In India, national policy on TM/Complementary and Alternative Medicine (CAM) was introduced in the form of Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. This has been updated in 1964, 1970 and 1982. These govern and 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 derived from traditional Indian medicine.

A number of expert committees have been appointed 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.

According to the Drugs and Cosmetics Act, herbal medicines are regulated as prescription and OTC medicines and dietary supplements. Herbal medicines may be sold with medical, health and nutrient content claims. No products derived from traditional Indian medicines may be manufactured without a licence from the State Drug Control Authorities. Patent and proprietary medicines derived from 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 (ASU) drugs. Criteria for all ASU drugs whether misbranded, adulterated or spurious are laid down under specific sections of the act as also the regulations for the manufacture, licensing and sale of these drugs. Categories of offences and penalties are also stipulated under this act. The Department of AYUSH further drafted certain rules to amend the Drugs and Cosmetics Rules, 1945 in the Gazette of India. The draft claims that the certificate of GMP to manufacturers of ASU drugs shall be issued to licensees who comply with the requirements of GMP of ASU drugs as laid down in Schedule T of the act. According to rules 157, 158 and 159 of the Drugs and Cosmetics Act, failure to comply with GMP’s notified Schedule T of the Drugs and Cosmetics Act and Rules leads to revocation of the manufacturers’ licence by the State Drug Licensing Authorities.

India has two multi-volume national pharmacopoeias – the Ayurvedic Pharmacopoeia of India and the Unani Pharmacopoeia of India. Both are considered to be legally binding. Several sources are used for national monographs, including a national database on medicinal plants used in Ayurvedic medicine and monographs contained in the national pharmacopoeias. Manufacturing regulatory requirements include adherence to information contained in pharmacopoeias and monographs and the same GMP rules required for conventional pharmaceuticals. Drug licensing, inspection and testing are employed to ensure compliance with these requirements. Safety requirements include those required for conventional pharmaceuticals, as well as special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. No control mechanism is used for these requirements, as the long-standing use of herbal medicines in the Ayurveda, Unani and Siddha systems demonstrates their safety for human use.

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 ASU 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 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 depends on whether the herbal medicines 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.

There are 4,246 registered herbal medicines and essential drug lists exist separately for the three systems of traditional medicine in India; the Ayurveda 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 1999, 2000 and 2001, respectively. In India, herbal medicines are sold in pharmacies as prescription and OTC medicines, in traditional medicine outlets by licensed practitioners without much restriction. Annual herb sales figures, based on sales of 162 medicinal plants between 1999 and 2000, were estimated at Rs. 6,705 million (US $149 million). Recognizing the global demand, the Government of India mandates GMPs for pharmacies manufacturing ASU medicines to improve the quality and standard of drugs in the June 2000 amendment to the Drugs and Cosmetics Act, 1940. Department of Indian Systems of Medicine and Homeopathy (ISM&H) has framed safety and efficacy regulations for licensing new patent and proprietary botanical medicines. Indian pharmacopoeia covers a few Ayurvedic medicines and monographs have been given for some Ayurvedic drugs like clove, guggul, opium, mentha and senna. The Ayurvedic Pharmacopoeia of India gives monographs for 258 different Ayurvedic drugs and The Indian Drug Manufacturers Association (IDMA) has published Indian Herbal Pharmacopoeia with 52 monographs of widely used medicinal plants found in India. The latest available scientific data has been incorporated in these monographs.

Traditional Knowledge Digital Library (TKDL) is an original proprietary database fully protected under national and international laws of Intellectual Property Rights containing information on names of traditionally used medicinal plants, traditional description of diseases under their modern names and therapeutic formulations. Enabled by decoding software it facilitates automatic conversion of information from Sanskrit to various European languages. Also the Indian Medicines Development Corporation Bill, 2005 established a corporation exclusively to promote and develop Indian systems of medicine. The Traditional Herbal Medicines Act, 2006 was introduced in the Indian Parliament to regulate the sale of traditional herbal medicines which are being marketed without any licence and control under the cover of being manufactured as traditional formulations.

For herbal remedies and medicinal plants that are to be clinically evaluated for use in the allopathic system and which may be used in allopathic hospitals, the procedure laid down by the office of the Drugs Controller General of India for allopathic drugs should be followed. When an extract of a plant or a compound isolated from the plant has to be clinically evaluated for a therapeutic effect not originally described in the texts of traditional systems or if the method of preparation is different, it has to be treated as a new substance or new chemical entity (NCE) and the same type of acute, sub-acute and chronic toxicity data will have to be generated as required by the regulatory authority before it is cleared for clinical evaluation.

An extract or a compound isolated from a plant which has never before been mentioned in ancient literature should be treated as a new drug, and therefore, should undergo all regulatory requirements before being evaluated clinically.

The June 2000 amendment to the Drugs and Cosmetics Act provides general guidelines on clinical trials of herbals, toxicity studies, need for standardization and compliance with GCP in all clinical trials. Some of its recommendations include adherence to GMP guidelines for manufacture and standardization. For herbal remedies, it is not necessary to undertake Phase I studies and for those requiring usage for more than three months, 4–6 weeks’ toxicity studies in two species of animals are needed for Phase II and Phase III trials. Clinical trials should be carried out with herbal preparations only after standardization and identification of markers to ensure that the substances being evaluated are always the same. Also ethical guidelines for biomedical research like patient information, informed consent, protection of vulnerable populations etc. should be followed. Clinical trials should be approved by the appropriate scientific and ethical committees of the concerned institutes. Clinical trials should be carried out when a competent ASU physician is a co-investigator.