The Drug Controller General of India (DCGI) is planning to draft a set of comprehensive guidelines to deal with botanical drugs in the Schedule Y of the Drugs & Cosmetics Act. Botanical drugs, which are clinically validated and standardized as in the case of modern drug development, will be promoted in ethical route.

Though this category of bulk drugs, sourced from either a known herb mentioned in Ayurveda/ Traditional medicine or from any other plant extract as potential molecules with modern therapeutic value, are approved with adequate support of clinical data in developed countries. This is yet to be recognized in India as different from herbal products.

However, few pharmaceutical companies in the country with enough capability in phyto-chemistry and herbal research, have attempted this route to develop successful therapeutic products. The Indian pharma majors like Dabur, Lupin, Alkem have recently launched high value therapeutic products as a result of their years long research on the plant substances. Several other companies both in the pharmaceutical sector and herbal research have also moved forward to take up such initiatives in the country currently.

According to Dr D B Anantha Narayana, Head, Herbals Research, HLL Research Centre, and former Director, Dabur Research Foundation, the clinically validated and standardized botanical products equal to any ethically promoted allopathic drugs are one of the emerging and most promising segments for the research based companies in India. Unfortunately, this area has not been explored well in India despite a well-recognized status for such drugs word wide.

Dr Narayana, who was speaking at a workshop organized by the Industry-Institute Partnership Cell of Bombay College of Pharmacy recently, said that since botanical drugs research, a real exploration of the natural sources to develop clinically validated drug molecule is an emerging area globally, several countries already have exclusive systems of evaluating the products for regulatory purpose. "In India too, the regulatory authority along with the industry should initiate such moves to promote the attempts by the industry and also to create a systematic approach to guide the industry," he said.

The regulatory authority has, however, moved forward to recognize this field and also to tackle the current dilemma on the analysis and approval method of botanical products. Thereby the creation of as special guideline to be referred in Schedule Y of the Drugs & Cosmetics Act as far as the clinical research of basic drugs is concerned, informed the DCGI sources. There is already a WHO guideline existing in this regard and the proposed Indian guideline will be almost in line with the same, the sources said.

Globally, the botanical products are defined and approved as per country specific guidelines. While Germany has Phytotherapy E Commission Monographs in this regard the USA follows DISHEA and in North America, there is FDA Guidance for Botanicals. France follows the Green Book, Hungary and Italy refers to Para-Medicine List A and List B respectively for botanical drugs approval. Australia, Malaysia and UK also have their respective regulatory guideline to approve and register botanical products. While Australia follows TGA- Lists, Uses, Formulations, Malaysia and the UK follows Traditional medicines / herbals and GSL / Herbal medicine, respectively.