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Drug authority on U.S. model

Aarti Dhar

To set standards for drugs and cosmetics


  • Will adopt best practices of FDA, says Minister
  • Drugs and Cosmetics Act to be brought under its purview
  • Possible tie-up with FDA on research projects

    NEW DELHI: India will set up a national drug authority on the lines of the Food and Drug Administration in the United States. It will act as a regulatory body and lay down standards for drugs, pharmaceuticals and cosmetics.

    The Drugs Controller-General of India is scheduled to visit the U.S. by month-end to study the FDA structure and its implementation. "We will not replicate the FDA because our requirements are different but adopt the best of its practices," Union Health and Family Welfare Minister A. Ramadoss told The Hindu. During his recent 11-day official visit to the U.S., the Minister held discussions with FDA officials on the issue.

    Autonomous body

    The national authority is planned as an autonomous body on the lines of the Telecom Regulatory Authority of India. "Once the authority is in place, the next step could be a possible tie-up with the Food and Drugs Administration on various research projects," Dr. Ramadoss said. The Drugs and Cosmetics Act and the Drugs and Magic Remedies Act will be brought under the purview of the authority. "As it is, we are planning amendments to the two laws to check advertising of pharmaceutical drugs and prevent hospitals from promoting magic remedies."

    Once the Integrated Food Law is in place, the Health and Family Welfare Ministry could also consider bringing food safety, particularly the genetically modified foods, under the purview of the authority.

    Dr. Ramadoss visited the National Institute of Health — the U.S. equivalent to the Indian Council for Medical Research — that funds about 80 projects in India. The Institute has assured India that it will consider its request on increasing the number of projects and making the funding pattern more flexible.

    More laboratories

    At the Centre for Disease Control and Prevention, Atlanta, he stressed the need for better coordination on setting up more laboratories in India for surveillance of infectious and non-infectious diseases and a specialised laboratory for testing the effects of tobacco and nicotine.

    "The laboratory was promised several years ago and we just reminded them of it," he said. The Centre maintains several departments on occupational safety and health.

    The Minister assured Indian doctors who expressed their desire to contribute to the country that the Government would allow them to teach in the State of their choice under the continuing medical education programme. In this connection, the Ministry will hold discussions with the Indian Medical Association. The requests came from the Indian faculty at the University of Illinois at Chicago. The university, which was instrumental in setting up the Indian Institute of Technology at Kanpur, has a large Indian faculty.

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