Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
Close this folderII. REGULATORY SITUATION
Open this folder and view contentsAfrica
Open this folder and view contentsThe Americas
Open this folder and view contentsEastern Mediterranean
Open this folder and view contentsEurope
Close this folderSouth East Asia
View the documentIndia
View the documentIndonesia
View the documentNepal
View the documentThailand
Open this folder and view contentsWestern Pacific
View the documentIII. CONCLUSION
View the documentIV. REFERENCES
 

India

Market Importance and Use of Herbal Medicines

In India, a great deal of folk knowledge exists among ordinary people about the traditional use of herbal medicines. It is difficult to quantify the market size of the traditional Indian systems since most practitioners formulate and dispense their own recipes. The present annual turnover of products manufactured by large companies is estimated at approximately US $ 300 million, compared to a turnover of approximately US $ 2.5 billion for modern drugs. According to a study on the attitude of modern medicine practitioners towards Ayurvedic products, general practitioners are relatively unfamiliar with Ayurvedic products even though some are prescribed. They are willing to try an Ayurvedic product if its efficacy is scientifically proven, and would try Ayurvedic products if no modern medicinal remedies were available. People use self-medication for minor ailments such as cough, cold, diarrhoea and stomach problems. Patent and proprietary Ayurvedic medicines are sold over the counter in pharmacies. These products appear to represent a major share of branded traditional products in India. Nevertheless, systems like Ayurveda still need to gain an empirical support of modern medical science to make them credible and acceptable for all. An innovative research effort to define the advantages of traditional systems of medicine with respect to their safety and efficacy could result in a better utilization of these complementary systems of medicine [109].

In India, there are currently about 250 000 registered medical practitioners of the Ayurvedic system (total for all traditional systems: approximately 291 000), as compared to about 700 000 of the modern medical system. In every Indian state, about one-third of the governmental medical posts are occupied by physicians who belong to the traditional systems [109].

Legal Status

In India, traditional medicines are governed by the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. They regulate the import, manufacture, distribution and sale of drugs and cosmetics. In 1959, the Government of India recognized the traditional Indian systems of medicine and amended the Drugs and Cosmetics Act to include drugs which are derived from traditional Indian medicine. No products derived from traditional systems may be manufactured without a licence from the State Drug Control Authorities. Patent and proprietary medicines derived from the traditional systems must contain ingredients which are mentioned in the recognized books of the above systems, as specified in the Drugs and Cosmetics Act. The government is advised by a special committee and an advisory board for Ayurvedic, Siddha and Unani drugs. Pharmacopoeia committees have been constituted to prepare pharmacopoeias for all these systems [109].

In 1993, an expert committee appointed by the Indian government developed guidelines for the safety and efficacy of herbal medicines which were intended to be incorporated into the Drugs and Cosmetics Act and rules. It was proposed that no new herbal medicines other than those authorized by the licensing authorities be allowed to be manufactured or marketed, except for those mentioned in and manufactured in compliance with the formulae given in the "authoritative" books for Ayurveda, Siddha and Unani herbal medicines. A manufacturer of a new herbal medicine must include safety data and appropriate efficacy data in the marketing authorization application. Herbal preparations are defined as natural products in which the predominant active constituents are of plant origin. A classification for herbal medicines was proposed depending on their market availability, and the nature of the herbs:

- Category 1: already in use for more than 5 years
- Category 2: in use for less than 5 years
- Category 3: new medicines.

The classification of herbal medicines depends on whether they contain processed or unprocessed parts of plants and whether they contain potentially poisonous plants. Requirements for safety and efficacy vary according to the classification and market availability of the product. Depending on the nature of herbs and market availability, different requirements exist for submission of clinical trial data and toxicity data [110].

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