FDA slaps down another Indian plant, adding to the industry's woes

Print 28 January 2015
Eric Palmer, FeircePharmaManufactoring

The FDA has banned imports to the U.S. from another Indian drugmaker, adding to a substantial list of Indian companies whose drugs are now prohibited from being sold in the U.S.

The agency has taken the step against a plant owned by generic drugmaker Ipca Laboratories, Reuters reports. The company had already stopped shipping to the U.S. last summer after an inspection by the FDA found that employees had been falsifying drug testing results and deleting failed tests, a practice that also contributed to bans the FDA has imposed on the plants of Ranbaxy Laboratories, Wockhardt and Sun Pharmaceuticals. Company officials told the news service that it is working to get the issues addressed as quickly as it can.

India is second only to Canada as a supplier of generic and over-the-counter drugs sold in the U.S., but some of its largest drugmakers have gotten crosswise with the FDA over practices that raise questions about the effectiveness and quality of its drugs. The bans have also taken a bit out of their earnings while reducing the country's export numbers. During a visit there last year, FDA Commissioner Margaret Hamburg urged government and industry leaders to do more to assure they were hitting the highest standards.

The Indian drug industry has pledged to do so but has also been somewhat defiant in the face of the actions, complaining that the U.S. has unfairly singled it out. It has hired a Washington, DC, media specialist and launched a campaign to refute suggestions that its products are inferior. At first defenders could point to the fact that other regulators, in Europe and the U.K. for example, were finding no problems with their products. But that has changed in the past year, as regulators in both areas have banned products from Wockhardt and some other Indian drugmakers over many of the same concerns raised by the FDA. Just last week, the MHRA in the U.K. broadened a ban against Wockhardt to include all of its APIs after initially allowing it to continue to ship some used in what it considered essential drugs.

According to Reuters, exports accounted for 63% of Ipca's sales for its last fiscal year, with Australia, Europe and Canada among its other markets. But following the FDA action last year, in October Canada banned almost 20 APIs--and 50 products in which they are used--from Ipca.

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