Bloomberg News

Indian Regulators to Shadow U.S. FDA Inspecting Generics Plants

February 11, 2014

Indian regulators will be told when the U.S. Food and Drug Administration is inspecting plants that produce generic drugs in that country, and will join to observe FDA standards.

The agreement between Indian government officials and FDA Commissioner Margaret Hamburg came during her visit to India this week, the FDA said yesterday. Hamburg, who told Bloomberg News last week she will expand overseas plant inspections, also met in a closed-door session with 16 drug companies and affiliated groups in India to discuss manufacturing quality.

U.S. lawmakers are scheduled to hear from doctors, researchers and patient advocates in a Feb. 26 briefing on whether substandard generic drugs are leaking into the U.S. medical system from overseas. Harry Lever, a Cleveland Clinic cardiologist, said he will tell them that generic drugs made by India-based companies for heart failure often don’t work the way they should, opening questions about the FDA’s ability to keep track of India’s growing generic business.

“It’s like taking a platoon to fight a huge army,” Lever said in a telephone interview, referring to efforts by the FDA to inspect drug plants in India.

Lever said he is awaiting test results from samples on the questionable drugs sent to Preston Mason, a researcher at Brigham & Women’s Hospital in Boston. Mason previously examined generic versions of Pfizer Inc. (PFE:US)’s Lipitor from 15 countries, and found manufacturing impurities sometimes rendered the drugs ineffective.

Pills produced by U.S. generic-drug makers Mylan Inc. (MYL:US) and Actavis Plc (ACT:US) weren’t contaminated, according to Mason’s report on his research published in the June issue of the Journal of Clinical Lipidology.

Fees Collected

In 2012, the FDA was given the power to collect fees from generic-drug makers in part to pay for an increase in inspections of facilities outside the U.S. While India’s government has cleared the way for the FDA to increase the number of its staff members to 19 from 12, it’s not clear how many are based there now. The agency has declined to provide a number.

Congressional aides are watching how well the FDA ramps up overseas inspections and may bring up the issue of drug quality as part of an FDA oversight hearing in the Senate in a few months, according to a staff member with the Senate Health, Education, Labor and Pensions Committee who wasn’t authorized to speak publicly on the issue.

Generic-drug makers Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL), whose executives were among those attending the meeting with Hamburg, have been banned from selling medicines in the U.S. from Indian plants due to quality concerns. In the latest incident last month, a fourth Ranbaxy facility was banned from U.S. exports after FDA inspectors found drugs were re-tested to gain favorable results after initial analyses failed.

‘Clearly Unacceptable’

Ranbaxy Chief Executive Officer Arun Sawhney said at the time it was “clearly unacceptable” and appropriate action would be taken after an internal investigation.

Hamburg turned down a request from Sawhney during the meeting to allow Ranbaxy to export products from the banned facilities while they are improved, the Economic Times reported, citing two people at the closed-door meeting who asked not to be named.

Lever, the Cleveland Clinic physician, said that in one case he switched a man in his late 70s with fluid retention from a generic drug made by one Indian company to another made by a different company and the man responded by losing 15 pounds of fluid in a week.

‘Switch Them’

“All we have to do is switch them and the patients were better,” Lever said.

Chuck Caprariello, a spokesman for Ranbaxy, didn’t respond to an e-mail or phone call seeking a response to Lever’s comments. Sagar Joshi, a spokesman for Wockhardt, didn’t respond to an e-mail or phone call after business hours in India.

Generic manufacturers don’t always replicate the manufacturing process used by brand-name companies resulting in changes to even just a few atoms that can cause the drug to become ineffective, Mason said in a telephone interview.

“There’s very little room for error in the manufacturing of these agents,” Mason said.

Ranbaxy Whistle-Blower

The Feb. 26 congressional briefing will also include Dinesh Thakur, the whistle-blower in allegations against Ranbaxy that the company settled for $500 million in May. Roger Bate, a scholar at the American Enterprise Institute in Washington who specializes in substandard drugs; and Amir Attaran, a law and medicine professor at the University of Ottawa, will also speak.

Bate and Attaran run Searching for Safety, a website that compiles articles, research and data on fake and substandard drugs and advocates for methods to avoid them.

Christopher Kelly, a spokesman for the FDA, said the agreement announced with Hamburg and the India government would strengthen the lines of communication between regulators in the U.S. and India.

“Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms,” Hamburg said in a blog post on her trip.

David Gaugh, a senior vice president with the Generic Pharmaceutical Association, which represents U.S. companies, praised the agency’s decision to work closer with their Indian counterparts.

“FDA leadership, insight and expertise can be a valued resource, particularly in emerging markets,” Gaugh said. “More can be done so that patients and consumers, regardless of geography, know that when they receive generic medicines that they are receiving the same medicine with the same active ingredients at lower cost.”

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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