Indian pharmaceutical companies are required to comply with the regulatory provisions

Bengaluru, December 12, 2015: In case of export of drugs, Indian pharmaceutical companies are required to comply with the regulatory provisions of the importing country. Isolated reports of the drugs not meeting the prescribed standards have appeared in the media and on the websites of the regulatory authorities of foreign countries etc. from time to time. As per recent media reports, regulatory action has been taken by USFDA against nine Indian pharmaceutical companies. Such instances impact our exports only marginally.

The gaps and weaknesses of our regulatory structures have been identified and the Government has, with a view to strengthen the regulatory regime, approved a proposal to strengthen the drug regulatory structures both at the Centre and in the States at a total cost of Rs.1750/- crore. The strengthening will include construction of new offices and laboratories, re-equipping existing laboratories, additional manpower, training, e-governance modules and IT infrastructure.

With a view to raise the credibility of our drugs, the Department of Commerce has introduced bar coding on secondary and tertiary packs for exports for tracking and tracing the medicines. Once fully implemented, it will remove the chances of someone else selling medical products that are not genuine.