Reviews of Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, follow an eight-day trip to India to meet with pharmaceutical companies in the production quality. The U.S. is increasing scrutiny of generic medicines manufactured in India, and in the last nine months banned imports from four plants in Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL)
The FDA will expand its offices in India, train regulatory officials of the nation and strengthen inspections of overseas plants, Hamburg said in an interview with Bloomberg TV India in Mumbai yesterday. Until recently, the U.S. I was not inspecting the manufacturers of other countries in the same frequency as in the U.S. Said Commissioner. That is changing, he said.
"If a company wants to do business in the United States, the responsibility lies with them to understand the rules and requirements," said Hamburg. “We want to work closely with business.”
During his trip, Hamburg agreed a plan that regulators from India will shadow FDA inspectors’ visits to the plant to observe the practices of the U.S. agency Bloomberg News reported on February 12.
In the interview of Mumbai, also urged the Comptroller General of India Drugs and other regulatory authorities in the country to attend international meetings to discuss the drug's safety.
‘Table’
"Very often, when convened meetings with my counterpart’s regulatory authorities around the world, India are not represented at the table," said Hamburg. "It's a loss for them; it's a loss for us. And the more I think India is playing a very important role in the global market, the more it needs to be on the table paper."
The FDA is the creation of an Office of Pharmaceutical Quality to improve control of the agency brand, generic and over- the-counter drugs, Bloomberg News reported Feb. 14. The agency is also talking directly with industry to develop the data may indicate that manufacturing plants are shifting rules and the need for inspection , said Janet Woodcock , director of the FDA Center for Drug Evaluation and Research .
Pharmaceutical companies in India provide 25 percent of drugs in the U.S. , According to Gaurav Pathak and Rao Shashikiran , analysts at Standard Chartered Plc in Mumbai.
