Is the FDA persecuting India's generics makers?

Indian drugmakers are feeling a bit paranoid these days. Big Brother, a.k.a. the FDA, is looking over their shoulders, and they're not happy about it.

There appears to be reason to fear, Pharmalot reports: Three major Indian pharma companies have felt the long arm of the law in recent months. First, the FDA banned 30 Ranbaxy Laboratories drugs because of manufacturing irregularities at two of its Indian plants. Then the agency nixed drugs made at Sun Pharma's Detroit plant. And last week, FDA warned Lupin about 15 manufacturing problems at a plant in Madhya Pradesh.

Some Indian pharma types are even wondering whether the regulatory scrutiny amounts to a sort of trade barrier. "[T]here may be an attempt by global innovator majors to question the standards of Indian drugs and stop their entry," Daara Patel, chief of India's pharma trade association, told the Economic Times.

But others say Indian generics makers just need to toughen up. The companies have an edge in the copycat-med market, and with the U.S. government and other payers looking to control healthcare costs, Indian drugmakers can certainly benefit. One expert told the Times, "The three companies who have come under (the FDA) scanner should be ready for any test conducted by any regulator, anytime." Hear, hear.

- check out the Economic Times story
- see the Pharmalot post
- get the Lupin news from NDTV

Suggested Articles

Imbruvica has enjoyed a nice run in previously untreated CLL over the last few years. But major competition is here in the form of AZ's Calquence.

Pennsylvania's Supreme Court revived thousands of lawsuits alleging the antipsychotic med Risperdal caused males to develop breasts.

In the asthma biologics race, there doesn't appear to be a clear favorite among Xolair, Dupixent, Fasenra and Nucala for a group of pulmonologists.