Indian Drugmakers Must Know Quality-Control Rules, FDA Says

Feb 19, 2014 4:15 am ET

(Updates to add increased inspections in first paragraph.)

Feb. 19 (Bloomberg) -- Indian companies supplying a quarter of the medicines used in the U.S. must take responsibility for the quality-control necessary to export their products, the top U.S. drug regulator said as it ramps up inspections.

The comments by Margaret Hamburg, the U.S. Food and Drug Administration commissioner, follow an eight-day trip to India to meet with pharmaceutical companies on production quality. The U.S. is increasing scrutiny of generic drugs made in India, and in the past nine months banned imports from four plants belonging to Ranbaxy Laboratories Ltd. and Wockhardt Ltd.

The FDA will expand its offices in India, train regulatory officials in the nation and step up inspections of overseas plants, Hamburg said in an interview with Bloomberg TV India in Mumbai yesterday. Until recently, the U.S. wasn’t inspecting manufacturers in other countries at the same frequency as in the U.S., the commissioner said. That’s changing, she said.

“If a company wants to do business in the United States, the responsibility is on them to understand the rules and requirements,” Hamburg said. “We want to work closely with companies.”

During her trip, Hamburg agreed to a plan in which Indian regulators will shadow FDA inspectors on plant visits to observe the U.S. agency’s practices, Bloomberg News reported Feb. 12.

In the Mumbai interview, she also urged India’s Drug Controller General and other regulatory authorities in the country to attend international meetings to discuss drug safety.

‘At the Table’

“Very often when I convene at meetings with my counterpart regulatory authorities from around the world, India is not represented at the table,” Hamburg said. “It’s a loss for them, it’s a loss for us. And I think that the more India is playing such an important role in the global marketplace, the more they need to be at the table.”

The FDA is creating an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic and over- the-counter drugs, Bloomberg News reported Feb. 14. The agency is also talking directly with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

India’s pharmaceutical companies supply 25 percent of drugs in the U.S., according to Gaurav Pathak and Shashikiran Rao, analysts at Standard Chartered Plc in Mumbai.

Share Gains

Wockhardt gained 2 percent to 404.30 rupees as of 2:42 p.m. in Mumbai trading, while India’s benchmark Sensex index added 0.3 percent.

Ranbaxy rose 4.2 percent to 365.55 rupees. U.S. units of the drugmaker and Teva Pharmaceutical Industries Ltd. agreed to settle New York state claims that they colluded to protect each other’s exclusivity on sales of generic medicines, the state’s Attorney General Eric Schneiderman said in a statement.

Ranbaxy’s Toansa facility in the north Indian state of Punjab is the latest Indian facility to face FDA restrictions, after inspectors last month found drugs were retested to gain favorable results after initial analyses failed.

In November, Wockhardt was banned from selling some medicines to the U.S. from its most lucrative factory in India after the FDA added the plant to its import alert list.

When the agency’s inspectors visited the Wockhardt plant in July, they found inconsistencies in drug-test results, urine spilling over open drains, soiled uniforms and mold growing in a raw-material storage area, according to findings detailed in an official document obtained by Bloomberg News via a Freedom of Information Act request.

Facility Inspections

FDA inspections of drug facilities in India rose to 195 in 2012 from 11 in 2002, according to data from the regulator.

“We’re trying to level the playing field,” Hamburg said. “Wherever a drug is made, if it is sold in the U.S. marketplace, if American consumers are using it, we need to assure that they are made according to our standards and expectations, and have undergone the appropriate review and inspection.”

The FDA was given the power to collect fees from generic- drug makers in 2012 through the Generic Drug User Fee Amendments, in part to pay for an increase in inspections of facilities outside the U.S. The regulator aims to inspect overseas facilities as frequently as it inspects domestic manufacturers by 2017.

Hamburg on Feb. 11 met in a closed-door session with 16 drug companies and affiliated groups in New Delhi to discuss manufacturing quality. Wockhardt and Ranbaxy executives were among the people who attended the meeting.

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, plans to say that generic heart-failure drugs made by India-based companies often don’t work the way they should.

--With assistance from Anna Edney in Washington. Editors: Angela Zimm, Lena Lee