Draft Amendment to Drugs and Cosmetics Rules to License Science Based Botanicals, Phytopharmaceuticals as Drugs in India

The Government of India has published a draft amendment to Drugs and Cosmetics Act, and Rules (D&C Act and Rules) on 24th October 2013.[1] This creates regulatory provisions of defi ning phytopharmaceuticals (botanicalbased drugs) and a schedule providing requirements of scientifi c data on quality, safety, and effi cacy to evaluate and marketing authorization for a plant-based lead as a drug on similar lines to synthetic, chemical moieties. In India, it is known that though the new draft regulation was not present, Guggulu tablets (for treatment of hypercholesterolemia), Gingko-biloba tablets (to treat temporary loss of memory), and Silymarin capsules (to treat liver disorders)[2] have been approved and marked as drugs by the Central Drugs Standards Control Organization (Drug Controller General of India). However, it is known that approval of Guggulu tablets took a more than a decade to get this approval as a drug. It had required efforts to convince the authorities that several requirements applicable to a synthetic chemical were not possible for a botanical-based product.