FDA in search of a new head for its Indian operations

Altaf Lal

When India-born Altaf Lal was named to run the FDA office in India last year, he pledged to work with Indian drugmakers there to improve quality and their chances of avoiding regulatory actions by the agency. But someone else will have to take on that challenge because Lal has left after just about 9 months on the job.

The FDA says that Lal returned to the U.S. and has left the FDA, Bloomberg reports. He was replaced June 1 by Carl Sciacchitano, who was named acting director while the agency looks for a permanent replacement, spokesman Christopher Kelly told the news service.

But Lal was not the only top official to leave the Indian office. Atul Agrawal, the supervisory consumer safety officer, also returned to the came back to the U.S. The FDA, citing privacy provisions, declined to say why the two officials left their posts.

The FDA says about 40% of the generic and over-the-counter drugs sold in the U.S. are made by Indian manufacturing plants, second only to Canada. But in the past few years, some of the country's largest drugmakers have had plants banned by the FDA for all sorts of quality failures. Ranbaxy last year even pleaded guilty to felony charges and agreed to pay $500 million to settle charges that reached back to 2008 and had left two of its plants unable to ship to the U.S. But even after that, the FDA banned two more Ranbaxy plants, as well as two plants owned by Wockhardt and one by Sun Pharmaceutical.

But given India's place in the U.S. market, the FDA had said it would not only step oversight in the country but work closely with drugmakers there to understand and meet its expectations. Last year it 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 appointed to lead those efforts and named to the top FDA spot in India last September. He had left India for the U.S. in 1980 but said he helped establish the FDA in his native country when he returned as health attaché for the U.S. embassy. In a blog post when he was named to the position, he said that cooperation would underpin his efforts there.

- read the Bloomberg story