The government on Monday expressed clearly to the US its growing unease over its drug regulator USFDA’s "disproportionate penalties" on India’s generic pharmaceutical companies, many of these which have been rattled by a string of import bans without getting sufficient opportunity to clarify details.
Commerce minister Anand Sharma told visiting US Food and Drug Administration’s (FDA’s) commissioner Margaret Hamburg that India is going to present a discussion document — a "non-paper"— to clarify India’s position on the issue.
“We are going to give a non-paper (to the US) overall on some of our concerns,” said Sharma. “We have told the commissioner that in some cases disproportionate penalties was levied on Indian drug makers,” he added.
India’s drug companies, which produce copies of expensive patented drugs at a fraction of the original prices, are facing increasing compliance scrutiny by world’s drug regulators.
According to estimates, nearly 40% of generic and over-the-counter-medicines sold in the US are produced by Indian firms.
Last month, USFDA blacklisted Ranbaxy Laboratories’ Punjab-based Toansa plant — the generic drug makers’ fourth factory to face such an import ban — dealing a body blow to the company’s reputation. Wockhardt, RPG Life Sciences, and Agila Specialities are other Indian companies that have come under USFDA’s lens.
The regulator’s actions could affect companies’ plans to exploit the “patent cliff” opportunities or take a shot at cornering a slice of a multi-billion dollar opening of drugs whose patents are set to expire soon.
Sharma said both sides recognise the importance of the partnership and are willing to address the issue affecting it.
“It was brought to the commissioner’s notice that even in instances when clarifications were sought from pharmaceutical companies, the USFDA decided on strong action even before the clarifications could be given,” an official present at the meeting said.