USFDA audit inspections are often not followed up by discussions with companies

Commerce and Industry Minister Anand Sharma, on Monday, raised concerns over the audit inspections of Indian pharma companies by the U.S Food and Drug Administration (USFDA) and said that India would soon submit a discussion document on the issues to the U.S.

“We are going to give a non-paper (to the US) overall on some of our concerns, when it comes to duration for the registration process for the filing. They have the process of filing and the fee, those issues have been discussed. But it will be general, the paper, which I have suggested, we will give them.” Mr. Sharma told reporters after finishing a meeting with USFDA Commissioner Margaret A. Hamburg.

The non-paper would highlight India's concerns with a view to seek an early resolution on these issues.

Ms. Hamburg said the meeting was “excellent”. She, however, did not comment further.

India drew the commissioner's attention to the fact that most of the time, audit inspections were not followed by discussions with companies, a Commerce Ministry official said. . In some cases clarifications were sought, but even before a response, harsh decisions were taken.

“Attention was also drawn to the disproportionate penalties imposed by USFDA on some companies,” the official added.

The USFDA, in recent times, has taken a series of actions against Indian pharmaceutical firms, restricting their shipments to the US, which is their largest export market.

The regulator, in January this year, had banned the import of products manufactured by Ranbaxy Laboratories at its plant in Toansa. This was the company's fourth plant to face regulatory action from the USFDA.

Another Indian firm, Wockhardt, has had two of its plants being put under import alert by the USFDA.

India also raised concerns over the high fees for certain services rendered by the USFDA and the delays caused in several approval processes.

Mr. Sharma said pharmaceutical issues were discussed “very clearly” as was cooperation in the sector.

“These issues do come up before the countries. What is important is the willingness to address those issues and resolve matters, which we have definitely mentioned,” the minister said.

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