Increased communication will address all concerns of Indian firms: US FDA Commissioner

The concerns of Indian pharma companies over the heightened level of inspections by the US Food and Drugs Administration (US FDA) could be addressed through increased communication, FDA Commissioner Margaret A. Hamburg assured on Friday.

Hamburg, who held a dial-in media briefing on her return from her first official trip to India, said: "There are companies in India which haven't been inspected before or are experiencing an increased number of inspections and are expressing concern or asking questions. But I think, with the entire process of enhanced communication and education about what we are doing and what we are looking for, some of those concerns will be addressed."

There were many pharma companies in India well accustomed to FDA inspections, she added. "I think one of the great things about having an office  (as we do in India) is that it enables greater communication so that people can better understand what we do, how we do and why."

To a question from Business Today about the problem of supply chain security and Indian concerns, she said: "The integrity of the supply chain is of utmost importance and in a modern globalised world, supply chains are much more complex and often involve different countries, manufacturers, distributors, exporters and importers. So, we feel that it is very important to have systems in place that really track (the supply chain)."

"Companies were happy to engage with us and to understand that quality matters," she said in reply to another question. "They wanted to be able to get more information about our activities."

Underlining the importance of the Indian regulators and the role they could play, she said, "One of the issues I discussed with both government officials (in India) and with the industry representatives was that it was increasingly important that Indian regulators be present at the table in the international meetings and for a for discussion of increased harmonization, communication and collaboration among nations....there is a an increasing need for a global coalition of regulators..."

She emphasised there was no question of targeting Indian companies. "What is happening in India is consistent with what has happened within the US and throughout the world," she said. "India stands out as particularly important considering that the country is now the third largest supplier of over the counter and prescription drugs in the US.... it is a very significant and a growing player in the US marketplace."