New Delhi : Taking up the case of domestic pharma sector with the US, India has pitched for review of America’s whistle blower policy and lowering of registration charges to help Indian firms seek greater market access. The concerns over four major issues were raised in a ‘non- paper’ (a kind of a discussion document) presented to the US authorities by India.
“In our non-paper, we have raised four major issues with the US. Their whistle blower policy needs to be reviewed as the reward under the policy is very high and employees fudge records to take such rewards. The fees for registration is exorbitant and it acts an additional burden for Indian pharma companies,” a top official in the commerce ministry said. The paper follows a meeting in February, between US Food and Drug Administration (USFDA) Commissioner Margaret A Hamburg and Commerce and Industry Minister Anand Sharma. Sharma has raised concerns over the USFDA’s audit inspections of Indian pharma companies and ‘disproportionate penalties’ in some instances.
Further, the official said that the registration process in the US is also very long and cumbersome.
“They do not follow the time limit for registration process. It becomes very lengthy, somtimes 6-8 months. The fourth matter is about the so-called Form 483, issued when the US regulator has queries regarding some Indian firm,” the official said, adding, “we have sought early resolution on these issues.” The USFDA has taken a series of actions against Indian pharmaceutical firms, restricting their shipments to the US, their largest export market.