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Indian clinical trials rules: the winners are spin doctors

Each side is using spin as India considers what to do about clinical trials in the long term. The LiveMint story that is getting picked up in trade media around the world quoted lots of people with an interest in less regulation (see for example this There’s a surprisingly one-sided story in the same vein in the Wall Street Journal: . This piece from the IndianExpress a couple of days ago was probably briefed by Ministry of Health and Family welfare sources. .

What is now clear is that the US National Institutes of Health has put a hold on a lot of trials

There is a detailed and fairly balanced view by a specialist Indian lawyer here (although it must be said that few experts are really worried about the “multinational companies” who will probably stick to the rules or pull out. The big problem will be smaller — and some larger — national companies who will ignore them as they always have). The amendments are explained in detail in this lawyerly post .

Ultimately, though, India’s regulatory framework still sits on an act passed by the colonial authorities in 1940 (as the UK struggled for its existence and the administration in Delhi wondered about Japanese intentions — thus probably reducing the amount of senior attention paid to regulation of medicines) and on rules passed in 1945 (at the tail end of a war that had seen parts of India invaded, a crippling famine and the inevitable coming of India’s freedom). Neither is really the basis for a 21st century lifesciences sector and comprehensive overhaul will have to come sooner or later. Maybe the NIH move will speed up that day but — in the run up to national elections — I wouldn’t count on it. Democracy is a reassuringly messy business

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