Policy & Issues

Amend clinical trial rules after wider consultations: health activists

Public health activists and women's rights groups have raised concerns over compensation-related amendments to the Drugs and Cosmetic Rules 2011 proposed by the Union Health Ministry for subjects of clinical trials. They have suggested wider consultations before the amendments are notified.

The proposed amendments pertain to the Drugs and Cosmetics Rules, 1945 (rule 122 DAA) saying that compensation in case of injury or death during the clinical trial would be solely decided by the Ethics Committee.

As of now, the compensation is decided by the trial sponsors, be it a pharmaceutical company, the government or an institution, in consultation with the Ethics Committee.

“While we believe that regulation is necessary given the unchecked proliferation of clinical trials in India today, we also believe that the proposed amendment falls short of ensuring comprehensive and effective regulation,” a statement issued by Sarojini N. of Sama and Srinivasan S. of Locost said here on Thursday.

Drawing the attention of the government to the problem areas, the statement says the issues of conflict of interest within the Ethics Committee remain to be resolved as there could be institutional biases with the committee depending on who the Principal Investigator of the trial is. Importantly, many independent Ethics Committees are formed to pass protocols rather than look at them objectively.

These are not part of any hospital but owned and operated by private commercial interest.

While compensation will depend on injury or death on a case-by-case basis and this cannot be standardised, a wide variation in compensation decided by different Ethics Committees may not be desirable because trials may start migrating to the centres with relatively lenient Ethics Committees. The government should arrive at a specific compensation amount for death whether related or unrelated to clinical trial. For serious adverse events, an algorithm could be developed and compensation awarded based on the algorithm points.

Further, the statement says new rules have been expanded to include protocol violation and negligence of researchers, failure of investigational products, administration of placebo, adverse effects due to concomitant medication, and injury to a child in uterus.

There needs much more discussion and elaboration as they still do not include many concerns. “The new rules will cover only permanent injury or death with no relief for even prolonged temporary injury. Also, death or injury in a trial is routinely attributed to the natural progression of the disease rather than the adverse effect of the drug being tested. There is no independent system of verification by outside experts which results in a large number of drug-related injuries and deaths being denied compensation,” says the statement.

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Printable version | Apr 13, 2021 11:01:05 AM | https://www.thehindu.com/sci-tech/health/policy-and-issues/amend-clinical-trial-rules-after-wider-consultations-health-activists/article2796468.ece

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