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Bring transparency in drug control system

Published: 24th July 2013 07:27 AM  |   Last Updated: 24th July 2013 07:27 AM   |  A+A-

The flip-flop on anti-diabetic drug pioglitazone has exposed the Centre’s lack of a proper system to deal with questionable drugs. A month ago when the ministry of health and family welfare banned the drug, it went solely by the letter a Chennai-based diabetologist had sent to the drug controller general of India (DCGI) in January last. His letter was based on observation of eight bladder cancer cases in patients taking the drug. His findings were not peer-reviewed as they appeared only as a letter to the editor in a journal. Normally, the government should have consulted the agencies concerned and evolved a consensus before taking any action.

What’s worse, the government did not even take the drugs technical advisory board (DTAB) into confidence before banning the drug. When the board took a strong stand and asked for revoking the ban, the government meekly obliged. Strangely enough, even the DTAB has recommended that the drug be sold with a boxed warning that it carries a significant “risk of serious or even life-threatening adverse effects”. If the risk is life-threatening, why should the drug be made available in the market at all? The simple question the government should answer is: Is it proper for doctors to prescribe this medicine and patients to consume it?

Alas, the government has exposed its inadequacies in dealing with the situation. It has to learn a lot from the US and European countries, which have a scientific system of issuing warnings, blacklisting and banning drugs. Unlike the US, India does not have an overarching agency like the food and drug administration (FDA). Instead, it has several agencies like the DCGI and DTAB without clear mandates and overlapping spheres of activity. Public health cannot be left to the mercy of drug manufacturers and their agents whose main motive is money. There has to be a rigorous system of evaluating the efficacy and side-effects of a drug before it is allowed to be sold.



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