Pleasantries aside, U.S. FDA keeps sharp eye on India pharma manufacturing

The exchange of niceties and promises of softness in recent meetings with India counterparts notwithstanding, the U.S. FDA continues to take harsh action against India drug-production plants. The latest is a ban on imports from two more Ipca Laboratories plants.

The FDA said it took the new action in the wake of inspections of Ipca plants at Pithampur and Silvassa that raised Form 483 concerns about their compliance with good manufacturing practices. The Silvassa plant is dedicated to drugs intended for the U.S. market, so presumably it would be shut down. The agency had already banned imports from another Ipca plant, at Ratlam.

Ipca said in a stock market filing that it had already complied with the ban on shipments of active pharmaceutical ingredients from its plant at Ratlam based on a January import alert issued by the FDA. Ipca has 12 plants in India.

Ipca officials said in a conference call that the company planned to have the plants compliant once again by December. Analysts scoffed, saying it probably would not be able to return to former U.S. levels for another two years.

- here are stories from Reuters and the Economic Times
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