Top U.S. Drug Regulator to Raise Quality Concerns in India

Feb 06, 2014 8:18 am ET

(Updates with company shares in the sixth paragraph.)

Feb. 6 (Bloomberg) -- The head of the U.S. Food and Drug Administration said she will visit India to talk with generic- drug makers and regulators about quality concerns and plans to expand overseas inspections to address the country’s growing role in producing medicines sold in the U.S.

FDA Commissioner Margaret Hamburg said she will ask the drug firms and Indian regulators to “build new partnerships” during her visit beginning Feb. 10. The goal is to reduce the sanitation and testing issues that have led to recent bans on Indian manufacturing plants. India is the second-biggest drug provider and eighth-largest food exporter to the U.S.

“We need to expand our overseas inspections to respond to the increasing role of India in the generic-drug products that are coming into this country,” Hamburg said yesterday in a telephone interview. “We’ll talk about our expectations and standards in regard to safety, quality, etc.”

Generic-drug makers Ranbaxy Laboratories Ltd. and Wockhardt Ltd. have been banned from selling medicines in the U.S. from Indian plants due to quality concerns.

A fourth Ranbaxy facility was prohibited last month from sending products to the U.S. after FDA inspectors found drugs were re-tested to gain favorable results after initial analyses failed. Ranbaxy Chief Executive Officer Arun Sawhney said at the time it was “clearly unacceptable” and appropriate action would be taken after an internal investigation.

Ranbaxy fell 1.3 percent to 335.95 rupees at the close in Mumbai trading today, while Wockhardt increased less than 1 percent to 410.50 rupees.

‘Learning Process’

“’We cannot possibly screen all of this as it comes across our borders,” Hamburg said. “We cannot even inspect every single facility that’s involved in the manufacture of products or components of products, so we really need to build new partnerships.”

India’s drugs controller general, G.N. Singh, is scheduled to meet Hamburg during her trip, he said in a phone interview.

The local regulator, the Central Drugs Standard Control Organization, wants to “harmonize” with the FDA to ensure safer drugs in both countries, according to Singh. Yet India must balance the need for more stringent regulations with an obligation to produce low-cost drugs, he said.

“There will be a learning process,” Singh said. “The U.S. has a high level of resources, and a very robust system in terms of procedures. So, we would be gradually graduating to those expectations.”

Ranbaxy Meet

Ranbaxy’s Sawhney is scheduled to attend a Feb. 11 roundtable discussion with Hamburg sponsored by the Federation of Indian Chambers of Commerce and Industry, Chuck Caprariello, a spokesman for the company, said in an e-mail. Ranbaxy, based in Gurgaon, India, is controlled by Daiichi Sankyo Co. of Tokyo.

Hamburg said she doesn’t plan to visit any drug facilities though she will tour a spice firm and a seafood-processing plant. She is scheduled to travel Feb. 10-18, including visits to Delhi, Cochin and Mumbai, the agency said in a statement. Hamburg has visited China twice as commissioner and isn’t planning another trip there with a similar itinerary to the Indian visit. Hamburg also said she is meeting with European Union regulators next month.

No Shortages

The U.S. Department of Health and Human Services Inspector General is reviewing “the extent to which FDA conducts inspections of generic drug manufacturers,” according to the office’s fiscal 2014 work plan. The review is being done from the inspector general’s Boston regional office and is expected to be completed this fiscal year, Donald White, a spokesman for the inspector general, said in an e-mail.

The FDA was given the power to collect fees from generic- drug makers in 2012, in part to pay for an increase in inspections of facilities outside the U.S.

While the FDA has said the bans on Indian plants may cause drug shortages, Hamburg didn’t reveal any immediate threat and said the agency is well-positioned to act if needed.

“Sometimes that means we identify another manufacturer that makes a similar product and help expedite their ability to ramp up production,” Hamburg said. “Sometimes it means working with the company in question so we don’t see a shortage. Sometimes it means looking overseas to see if there’s a similar product that can be brought in.”

Tainted Spice

An FDA office opened in New Delhi in 2008 and in Mumbai in 2009. Former Commissioner Andrew von Eschenbach visited the country in December 2008, along with a delegation to discuss staffing at those centers. The FDA has approval from India to increase its workforce in the country to 19 from 12, though it’s not clear whether the agency has reached that level yet.

Wockhardt is banned from selling medicines from two plants, including its Chikalthana factory in Aurangabad, India, where Bloomberg first reported violations in September, such as missing and undocumented drug samples, mold growth on raw- material storage and urinals with inadequate drainage. The violations were listed on an FDA Form 483 obtained through a Freedom of Information Act request.

The Mumbai-based company said in a November statement that it had “already initiated several steps to address the observations made by the U.S. FDA and shall put all efforts to resolve the matter at the earliest.”

Besides generic drugs, about 9 percent of spice imports from India were found to be contaminated with salmonella, second only behind Mexico. Those findings came from a study in October that looked at dry spice shipments from fiscal 2007 through fiscal 2009. In 2010, India exported the most spices to the U.S. of any country, 16 percent of spice imports, according to the agency.

--With assistance from Ketaki Gokhale in Mumbai. Editors: Andrew Pollack, Lena Lee, Marthe Fourcade.