India, US must work jointly for lifting FDA ban: Hamburg
19 Feb 2014
The US Food and Drug Administration (FDA) on Tuesday said it was working with Indian regulators to improve the quality and safety of drugs, after the US health regulator banned several drugs made in India from export to that country over quality issues.
FDA commissioner Margaret Hamburg, concluding her visit to the country, told newspersons in New Delhi, "India is a very important partner and nearly 40 per cent generic drugs in the US come from India. The Indian pharmaceutical industry is leader in many areas. They need to meet the standards and expectations of American regulatory system and we want to work with them. We need to work together to ensure quality and safety."
Indian pharma companies have good growth potential, Hamburg said, adding if any company wants to become a significant player in the international market it will have to pay attention to global standards.
Hamburg's visit came after virtually all drugs made by two leading Indian generics makers, Wockhardt and Ranbaxy Laboratories, were banned from export to the US. "We are increasing our focus as a community of regulators to address global challenges and we work together to share information. We urge Indian regulators to join with us," she said.
As part of an enhancing mechanism across the world, the FDA is strengthening its India operations by having 19 investigators from the present 12, she said.
Western observers, however, say that the FDA and Hamburg are far from being convinced that the import ban on Indian drugs can be lifted anytime soon. (See: Appeals by Indian drug firms fail to impress FDA's Hamburg)
India is also 8th largest exporter of seafood and leading exporter of spices to the US. On food safety regulations, Hamburg said, "We had very encouraging discussion with the Export Inspection Council and representative of food exporters. We have had a number of areas where we worked together to address food safety problems. We are preparing a framework for action and a number of collaborative activities like training and education.''
