Clinical Trials: Waking From Slumber?

Author:Mr Neeraj Tuli and Celia Jenkins
Profession:Tuli & Co

In 2011 the size of the clinical trials business in India was estimated to have grown to c. $1.6 billion. The growth has been rapid, and some of the factors that are said to have contributed include the patent protection laws introduced in 2005, India's diverse gene pool and low costs. Some also point to the relatively low levels of compensation payable when all does not go to plan. The Supreme Court at least feels that all is not as it should be in the light of reports that almost 2,242 people have died in India during clinical trials.

Clinical trials are conducted by Contract Research Organisations (CROs) under regulation by the Central Drugs Standard Control Organisation (CDSCO). CROs conducting clinical trials are meant to constitute ethics committees at the location of the clinical trial. These committees must approve the proposed trials, monitor them, and be concerned for the protection of the rights and interests of subjects participating in the trials. These committees are not, however, regulated. There is also presently no requirement for insurance for the trial sponsors or participants.

In February 2012 the Swasthya Adhikar Manch, a NGO, brought Public Interest Litigation before the Supreme Court of India. The litigation names the Ministry of Health as a party and it alleges that illegal and unethical clinical trials are conducted on adults, children and mentally ill patients.

In January 2013 the Supreme Court observed that unregulated clinical trials had caused havoc to human life, and the Court reprimanded the central government for failing to take proper note of the legal and ethical ramifications of clinical trials. The Court said:

"You have slipped into deep slumber. It pains us that children of the country are being used as guinea pigs by the companies. You do not have even respect of the Parliamentary Committee which has said that the companies are running racket and you are showing just draft rules..."

The Court also criticised state governments for failing to penalise and punish erring medical practitioners.

Immediately thereafter the government announced that it would review the Drugs & Cosmestics Act 1940 and the Drugs and Cosmetic Rules, 1945 with a view to putting in place a proper regulatory structure for monitoring clinical trials and compensating victims. The new rules framed and notified by the Health Ministry envisage the compulsory registration of ethics committees and regular monitoring of clinical trials...

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