With the Central Drugs Authority is in the offing to streamline the licensing system across the country, the Government in association with the industry is planning to introduce quality mark like the ISI or the Agmark approvals, for drugs to be manufactured and sold in the country.

Apart from the collaboration with the industry, the quality registration body Bureau of Indian Standards (BIS) would also be involved to set up and maintain a new method of granting quality marks for the drugs.

These marks would be awarded only on submission of bioequivalence and bioavailability studies to the DCGI. The proposed national pharmaceutical policy is expected to give shape to this new system, sources said.

It is viewed that the prevailing system of drug certification was completely opaque as far as the therapeutic quality and effectiveness of different brands are concerned, certainly to the patient and also possibly for the doctors. The Indian Pharmacopoeia (IP) certification or its equivalent in other countries , attests the quality of the API in most cases, and not to the quality of formulation, which is what the patient actually purchases.

However, it is cited that different formulations of the same API are perceived to have different levels of effectiveness due to different bioequivalence of the APIs, differences in the excipients or the drug delivery technology. Lack of adequate information and awareness sometimes lead to 'adverse selection' behaviour , whereby a higher price is associated with better 'quality.'

Against this background, the Government is planning institute a method of widely publicizing GMP certification as a guarantor of quality of the certified drugs and creating a quality mark for the drugs.