Indian pharmaceutical industry facing tough foreign regulations to meet western standards

Indian pharmaceutical firms are accumulating problems one after another so that the domestic industry may lose revenue and credibility in foreign markets. The latest is the USFDA’s data fudging accusation against Mumbai based USV Lab. Already, Ranbaxy, Wockhardt and Posh have received warning letters from the FDA (Food and Drug Administration) which has the largest drug monitoring infrastructure in the world.

 An interesting turnaround of the new USFDA action is that other advanced country regulators which have not big inspection infrastructure, are following the US moves. Regulators from EU especially UK (MCA) and Australia (TGA) are working with the USFDA on the matter. These countries are seeking information from the US while initiating their plan.

The FDA has inspected various production facilities of Indian pharmaceutical plants after getting complaints in the US.

Last week, the US pharma watchdog has imposed a ban on imports from Ranbaxy Lab’s Mohali plant. The Mohali plant was commissioned under the new owner of Ranbaxy- Japan’s Daiichi Sankyo. Mohali plant is the third manufacturing facility of Ranbaxy to face Food and Drug Administration FDA action, after the Dewas and Paonta Sahib plants. Ranbaxy has sixteen manufacturing facilities in eight countries.  The USFDA is citing problem mainly related to drug making in its Indian facilities.

Most of the action is due to the failure of the company to contain human generated errors while handling drug contents. The USFDA follows advanced drug manufacturing norms on various aspects and is monitoring it with strict onsite inspection. Besides, competition from generic manufactures from India compels it to tighten the regulations. Hence, the leading challenge of the domestic industry is to meet western standards while serving these markets.