FDA will add inspectors in India to oversee safety, quality of growing number of imported meds

WASHINGTON – The head of the Food and Drug Administration said Friday that her agency will add more inspectors in India to better monitor drugs from the country’s burgeoning pharmaceutical industry, even as her agency also seeks closer co-operation from Indian regulators.

FDA Commissioner Margaret Hamburg said the FDA will expand to 19 staffers in India from its current 12, as the U.S. tries to assure the safety of medications from companies like Ranbaxy Laboratories Ltd. and Wockhardt Ltd. Hamburg spoke with reporters following an eight-day trip to the Southeast Asian nation, where she met with Indian health regulators and drug industry executives.

With sales of more than $26 billion, India’s burgeoning drug sector has grown into the U.S.’s second-largest supplier of prescription and over-the-counter medications, behind only Canada.

But that growth has come with increased scrutiny. And in recent years the FDA has issued a stream of warnings letters and import bans to some of India’s largest drugmakers over manufacturing and quality control problems.

The capstone of Hamburg’s visit was a “statement of intent” agreement between the U.S. and India, in which both parties pledged to co-operate on safety and quality inspections. Under the non-binding agreement, Indian inspectors will be able to shadow their FDA counterparts as they inspect factories in India. The document is supposed to cover a 5-year preliminary period, though it’s unclear how or when it might lead to more formal requirements.

Hamburg suggested during a press teleconference that India’s Ministry of Health and Family Welfare needs to become more engaged in regulation on both a domestic and international scale.

“India, as such a significant player in the global marketplace, really needs to be a full participant at the table,” Hamburg said.

Several journalists for Indian publications questioned whether the FDA is specifically targeting Indian companies for enforcement, specifically the company’s largest drugmaker, Ranbaxy Laboratories.

But Hamburg rejected that assertion, saying that the agency takes action against all companies that violate FDA standards, regardless of where they are based.

“If a company is manufacturing a product for sale within the United States, they have to meet our regulatory standards and requirements,” Hamburg said. “What’s happening in India is consistent with what happens in the United States and throughout the world.”

Since 2008, the FDA has blocked imports from four different Ranbaxy plants in India, most recently the company’s Toansa plant in the Punjab province, where inspectors found drugs that failed quality testing. In 2012, the company was forced to recall dozens of batches of its generic version of Lipitor after finding tiny glass particles among the ingredients used in production.

Last May the company’s American subsidiary agreed to pay $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators, the largest financial penalty ever against a generic drug company under U.S. law.