Home / Industry / Manufacturing /  Ministry gets 2 months to define clinical trials regulatory regime

New Delhi: No new clinical trials will be approved in India for at least two months, by which time the health ministry has to define a regulatory regime for such tests in keeping with a Supreme Court directive, according to the drug controller general of India, G.N. Singh.

The move is aimed at combating rampant irregularities in such trials in India.

On 3 January, the apex court revoked the powers of the Central Drugs Standard Control Organization (CDSCO), which has so far been the nodal agency for monitoring clinical trials in India. It asked the health ministry to monitor trials after laying down clearly defined terms for seeking approval, oversight mechanisms and penal provisions in case of conflict.

“Until we have clear-cut rules to conduct clinical trials, no new trials are being allowed prima facie," said Singh.

The Supreme Court directives came in response to a public interest litigation filed by activist group Swasthya Adhikar Manch (SAM) in February 2012. In October last year, the apex court had asked the health ministry to make public information regarding deaths during trials, the compensation paid and other general practices related to the conducting of such trials.

Drugs Controller General of India (DCGI) said in a 3 January filing to the Supreme Court that between January 2005 and June 2012, it approved 475 clinical trials for “new chemical entities" not used as drugs elsewhere in the world. It said that 11,972 adverse effects, excluding deaths, were reported in the period, with 506 of these being directly attributable to the trials. It put deaths from trials at 2,242 over the last five years.

A spokesperson for Quintiles, one of the world’s leading contract research organizations (CROs), said in an email that the Supreme Court’s order was being misinterpreted. CROs conduct clinical trials on behalf of multinational pharmaceutical companies.

“What we understand is that the Supreme Court has directed that clinical trials of new chemical entities shall be conducted strictly in accordance with Schedule Y of the Drugs and Cosmetics Act and shall be under the direct supervision of the secretary, ministry of health and family welfare. It does not undermine or negate the role of the CDSCO or the DCGI."

The spokesperson also added that the delay in approving new trials has nothing to do with the court order.

“With regard to new drug approvals, while it is true that new drug reviews and approvals have been delayed, we understand that this is a temporary phase on account of the regulatory machinery directing its efforts to address some areas of high priority and are confident that normalcy will be restored soon enough," the spokesperson said.

India’s clinical trials industry has grown in size since the introduction of product patent laws in 2005, and the country’s ethnically diverse pool of patients and huge regulatory gaps have drawn several multinational companies, Chinmay Mishra, an activist at SAM, said in a 3 January Mint report.

An Associated Chambers of Commerce and Industry of India report said in 2011 that nearly 100 domestic and multinational pharmaceutical companies were conducting trials in the country and the business was worth 8,000 crore.

Clinical trials are an important stage in a drug’s development cycle and constitute tests that help companies understand the safety and efficacy of a drug as well as monitor adverse effects.

Meanwhile, the health ministry’s draft guidelines for reforms in the clinical trials industry will be making the registration of institutional ethics committees and CROs mandatory.

“The current Drug and Cosmetics Act does not have a chapter on clinical trials. So we will be making those amendments and sending it for cabinet approval. The matter of compensation will also be covered under the Act," said Union health secretary P.K. Pradhan.

The ministry has also suggested that all serious adverse events reported during a trial be referred to an independent expert ethics committee.

Currently, clinical trials in the country are regulated under Schedule Y of the Drug and Cosmetics Act. The Act, last amended in 2005, lays down guidelines instead of mandatory norms and does not define compensation rules or penal provisions in cases of errors. It also does not mention the role of CROs.

“There is a huge void of governance in this area and, in a limited time frame, all these norms need to be clearly laid out," said Amulya Nidhi, an activist with SAM.

“Registration of ethics committees will not solve the problem. Our view is that clinical trials should be allowed only in research-based hospitals, and CROs should not have any role in this. Involving CROs only makes it possible for big pharma companies to outsource responsibilities of conducting the trial as per norms," he added.

The Quintiles spokesperson said the amendment of the law had nothing to do with the apex court’s order.

“The amendments to Schedule Y of the Drugs and Cosmetics Act have been in discussion for a while now and independent of any Supreme Court intervention."

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