Cheaper drugs not necessarily spurious, India tells US FDA

India's commerce and industries minister Anand Sharma as well as health minister Ghulam Nabi Azad on Monday raised concerns over the audit inspections of Indian pharmaceutical companies by the US Food and Drug Administration (FDA) and said that India would soon submit a discussion document on the issues to the US.

Sharma told reporters after a meeting with FDA commissioner Margaret A Hamburg in New Delhi, ''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.''

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

Azad on his part asserted that Indian drugs should not be treated as spurious just because they are affordable.

Hamburg merely said the meeting was ''excellent'', but did not elaborate.

India drew the FDA commissioner's attention to the fact that most of the time, audit inspections were not followed by discussions with the companies concerned. 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 the FDA on some companies,'' a commerce ministry official said.

The FDA in recent times has taken a series of actions against Indian generic drug makers, restricting their shipments to the US, which is their largest export market (See:Ranbaxy hit afresh by FDA; all its India-made products banned).

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 FDA (US FDA raises concerns over a fourth Ranbaxy facility). Another Indian firm, Wockhardt, has had two of its plants being put under import alert.

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

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.