FDA takes aim at yet another Indian API maker

FDA Commissioner Margaret Hamburg's recent trip to India drew international attention to how many Indian drug and ingredient manufacturers have failed plant inspections by the FDA. Fueling the perception that India has issues when it comes to quality is the steady string of warning letters issued to Indian drug and ingredient makers as the agency has added to its staff there. Now another has been issued.

A March 6 warning letter posted this week to the FDA's website shows that inspectors found some of the usual problems during an inspection of an active pharmaceutical ingredient plant in Solapur operated by Smruthi Organics. Among those were a host of problems raising questions about the accuracy and authenticity of analytical data used to approve its products.

During their visit in November, inspectors said audit records had been deleted without explanation and there were incomplete raw data to support the test method validation/verification activities for the test APIs. They also said some of the records were not authentic because they had approval signatures by people who were not at work on the days they were supposedly signed. The company was also cited for blending out-of-spec APIs with other API batches, and the warning said the plant did not investigate complaints of particulate matter found in APIs.

In the past month, the FDA has cited two other Indian facilities, Canton Laboratories in Vadodara and USV lab in Mumbai, for many of the same kinds of observations. It has also issued a series of import alerts against plants operated by some of India's biggest generic drugmakers, banning products from those plants from coming into the U.S. Earlier this month it took that action against a Sun Pharmaceuticals plant. In January it was a Ranbaxy Laboratories API plant that got the treatment, after one of its key manufacturing plants was banned in September. Two Wockhardt plants were banned last year by the FDA, as well as by European authorities.

India produces 40% of the generic and over-the-counter drugs used in the U.S., and many of those drugmakers have good records when it comes to quality of their products. Hamburg highlighted that fact during her trip in February to meet with government and industry officials. But she also addressed the highly publicized failings there that have begun to raise concerns among some doctors about the quality and effectiveness of Indian-made drugs. The number and seriousness of those have industry officials worried they will put a cloud over the entire Indian generic drug industry. One analyst recently reported that some companies are even looking at buying or building new plants in Europe or the U.S. to fight the perception.

- here's the warning letter