FDA Commissioner Margaret Hamburg, during her first-ever trip to India this year, urged its drugmakers and regulators to get on board with international quality standards, while promising close cooperation from its expanded office there. But just months after making those pledges, the efforts are being hampered by the exit of top officials, including its India-born director, who was named just last year.
Office director Altaf Lal was replaced June 1 by a temporary director and has returned to the U.S. but left the FDA, spokesman Christopher Kelly told Bloomberg. Also leaving was Atul Agrawal, the supervisory consumer safety officer, who also came back to the U.S. The FDA, citing privacy provisions, declined to say why the two officials left their posts. Kelly said that Carl Sciacchitano was named acting director while the agency looks for a permanent replacement.
Indian drugmakers produce about 40% of the generic and over-the-counter drugs sold in the U.S., second only to Canada. But in the past few years, the FDA has been cracking down hard on some of the biggest drugmakers for failing quality standards, banning plants operated by Ranbaxy Laboratories, Wockhardt, Sun Pharmaceutical and more. The actions have put the hurt on the drugmakers and attracted substantial criticism from the Indian drug industry.
Given its place in the U.S. market, the FDA had said it would expand its office in India to about 19 employees from 12, with at least 10 of those devoted to oversight of India's 600 FDA-approved manufacturing facilities. Lal, a Kashmir-born Ph.D., was named to the top FDA spot in India last September. He had left India for the U.S. in 1980 but said he had helped establish the FDA in his native country when he returned as health attaché for the U.S. embassy. In a blog post when named to the position, he said that cooperation would underpin his efforts there. He had plans to work with India's drug industry so that drugmakers that are not passing inspections understand exactly what procedures are essential to producing safe and effective products the U.S. will accept.
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