US FDA to soon name permanent India head

The US Food and Drug Administration (FDA) expects to name a permanent director for India in coming months and is in the final stages of hiring additional investigators for the country, a spokesman for the health regulator told Business Today.

The spokesman said that Carl Sciacchitano, Senior Science Advisor in the FDA's Office of International Programs, is serving as acting director of the India Office since June 1. The move came after Altaf Ahmed Lal quit as the FDA's India head in May. Lal has since left the FDA.

The FDA spokesman was responding to queries from BT on the regulator's staffing plan for India.

Sciacchitano will lead the India office's efforts "toward greater coordination and enforcement of regulatory standards to ensure safety, efficacy, and quality of products entering the US market", the spokesman said.

Giving a breakup of the people in India, the spokesman said the FDA has six medical products investigators in India. They are part of a total staff of 14, which also include foods investigators and policy analysts.

He also said that, in March 2013, the FDA received approval from the Indian government to add seven additional permanent medical products investigators. "Once fully staffed, this will increase our presence to 19 permanent American staff based in-country, including 10 dedicated specifically to medical products."

The FDA's response seeks to put to rest some speculation about Lal's sudden exit after barely 10 months into the job.

In fact, Business Today's requests for an interview with Lal had been pending for some time and a repeat request, made as recently as June 24, did not get any response from the FDA.

After taking charge of the India office on September 24, 2013, Lal had talked about his plans on the FDA blog. "Over the next 12 to 24 months, I look forward to hosting several workshops for open, transparent discussions with industry and regulators on what systems of preventive controls need to be in place throughout the lifecycle of any manufacturing process," he had said.