Working with India to improve drug quality, safety: USFDA

The US Food and Drug Administration (USFDA) today said it was working with regulators here to enhance the quality and safety of drugs as 40 per cent of generic drugs exported to America were from India. 

Margaret Hamburg, the visiting Commissioner of the US health regulator, termed India as a very important partner for her country in the pharma sector. 

"India is a very important partner and nearly 40 per cent generic drugs in the US come from India. Indian pharma 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," Hamburg told reporters here at the end of her first official trip to India. 

"If Indian pharma companies want to sell in the US, they need to comply with our standards, practices and expectations. By working together we can enhance quality and better ensure the health of public," she said in response to queries over FDA decision to ban leading pharma players like Ranbaxy and Wockhardt for not following quality standards. 

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 asked the Indian health regulators to work closely with their foreign peers. "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." 

As part of an enhancing mechanism across the world, the USFDA is strengthening its India operations by having 19 investigators from the present 12, she said. 

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.