IMPLICITY

recent development on the human guinea pigs

Posted in DGCI by Gautam on June 19, 2009

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India has of late become the hub of a clinical trial research market with earnings from this industry touching  $ 1 Billion this year. The Drug Controller General of India has seen the potential dangers of this expanding unregulated industry and proposes to take steps insuring that such tests will not only not go unrecorded but will also be subject to very strict scrutiny by the Indian Council of Medical Research.

the picture on the side is one advertising to invite healthy patients to participate in clinical trials

So earlier the trend seemed to be that phase I trials of drug testing (which are trials on humans) took the farily long process of getting approval from the DCGI; but once approved, the area was pretty much open to the endeavours of big pharma and fantasies of nazi wannabes alike. basically, onyl “positive cases”  were reported, and such reporting too to be under the scanner of the ICMR was completely voluntary. Now, not only will such registration with the ICMR be compulsory and open to rigorous scrutiny by the institution but will also be open to the public.

basic featurs of these regulations which come into force from monday are:

– All clinical trials in India, by all actors and involving Indian participants would need to be registered

– early and late trials, trials of marketed or non-marketed products, random or non-random trials – all should be registered

Apparently people are pushing forward for a law in this direction which will be much wider in tis ambit to include various other products that come within the Drugs and Cosmetics Act.

On a different note, DCGI seems to be very proactive over the recent year. Very commendable work in some areas I must say.

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