The Hindu Business Line : US open to setting up FDA branch office in India

The US is open to the idea of setting up a branch office of its Food and Drug Administration (FDA) in India, Mr Micheal O. Leavitt, Secretary, US Department of Health and Human Services, said here on Monday.

However, no formal discussions in this regard have been initiated as yet, Mr Leavitt said while answering a question at a meeting organised by the Confederation of Indian Industry (CII).

A delegation led by Mr Leavitt is here on a six-day visit of India. The delegation is scheduled to visit Kochi and New Delhi also.

Speaking at the meeting, the Union Minister for Health and Family Welfare, Dr Anbumani Ramadoss, said that in light of the recent concerns on quality of products imported into the US, the Indian Health Ministry would join hands with the US Department of Health and Human Services to set up working groups in each other’s countries to address quality related issues in areas such as food, drugs and medical treatment.

From the Indian side, two bodies — one bureaucratic and one technical — will be set up shortly to work on how the gaps between Indian and US medical and public health systems can be bridged.

This will include developing common quality standards for the import-export of drugs, said Dr Ramadoss.

The technical body would comprise the Drug Controller General of India and eminent scientists like Dr R.A. Mashelkar and Dr N.K. Ganguli. Simultaneously, the Government would also restructure the existing regulatory body the Central Drugs Control Administration, he said at a press conference on exploring Indo-US collaborations in life sciences, health sciences and public health.

Dr Ramadoss added that the Centre was likely to set up such a centre — a decentralised independent drug authority on the lines of the US FDA — hopefully, in the next one year. “A Bill outlining the same has been submitted in the Parliament,” he said.

On the subject of patents and intellectual property rights, Dr Ramadoss said that the Government had registered about 90,000 modules comprising various treatment methods from Indian medicine such as Ayurveda, Siddha, Unani and Homeopathy with the World Intellectual Property Organisation.

“We are also trying to register all of these with the patents offices of countries around the world, including the US,” he said.