'USFDA has imposed disproportionate penalties on Indian pharma cos'

Reacting strongly to the recent string of actions against Indian pharmaceutical companies by the US Food & Drug Administration (FDA), India has said that in some cases the authority has imposed disproportionately strong penalties.

Commerce and Industry Minister Anand Sharma, in a meeting with US FDA Commissioner Margaret Hamburg on Monday, said that the authority was not giving enough opportunity to Indian pharmaceutical companies to explain themselves before taking action against them for flouting quality norms.

The Commerce Ministry proposed that it would come up with a paper voicing its concerns with a view to seeking a resolution to the problem at an early date, a Commerce Ministry official said.

"It was brought to the Commissioner's notice that even in instances when clarifications were sought from pharmaceutical companies, the US FDA decided on strong action even before the clarifications could be given," the official added.

Over the last one-and-a-half years, the USFDA has cracked down on several generic drug-manufacturing facilities owned by Indian companies, citing quality problems. Last month, the FDA banned products from Ranbaxy’s active pharmaceutical ingredient-manufacturing factory in Toansa (Punjab) — the fourth factory owned by the company to come under its scanner.

Wockhardt, RPG Life Sciences, and Agila Specialities are the other Indian companies that have come under the USFDA’s lens.

COMMENT NOW