India

In the Republic of India, the national policy on TM/CAM was introduced in 1940.
National laws and regulations were also issued in 1940, and updated in 1964, 197
0 and 1982. The national programme was issued in 1964. The national office, the
Department of Medicine and Homeopathy, was established in 1995 as part of the Mi
nistry of Health and Family Welfare. There are a number of expert committees for
different forms of TM/CAM; the earliest was established in 1962. There are also
a number of national research institutes; the first was the Central Council of
Indian Medicine, established in 1970.
National regulation of herbal medicine began in 1940 with the publication of the
Drugs and Cosmetics Act; the laws and regulations on herbal medicines are partl
y the same as those for conventional pharmaceuticals. Herbal medicines are regul
ated as prescription and over the counter medicines and dietary supplements. Her
bal medicines may be sold with medical, health and nutrient content claims.
India has two multivolume national pharmacopoeias, the Ayurvedic pharmacopoeia o
f India and the Unani pharmacopoeia of India. Both are considered to be legally
binding. Regarding national monographs, several sources are used, including a na
tional database on medical plants used in ayurvedic medicine and monographs cont
ained in the national pharmacopoeias.
Manufacturing regulatory requirements include adherence to information contained
in pharmacopoeias and monographs and the same GMP rules required for convention
al pharmaceuticals. Drug licensing, inspection and testing are employed to ensur
e compliance with these requirements. Safety requirements include those required
for conventional pharmaceuticals, as well as special requirements of traditiona
l use without demonstrated harmful effects and reference to documented scientifi
c research on similar products. No control mechanism is used for these requireme
nts, as the long standing use of herbal medicines in the ayurveda, unani and sid
dha systems demonstrates their safety for human use.
There are 4 246 registered herbal medicines. Essential drug lists exist separate
ly for the three systems of traditional medicine in India; the ayurveda list has
315 herbal medicines on its essential drug list, the unani list has 244 herbal
medicines and the siddha list has 98. These lists were issued in 2001, 2000 and
2001, respectively. There are currently plans to establish a post marketing surv
eillance system. In India, herbal medicines are sold in pharmacies as prescripti
on and over the counter medicines, in special outlets, by licensed practitioners
and without restriction. Annual herb sales figures, based on sales of 162 medic
inal plants between 1999 and 2000, were estimated at 6 705 million Indian rupees
(US$ 149 million).
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National Policy on Traditional Medicine and Regulation of Herbal Medicines - Rep
ort of a WHO Global Survey
(2005; 168 pages)
Abstract
Various types of traditional medicine (TM) and medical practices referred to as
complementary or alternative medicine (CAM), have been increasingly used in both
developing and developed countries. One of the major components of the WHO Trad
itional Medicine Strategy is to promote the integration of TM and CAM into natio
nal health care systems where appropriate. Development of national policy and re
gulations are an essential indicator of the level of integration of such medicin
e within a national health care system.
The use of medicinal plants is the most common form of traditional medication wo
rldwide. Regulation of herbal medicines is a key means of ensuring safety, effic
acy and quality of herbal medicinal products. WHO has been receiving an increasi
ng number of requests from governments for guidance on how to regulate herbal me
dicines.
During the last four years, many countries have established, or initiated the pr
ocess of establishing national regulations regarding herbal medicines. WHO has b
een conducting a global survey on national policy on traditional medicine and on
the regulation of herbal medicines; aiming to:
Collect updated and comprehensive information on TM/CAM policies and regulations
of herbal medicines
Clarify the current situation, in each country, on the TM/CAM national policies
and regulation of herbal medicines, and their major challenges on these particul
ar area
Identify the specific needs on capacity building for TM/CAM policy development i
ncluding establishment of regulations of herbal medicines, and the type of direc
t support WHO should provide to Member States
Monitor the impact of the WHO Strategy for Traditional Medicine in relation to p
resent national policy and regulation on TM/CAM/herbal medicines
WHO had received completed survey return from 141 countries. The raw data of the
survey results were fed into a database specifically designed for this project,
to create basic country profiles. Government clearance has been obtained for ea
ch country profile, the manuscript of the draft summary report was finalized in
English. The present document provides a summary of the results of the WHO globa
l survey with information from 141 Member States.
The baseline information gathered in the first of its kind, and will be valuable
not only to help countries compare and learn each other's experiences in streng
then their current TM/CAM system, but also for guiding WHO on provision of suppo
rt to Member States.

http://apps.who.int/medicinedocs/en/d/Js7916e/#Js7916e