India Increases Inspections of Foreign Drug Manufacturers

The Drug Controller General of India (DCGI) will begin inspecting importers’ overseas manufacturing facilities to ensure compliance with standard industry practices. Despite having established provisions for such inspections in the Drug and Cosmetic Act, this is the first time the DCGI will do so. Over 100 import licenses have been cancelled this year by the DCGI due to quality issues, putting the heat on officials to begin verifying quality parameters with manufacturers. As a first step, inspectors from India will be sent to facilities in China and Europe by early 2011.

India imports almost $3 billion (US) worth of pharmaceuticals each year, according to DCGI estimates. India’s total pharmaceutical industry is worth about $22 billion (US). “With increasing volumes, we have decided to send our drug inspectors before we grant registration to import bulk drugs,” says the DCGI Surinder Singh. “Though there was a provision in the Drugs and Cosmetics Act earlier too, it required a lot of budgetary support. But in the current scenario, we are serious in conducting audits before allowing imports and have taken up the issue with the ministry. We are awaiting ministry approval for the step and bring more transparency into the system.”