India raises pitch against US actions on domestic pharma firms

India today raised serious concerns over the USFDA's actions against domestic pharma companies and 'disproportionate penalties,' saying making affordable drugs does not mean they are spurious.
In separate meetings with visiting US Food and Drug Administration (USFDA) Commissioner Margaret A Hamburg, Commerce and Industry Minister Anand Sharma and Health Minister Ghulam Nabi Azad expressed concern over the treatment meted out to Indian companies, including Ranbaxy, by the US health regulator.
Although the ministers stopped short of calling the USFDA actions as discriminatory, India in no uncertain terms said the country's pharma firms were being subjected to 'disproportionate penalties' in some instances.

Sharma said India would submit a discussion document on the issues to the US.
"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," Sharma told reporters after the meeting.
Hamburg said the meeting was "excellent" and didn't comment further.

An official said India drew the Commissioner's attention to the fact that most of the time, audit inspections were not followed by discussions with companies. In some cases, clarifications were sought but even before a response, harsh decisions were taken.
"Attention was also drawn to disproportionate penalties imposed by USFDA on some companies," the official added.

The non-paper would highlight India's concerns with a view to seek an early resolution on these issues.
Azad, in his meeting with Hamburg later in the day, defended Indian medicines, saying "being affordable should not mean they are cheap and spurious.