Stiff dose

The curb fake drug trade

Published: Monday 15 September 2003

EMKAY the lack of testing facilities and an antiquated legal framework -- these are the primary culprits behind India's booming spurious drugs racket, which is estimated to be causing an annual loss of over Rs 4000 crore to the domestic pharmaceutical industry.

This observation was made in an interim report on fake drugs and regulatory issues. A committee, headed by Council for Scientific and Industrial Research (csir) director general R A Mashelkar, authored the document and recently submitted it to the Union ministry of health and family welfare. The report recommends amendment of the Drugs and Cosmetics Act of 1940 to make the sale and manufacture of spurious drugs punishable with the death sentence instead of the currently stipulated maximum penalty of life imprisonment.

Other suggestions include empowering the police to file cases against offenders (at present only drug inspectors are authorised to take such action), and setting up of a body along the lines of the us Food and Drug Administration .

The Union government would also bring licensing procedures within its ambit so that manufacturers can be prevented from exploiting loopholes in the states' laws. "Drugs and pharmaceuticals are now going to be treated as high-priority areas," points out Mashelkar.

Another change that has been envisaged relates to the active involvement of pharmaceutical companies in monitoring the spurious drugs market. "Such regulations would help the industry," avers Sandhya Tewari, deputy director, Confederation of Indian Industry.

The final report is likely to be handed over by October 27, 2003. It would deal with regulation issues pertaining to traditional medicine, therapeutic foods and dietary supplements. "These measures would infuse professionalism into the sector and provide a direction in which to move," feels drug controller general of India Ashwini Kumar. He is, however, not sure how much time the policy changes would take.

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