against COVID-19, several measures have been undertaken by IPA-Maharashtra State Branch (IPA-

MSB). IPA-MSB has supported opening of a Community Clinic, which is first of its kind, jointly with Prabhat Charitable Trust and Om Gagangiri O c c u p a t i o n a l Health Services, along with mobile

van facility for digital X-ray and blood sample collection at Ghansoli, Navi Mumbai. Mr. Satish Shah Vice President, IPA-MSB and the Council Members, Mr. Vijaykumar Ghadge and Mr. Sureshkumar C h a u d h a r y h a v e been instrumental in providing medicines and other re lated materials l ike face masks and sanitizers worth Rs. 25,000. Four Community Cl inics have been opened till the third week of April jointly with Indian Medical Association and Ghatkopar Medical Association at four localities in Ghatkopar, Mumbai. Medicines and other related materials like face masks, sanitizers, infrared thermometers worth one lakh rupees were

provided. IPA-MSB also demonstrated efforts to support the Corona health warriors. 50,000 Hydroxychloroquine Tablets were received from Sun Pharma Ltd. and The Pharmaceutical Wholesalers

A s s o c i a t i o n , w i t h coordinated efforts, for distribution to Municipal Corporat ion’s health wo rke r s a t M u m b a i and Navi Mumbai. The branch has also aided in arranging four blood donation camps with

Mobile Blood Donation Facility. Timely availability of 140 units of blood benefited 130 Thalassaemic Major children for maintaining their haemoglobin level and boosting their immunity during this critical period.

M s . M a n j i r i G h a r a t , Chairperson, Community P h a r m a c y D i v i s i o n -IPA, delivered a talk in a webinar organised by Cipla Ltd. for Practising Pharmacists on ‘Safety of Pharmacist & Responsible

use of medicines’, on 20th April, 2020 which was attended by more than 3,200 Practising Pharmacists across India. On announcement of lockdown, the BCP m a n a g e m e n t h a s ensured enforcement of proper measures on campus to prevent any infection. The management has also successfully accommodated all 45 labourers involved in construction of the IPA building. The migrant workers from Bihar, UP, West Bengal, Jharkhand, etc. have been provided with proper facilities related to stay at IPA building with social distancing and food. Counselling is being provided to them in a simple language

and periodic interactive sessions are conducted about dos and don’ts to prevent Covid 19 infection and to raise awareness. Proper quarantine measures and facilities including bedding, pedestal fans were provided to the laborers. One of the laborers showing malaria symptoms was provided proper treatment. To prevent further


from government and other agencies. IPA-MSB’s BCP has also undertaken various academic initiatives to support its staff, faculty and students during the lockdown period. The faculties and students are using the various digital tools from the licensed version of Microsoft 365 to aid visualization-based learning. Few of the students have contributed by preparing hand sanitizer using WHO formula and cloth face masks which were distributed by them to needy persons.

and housekeeping personnel have been provided accommodation in campus. The campus has been frequently sanitized using

fogging technique and all personnel have been provided with face masks a n d i n d i v i d u a l h a n d s a n i t i z e r bottles. Everyone staying on campus

is being monitored p e r i o d i c a l l y fo r body temperature us ing a thermal thermometer. The p e r s o n n e l a r e supported financially to buy personal hygiene materials. The resident team of senior Ph.D. student and maintenance staff also helped people in surrounding localities to maintain social distancing while buying vegetables and grocery from local vendors. To ensure good health of al l students of IPA MSB’s BCP, IPA-MSB staff enquired numerous times with students and their parents about their health and assured them of providing any aid, if needed. The BCP management has also created a class wise group of students along with their parents on WhatsApp for sharing information quickly

such cases, mosquito repellent cream was provided to everyone in campus. Furthermore, to boost their immunity levels, they are given lemon water and hot turmeric water twice a day. The security

IPA Students’ Forum Indian Pharmaceutical Association Students’ Forum (IPA-SF) organized various awareness campaigns, camps, community drives, competitions all across the country for the prevention and management of COVID-19 with banners, posters and quotes.1. Indian Pharmaceutical Association and IPA-SF-BIHAR organized

a community-based awareness program on prevention and management of COVID-19 in the month of February in different hospitals and rural areas of Bihar. Members of IPA-SF explained about the importance of social distancing, hand washing techniques, maintaining hygienic conditions and building immunity by food with the help of banners, posters and leaflets on Corona printed both in English and Hindi.

The first camp was organized at 8th February, 2020 at Nalanda

Medical College and hospital (NMCH), Agamkuan, Patna. Second camp was at Patna Medical College and hospital (PMCH), Patna and third on 21th February, 2020 at SKMCH, Muzaffarpur.

The awareness camp was successful under the guidance of Secretary of IPA Bihar State Branch Shri R. Bandopadhyay and Mr. Sanjeev Rai.

2. The members of the IPA-SF SJCOPS Chapter, Chalakudy, Kerala in coordination with the Students Council of St. James College of Pharmaceutical Sciences, Chalakudy conducted an awareness program on the 'Current scenario of Novel Corona virus and its preventive measures' on 7th February, 2020. A total of about 600 students and staffs participated in the session.

The students and members of IPA-SF SJCOPS chapter also

reached the public by counselling the individuals by visiting their homes in the municipal ward and educating them about the preventive measures, hand washing techniques to prevent the pandemic disease. They distributed the pamphlets which include the preventive and safety measures against COVID-19.

and effectively. Ms. Swati has been coordinating with parents and students to ensure effective communication of directives


Awareness campaign was successful under the guidance of Dr. KrishnaKumar, Principal St. James College of Pharmaceutical Sciences and Dr. David Paul, Dean, Pharmaceutical Sciences. The students and the public given a good response and actively listened to the instructions.

3. Chebrolu Hanumaiah Institute of Pharmaceutical Sciences along with its IPA-SF Chapter organised awareness campaign about Coronavirus and COVID - 19 in the villages of Obulunaidupalem, Potturu, Yanamadala, Chowdavaram and Dasaripalem in Guntur district well before the spread of Corona virus in the country.

The Principal of CHIPS, Dr. S. Vidyadhara flagged off the event.

The students organised a rally and also went on a door to door campaign educating the people about the virus, it's spread, maintenance of self hygiene, hand washing and importance of social distancing. So far, no cases of coronavirus were reported in all the five villages and people are healthy, practicing the isolation measures. Nagarjuna Education Society, contributed an amount of Rs. 5,00,000/- each to PM Cares and to Andhra Pradesh CM's Relief Fund.

4. Department of pharmacy practice, ASN Pharmacy College, Tenali, Andhra Pradesh organized a community based awareness program on COVID pandemic on 20th March, 2020 at some rural areas surrounding Tenali. IPA-SF members distributed the pamphlets to them regarding steps to be followed to prevent COVID-19, as per safety measures to be followed given by WHO. The villagers listened to all suggestions actively in large number and presented good response.

Shri. A. Sivakumar, MLA Tenali sponsored sanitizer bottles that were distributed to rural people. The awareness camp was successful under the guidance of Dr. K. Venkata Ramana, Professor & Principal, ASN Pharmacy college, Tenali.

5. IPA-SF St. Pauls chapter from St. Pauls College of Pharmacy conducted awareness programs about COVID-19 in Shanti kiranalu orphanage, Hyderabad on 18th March, 2020 and

IPA Enikepadu Local Branch

Prepared by Y.S.N.S. Surya Akhila Pharm.D – V/VI Year

IPASF-VIPW VIJAYA INSTITUTE OF PHARMACEUTICAL SCIENCES FOR WOMEN

(Approved by AICTE & PCI, New Delhi; Recog. by Govt. of AP & Affiliated to JNTU, Kakinada) ENIKEPADU, VIJAYAWADA - 521108, ANDHRA PRADESH, INDIA

RESPIRATORY DROPLETS - When droplet particles are > 5-10μm in diameter, then they are called respiratory droplets and can travel up to 6 feet (nearly 2 meters). - When droplet particles are < 5μm in diameter, then they are called respiratory nuclei and can travel longer distances in air. - Coronavirus is primarily transmitted through respiratory droplets.

CLOSE CONTACT - Respiratory droplet transmission occurs when a person is in close contact (within 1m) with someone who has respiratory symptoms (cough or sneeze). - Hence the person is at risk of having his/her mucosa (mouth, nose) or conjunctiva (eyes) exposed to potentially infective droplets.

CONTACT WITH INFECTED SURFACES OR OBJECTS

- Coronavirus can transmit through indirect contact with surfaces in the immediate environment or with the objects used on the infected person (e.g., stethoscope or thermometer). - Some of the objects or surfaces that may transmit the virus from the infected person are digital devices (mobile, laptops, mouse), lift buttons, pens, door knobs, stair bannister.

Should be breathable. Should have elastic strap band instead of tie-

on strap and is made of soft materials. Should have 2 headbands, nose foam & clip.

Difference between surgical masks and respirators: Surgical masks help to prevent droplets being expelled out to the environment by the wearer and to protect patients and operative site.

Respirators are used to potential contact of the wearers to airbone hazardous contaminants.

When to Use Mask?

Wear a mask if you are coughing or sneezing.

Masks are effective only when used in combination with frequent hand cleaning with alcohol-based hand rub or soap & water.

How to Put on, Use, Take off and Dispose the mask? Loosely cover the mouth and nose. Should be light in weight. Avoid touching the mask while using it. If in need to touch clean the hands with

alcohol-based hand rub or soap and water.

To remove mask: Remove it from the

behind and do not touch the front of the mask.

Discard immediately in a closed bin and immediately clean the hands.

Prepared by: M. Sivakshari, Pharm.D - V/VI Year, IPASF-VIPW

VIJAYA INSTITUTE OF PHARMACEUTICAL SCIENCES FOR WOMEN

(Approved by AICTE & PCI, New Delhi, Recog. By Govt of AP & Affiliated to JNTU Kakinada)

ENIKEPADU, VIJAYAWADA – 521108, ANDHRA PRADESH, INDIA

IPA Khammam Local BranchAs a generous move towards the pandemic outbreak of COVID-19, the IPA Khammam local branch in association with KLR Pharmacy College conducted Covid-19 awareness program and distributed free food packets to the commuters on highways, orphanages and

explained handwashing and other social distancing techniques to 70+ orphan kids. IPA-SF team prepared posts in English and vernacular languages and uploaded in social media to make sure it reaches each and every person in the society.

Dr.G.Nagarjuna Reddy (Left side Photo) and Dr.J.V.Suresh (Right side Photo) Distributing Food & water for high way

commuters, poor and daily wage workers.

Voluntary service activities for containment of Naval Corona Virus (Covid-19) and financial contribution to CM Relief Fund of AP and Telangana

As a generous move towards the pandemic outbreak of COVID-19, the IPA Khammam local branch in association with KLR Pharmacy College conducted covid-19 awareness program and distributed free food packets to the commuters on highways, orphanages and poor people at Paloncha, Bhadradri Kothagudem district of Telangana state; Rajanagaram of East Godavari district and Ongole district in Andhra Pradesh.

Mrs.K.Nagamani Chairman and Mr.Y.Madhusudan Reddy Secretary of KLR Institutions along with Prof.G.Nagarjuna Reddy, Director of KLR Pharmacy college and KLR Lenora Dental College and all its KLR Institutions students and staff members have contributed Rs.10,00,000/- to CM Relief fund of Telangana and Andhra Pradesh states. Mrs.K.Nagamani Chairman also came forward and provided the ration and shelter for about 150 commuters at Rajahmundry and Rajanagaram of East Godavari district in Andhra Pradesh. We are also providing all personal care products (Bedding, soap, brush, paste, hair oils, first aid kit etc.) for above 150 people in shelter.

The Staff of KLR Lenora Dental College have trained the staff and students of KLR Pharmacy College who were involved in volunteering and educating the public safety measures of COVID-19. The final year Pharm.D students and staff of KLR Pharmacy College along with Govt. officials and Students and staff of KLR Lenora Dental College, educated the public over importance of social distance, usage of mask, sanitizer and method of washing the hands etc., for the containment of COVID-19.

Dr.G.Nagarjuna Reddy (Left side Photo) and Dr.J.V.Suresh (Right side Photo) Distributing Food & water for high way commuters, poor and daily wage workers.

(Right to left) Shri V.Vijaya Sai Reddy Member of Rajya Sabha; Dr.Satheesh Kumar Reddy President A.P. State Dental Council and Dean of KLR

Lenora Dental College; Dr. T. Murali Mohan Registrar, AP State Dental Council and Mr.Y.Madhusudan Reddy Secretary of KLR Institutions handing over the Cheque to A.P. Chief Minister Relief fund.








poor peop le at Paloncha, Bhadradri Koth-agudem district of Telangana state; Rajana-garam of East Godavari dis-trict and Ongole district in And-hra Pradesh. Mrs. K. Naga-


VIPER IPASF prepared placards to promote community education r e g a r d i n g significance of lockdown and importance of staying home.D e v e l o p e d sensor based hand sanitizer c h a m b e r for students p o s t C OV I D PreparationsC l i c k t h e below link to w a t c h h o w sensor-based hand sanitizer

mani, Chairperson and Mr. Y. Madhusudan Reddy, Secretary of KLR Institutions along with Prof. G. Nagarjuna Reddy, Director of KLR Pharmacy college and KLR Lenora Dental College and all its KLR Institutions, students and staff members contributed Rs.10,00,000/- to CM Relief fund of Telangana and Andhra Pradesh








(Right to left) Shri V.Vijaya Sai Reddy Member of Rajya Sabha; Dr.Satheesh Kumar Reddy President A.P. State Dental Council and

Dean of KLR Lenora Dental College; Dr. T. Murali Mohan Registrar, AP State Dental Council and Mr.Y.Madhusudan Reddy Secretary of KLR

Institutions handing over the Cheque to A.P. Chief Minister Relief fund.

states. Mrs. K. Nagamani also provided the ration, shelter and personal care products (Bedding, soap, brush, paste, hair oils, first aid kit etc.) for about 150 commuters at Rajahmundry and Rajanagaram of East Godavari district in Andhra Pradesh. The Staff of KLR Lenora Dental College trained the staff and students of KLR Pharmacy College who were involved in volunteering and educating the public safety measures of COVID-19. The final year Pharm. D. students and staff of KLR Pharmacy College along with government officials and students and staff of KLR Lenora Dental College, educated the public over importance of social distance, usage of mask, sanitizer and method of washing the hands etc., for the containment of COVID-19.

IPA Narsapur Local BranchAs the whole world grapples with global pandemic of COVID-19, Vishnu Institute of Pharmaceutical Education & Research (VIPER), Sri Vishnu Educational Society (SVES), in association with IPA & IPASF Narsapur Branch, Telangana has been taking a number of

VIPER IPASF has prepared pamphlets in local language which explain how to boost the immunity and the preventive measures to be taken by the individual.

steps to prevent the spread of virus, educating society and service at different level during the pandemic conditions.One of the main strategies is to make sure there is no 'food insecurity'. With this objective, the branch has distributed rice, oil, vegetables and essential commodities to the homeless and migrants, most importantly to the people from other states residing in Narsapur.VIPER has prepared sanitizers as per the WHO guidelines and handed the sanitizers to the SI of Narsapur police station.

All the above a c t i v i t i e s were done under the guidance of Dr. Ramesh A l l u r i , President ,

IPA Narsapur Branch and Coordinated by Mr. Rajashekar Perusomula, Secretary, IPA Narsapur Branch, Telangana.

Vaccines against Novel coronavirusIndia sets up high-level task force to develop vaccine for coronavirus; to co-ordinate with global researcherswww.businesstoday.in; 20 April, 2020India has formed a high level task force to research on coronavirus and develop a vaccine. The task force will also coordinate with international community on vaccine development process for coronavirus. The task force will be co-chaired by Member, Niti Aayog, and Principal Scientific Adviser to the Government of India, Professor K Vijay Raghavan. AYUSH, ICMR, Department of Science and Technology (DST), Department of Biotechnology (DBT), CSIR, DRDO, DG-Health Services, and Drug Controller General of India are also members of the task force. The task force has Department of Biotechnology (DBT) as central coordinating authority. Its main focus will be to set up a process for vaccine development. The task force will make a list of national and international organisations working on vaccine development. DBT will monitor the progress of research works and also facilitate the process. The task force will create clinical cohorts focussing on long term follow-up of people for better understanding of the disease. DBT approves funding for three companies for developing COVID-19 vaccinewww.outlookindia.com; 20 April, 2020The Department of Biotechnology has so far short-listed three companies for funding the development of a vaccine for COVID-19, besides 13 other proposals it received for diagnostics, therapeutics and other interventions to fight coronavirus. The three companies are Cadila Healthcare Ltd, Bharat Biotech International Ltd and Serum Institute of India Private Limited. The Department of Biotechnology and the Biotechnology Industry Research Assistance Council had invited applications on the COVID-19 Research Consortium. The first phase of the call ended on March 30 and around 500 applications were received from academia and industry. Funding support has been recommended to Cadila Healthcare Ltd for advancing the development of a DNA Vaccine candidate against novel coronavirus SARS-CoV-2 and to Bharat Biotech International Ltd for COVID-19 vaccine candidate utilising the inactivated rabies vector platform. For the Phase III human clinical trials study of recombinant BCG vaccine planned in high-risk population, Serum Institute of India Private Limited (SIIPL) will be supported. Development of a novel vaccine evaluation platform at National Institute of Immunology, an institute under the Department of Biotechnology, to support SARS-CoV-2 vaccine development has also been approved for financial support. The DBT has been designated the central coordination agency for the development of a vaccine for COVID-19. To boost indigenous production and to scale-up the production of molecular and rapid diagnostic tests, Mylab Discovery Solutions Pvt Ltd, Huwel Lifesciences, Ubio Biotechnology Systems Pvt Ltd, Dhiti Life Sciences Pvt Ltd, MagGenome Technologies Pvt Ltd, Bigtec Pvt Ltd and Yaathum Biotech Pvt Ltd will also receive funding.IISc, start-up developing vaccine for Covid-19www.thehindubusinessline.com; 17 April, 2020The Indian Institute of Science (IISc) has jumped into the fray to develop a vaccine for coronavirus (Covid-19). A team headed by

Dr Raghavan Varadarajan of the Molecular Biophysics Unit of IISc is looking at a bunch of vaccine candidates to determine which is the most efficacious. Drawing upon previous studies on the 2003 SARS-CoV virus, these studies have shown that the antibodies against the spike glycoprotein found on the surface of the SARS-CoV virus inhibit viral infection. IISc (like some other researchers) is trying to design and test variants of the spike glycoprotein as vaccine candidates. Currently, these vaccine candidates are being tested in animal models through Mynvax, a start-up jointly founded by Dr Varadarajan and one Dr Gautham Nadig. The team estimates that at least 10 crore doses would be required to meet India’s requirement if the SARS-CoV-2 infection persists for the medium to long term. It has given itself four months to identify a first generation vaccine candidate, develop production technology in eight months and begin human clinical trials in a year.China approves third COVID-19 vaccine for clinical trialswww.expresspharma.in; 25 April, 2020China has approved its third coronavirus vaccine for the second phase of clinical trials. An “inactivated” vaccine developed by Wuhan Institute of Biological Products under the China National Pharmaceutical Group (Sinopharm) and the Wuhan Institute of Virology (WIV) started its clinical trials, state-run Xinhua news agency reported. An “inactivated” vaccine consists of virus particles, bacteria, or other pathogens that have been grown in culture and then lose disease-producing capacity. In contrast, live vaccines use pathogens that are still alive. A total of 96 persons in three age groups have received the vaccine in the first phase of clinical trial as of April 23. The vaccine has shown good safety results so far and vaccine receivers are still under observation. The randomised, double-blind and placebo-controlled clinical trials of the inactivated vaccine are conducted in Jiaozuo, central China’s Henan Province, and the second phase of clinical trial will focus on the vaccination procedure. The vaccine will also go through the third phase of the clinical trial, and it may take about one year to complete the clinical trial before finally reaching the conclusion on the vaccine’s safety and efficacy. An adenovirus vector vaccine, developed by Institute of Military Medicine under the Academy of Military Sciences, was the first vaccine approved in the country to enter a clinical trial. Coronavirus vaccine: hyderabad’s iil fourth indian firm to join questwww.businesstoday.in; 07 April, 2020The Hyderabad-based Indian Immunologicals Limited (IIL) has joined hands with Griffith University of Australia to conduct exploratory research to develop a lead vaccine candidate for coronavirus. The IIL-Griffith combine is the fourth Indian biotech company, after Serum Institute, Zydus Cadila and Bharat Biotech, to join 60-plus research initiatives worldwide to develop a vaccine against the virus, which has so far killed over 155,000 globally. Scientists of the company and Griffith University will develop a ‘Live Attenuated SARS - CoV-2 vaccine’ using the latest codon de-optimisation technology. Upon completion of the research, the vaccine strain will be transferred to Indian Immunologicals and the vaccine maker will work accordingly with the country’s regulator - Central Drugs Standard Control Organisation - to further conduct clinical trials which will be taken up in a phased manner. IIL intends to use its existing Vero cell platform technology for mass production of the virus. IIL, India’s largest veterinary biologicals and the third largest animal health drug maker, is already working with Griffith University, Australia for conducting research and development of a Zika virus vaccine, which is currently at pre-clinical toxicology testing stage. The technology looks promising for developing a vaccine for prophylactic, active, single dose immunisation against coronavirus in humans, with an

VIPER IPASF has done various activities such as community education through video of about 5 minutes which explains information about COVID-19, DOs and DONT's, preventive measures and circulated to community through all the social networks.https://drive.google.com/file/d/1X355RkUczynzfVuWmBQvp7CsrvYAQaR4/view?usp=sharing

chamber workshttps://drive.google.com/file/d/1fqTGo1W03izzxmQWiC7u_h c U Q j W 0 G t x G /view?usp=sharingVIPER staff is also supporting e n g i n e e r i n g f a c u l t y i n developing ventilators.


Vaccines against Novel coronavirusIndia sets up high-level task force to develop vaccine for coronavirus; to co-ordinate with global researcherswww.businesstoday.in; 20 April, 2020India has formed a high level task force to research on coronavirus and develop a vaccine. The task force will also coordinate with international community on vaccine development process for coronavirus. The task force will be co-chaired by Member, Niti Aayog, and Principal Scientific Adviser to the Government of India, Professor K Vijay Raghavan. AYUSH, ICMR, Department of Science and Technology (DST), Department of Biotechnology (DBT), CSIR, DRDO, DG-Health Services, and Drug Controller General of India are also members of the task force. The task force has Department of Biotechnology (DBT) as central coordinating authority. Its main focus will be to set up a process for vaccine development. The task force will make a list of national and international organisations working on vaccine development. DBT will monitor the progress of research works and also facilitate the process. The task force will create clinical cohorts focussing on long term follow-up of people for better understanding of the disease. DBT approves funding for three companies for developing COVID-19 vaccinewww.outlookindia.com; 20 April, 2020The Department of Biotechnology has so far short-listed three companies for funding the development of a vaccine for COVID-19, besides 13 other proposals it received for diagnostics, therapeutics and other interventions to fight coronavirus. The three companies are Cadila Healthcare Ltd, Bharat Biotech International Ltd and Serum Institute of India Private Limited. The Department of Biotechnology and the Biotechnology Industry Research Assistance Council had invited applications on the COVID-19 Research Consortium. The first phase of the call ended on March 30 and around 500 applications were received from academia and industry. Funding support has been recommended to Cadila Healthcare Ltd for advancing the development of a DNA Vaccine candidate against novel coronavirus SARS-CoV-2 and to Bharat Biotech International Ltd for COVID-19 vaccine candidate utilising the inactivated rabies vector platform. For the Phase III human clinical trials study of recombinant BCG vaccine planned in high-risk population, Serum Institute of India Private Limited (SIIPL) will be supported. Development of a novel vaccine evaluation platform at National Institute of Immunology, an institute under the Department of Biotechnology, to support SARS-CoV-2 vaccine development has also been approved for financial support. The DBT has been designated the central coordination agency for the development of a vaccine for COVID-19. To boost indigenous production and to scale-up the production of molecular and rapid diagnostic tests, Mylab Discovery Solutions Pvt Ltd, Huwel Lifesciences, Ubio Biotechnology Systems Pvt Ltd, Dhiti Life Sciences Pvt Ltd, MagGenome Technologies Pvt Ltd, Bigtec Pvt Ltd and Yaathum Biotech Pvt Ltd will also receive funding.IISc, start-up developing vaccine for Covid-19www.thehindubusinessline.com; 17 April, 2020The Indian Institute of Science (IISc) has jumped into the fray to develop a vaccine for coronavirus (Covid-19). A team headed by

Dr Raghavan Varadarajan of the Molecular Biophysics Unit of IISc is looking at a bunch of vaccine candidates to determine which is the most efficacious. Drawing upon previous studies on the 2003 SARS-CoV virus, these studies have shown that the antibodies against the spike glycoprotein found on the surface of the SARS-CoV virus inhibit viral infection. IISc (like some other researchers) is trying to design and test variants of the spike glycoprotein as vaccine candidates. Currently, these vaccine candidates are being tested in animal models through Mynvax, a start-up jointly founded by Dr Varadarajan and one Dr Gautham Nadig. The team estimates that at least 10 crore doses would be required to meet India’s requirement if the SARS-CoV-2 infection persists for the medium to long term. It has given itself four months to identify a first generation vaccine candidate, develop production technology in eight months and begin human clinical trials in a year.China approves third COVID-19 vaccine for clinical trialswww.expresspharma.in; 25 April, 2020China has approved its third coronavirus vaccine for the second phase of clinical trials. An “inactivated” vaccine developed by Wuhan Institute of Biological Products under the China National Pharmaceutical Group (Sinopharm) and the Wuhan Institute of Virology (WIV) started its clinical trials, state-run Xinhua news agency reported. An “inactivated” vaccine consists of virus particles, bacteria, or other pathogens that have been grown in culture and then lose disease-producing capacity. In contrast, live vaccines use pathogens that are still alive. A total of 96 persons in three age groups have received the vaccine in the first phase of clinical trial as of April 23. The vaccine has shown good safety results so far and vaccine receivers are still under observation. The randomised, double-blind and placebo-controlled clinical trials of the inactivated vaccine are conducted in Jiaozuo, central China’s Henan Province, and the second phase of clinical trial will focus on the vaccination procedure. The vaccine will also go through the third phase of the clinical trial, and it may take about one year to complete the clinical trial before finally reaching the conclusion on the vaccine’s safety and efficacy. An adenovirus vector vaccine, developed by Institute of Military Medicine under the Academy of Military Sciences, was the first vaccine approved in the country to enter a clinical trial. Coronavirus vaccine: hyderabad’s iil fourth indian firm to join questwww.businesstoday.in; 07 April, 2020The Hyderabad-based Indian Immunologicals Limited (IIL) has joined hands with Griffith University of Australia to conduct exploratory research to develop a lead vaccine candidate for coronavirus. The IIL-Griffith combine is the fourth Indian biotech company, after Serum Institute, Zydus Cadila and Bharat Biotech, to join 60-plus research initiatives worldwide to develop a vaccine against the virus, which has so far killed over 155,000 globally. Scientists of the company and Griffith University will develop a ‘Live Attenuated SARS - CoV-2 vaccine’ using the latest codon de-optimisation technology. Upon completion of the research, the vaccine strain will be transferred to Indian Immunologicals and the vaccine maker will work accordingly with the country’s regulator - Central Drugs Standard Control Organisation - to further conduct clinical trials which will be taken up in a phased manner. IIL intends to use its existing Vero cell platform technology for mass production of the virus. IIL, India’s largest veterinary biologicals and the third largest animal health drug maker, is already working with Griffith University, Australia for conducting research and development of a Zika virus vaccine, which is currently at pre-clinical toxicology testing stage. The technology looks promising for developing a vaccine for prophylactic, active, single dose immunisation against coronavirus in humans, with an


enhanced safety profile. Indian Immunologicals Limited is expected to submit the application for conducting clinical trials in due course.Bharat Biotech in tie-up to develop a Covid vaccinewww.economictimes.indiatimes.com; 04 April, 2020Bharat Biotech has partnered with the University of Wisconsin Madison and US-based Company FluGen to develop a vaccine, Coro-Flu, against Covid-19. The Hyderabad-based company will manufacture the vaccine, conduct clinical trials and prepare to produce almost 300 million doses of vaccine for global distribution. Under the collaboration agreement, FluGen will transfer its existing manufacturing processes to Bharat Biotech to enable the company to scale up production and produce the vaccine for clinical trials. CoroFlu will build on the backbone of FluGen’s flu vaccine candidate known as M2SR, which is a self-limiting version of the influenza virus that induces an immune response against the flu. Kawaoka’s lab will insert gene sequences from SARS-CoV-2, the novel coronavirus that causes the disease Covid-19, into M2SR so that the new vaccine will also induce immunity against the coronavirus. Refinement of the CoroFlu vaccine concept and testing in laboratory animal models at UW-Madison is expected to take three to six months. Bharat Biotech will then begin to scale up production for safety and efficacy testing in humans. Four Phase I and Phase II clinical trials have shown the M2SR flu vaccine to be safe and well tolerated.Johnson & Johnson announces a lead vaccine candidate for COVID-19www.worldpharmanews.com; 30 March, 2020Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA) with the goal of providing global supply of more than one billion doses of a vaccine. The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates that the first batch of COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process. Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts. Serum Institute eyes COVID-19 vaccine by Octoberwww.thehindu.com; 24 April, 2020City-based Serum Institute of India has said that it expects the vaccine for coronavirus (COVID-19) developed by the University of Oxford (ChAdOX1) in the market by October or November provided the safety and efficacy of the product is established during trials. The institute has partnered with the Oxford vaccine project as one of the seven global institutions that will manufacture the vaccine. If the vaccine works in UK, another trial will start shortly in India. The Institute will use one of its existing facilities to manufacture the vaccine. A new facility will be setup in a year or two. SII would be partnering with ICMR for the clinical trials and that he was in touch with the Department of Biotechnology. The manufacturing plant in Pune would have an investment of INR 500-600 crore

HYDROXYCHLOROQUINE: SAVING THE WORLDNovartis to sponsor large clinical trial of hydroxychloroquine in hospitalized COVID-19 patientswww.sandoz.com; 20 April, 2020Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis. The large trial sponsored by Novartis will be conducted at more than a dozen sites in the United States. Novartis plans to begin enrollment for this study within the next few weeks and is committed to reporting results as soon as possible. To help achieve broad access to hydroxychloroquine as quickly as possible in these extraordinary circumstances, Novartis will make any intellectual property within our control that relates to the use of hydroxychloroquine to treat or prevent COVID-19 available through non-exclusive voluntary licenses, appropriate waivers, or similar mechanisms. Patients in the trial will be randomized into three groups. The first group or arm will receive hydroxychloroquine. The second group will receive hydroxychloroquine in combination with azithromycin, which is an antibiotic therapy. The third group will receive placebo. Patients in all treatment groups are receiving standard of care for COVID-19. Researchers at the company compressed months of work into a few weeks to design the large clinical trial in order to rapidly respond to the need for COVID-19 disease treatments. In addition to hydroxychloroquine, Novartis plans to sponsor or co-sponsor clinical trials to study ruxolitinib and canakinumab for hospitalized patients with COVID-19 infections. Requests for investigator-initiated trials have been granted for COVID-19-related clinical studies of ruxolitinib, canakinumab, imatinib mesylate, secukinumab, hydroxychloroquine and valsartan.Coronavirus pandemic: India to export anti-malaria drug hydroxychloroquine to 55 countrieswww.financialexpress.com; 17 April, 2020India has cleared the export of the anti-malaria drug – Hydroxychloroquine (HCQ) tablets to 54 more countries across the globe along with the US. Leaders from across the globe have been reaching out to India seeking help in the form of HCQ. The Ministry of External Affairs which is handling the requests has prepared two lists so far and a third one is in the process of being finalized. A list of 55 countries has been readied and this was prepared on the basis of specific requests received from the leaders of these countries. Exporting of HCQ tablets to these countries whether in the form of aid or through commercial basis has been decided after ensuring that there is adequate supply for the domestic market. The export of HCQ is being done in small quantities. Out of the 55 countries, 34 will receive the HCQ as a grant and the balance of 21 nations have purchased these tablets from India. Countries getting HCQ from India include - Afghanistan, Bhutan, Bangladesh, Nepal, Maldives, Mauritius, Seychelles, Sri Lanka, Philippines, Myanmar, Slovenia, France, the Netherlands, the UK, the US, Marshall Islands, Ukraine, Russia, Bolivia, Peru, Ecuador, Uruguay, Colombia, Guyana, Dominican Republic, Jamaica, Bahamas, Senegal, Jordan, Zimbabwe, Nigeria, Egypt, Republic of Congo, Sierra Leone, Chad, Burkina Faso, Niger, Mali, Syria, Kenya, Eswatini, Tanzania, Algeria, Madagascar, South Africa, Zambia, Uganda, Oman, UAE, Uzbekistan, Kazakhstan.Bajaj Healthcare gets Gujarat FDA nod to manufacture hydroxychloroquine sulphatewww.moneycontrol.com; 17 April, 2020


Drug firm Bajaj Healthcare has received approval from the Gujarat Food and Drug Administration for manufacturing hydroxychloroquine sulphate active pharmaceutical ingredient (API) and formulations. The company will commence production of hydroxychloroquine sulphate API at its Vadodara facility and is estimated to produce 15 metric tonnes of API per month. It has already started the production of hydroxychloroquine FDF (tablets) at Vadodara unit and is expected to produce around 1.5 crore hydroxychloroquine sulphate tablets.hydroxychloroquine makers Zydus, ipca, others plan 6 times capacity to meet demandwww.businesstoday.in; 13 April, 2020Indian pharmaceutical companies are raising monthly production of anti-malarial drug Hydroxychloroquine (HCQ) four times to 40 metric tonnes (MT) by the end of this month and five to six times to over 70 metric tonnes (MT) by next month. The plan to step up production came after the Government of India indicated it will help countries in dire need of the drug to fight novel coronavirus. Peak capacity would produce 35 crore (350 million) tablets of 200 mg dosage every month. India’s own requirement is unlikely to exceed 10 crore tablets for which the government has already placed an order with leading domestic manufacturers Zydus Cadila and Ipca Laboratories. Industry experts say 10 crore tablets are good enough to treat seven crore people, if required. In India, HCQ costs less than Rs 3 per tablet. The remaining production will be exported to neighbouring countries as well as countries such as the US which need them. According to some studies, HCQ has shown strong antiviral effects on the coronavirus infection, which prompted US President Donald Trump to seek India’s help in procuring the drug. Other leading manufacturers of HCQ include Intas Pharmaceuticals, McW Healthcare of Indore, Macleods Pharmaceuticals, Cipla and Lupin. API suppliers for the drug include Abbott India, Rusan Pharma, Mangalam Drugs, Unichem Remedies, Laurus Labs, Vijayasri Organics, etc. Two major Indian manufacturers - Zydus Cadila and Ipca Laboratories have backward integrated production capacity - from key raw materials that can be converted to intermediates and then to APIs and to final formulations, in the 12-15 step process to make the medicine. Most of the other Hydroxychloroquine API manufacturers import some key raw materials and intermediates from China or source them from countries like South Korea, Italy or Finland.Bengal Chemicals to produce hydroxychloroquinewww.expresspharma.in; 11 April, 2020Bengal Chemical has got the necessary license from West Bengal Directorate of Drugs Control to manufacture hydroxychloroquine. The West Bengal government has granted approval to Bengal Chemical and Pharmaceuticals Limited to manufacture hydroxychloroquine (HCQ) to fight against COVID-19 infection. The West Bengal Directorate of Drugs Control gave necessary license to the country’s first and oldest pharmaceutical company after the Kolkata-based firm, the only public sector unit that manufactures anti-malarial drug in India, recently applied for a licence to produce HCQ. During a meeting with Chief Minister Mamata Banerjee, a senior official of the company requested the state government to grant them licence to that it could produce the drug. After getting the sanction, the PSU will now be able to manufacture hydroxychloroquine tablet IP 200 and 400 mg. The company has a capacity of producing 10 lakh tablets every day. Use of hydroxychloroquine as prophylaxis has been suggested by a section of experts to combat COVID-19 infection.Sanofi to donate 100 million doses of hydroxychloroquine across 50 countrieswww.thepharmaletter.com; 10 April, 2020

Sanofi has committed to donating 100 million doses of hydroxychloroquine to 50 countries around the world, and has begun to progressively deliver the medicine to authorities that have requested it. In this global health emergency, Sanofi stands ready to assist as many countries as possible, starting with countries where its medicine is registered for current approved indications as well as countries where there are no hydroxychloroquine suppliers or countries with underserved populations. Since the beginning of the COVID-19 crisis, Sanofi has received a growing number of requests from local governments around the world. The company is regularly evaluating its increasing supply capacity and re-assessing how best to help those countries in the most ethical way. Sanofi’s priority is to ensure supply continuity for patients treated under the current approved indications of the medicine, notably including lupus and rheumatoid arthritis, while working hard to supply governments wishing to increase stocks in the hope that it may be an effective treatment of COVID-19. Sanofi will continue to donate the medicine to governments and hospital institutions if ongoing clinical studies demonstrate its efficacy and safety in COVID-19 patients.Zydus Cadila boosts HCQ production 10Xwww.economictimes.indiatimes.com; 08 April, 2020Zydus Cadila, one of the two largest manufacturers of key Covid drug hydroxychloroquine (HCQ), has ramped up its production by nearly 10X to 30 metric tonnes (15 crore tablets of 200mg) per month in view of the huge spike in demand expected due to rising cases of Covid-19.The company will be supplying the drug to ICMR (Indian Council of Medical Research) at a price even lower than the government-regulated price, at a little over Rs 3 per tablet.Prepared to supply 10 crore tablets of Hydroxychloroquine to Indian government: IPCA Labswww.economictimes.indiatimes.com; 07 April, 2020Hydroxychloroquine, the anti-malarial drug that is used for treating patients of Rheumatoid Arthritis has become a test case for India-US diplomatic relations. The drug has come to focus as several countries are using this drug as a preventive measure for Covid-19, despite inconclusive studies on its effectiveness. US President Donald Trump who has also been promoting this drug for Covid-19 treatment has prompted India to lift the ban on exports of Hydroxychloroquine. Indian government has ordered around six crore tablets from IPCA Labs which it will supply by the end of this month. IPCA will also stock around 20 tonnes of HCQ API to ensure smooth and uninterrupted supply of HCQ tablets.ICMR recommends HCQ for prophylaxis against COVID-19 for healthcare professionals and contacts of confirmed caseswww.icmr.nic.in; 23 March, 2020Hydroxychloroquine is found to be effective against coronavirus in laboratory studies and in-vivo studies. Its use in prophylaxis is derived from available evidence of benefit as treatment and supported by pre-clinical data. The National Taskforce for COVID-19 recommends the use of hydroxychloroquine for prophylaxis of SARS-CoV-2 infection for asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19 and asymptomatic household contacts of laboratory confirmed cases. Dose for healthcare workers should be 400 mg twice a day on Day 1, followed by 400 mg once weekly for next 7 weeks and for asymptomatic household contacts - 400 mg twice a day on Day 1, followed by 400 mg once weekly for next 3 weeks. The drug is not recommended for prophylaxis in children under 15 years of age and contraindicated in persons with known case of retinopathy, known hypersensitivity to hydroxychloroquine, 4-aminoquinoline compounds. ICMR reiterates that intake of HCQ in no way should instill a feeling of false security against corona virus.


Testing kits for Covid-19ICMR approves the Probe-free COVID-19 detection assay developed at IIT Delhiwww.iitd.ac.in; 23 April, 2020Researchers at IIT Delhi Kusuma School of Biological Sciences (KSBS) have developed a detection assay for COVID-19 which has now been approved by ICMR. The assay has been validated at ICMR with a sensitivity and specificity of 100%. This makes IITD the first academic institute to have obtained ICMR approval for a real-time PCR-based diagnostic assay. Using comparative sequence analyses, the IIT Delhi team identified unique regions (short stretches of RNA sequences) in the COVID-19 /SARS COV-2 genome. These regions are not present in other human corona viruses providing an opportunity to specifically detect COVID-19. This method uses primers targeting unique regions of COVID-19 that were designed and tested using real time PCR. These primers specifically bind to regions conserved in over 400 fully sequenced COVID-19 genomes. This highly sensitive assay was developed by extensive optimization using synthetic DNA constructs followed by in vitro generated RNA fragments. This is the first probe-free assay for COVID-19 approved by ICMR and it will be useful for specific and affordable high throughput testing. This assay can be easily scaled up as it does not require fluorescent probes. The team is targeting large scale deployment of the kit at affordable prices with suitable industrial partners as soon as possible. The team includes Prashant Pradhan (PhD Scholar), Ashutosh Pandey (PhD Scholar), Praveen Tripathi (PhD Scholar), Dr. Akhilesh Mishra, Dr. Parul Gupta, Dr. Sonam Dhamija, Prof. Vivekanandan Perumal, Prof. Manoj B. Menon, Prof. Bishwajit Kundu, Prof. James Gomes.Andhra Pradesh starts making rapid Covid-19 testing kitswww.economictimes.indiatimes.com; 08 April, 2020Andhra Pradesh has started manufacturing Covid-19 rapid testing kits that can offer results in less than an hour. The facility is also expected to start making ventilators from April 15, increasing the capacity in phases to 6,000 units per month. The unit at AP MedTech Zone in Visakhapatnam can produce 2,000 testing kits a day, according to the state government. This capacity may be ramped up to 25,000 kits a day soon. The Indian Council of Medical Research had approved the manufacture of the testing kits at the AMTZ while the Drug Controller General of India granted exemption from manufacturing approvals for ventilators in view of the current crisis, the state government said in a statement.Siemens Healthineers Releases Test Kit for Coronavirus COVID-19www.siemens-healthineers.com; 02 April, 2020Siemens Healthineers announced the availability of its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. Test kits are already being shipped within the European Union for research use only (RUO) to expedite availability while the company continues to pursue Emergency Use Assessment and Listing (EUAL) from the World Health Organization (WHO) for clinical use. In addition, Siemens Healthineers has begun discussions with the U.S. Food and Drug Administration (FDA) for release of the test under Emergency Use Authorization (EUA). Both applications are in progress. While the controlled roll-out of the assay for research use is continuing, Siemens Healthineers is simultaneously expanding its production capacity. The FTD SARS-CoV-2 Assay was developed by Fast Track Diagnostics, a Siemens Healthineers Company, in Esch-sur-Alzette, Luxembourg. Fast Track Diagnostics was acquired by Siemens Healthineers at the end of 2017.

Biolidics to launch ten-minute rapid test kits for COVID-19www.mobihealthnews.com; 31 March, 2020Singapore-listed medtech company Biolidics recently launched its rapid test kit for COVID-19 and has entered into a manufacturer agreement with a diagnostic kit manufacturer to customize and manufacture the rapid test kits. The first batch of Biolidics’ rapid test kits is expected to be available in April 2020. Biolidics has obtained provisional authorization from Singapore’s Health Science Authority (HSA) for its rapid test kit to be used in Singapore. The medtech company, which focuses on diagnostic cancer solutions, is working closely with Clearbridge Health to obtain the relevant approval and/or authorization from the various health authorities in the region for the use of the rapid test kit. Firms shortlisted for rapid antibody testing kitswww.economictimes.indiatimes.com; 29 March, 2020Singapore based Sensing Self Ltd and China’s Wondfo are the two companies who have cleared the National Institute of Virology (NIV) validation for the rapid antibody test kit for Covid-19. The decision comes days after the Indian Council of Medical Research (ICMR) decided to start antibody tests to check whether an individual was previously infected with the SARS-Cov2 virus before. This is done to understand the epidemiology of the disease. The company will offer the kits at an affordable price to the Indian government and prioritise the shipment to the country.pune based Mylab becomes first indian company to get Covid-19 test kits validatedwww.economictimes.indiatimes.com; 24 March, 2020Pune based molecular diagnostic company Mylab has become the first Indian company to receive the validation for its Covid-19 diagnostic test kits also known as the Reverse transcription polymerase chain reaction (RT-PCR) tests by the Drug Controller of India, after the National Institute of Virology validated its test. The other company to have received the approval is Germany’s Altona Diagnostics. In the current lab based testing it takes four hours for test results to come out whereas Mylab’s turnaround time is 2 1/2 hours. The company’s kits can study 1000 samples from large labs and 200 from smaller labs. Mylab is looking to price its kits around INR 1200.IIT Delhi researchers develop affordable test for COVID-19www.economictimes.indiatimes.com; 22 March, 2020Researchers at the Indian Institute of Technology here have developed a method to detect COVID-19 which can significantly reduce the test cost making it affordable for large sections. The National Institute of Virology (NIV), Pune is in the process of validating this test on clinical samples. The “probe-free detection assay” developed by the researchers at the prestigious institute’s Kusuma School of Biological Sciences has been optimised and tested for sensitivity at the research laboratories of the Institute. According to the team, considering the scale of the ongoing pandemic, development of indigenous kits is the need of the hour. The central government on Saturday recommended that the maximum charge for each COVID-19 test by private laboratories should not exceed Rs 4,500. However, the team at IIT claims that their test can be performed at a much cheaper cost and hence will be affordable for general public.14 firms get license to evaluate COViD-19 tests kitswww.economictimes.indiatimes.com; 20 March, 2020Fourteen private companies including Swiss firm Roche Diagnostics India have been given test license by the drug regulator DCGI for evaluation of the quality of COVID-19 testing kits. Apart from Roche Diagnostics India, rest of the 13 are Indian firms include CoSara


Diagnostics from Ahmedabad and CPC Diagnostics from Chennai. All these companies will evaluate the quality of testing kits and submit their data to the Drug Controller General of India. Roche Diagnostics India received the license from the country’s drug regulator DCGI for its ‘cobas SARS CoV-2’ diagnostic test kit on March 17.

Industries and Research Institutes at forefront against CORONA

Strides Pharma develops Favipiravir antiviral tablets; drug shows positive outcome in COVID-19 treatmentwww.economictimes.indiatimes.com; 29 April, 2020Strides Pharma Science Ltd has developed and commercialised Favipiravir antiviral tablets and stressed that the drug has demonstrated positive outcomes in COVID-19 treatment globally. Favipiravir is an antiviral medication that was initially developed to treat influenza in Japan. In February 2020, post the outbreak of Novel Coronavirus (COVID-19), Favipiravir was studied in China and several other countries as an experimental treatment of COVID-19. The drug has demonstrated positive outcomes, including a reduction in the duration of COVID-19 and improved lung conditions for the patients. The product is a generic version of Avigan of Toyama Chemical, Japan. The filing said Strides is the first Indian company to have commenced export of Favipiravir tablets. The company will immediately apply to Indian Drug Authorities to commence necessary studies and make the drug available to Indian patients expeditiously. Strides has developed Favipiravir tablets in 400mg and 200mg strengths for convenient dosage administration. The product is currently being exported to Gulf Cooperation Council (GCC) countries to treat patients under their treatment programme for COVID-19. Favipiravir tablets are being manufactured at Strides' flagship facility in Bangalore, India. The facility can produce up to 6 billion units of solid orals annually and is approved by the USFDA, MHRA, WHO, TGA, among others.First trial for potential Covid-19 drug shows it has no effectwww.theguardian.com; 23 April, 2020Remdesivir, a drug thought to be one of the best prospects for treating Covid-19, failed to have any effect in the first full trial. The drug is in short supply globally because of the excitement it has generated. It is one of the drugs Donald Trump claimed was “promising”. In a “gold standard” trial of 237 patients, some of whom received remdesivir while others did not, the drug did not work. The trial was also stopped early because of side-effects. The drug, made by the US company Gilead Sciences, is an antiviral that was trialled in Ebola, but which failed to show benefits in Africa. In the trial, 158 patients were randomly assigned to be given remdesivir, while 79 others had standard care with a placebo instead. There was no difference between the groups with respect to recovery time. Just under 14% of those on remdesivir died, compared with nearly 13% of those not taking the treatment. Remdesivir was stopped early in 18 (11.6%) patients because of adverse effects, compared with 4 (5.1%) in the control group. The trial of the drug in China, on patients with severe Covid-19 symptoms, may give some doctors pause. Gilead, however, claimed there were still signs that it could be useful, possibly in patients with milder versions of disease.Zydus explores the biologicals route to treat novel Coronavirus with long-acting Interferon alpha-2bwww.zyduscadila.com; 20 April, 2020Zydus Cadila has announced that its biological therapy Pegylated Interferon alpha-2b, ‘PegiHepTM’ can emerge as one of the pathways to treat COVID 19. The treatment has emerged after the publication of

two non-peer reviewed research articles. The first one by the University of Texas Medical Branch, Galveston, showed an evidence of a direct anti-viral effect of Interferon alpha against novel Coronavirus in vitro. The study demonstrated around 10,000 fold reduction in virus titre in cells that were pre-treated with Interferon alpha 48 hours earlier. The second by a group of universities in China, Australia and Canada retrospectively analysed 77 moderate COVID-19 subjects in Wuhan and observed that those who received Interferon alpha-2b showed a significant reduction in the duration of virus shedding period and even in levels of the inflammatory cytokine, IL-6. This suggests that if a long-acting molecule like Pegylated Interferon alpha is given early on in the infection, the patient suffering from COVID 19 will have a significant benefit as the viral load is reduced, lesser IL-6 is produced and virus eliminating specific immune response is generated. When the human body contracts an infection due to a viral attack, it produces a group of molecules called Type 1 interferons as a first line of defence. Interferon alpha is one such Type 1 Interferon molecule, that not only slows down the viral replication but also helps activate the two arms of our immune system – Innate, for immediate killing of the virus and Adaptive, for long lasting immunity. To make it more effective, the molecule is coupled with polyethylene glycol to produce a new molecule called, Pegylated Interferon alpha, that has the same functionality as Interferon alpha but remains in the body longer and therefore requires only once-a-week injection, thus providing a much better efficacy profile. Interferon alpha-2b has been used in the treatment of COVID-19 in China and Cuba and is a part of treatment guidelines of the Chinese Government. Zydus has been commercially manufacturing Pegylated Interferon alpha-2b under the brand name, PegiHep, since 2011 for the treatment of Hepatitis B and C with 1.5 lac doses being administered. PegiHep is not yet licensed or approved for the treatment of COVID-19.Coronavirus vaccine soon? Oxford scientists aim for 1 million doses of drug candidate by Septemberwww.businesstoday.in; 18 April, 2020Scientists at Oxford University have said that they will be able to come up with a vaccine for the coronavirus by September this year. Earlier, WHO health experts had said that a possible coronavirus vaccine was 1.5 years away at the minimum. Lead researcher of the vaccine development programme, Prof Sarah Gilbert and her team were confident that ChAdOX1 vaccine can work against the coronavirus. The group has promised that they will make one million vaccine doses available by September. The ChAdOx1 is the fourth COVID-19 vaccine candidate in the world which has entered the clinical trial phase of vaccine development. What’s different about the ChAdOx1 is that it will take significantly less time than other vaccine candidates to be delivered in mass quantities. The other three vaccine candidates have been proposed by two US groups and one Chinese group, it is expected to take at least 12 to 18 months to mass produce these vaccines.Covid medicine: Dr Reddy’s Laboratories begins work on Gilead drug clonewww.economictimes.indiatimes.com; 17 April, 2020Dr Reddy’s Laboratories is in the early stages of creating a generic copy of remdesivir, the experimental drug developed by Gilead that’s said to have improved the condition of critically ill coronavirus patients in a multi-country trial. While scientists across the world are racing to develop drugs and vaccines against the coronavirus, remdesivir is among the few that have shown promise. The antiviral was originally meant to treat ebola but wasn’t successful. Gilead said earlier that a compassionate drug use programme sponsored by the company found that out of 53 patients with severe Covid-


19 (coronavirus) infections, clinical improvement was observed in 36.Rome varsity conducting pilot run of tool to test COVID-19 through voice-based diagnosis developed by Indian studentswww.businessinsider.in; 16 April, 2020A university in Rome is conducting a pilot run for a patented artificial-intelligence based tool developed by three biotechnology students and a professor from Mumbai which they claim can test COVID-19 through voice-based diagnosis using a smartphone. The tool is being tested by University of Tor Vergata in Rome and has already been tested on 300 individuals and has yielded 98% accurate results. According to the team from DY Patil Institute of Bio Technology and Bio Informatics, Mumbai, the tool is based on a voice-based diagnosis through an app. The team includes bioinformatics students - Rashmi Chakraborty, Priyanka Chauhan and Priya Garg. While several foreign universities are trying to launch a voice-based AI tool for COVID-19 detection, this Indian tool is fully functional and currently in use in Italy to successfully identify COVID-19 patients. The students have a full-fledged working software with a rich database of patients and healthy samples. The project is being supervised by professor Santosh Bothe.IISc researchers working on tool for COVID-19 diagnosis based on cough, speech soundswww.financialexpress.com; 15 April, 2020A team of researchers at the Indian Institute of Science (IISc), Bangalore, is working on a tool for diagnosis of COVID-19 based on respiratory, cough and speech sounds. The tool, once validated, will offer a test which poses minimum risk of exposure to the healthcare professional and can give the results faster than the current testing method. The eight-member team, has named the project for speech and sound based diagnostics “Coswara”, with an aim to detect and quantify biomarkers of the disease in the acoustics of these sounds. The project requires participants to perform a recording of breathing sounds, cough sounds, sustained phonation of vowel sounds and a counting exercise. The entire response requires about five minutes of recording time. ICMR announces protocol for Therapeutic Plasma Exchange therapy in COVID-19 patientswww.pharmabiz.com; 15 April, 2020The Indian Council of Medical Research (ICMR) has announced protocol for a multi-center, phase II, open label, randomized controlled study named Therapeutic Plasma Exchange (TPE) in COVID-19 for its therapy. The therapy is also called convalescent plasma therapy which according to health experts has the potential to treat critically ill COVID-19 patients. The primary objective of the study is to assess the efficacy of TPE in improving the clinical status of COVID-19 patients. It will also evaluate the safety of treatment with anti SARS-CoV-2 plasma in patients with COVID-19. The subjects for inclusion in the trial study are hospitalised COVID-19 patients who are critically ill, fulfill the inclusion and exclusion criteria and are admitted for care at COVID-19 management facilities in India. In this experimental treatment, plasma of a treated COVID-19 patient is indicated to an existing patient. Theoretically, plasma from a cured patient is assumed to have antibodies against the virus and this can then be used to cure another patient. At this moment, ICMR does not recommend this as a treatment option outside of clinical trials. ICMR has invited LOI from institutions with the equipment and infrastructure available to participate in a clinical trial to study the safety and efficacy of therapeutic plasma exchange in COVID-19 patients, subsequent to necessary approvals and clearances.

AstraZeneca initiates CALAVI clinical trial with Calquence against COVID-19www.fiercepharma.com; 14 April, 2020AstraZeneca will initiate a randomised, global clinical trial to assess the potential of Calquence (acalabrutinib) in the treatment of the exaggerated immune response (cytokine storm) associated with COVID-19 infection in severely ill patients. The trial design is based upon strong scientific evidence supporting the role of the Bruton’s tyrosine kinase (BTK) pathway in the production of inflammatory cytokines and on encouraging early clinical data. Calquence is a next-generation, highly selective BTK inhibitor currently used to treat certain types of blood cancers. The trial, called CALAVI, is based on early clinical data with Calquence demonstrating that a decrease in inflammation caused by BTK inhibition appears to reduce the severity of COVID-19-induced respiratory distress. The goal of the trial is to evaluate the efficacy and safety of adding Calquence to best supportive care (BSC) to reduce mortality and the need for assisted ventilation in patients with life-threatening COVID-19 symptoms. This large, multicentre, global, randomised trial uses a two-part patient-centric design developed in record time to accelerate data capture and analysis. Part one evaluates the addition of Calquence to BSC versus BSC alone in patients hospitalised with COVID-19 who are not in the intensive care unit (ICU). Part two evaluates the addition of Calquence to BSC in a cohort of patients in the ICU.Airtel and Apollo Hospital join forces to help India break the COVID-19 chainwww.pharmabiz.com; 13 April, 2020Bharti Airtel has collaborated with Apollo 24|7, the digital business unit of The Apollo Hospitals Group to support India’s battle against the COVID-19 pandemic. The partnership aims to bring together Airtel’s pan-India network reach and Apollo Hospital’s industry leading digital healthcare platform – Apollo 24/7 to raise awareness and break the chain of spread of COVID-19. It has launched a free digital self-assessment test on Airtel Thanks app to enable its customers to check their COVID-19 risk profile. The test uses AI based technologies to allow users to assess their COVID-19 risk profile by answering a few simple questions. Based on the user responses, the digital tool generates a risk score and suggests next best action including online consults on Apollo 24|7 free, dialing COVID non-prescriptive helpline from the app itself, self-care tips, social distancing guidelines and other important prevention steps as suggested by WHO and MOHFW.ICMR validates TB-testing machine for COVID-19 screening.www.businesstoday.in; 10 April, 2020The Indian Council of Medical Research (ICMR) has approved the use of diagnostic machines used for testing drug-resistant tuberculosis for conducting coronavirus tests. The ICMR has validated ‘TruenatTM beta CoV test on TruelabTM workstation’ and has recommended it as a screening test. Issuing a guidance on the use of Truenat beta CoV, the ICMR said throat/nasal swabs will be collected in the viral transport medium (VTM) with virus lysis buffer provided along with the kit. Earlier studies have shown that virus lysis buffer neutralizes Nipah and H1N1 viruses. The results of stability of viral RNA after neutralization of SARS-CoV-2 by virus lysis buffer are awaited from ICMR-NIV, Pune. COViD-19 drug leads identifiedwww.uq.edu.au; 09 April, 2020An international team of researchers has tested more than 10,000 compounds to identify six drug candidates that may help treat COVID-19. The research, involving University of Queensland scientist


Professor Luke Guddat, tested the efficacy of approved drugs, drug candidates in clinical trials and other compounds. Currently there are no targeted therapeutics or effective treatment options for COVID-19. In order to rapidly discover lead compounds for clinical use, high-throughput drug screening, both in laboratories and also using the latest computer software was used to predict how different drugs bind to the virus. The project targeted the main COVID-19 virus enzyme, known as the main protease or Mpro, which plays a pivotal role in mediating viral replication. This makes it an attractive drug target for this virus, and as people don’t naturally have this enzyme, compounds that target it are likely to have low toxicity. The drugs are added directly to the enzyme or to cell cultures growing the virus and assess how much of each compound is required to stop the enzyme from working or to kill the virus. After assaying thousands of drugs, researchers found of the six that appear to be effective in inhibiting the enzyme, one is of particular interest.Boehringer Ingelheim steps up effort with Global Support Programwww.worldpharmanews.com; 08 April, 2020Boehringer Ingelheim has significantly stepped up its support to the fight against COVID-19. A Global Support Program has been set up to bring more financial relief, protective materials and medicine donations to healthcare institutions and communities in need around the world. Boehringer Ingelheim initially started a EUR 1 million donations program in January for affected regions in China. With the Corona virus spreading to become a global pandemic, efforts to provide relief and scientific support grew strongly these past few weeks. This ultimately resulted in a Global Support Program with four focus areas like donations, research for Covid-19, volunteering, and making more health relief fund. ICMR sets up national task force to carry out COVID-19 researchwww.businesstoday.in; 08 April, 2020The Indian Council of Medical Research (ICMR) has set up a national task force to aid in fight against COVID-19. The national task force has been divided into five research groups to identify research priorities and initiate research studies. The research groups include clinical research, research on diagnostics and biomarkers, epidemiology and surveillance, operation research, and vaccines/drug research and development. Members had already been nominated for each research group which was a part of the task force. It also said the Terms of Reference (ToR) for all groups had been decided. The clinical research group will be led by AIIMS Director Dr Randeep Guleria and its immediate priority is to establish an India COVID-19 clinical research collaborative network. The diagnostics and biomarkers group is headed by Dr DA Gadkari, who is a former director of the National Institute of Virology in Pune. The priority for this group is to periodically advise on testing strategy. Epidemiology and surveillance group will be looked over by Dr DCS Reddy, community medicine expert. Its priority is to decide on lockdown or partial lockdown. NK Arora, who heads a health research organization, will head the operations research group and Dr Gagandeep Kang, Executive Director, Translational Health Science and Technology Institute, will head the group on vaccines.iCMR scales up its capacity to fight COViD-19www.icmr.nic.in; 06 April, 2020The Indian Council of Medical Research (ICMR) is working relentlessly to implement scientific interventions to combat the SARS-CoV-2 (COVID-19) pandemic. The Council has expanded its capacity to diagnose and manage COVID-19. In addition to the diagnosis, ICMR has isolated and sequenced the SARS-Cov2 virus and the scientists at ICMR are

engaged in planning research studies to give insights into the virus, the disease, and its prevention and management. A review committee to formulate National Task Force studies has been constituted for the same. At the national level, ICMR is also collaborating with other science and research agencies (DST, DBT, CSIR, DRDO, DAE, ICAR) for developing research solutions to the COVID-19 situation. ICMR will also collaborate with the World Health Organization for public health emergency SOLIDARITY TRIAL – an international randomised trial of additional treatments for COVID-19 in hospitalised patients.Trial drug can significantly block early stages of COViD-19 in engineered human tissueswww.worldpharmanews.com; 06 April, 2020An international team led by University of British Columbia researcher Dr. Josef Penninger has found a trial drug that effectively blocks the cellular door SARS-CoV-2 uses to infect its hosts. The findings, published in Cell, hold promise as a treatment capable of stopping early infection of the novel coronavirus. The study provides new insights into key aspects of SARS-CoV-2, the virus that causes COVID-19, and its interactions on a cellular level, as well as how the virus can infect blood vessels and kidneys.ACE2 - a protein on the surface of the cell membrane - is now at centre-stage in this outbreak as the key receptor for the spike glycoprotein of SARS-CoV-2. ACE2 is the key receptor for SARS, the viral respiratory illness recognized as a global threat in 2003. His laboratory also went on to link the protein to both cardiovascular disease and lung failure. In cell cultures analyzed in the current study, hrsACE2 inhibited the coronavirus load by a factor of 1,000-5,000. In engineered replicas of human blood vessel and kidneys - organoids grown from human stem cells - the researchers demonstrated that the virus can directly infect and duplicate itself in these tissues. This provides important information on the development of the disease and the fact that severe cases of COVID-19 present with multi-organ failure and evidence of cardiovascular damage. Clinical grade hrsACE2 also reduced the SARS-CoV-2 infection in these engineered human tissues.possible coronavirus drug identified by Australian scientistswww.sciencedaily.com; 03 April, 2020A collaborative study led by Monash University’s Biomedicine Discovery Institute (BDI) in Melbourne, Australia, with the Peter Doherty Institute of Infection and Immunity (Doherty Institute), has shown that an anti-parasitic drug already available around the world kills the virus within 48 hours. The Monash Biomedicine Discovery Institute’s scientists showed that the drug, Ivermectin, stopped the SARS-CoV-2 virus growing in cell culture within 48 hours. Ivermectin is an FDA-approved anti-parasitic drug that has also been shown to be effective in vitro against a broad range of viruses including HIV, Dengue, Influenza and Zika virus. Scientists also cautioned that the tests conducted in the study were in vitro and that trials needed to be carried out in people. These scientists have been researching Ivermectin for more than 10 years with different viruses. Scientists started investigating whether it worked on the SARS-CoV-2 virus as soon as the pandemic was known to have started. The use of Ivermectin to combat COVID-19 would depend on the results of further pre-clinical testing and ultimately clinical trials, with funding urgently required to keep progressing the work.Clues to COVID-19 coronavirus’s vulnerability emerge from an antibody against SARSwww.worldpharmanews.com; 03 April, 2020An antibody recovered from a survivor of the SARS epidemic in the early 2000s has revealed a potential vulnerability of the new coronavirus at the root of COVID-19, according to a study from


scientists at Scripps Research. The study is the first to map a human antibody’s interaction with the new coronavirus at near-atomic-scale resolution. Although the antibody was produced in response to an infection of SARS (severe acute respiratory syndrome), which is caused by the SARS-CoV virus, it cross-reacts with the new coronavirus, SARS-CoV-2.The structural mapping revealed a nearly identical site on both coronaviruses to which the antibody binds, suggesting a functionally important and vulnerable site for this family of coronaviruses. Along with hundreds of other labs around the world, Wilson’s team is now focused on SARS-CoV-2.The new study centers on an anti-SARS-CoV antibody called CR3022 that was originally isolated in 2006 by the pharmaceutical company Crucell Holland B.V. in the Netherlands. A report from Chinese scientists earlier this year indicated that CR3022 cross-reacts against SARS-CoV-2. Wilson’s team used their structural mapping expertise to determine how the antibody binds to SARS-CoV-2. A key finding is that the antibody’s binding site is highly similar between the two coronaviruses--differing by just four protein building blocks called amino-acids. The high degree of similarity implies that the site has an important function that would be lost if it mutated significantly. Novartis announces plan to initiate clinical study of Jakavi® in severe COVID-19 patients and establish international compassionate use program.www.worldpharmanews.com; 02 April, 2020Novartis announced plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) for treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-19. The decision is based on pre-clinical evidence and preliminary reports from independent studies, and is supported by extensive data on the safety and efficacy of Jakavi in conditions like acute graft versus host disease and myeloproliferative neoplasms. The proposed trial will assess Jakavi in combination with standard of care (SoC) therapy, compared to SoC therapy alone, in patients with severe COVID-19 pneumonia as a result of SARS-CoV-2 infection. CSIR lab working on the genome sequencing of Covid-19www.thehindubusinessline.com; 26 March, 2020The Hyderabad-based Centre for Cellular Molecular Biology (CCMB), which is one of the 38 research institutes under the Government of India’s Council for Scientific and Industrial Research (CSIR), is working on sequencing the whole genome of the Covid-19 virus taken from “isolates” from people who have tested positive. The Centre’s Director said that large-scale genome sequencing will help understand how similar or different Indian isolates are compared with others. For this purpose, the Centre had sought samples from AIIMS, Delhi. Another CSIR institute, the Kolkata-based Indian Institute of Chemical Biology, has also got into the act. Two scientists in the division have designed a research proposal to find “inhibitors” against the coronavirus’ proteins.CSIR-IICT ties up with Cipla to develop anti-COVID-19 drugwww.expresspharma.in; 19 March, 2020Hyderabad-based CSIR – Indian Institute of Chemical Technology (IICT) has tied up with pharmaceutical giant Cipla to work on development of anti-viral drugs to contain COVID-19. Research on anti-viral drugs has been on throughout the world for long and many companies have developed molecule shaving anti-viral properties. But due to lack of demand, these molecules were not widely marketed. However, the CSIR-IICT decided to work on three such molecules — remdesivir, favipiravir and baloxavir. Cipla urged the IICT director S Chandrasekhar to start work on these molecules on

an immediate basis. Cipla would upscale the process on the basis of know-how given by CSIR-IICT.

REGULATORY AFFAIRSGlenmark receives approval from the regulator (DCGI) to conduct Clinical Trials in India on Favipiravir Antiviral tablets for COVID-19 patientswww.glenmarkpharma.com; 30 April, 2020Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company has announced that it has received approval from the DCGI (Drug Controller General of India), the regulator in India to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 patients. The product is a generic version of Avigan® of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. Recently in the past few months, post the outbreak of COVID-19, multiple clinical trials have been initiated on COVID-19 patients in China, Japan and in the US. Having internally developed the API and the formulations for the product, Glenmark filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients. As on date, Glenmark is the first pharmaceutical company in India to be given an approval by the regulator to start the trial on COVID-19 patients in India. As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomized in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment duration is a maximum of 14 days and the total study duration will be maximum for 28 days from randomization.Algernon receives positive feedback from USFDA for Ifenprodil for COVID-19 human trialwww.pharmabiz.com; 15 April, 2020Algernon Pharmaceuticals, a clinical stage pharmaceutical development company, announced that it has received positive feedback from the US Food and Drug Administration (FDA) regarding the company’s plans to conduct a phase 2 COVID-19 clinical trial using its repurposed drug NP-120 (Ifenprodil). Based on the feedback, the company plans to submit, as soon as possible, an Investigational New Drug (IND) application to the FDA, to conduct a phase 2 clinical trial with Ifenprodil, as a therapy for patients who experience respiratory complications as a result of contracting COVID-19. NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. Government removes custom duty, health cess on test kits, ventilators till Sept 30www.businesstoday.in; 10 April, 2020The central government has removed customs duty and health cess till September on ventilators, coronavirus testing kits and other medical supplies to increase domestic availability of these products to fight the COVID-19 pandemic .With the removal of the duty and cess, prices of these products that include personal protection equipment and face and surgical masks would also come down. These exemptions will also be applicable on inputs used to manufacture these items. Currently, there is a 10 % duty on ventilators, and test kits; and 7.5 % on face and surgical masks. It ranges from 7.5 % to 10 % on PPE. Health cess is flat 5 % on all these goods. With the number of COVID-19 patients increasing, there is a significant rise in demand for these items in the domestic market.


India has already restricted exports of diagnostic kits to discourage outbound shipments. The government has also banned exports of all kinds of ventilators, sanitizers, and textile raw materials for masks and coveralls.

Collaborations IIT Guwahati collaborates with Hester Biosciences for Covid-19 vaccinewww.business-standard.com; 29 April, 2020The Indian Institute of Technology (IIT), Guwahati, is collaborating with Ahmedabad-based animal healthcare company Hester Biosciences to develop a vaccine against Covid-19. It expects the vaccine to be ready for animal studies by the end of this year. The vaccine is planned to be based on the recombinant avian paramyxovirus-based vector platform. The recombinant avian paramyxovirus-1 will be used to express the immunogenic protein of SARS-CoV-2, and that will be a vaccine candidate for further study. The avian paramyxovirus-1 has been explored as a vaccine vector for various animals and human pathogens and used to express the immunogenic protein of human pathogens like human immunodeficiency virus (HIV), avian influenza virus, human parainfluenza virus, and SARS-CoV. Similarly, it has also been explored as a vaccine vector for animal pathogens like infectious bursal disease virus, infectious laryngotracheitis virus, bovine herpes virus, and Nipah virus, among others. The work is currently in its early stage of development. The institute’s role will be to produce the recombinant vaccine candidate.GSK, Sanofi team up to bring out Covid-19 vaccinewww.economictimes.indiatimes.com; 15 April, 2020Two of the world’s largest vaccine manufacturers, GSK and Sanofi are coming together to work on a Covid-19 vaccine, which if it passes the clinical trials would become available by 2021. Sanofi and GSK’s announcement comes a few days after Pfizer announced that it had invested in a New York-based company that was developing a vaccine for Covid-19. French company Sanofi and UK’s GSK would be collaborating to develop an adjuvanted vaccine using technology from both companies. Sanofi and GSK have vaccines for pneumonia and flu, which are among the commonly administered vaccines in the West. In this new JV, Sanofi would contribute its S-protein Covid-19 antigen, which is based on the recombinant DNA technology. The technology has produced an exact genetic match to the proteins found on the surface of the SARS-Cov2 virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculorvirus expression platform which is the basis of Sanofi’s influenza vaccine. GSK will provide its adjuvant technology platform which helps in mass production of dosages with less dose of vaccine proteins. The companies are aiming to get on with the Phase 1 of the clinical trial by the second half of 2020 and expect to make the vaccine available by 2021. pfizer and bioNTech announce further details on collaboration to accelerate global COVID-19 vaccine development.www.worldpharmanews.com; 10 April, 2020BioNTech SE and Pfizer Inc. disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program. The collaboration aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms, with the objective of ensuring rapid worldwide access to the vaccine, if approved. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network. The two companies plan to jointly conduct

clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple0 sites. BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance. During the clinical development stage, BioNTech and its partners will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. BioNTech and Pfizer will also work jointly to commercialize the vaccine worldwide (excluding China, which is already covered by BioNTech’s collaboration with Fosun Pharma) upon regulatory approval. GSK and Vir biotechnology enter collaboration to find coronavirus solutionwww.worldpharmanews.com; 08 April, 2020GlaxoSmithKline and Vir Biotechnology, Inc have announced a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.The collaboration will use Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines. Due to the urgent patient need for COVID-19 solutions, the initial focus of the collaboration will be to accelerate the development of specific antibody candidates identified by the Vir platform, VIR-7831 and VIR-7832 that have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralising SARS-CoV-2 in live virus-cellular assays. Subject to regulatory review, the companies plan to proceed directly into a phase 2 clinical trial within the next three to five months. The collaboration will also utilise Vir’s CRISPR screening and machine learning approach to identify cellular targets whose inhibition can prevent viral infection. Amgen and Adaptive Biotechnologies announce strategic partnership to develop a therapeutic to prevent or treat COVID-19.www.worldpharmanews.com; 02 April, 2020Amgen and Adaptive Biotechnologies announced a collaboration aimed at helping address the COVID-19 pandemic. The companies will combine expertise to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19. The mutually exclusive collaboration brings together Adaptive’s proprietary immune medicine platform for the identification of virus-neutralizing antibodies with Amgen’s expertise in immunology and novel antibody therapy development. Given the rapidly rising incidence of COVID-19 around the world, the companies will begin work immediately and finalize financial details and terms in the coming weeks. Amgen will leverage its world-class antibody engineering and drug development capabilities to select, develop and manufacture antibodies designed to bind and neutralize SARS-CoV-2. deCODE Genetics, a subsidiary of Amgen located in Iceland, will provide genetic insights from patients who were previously infected with COVID-19. The two companies have signed a Memorandum of Understanding to enable the parties to start work immediately and are planning to execute a Collaboration and License Agreement. Terms of the agreement are not being disclosed. Both companies aim to accelerate the development of a potential antibody against COVID-19 as fast as possible for patients in need.


COL


Date of Publication on 17th April, 2020RNI No. 18943/69Regd. No. MCN/206/2018-2020 at Mumbai Patrika Channel Sorting OfficeMumbai - 400 001 on 21st of every month.Licence to post without prepayment No. MR/Tech/WPP-151/North/2018-20

Prin

ted

at E

bene

zer

Pri

ntin

g H

ouse

, Dad

ar (W

), M

umba

ion

beh

alf o

f the

Indi

an P

harm

aceu

tical

Ass

ocia

tion

Pharma Times - COVID19 Special.pdf - Sri Adichunchanagiri ...

Documents

Transcript of Pharma Times - COVID19 Special.pdf - Sri Adichunchanagiri ...