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Abandon hope for overhaul of India’s drug regulations

Today’s article in the Business Standard a good, albeit very harsh, summary of the debate over the regulation of clinical trials and drug manufacturing in India and gives a suggestion of the ways in which government wants to revise it. There are plans for a Drugs and Cosmetics Act 2013 to replace the colonial-era framework that is so evidently sagging dangerously. Government plans to introduce the bill into the Monsoon Session of Parliament , which began yesterday. Can this kind of complex legislation which targets so many interests be passed in the year before general elections? Especially proposals that will involve transferring power from the states to New Delhi? Some doubt it. Even if it does, will it address the central organisational problems besetting the Drugs Controller General of India and the organisation he oversees? On that the Business Standard is even more sceptical.

The article is, by the way, mostly about India’s odd U-turn on the diabetes drug pioglitazone (it was banned  a couple of months ago and seems likely to be allowed back on the market soon).


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