UpFront/Check-in | Oct 19, 2013 | 6186 views

Clinical Trials and Safety: Not Mutually Exclusive

Clinical Trials and Safety: Not Mutually Exclusive
Image: Rafael Marchante / Reuters


ndia was once hailed as a fertile ground for clinical trials with a large drug-naïve population. Today, the international community, and its own apex court, is unconvinced.

On September 30, the Supreme Court directed the Union health ministry to halt clinical trials in 162 cases where it had given approval until it provided assurances on safety regimes. It has given two weeks to the ministry before announcing a formal ban on clinical trials in the country. Nearly 40 trials involving the US National Institutes of Health are also on hold.
The industry has already shrivelled. McKinsey had projected the clinical trials industry in India to reach $1 billion by 2010, but it was under $500 million in 2012.

As India struggles to clean up its regulatory mess, it should heed the latest study published in PLOS Medicine which shows that clinical trial outcomes are more complete in unpublished reports than in published sources (which contain less information about the benefits and potential harms of an intervention).

The Indian clinical trial registry says those conducting trials “are expected to regularly update the trial status” but the reality is far from it. This is a global phenomenon, says the PLOS study.

Now that the health ministry is forced to submit a safety regimen, it may be a good idea to take a long-term view and make it mandatory for all institutions and drug companies to make trial data public.

This article appeared in the Forbes India magazine issue of 01 November, 2013
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Comments (3)
Anirudhsahoo Oct 21, 2013
It is really the sluggishness of GOI (Govt. Of India). Rome was not built in a day. So for metamorphosis, supreme court should give some time by approving projects. If there will be no projects (International) what will be the strict regulatory and staff force. I request our govt kindly grant permission and then you inspect the centres.
Response to Anirudhsahoo:
Sasmita Puthal Oct 21, 2013
Its a good comment......keep it up.
Response to Sasmita Puthal:
Jagaruk Pathak Oct 21, 2013
Protection of Public health is of utmost concern. So there must be regulatory norms first. Historically WMA, looking at the autocracy during early 1940s in clinical trials under Nazi regimes, Notified Helsinki Declaration which should be maintained in letter and spirit. Just taking permission under weak regulations from an authority for the sake of running an industry would not serve the purpose. Had the hon'ble Supreme court and Parliamentary committee not intervened in the matter the same same joy riding on trial would have been still prevailed.
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