US FDA sends warning letter to Cadila Pharma

Says it may withhold approvals for new drugs, put import alert if problems not addressed

The US Food and Drug Administration (FDA) has sent a warning letter to Cadila Pharma over several manufacturing deficiencies at its Gujarat plant.

 

The plant has had manufacturing issues on multiple occasions, it said in a letter to the Rajiv-Modi led company, pointing out that more than the permitted level of impurities were allowed that were not adequately investigated.

 

The America drug regulator further pointed out that this was not the first time such poor practices were found to be exercised in the Gujarat plant.

 

"This is a repeat deficiency from our 2012 inspection which also identified a large stability sample backlog. Your 2012 investigation failed to address the impact of delayed sample testing on your known typical impurity profile," the letter added.

 

Cadila Pharma has been given 15 days to respond to the regulator's query.  

 

The FDA has mentioned in its warning letter that it may withhold approval for any new drugs using materials manufactured at the Gujrat facility. It may also put the company's products on import alert, it added.

 

Of late, Indian drug makers have been facing stringent enforcements in the US, the world’s largest pharmaceutical market. Several manufacturing plants of leading domestic companies including Ranbaxy, Sun Pharma, Wockhardt and Strides Arcolab have come under the US FDA scanner for compliance related issues. The frequency of regulatory inspections in Indian plants has also increased significantly in past few years.