The Drug Controller General of India (DCGI) will shortly announce WHO's supplementary good manufacturing practices guidelines for the herb-based drugs development and production. The move is in the wake of the growing number of pharma companies coming out with plant-based products.
The WHO guideline, originally issued in 1996 as a supplementary GMP guideline for specific pharmaceutical products and reproduced in the second volume of WHO compendium on Quality Assurance of Pharmaceuticals, deals with the assessment of herbal medicines as well as quality control methods of medicinal plant materials.
The plant-based medicinal products, unlike the conventional pharma products produced from synthetic materials by means of reproducible manufacturing techniques and procedures, are prepared from material of plant origin. Since the materials of plant origin may vary in composition and properties, the procedures and techniques in the manufacture and quality control of herbal medicinal products often substantially different from those employed for conventional pharmaceutical products.
It may be mentioned that earlier Chronicle Pharmabiz had reported that the DCGI has plans to draft a set of guidelines to deal with botanical drugs (plant based medicinal products) 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, are 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 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 Ranbaxy, Dabur, Himalaya, Lupin and 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 pharma sector and herbal research including Lever and Procter and Gamble have moved forward to take up such initiatives in the country recently.
According to CDSCO sources, 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. Still, this area has not been explored well in India despite a well-recognized status for such drugs world wide, the sources added.