Quality, Safety, and Efficacy of Herbal Products through Regulatory Harmonization

Drug Information Journal, Vol. 45, pp. 45–53, 2011 • 0092-8615/2011Printed in the USA. All rights reserved. Copyright © 2011 Drug Information Association, Inc.

n a t u r a l h e a l t h p r o d u c t s 45

Quality of herbal medicines is a great concern to consumers and regulators throughout the world. The quality of herbal medicines mainly depends on regulatory requirements of respec-tive countries. To probe the role of regulatory standards and their harmonization in improv-ing quality, safety, and efficacy, legislation on herbal medicines of different countries was an-alyzed. Results show that different countries have been changing and upgrading quality re-

quirements over the last few years, and those who have no legislation presently have started framing suitable legislation. Like other coun-tries, India has also adopted prudent measures to improve the quality of herbal medicines. Though there is a general trend to incorporate stringent measures worldwide, there is little ini-tiative to harmonize regulations, which is es-sential for providing quality herbal medicines globally.

Key WordsHerbal; Standard;

Regulation; Harmonization; Pharmacopoeia

Correspondence AddressSubhash C. Mandal,

MPharm, PhD (Pharm), FIC, “Nalanda,” Fartabad,

Amtola (near Bhangabari), PO: Garia,

Kolkata-700084, India (email: subhash.mandaldr

@gmail.com).

Subhash C. Mandal, MPharm, PhD (Pharm), FIC

Senior Inspector of Drugs, Directorate of Drugs

Control, Birbhum District Drugs Control Office, Suri,

Birbhum, India

Moitreyee Mandal, MPharm, PhD (Pharm), FIC

Lecturer, Department of Pharmacy, Jnan Chandra

Ghosh Polytechnic, Kolkata, India

Quality, Safety, and Efficacy of Herbal Products Through Regulatory Harmonization

Submitted for Publication: June 1, 2010Accepted for Publication: August 25, 2010

I n t r o d u c t I o nThroughout the world, there has been an up-surge in the use of natural products. Presently they are classified into different categories. Natural products of herbal origin are also used in different systems of medicine. For example, herbs are used in allopathy, homeopathy, Unani, Siddha, and Ayurvedic systems of medicine in India. In China, medicines of herbal origin have been extensively and traditionally used since the Yin Dynasty. The status of natural products is changing due to incorporation of the princi-ples of modern science and enforcement of strict regulations. For example, US FDA has ap-proved herbal products as medicine. The re-cently published National Essential Drug list of China includes 102 traditional Chinese medi-cines in a list of 307 drugs.

Herbal medicines are popular because of ex-perience and the abundant availability of plants in India due to its varied climatic zones. India has around 45,000 species of plants, out of which 15,000–20,000 plants have proven me-dicinal value. The traditional system of medi-cine utilizes around 7,000–7,500 species in its formulations. Ayurveda uses 2,000, Unani 1,000, Siddha 1,300, Tibetan 500, and 200 va-rieties are used in modern medicine (1).

Interest in herbal products has been increas-ing over the last few decades, not only in under-developed and developing countries but in the

developed countries. A large number of big pharma companies as well as many government institutions have started redirecting their busi-ness strategy by investing in research and man-ufacturing of herbal medicines.

Herbal medicine has a global market pres-ence of US$80–100 billion (2) and this market was expected to reach US$2,500 billion by 2010 and US$5 trillion by 2050. The Indian herbal drug market is about $1 billion and the export of herbal crude extracts is about $80 million (3). India has about 7,800 units en-gaged in manufacturing herbal drugs, which consume about 200 tons of herbs annually.

Initially there was no regulation of the quality of herbal medicines and practitioners relied on their experience for proper identification of plants. Gradually regulations were put into force and the first organized regulatory publi-cation on herbal drug quality was the Drugs and Cosmetics Act 1940 and Drugs and Cos-metic Rules 1945. These acts initially prescribed the standards of Ayurvedic, Siddha, and Unani (ASU) medicines and laid down rules and regu-lations on manufacturing.

In the meantime several reports had docu-mented that not all herbs are safe, as per gen-eral belief, and some are quite toxic, having se-vere adverse effects (4). It has also been reported that some products are not of desired quality due to absence of a regulatory stan-

n a t u r a l h e a l t h p r o d u c t s46 Mandal, Mandal

dard. As a result, the quality, safety, and efficacy of herbal products have become an important concern for both consumers and health au-thorities throughout the world. Consequently, efforts are being made globally to frame re-quired legislation, publish pharmacopoeias, develop monographs, improve existing mono-graphs, and so on.

o B J e c t I V eOur objective was to analyze the legislation of different countries and agencies on drugs of herbal origin and track recent global develop-ments to identify how the relevant legislation is being improved and updated to improve the quality, safety, and efficacy of herbal drugs. Eval-uation has also been done on how harmoniza-tion of regulation helps to improve quality, safe-ty, and efficacy of herbal drugs.

M e t h o dInformation and data have been collected on legislation from various countries. Monographs

of herbs and herbal products have also been studied to understand the effect of a scientific monograph on the quality, safety, and efficacy of herbal drugs.

r e s u lt sIt has been observed that there has been an up-surge in consciousness of quality during the past decade. Initially, herbal medicines were used as food and there were no quality require-ments. Presently they are classified into differ-ent categories such as drugs, health products, nutritional substances (neutraceuticals), cos-metics, and so on according to the laws of vari-ous countries. The status of herbal products is also changing due to the incorporation of mod-ern science. To maintain quality control over the products, some countries have published pharmacopoeias of herbs and herbal products (eg, UK, India, United States, EU) prescribing specific monographs of the herbs used (Table 1). Several other countries are in the process of developing monographs (eg, Brazil). Some countries are using pharmacopoeias of other countries to standardize their products. The number of monographs varies in different phar-macopoeias and also from one edition to anoth-er (Tables 2 and 3) (5–8).

A recent survey of WHO member countries has shown that 34 countries have a national pharmacopoeia and 104 countries do not pos-sess their own pharmacopoeia (4). Quality requirements also vary. For example, pharmaco-poeial specification for Andrographis paniculata is not less than 1% andrographolide in the In-dian Pharmacopoeia (IP) 2007, 0.5–0.9% an-drographolide in the Indian Herbal Pharmaco-poeia (IHP), 6% andrographolide in the WHO specification, not less than 0.8% androgra-pholide in the Pharmacopoeia of the People's Republic of China (CP), and so on. India has seven volumes of Ayurvedic Pharmacopoeia and recently published two volumes of Ayurvedic Pharmacopoeia of India (Formulations), two volumes of Herbal Pharmacopoeia, two volumes of Ayurvedic Formulary, and eight volumes of Homeopathic Pharmacopoeia. But unfortu-nately, the Herbal Pharmacopoeia is neither

t a B l e 1 Pharma- copoeia

Mono- graphs

having their own

Yes 34 (24%) 46 (33%)

no 104 (74%) 90 (63%)

using others in absence of a national one

Yes 58 (56%) 34 (38%)

no 31 (30%) 39 (43%)

national document legally binding

Yes 29 (85%) 24 (52%)

no 4 (12%) 17 (37%)

other national documents legally binding

Yes 34 (59%) 15 (44%)

no 18 (31%) 13 (38%)

data from ref. 5.

Status of Pharmacopoeias and Monographs in Different Countries According to a WHO Survey

Regulatory Harmonization of Herbal Products n a t u r a l h e a l t h p r o d u c t s 47

Drug Information Journal

published by the Government of India nor an official pharmacopoeia. A number of restric-tions have been introduced regarding the maxi-mum limit of heavy metals permitted in herbal products in India and they have been enforced rigidly. There are lots of conceptual changes too. EU has expressed interest in adopting some monographs from the Indian pharmacopoeia. This could be viewed as an initiative to harmo-nize regulatory requirements to ensure uniform global standards. Pharmacovigilance of herbal products is an important issue, though it is not considered that seriously in legislation in gen-eral. But recently pharmacovigilance has gained importance globally. Some countries have passed necessary legislation and some are in the process of developing it and activating suit-able mechanisms. The Government of India started a pharmacovigilance system in 2005

that examines all systems of medicine including drugs of herbal origin.

d e V e l o p M e n t I n I n d I aStandards for medicines are prescribed in the Drugs and Cosmetics Act 1940 and individual monographs have been prescribed in the Indi-an pharmacopoeia. Recently the Government of India has published four volumes of Ay-urvedic Pharmacopoeia encompassing stan-dards for 326 drugs, which is grossly inadequate in comparison to the number of herbs used in the Ayurvedic system of medicine. A positive step has been taken in this direction by pub-lishing herbal pharmacopoeias, with standards for 52 drugs (9).

Unfortunately neither the herbal products nor the herbal pharmacopoeias have any statu-tory standing in India (10). There are a large

t a B l e 2

Category of Monographs

USP 31/NF 26 (2nd

Supplement) BP 2005EP, 5th Ed.,

2005

IP, 2007 + IP Addendum

2008

raw herbs 37 67 80 44

excipients (natural) 22 15 25 6

processed herbs (extracts, volatile oils, essential oils, resins, etc)

61 60 54 15

Finished products (tinctures, waters, syrups, tablets, capsules, ear drops, etc)

84 47 14 2

total 204 189 173 67

Monographs of Herbs or Phytopharmaceuticals in Recent Editions of Different Pharmacopoeias

t a B l e 3USP Editions IP Editions

Category of Drugs 1955 1966 1985 1996 1955 1966 1985 1996

2007 + IP Addendum

2008

crude drugs 39 42 37 24 108 76 9 10 53

extracts 4 2 10 10 38 21 2 2 6

Finished product 24 14 10 8 70 41 0 0 2

pharmaceutical aid 41 17 5 4 21 17 6 9 6

total 108 75 62 46 237 155 17 21 67

Number of Monographs in Editions of the US Pharmacopoeia (USP) and Indian Pharmacopoeia (IP)


number of herbal products on the market, though it is difficult to categorize these prod-ucts according to the Drugs and Cosmetics Act and Rules. Some herbal drugs are also marketed as food or nutritional supplements, with medic-inal claims.

In some countries herbal products are con-sidered drugs (eg, China, Germany), while some countries do not do so (eg, United States, Neth-erlands). They consider them nutritional sup-plements, and have framed definite legislation (eg, United States) (11).

In India there are some gray areas in the sta-tus of herbal drugs and there are no definite policies about food supplements. Recently the Government of India published the Food Safety Act to resolve this problem (12). According to experts, this act has not been implemented and has failed to overcome the complexities of the issue.

Some countries have made adherence to GMP mandatory for manufacturing of drugs of herbal origin. For example, in India GMP has been mandatory for manufacturing of ASU medicines since the incorporation of revised Schedule T in 2003.

AMENDMENT OF SCHEDULE TSchedule T was incorporated into the Drugs and Cosmetics Act in 1970 mentioning only a few points. These guidelines were not sufficient to ensure quality, safety, and efficacy. Because of this, the schedule was amended in 2003 (13) with elaborate provisions. The salient features are as follows:

1. Raw materials to be used in the manufacture of

medicines must be authentic, of prescribed quali-

ty, and free from contamination.

2. Manufacturing process must be as prescribed, to

maintain the standard.

3. Adequate quality control measures must be adopt-

ed.

4. Drugs released for sale shall be of acceptable qual-

ity.

5. To achieve the objectives listed above, the firm is

required to maintain the following conditions

stringently:

• Well-designed factory premises with sufficient

space must be provided.

• Proper machinery must be provided.

• Quality control laboratory must be provided

with required instrumentation and well-quali-

fied personnel.

• Shall evolve methodology and procedures for

following the prescribed process of manufac-

ture.

• The manufacturing process should be properly

documented and the documents kept for refer-

ence and inspection.

MANDATORY LISTING OF INGREDIENTS OF ASU PRODUCTSIn 2005 the Government of India directed the state licensing authorities of ASU drugs to en-sure full compliance by all ASU drug manufac-turers with the provisions of Rule 161(1) and 161(2) relating to displaying on the label of the container or package the true list of all the in-gredients (official and botanical names) used in the manufacture of the preparation together with the quantity of each of the ingredients in-corporated therein. In case all the ingredients cannot be listed on the label because of their large number, they shall be listed on the leaflet to be inserted in the package. Further, the con-tainer of a medicine shall conspicuously display the words “Caution, to be taken under medical supervision” if the list of ingredients contains a substance specified in Schedule E(1) of the Drugs and Cosmetics Rules 1945 (14).

INTRODUCTION OF NEW RULES

Rule 157A. The rule concerns maintenance of records of raw materials used by licensed manu-facturing units of ASU drugs in the preceding financial year. Each licensed manufacturing unit of ASU drugs shall keep a record of all raw materials used in the performa given in Sched-ule TA by that unit in the manufacture of ASU drugs in the preceding financial year, and shall submit the record by June 30 of the succeeding financial year to the State Drug Licensing Au-thority of Ayurveda, Siddha and Unani drugs and to the National Medicinal Plant Board or



any agency nominated by the National Plant Board for this purpose (15).

Rule 169, Permitted Excipients. Permitted ex-cipients along with their standards, that is, ad-ditives, preservatives, flavoring agents, chelating agents, and so on permitted in the Indian Phar-macopoeia (16). Prevention of Food Adultera-tion Act, 1954 and Bureau of Indian Standard Act, 1986 are permitted for use in ASU drugs with the following conditions:

1. The above excipients shall be used within permis-

sible limits as prescribed in the Indian Pharmaco-

poeia Prevention of Food Adulteration Act, 1954,

Food Product Order Bureau of Indian Standard

Act, 1986, and they shall comply with the respec-

tive quality specifications, not exceeding any spec-

ified limits of usage therein, and except hydroge-

nated vegetable oil.

2. Only natural coloring agents as permitted under

rule 26 of Prevention of Food Adulteration Rules

1955 will be used for ASU drugs and additionally,

colors permitted under rule 127 of Drugs and Cos-

metics Rules 1945 shall be used for proprietary

ASU drugs as defined in subclause (i) of section 3

of Drugs and Cosmetics Act 1940, not exceeding

any specified limits of usage therein.

3. Preservatives and coloring agents shall be men-

tioned on the label for the information of the con-

sumer as required under rule 161 of the Drugs and

Cosmetics Rules 1945.

4. Additives used in various processes and in formu-

lating dosage forms shall be mentioned clearly

with quantities used in the application for licens-

es, and the record for the same shall be mentioned

by the manufacturers.

5. Manufacturers shall be responsible to ensure ratio-

nality, safety, and quantity of various excipients

used in the formulation.

6. If any excipient, additive, preservative, and so on

referred to in the Indian Pharmacopoeia Preven-

tion of Food Adulteration Act, 1954, or Food Prod-

uct Order Bureau of Indian Standard Act, 1986, is

deleted at a particular point in time, it will also be

deleted simultaneously for use in ASU drugs.

7. Artificial sweeteners may be used in various dos-

age forms of ASU proprietary medicines as per the

maximum limits indicated below.

8. Artificial sweeteners may be used only in proprie-

tary ASU products and the label of such products

should carry a statutory warning stating the name

and quality of the artificial sweeteners used.

The recommended acceptable daily intake of these sweeteners as laid down by US FDA is as follows:

• Sucralose: 5 mg/kg body weight

• Aspartame: 40 mg/kg body weight

• Saccharine: 5 mg/kg body weight

• Accsulfame K: 15 mg/kg body weight

MANDATORY HEAVY METAL TESTINGThe necessary law was framed by the Govern-ment of India in 2006 to make heavy metal test-ing mandatory for each batch. According to the law, testing for heavy metals, namely arsenic, lead, mercury, and cadmium will be as recom-mended by the WHO publication “Quality Con-trol Methods for Medicinal Plant Materials.” In the case of mercury, the permissible limit will be 1 ppm (14).

STIPULATION OF EXPIRY DATE FOR AYURVEDIC MEDICINESIt was long felt that Ayurvedic medicines should have a defined shelf life and the Government of India has made it mandatory to mention the ex-piration date of Ayurvedic medicines as of April 1, 2010 (Table 4) (17).

REINTRODUCTION OF MONOGRAPHS OF HERBS AND HERBAL PRODUCTS IN INDIAN PHARMACOPOEIAOver the years there have been many conceptu-al changes in India, and quite a few herbal monographs were included in the 1966 edition of the Indian Pharmacopoeia (18–22). Subse-quently those were deleted and incorporated into the Ayurvedic Pharmacopoeia. Later 58 monographs were reintroduced into the Indian Pharmacopoeia published in 2007 and 9 more monographs were introduced in the addendum of IP 2009 (Table 3). Quality parameters pre-scribed in the 2007 edition of IP are more strin-gent than those of earlier editions (Table 5).


The United States, UK, and EU have expressed interest in adopting some monographs from the Indian Pharmacopoeia. This may be the start of an initiative to harmonize regulatory require-ments to ensure herbal product quality.

CLINICAL TRIALSThere is always a lack of enthusiasm for con-ducting clinical trials, and also a dearth of coor-dination and effort to translate and utilize the results of clinical trials among various working groups and professionals. While most modern clinicians and researchers believe in rigorous screening and clinical trials, most specialists in traditional medicine are convinced of 100% ef-ficacy of their drugs and consider clinical trials redundant. Proper research requires coordinat-ed efforts between experienced clinical phar-macists, pharmacologists, and experts in tradi-tional systems of medicine.

Keeping this fact in mind, the Government of India has started a project called the Golden Triangle Partnership. Under this scheme, the Department of AYUSH, through its research councils—Central Council for Research in Ay-urveda and Siddha, Central Council for Re-search in Unani Medicines, and Central Coun-cil for Research in Homeopathy—will work together with two other major partners (CSIR and ICMR) to achieve the following objectives:

• To market safe, effective, and standardized Ayurve-

da, Siddha, homeopathy, and Unani products for

the identified disease conditions.

• To develop new ASU and homeopathic products ef-

fective in disease conditions of national or global

importance. Products should be better than the

available products on the market for such disease

conditions.

• The criteria should guarantee high-quality, safe,

and effective products. Mechanisms will be evolved

to make the products affordable for the domestic

market.

• To utilize appropriate technologies for development

of single and polyherbal products to make them

globally acceptable.

• To promote collaborative research on AYUSH with

state-of-the-art technical institutions, specializing

in drug and DDS research.

ESTABLISHMENT OF A PHARMACOVIGILANCE SYSTEMPharmacovigilance of herbal products is an im-portant issue throughout the globe, but is not considered seriously in legislation in general. But recently pharmacovigilance has gained im-portance globally. Some countries have framed necessary legislation and some are in the pro-cess of developing their legislation and suitable mechanisms and modalities.

Presently an effective pharmacovigilance sys-

t a B l e 4 Expiration Date

1 Year 2 Years 3 Years 5 Years 10 Years No Expiration

type of Medicine

arak Inhaler/dhoopan tablets (100%)/chooma

tablets of rasa bhasmas

all mandoor and loha medicines

all rasaaushadhis

eye drops ear drops Ghanvati Guggulikalpa Kupipakva rasa

shweta parpati soft gelatin capsules dravak lavan ksnar

all asav and arishtas

dantamanjan (powder or paste)

syrups nag vanga and tamra bhasma

all other bhasmas

Ghruta oils hard gelatin capsules

pishti

choorans lotion, cream or gel

Expiration Date of Ayurvedic Medicines



tem is in place in India. Two zonal centers have been established at Mumbai and Delhi. Five re-gional centers were established at Kolkata, Mumbai, Nagpur, New Delhi, and Pondicherry. Twenty-four peripheral centers are now operat-ing from different medical colleges or pharmacy colleges throughout the country. The national pharmacovigilance program encourages the re-porting of all suspected adverse reactions to drugs and other medical substances including herbal, traditional, or alternative remedies. Re-cently Schedule Y has been amended including a mandatory requirement for postmarketing surveillance of any new drug. A National Phar-macovigilance Advisory Committee (NPAC) has been formed to oversee the performance of var-ious zonal, regional, and peripheral centers and to recommend possible regulatory measures based on data received from different centers. Pharmacists can report any adverse drug reac-tion detected in the centers mentioned above. Health care professionals can report any ad-verse reaction online at this center. Additional initiatives are being taken to improve and re-vamp the existing pharmacovigilance system.

India is adopting proactive steps to promote AYUSH including herbal medicines and to im-prove their quality, safety, and efficacy (23).

Harmonization of regulation of herbal prod-ucts has been needed for some time and some isolated efforts have already been made by some countries and international agencies. The World Health Organization’s Traditional Medi-cine Strategy is one of the milestones in this di-rection (24). The International Conference on Drug Regulatory Agencies held at Madrid in 2004 requested that regulatory agencies should work together to make the best use of scientific resources related to herbal medicines, and stat-ed that sharing national experience and infor-mation was crucial (25). The International Reg-ulatory Cooperation on Herbal Medicines (IRCH) network, set up under the aegis of WHO in 2005 on the recommendations of the 11th International Conference of Drug Regulatory Authorities, is presently made up of 16 coun-tries (Australia, Brazil, Canada, China, Hong Kong, Ghana, Hungary, India, Indonesia, Japan,

Malaysia, Mexico, Korea, Singapore, UK, and United States) and five regional groups. The fo-rum provides a platform for electronic exchange of regulatory information on herbal and tradi-tional medicines through a collaborative web space provided to individual focal points of each member country. The European Commis-sion has issued a directive 2004/24/EC for har-monizing the definition of traditional herbal medicinal products all over Europe, resulting in a simplified registration procedure and set-up of a full-fledged Committee on Herbal Medici-nal Products within the European Medicines Agency (26). India is also a part of this process, being a member of IRCH and signing MOU with several countries, including China.

c o n c l u s I o nHerbal medicines have been used by a majority of the global population since the early days of

t a B l e 5

1966 Edition 2007 Edition

description

Macroscopic

Microscopic

ash

acid-insoluble ash

Foreign organic matter

alcohol (60%)-soluble extract

Water-soluble extract

assay: gravimetric method

storage

category

preparation

description

Identification

Macroscopic

Microscopic

determination by tlc

tests

Foreign organic matter

ethanol-soluble extract

Water-soluble extract

ash

acid-insoluble ash

heavy metals

loss on drying

Microbial contamination

assay: determination by liquid chromatography

storage

Comparison of Quality Parameters of Kalmegh as Specified in the Monographs of

the Indian Pharmacopoeia


civilization. As in Ayurveda, its common basis is a holistic approach to life, equilibrium between the mind, body, and environment, and an em-phasis on health rather than on diseases. Gen-erally the treatment focuses on the overall con-dition of the individual patient, rather than on the ailment or disease. During the last couple of decades there has been a global upsurge in the use of herbal medicines. In the meantime, several reports have documented that not all herbs are safe, and many of them are quite toxic and have adverse effect. It has also been report-ed that some products are not of standard quality, which has raised serious concerns about safety and efficacy. As a result the quality, safety, and efficacy of herbal products have be-come an important concern for both consum-ers and health authorities the world over. Countries including India and international agencies have taken stringent measures by amending laws to ensure quality, safety, and ef-ficacy of herbal medicines. Further efforts are being made universally to frame required leg-islation, publish pharmacopoeias, develop monographs, improve existing monographs, and so on. But unfortunately the majority of countries do not have their own legislation, pharmacopoeia, or monographs. More inten-sive research needs to be carried out for estab-lishing quality control procedures for herbal drugs, especially multi-ingredient products, and more coordinated efforts need to be initi-ated for conducting clinical trials for establish-ing the efficacy of herbal products. Some ini-tiatives have already been taken in this arena by several countries and agencies including WHO, IRCH, EU, and so on. In spite of such isolated initiatives, there is a need for global harmonization of the legislation and associat-ed instruments to provide quality, safe, and ef-ficacious herbal medicines for the benefit of humanity.

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Quality, Safety, and Efficacy of Herbal Products through Regulatory Harmonization

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