Supreme Court directs Centre to quickly finalise regulatory framework for clinical trials on humans

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The Supreme Court has directed the Central government to formulate regulatory framework for clinical trials on humans by pharmaceutical firms, saying it would have a “serious impact” on the health of the people.

The government told the apex court that it has issued draft rules on clinical trials in February this year, which includes a compensation ranging from Rs. 5 – 75 lakh to the victims of such trial, and 45 days had been given for objections and suggestions on it.

A bench of Justices Madan B Lokur and Deepak Gupta told the petitioners, who have alleged that large-scale clinical drug trials were being conducted on humans across India by various pharmaceutical firms which has led to several deaths, to give their objections and suggestions on the draft rules to the government so that these could be considered.

The Centre’s counsel told the court that they would issue notice inviting objections and suggestions to the draft rules and those who file them would be heard. When the counsel said that around 100 persons have given their objections and suggestions on the draft rules, the bench observed, “It will have a serious impact on the health of people of this country. You call these people and talk to them”. The national drug regulator is getting ready to finalise new rules for clinical trials soon that would shorten the review time to boost clinical research in the country. The country’s 1.2 billion people and large burden of diseases make for an attractive patient pool for global pharmaceutical companies looking to test new drugs, but stringent rules in the last few years have caused some companies to move their research work to other countries.

New rules drafted by the Central Drug Standard Control Organisation (CDSCO) aim to change that, reducing the approval time for review of applications to between 30 and 60 days.

The petitioners told the court that the rules have to be framed to regulate the issue of clinical drug trial as people were being treated as “subjects” during the process.

A senior consul appearing for the petitioner said there was blatant violation of the law by the state governments and a number of deaths have taken place due to such clinical trials. He also referred to reports of the Parliamentary Standing Committee in 2012 and 2013 on the issue. Multinational companies have been excluded from paying compensation to the victims of clinical trials and those engaged as contractors of these firms have been made liable to pay the damages.

The draft clinical trial rules, once finalised, would go to the country’s health ministry for approval before being published. The regulator had tightened rules for clinical research a few years ago after cases emerged of some patients being enrolled into trials without informed consent, and not being adequately compensated. The new rules would let the ‘ethics committees’ – groups of medical experts – that oversee clinical trials decide on the level of compensation for patients who suffer adverse events.

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