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New Delhi:The Supreme Court of India directed the health ministry to review the approvals granted to 157 clinical trials cleared by the country’s drug regulator in less than two months, increasing the uncertainty faced by a $500 million industry.

The move comes after the government admitted to the court that it had not followed a 3 January Supreme Court order while clearing these trials.

The court, in an oral order, asked for the approvals, all given between 3 July and 31 August, to be re-examined.

The court will hear the matter again on 16 December.

The Indian Society for Clinical Research said it would react to the directive only after going through the court order.

Clinical trials in India are usually approved by the Central Drug Standard Control Organization (CDSCO) but in a 3 January order, the Supreme Court had stopped it from allowing trials for new medicines after allegations of irregularities in the approval process. The court banned clinical trials for new chemical entities unless they were personally vetted and cleared by the health secretary.

For six months after the order, the health ministry didn’t approve any trials. Agencies such as the US National Institutes of Health cancelled nearly 40 clinical trials in India because of the uncertain regulatory environment. Several drug makers moved their trials to other locations.

Then, in two months, the ministry approved 162 trials, prompting the court to ask it on 29 September for the basis for doing so.

On Monday, the ministry admitted that only five of the 162 were vetted by the health secretary.

A total of 1,122 applications for clinical trials were received this year till 31 August, the documents show.

The health ministry now has to re-evaluate these trials, “particularly in terms of assessment of risk and benefits for patients, innovations to existing therapeutic options and benefits to medical needs of the country", justices R.M. Lodha and S.K. Singh said.

The Supreme Court was hearing a public interest litigation filed by Swasthya Adhikar Manch, an Indore-based non-governmental organization that flagged concerns over contradictions in the data submitted in court by the health ministry.

“The affidavits submitted on 26 July state that only 26 global clinical trials were approved, while in current affidavit of 18 October states that only five trials are approved after 3 January by the apex and the technical committee," said Sanjay Parikh, a lawyer representing the petitioner.

“There are serious concerns on the current approval process as well as the one recommended by the ministry’s expert Ranjit Roy Chaudhury committee. We will be moving court against several recommendations that we consider to be industry-friendly."

The health ministry had, in February, appointed a committee under Roy Chaudhury to come up with ways to improve the approve process for clinical trials. Jagdish Prasad, director general of health services at the ministry, said on 30 September that the recommendations of the committee “were kept in mind" while approving the 162 trials.

Interestingly, Roy Chaudhury said that none of the 30 recommendations given by his committee “have been incorporated in the approval process yet".

India is yet to lay down clear rules to regulate the clinical research industry. Industry analysts estimate a loss of $150-200 million this year due to the regulatory uncertainty.

Researcher Frost and Sullivan puts the size of the clinical trials business in India at $500 million and expects it to grow to $1 billion by 2016.

Between January 2005 and June 2012, India approved 475 clinical trials for new chemical entities not used as drugs elsewhere in the world, CDSCO had earlier told the Supreme Court.

As many as 11,972 adverse effects, excluding deaths, were reported in the period, out of which 506 can be directly attributed to the trials. There were 2,644 deaths in the past five years in these trials, the regulator had said.

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