US offers help to set up an FDA-style body in India

But US drug authority doesn’t have any plans to open shop here

HYDERABAD: India and the US are moving closer to setting up joint mechanisms to ensure common food and drug safety regulations on the lines of the US Food & Drug Administration (USFDA). The step would make it easier for Indian companies to export to the US and elsewhere.

The US was willing to help out India in this process with technical assistance, the visiting US health and human services secretary Michael O Leavitt said here on Tuesday.

The offer comes close on the heels of an announcement by Union health minister Anbumani Ramadoss on Monday that India will have a drug regulatory body modeled on the USFDA. The high ranking US government official is on a four-city trip to India visiting drug and vaccine making plants and meeting policy-makers and senior government officials.

He is accompanied by USFDA commissioner Andrew Eschenbach. The USFDA commissioner, however, clarified there was no plan to open an office of the US regulatory body in India. He was interacting with mediapersons during a visit to the vaccine maker Bharat Biotech’s facilities here.

“The emphasis is on systems that will make it easier for companies to access markets by creating partnerships beyond borders for ensuring adherence to standards,” Leavitt said earlier in the day during a visit toDr Reddy’s Labs.

While the US has a very good system of monitoring standards it is not adequate for the future, Leavitt said, adding the system was being redesigned. “We intend in the US to make it easier to those who maintain quality and difficult who don’t,” he said.

While three of Leavitt’s predecessors and some former senior FDA officials have been pushing for a greater reform of the regulatory mechanism, studies commissioned by the FDA itself have pressed for greater funding and authority for the body recently.

The noise over standards in the US gains significance in the backdrop of the increasing concerns over quality of imports from China into the US of late.

Leavitt has been touring the world for the past seven months since President George Bush gave him the mandate to improve the system. “I have visited sea ports and border crossings, and facilities like this apart from ginger break making shops,” he said. After Chennai and Hyderabad, the US health secretary will travel to Cochin and wind up his first trip to India with high-level meetings with the Union health and commerce ministers in New Delhi.