Ministry prepares response to SC query on clinical trial

In January, the Supreme Court revoked Indian drug regulator’s powers to approve clinical trials due to serious irregularities in the process.

In keeping with its directive, clinical trials are being approved by the health ministry after being personally vetted and cleared by the health secretary.

For six months, the health ministry didn’t approve any trials.

In that period, top agencies like the US National Institutes of Health cancelled nearly 40 clinical trials in the country due to the uncertain regulatory environment and multinational pharmaceutical companies moved trials to other locations.

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

It will hear the matter on 24 October.

Meanwhile, the pharma industry is watching nervously as another freeze could see more business moving to favourable locations like Malaysia and Singapore.

“The ball is in the ministry’s court and our functioning will depend on how it presents our case in the court,” said Suneela Thatte, president of the Indian Society of Clinical Research, an industry lobby. “We do hope the ministry can assure the court that every precaution is being taken while approving trials.”

The health ministry is banking on recommendations by the Ranjit Roy Choudhury committee and the amendments to Drugs and Cosmetics (Amendment) Bill of 2013 to avert a shut down of the clinical trial industry.

Several aspects of the legislation, concerning regulation and ethical supervision of trials, compensation of trial subjects and mandatory accreditation of all stakeholders—institutional review boards, research institutions and sponsors—are being debated.

Even though the Choudhury’s committee’s recommendations have not been implemented yet, the ministry maintains that the recommendations were followed when it approved the 162 trials.

“We have two weeks, within which we will file our response. We have taken these decisions keeping patient safety at the centre, but obviously we do not know what will happen in court,” said Jagdish Prasad, director general of health services at the health ministry.

“Recommendations of the expert committee were kept in mind while granting permission,” he said.

On 3 January, the Supreme Court, hearing a public interest litigation by Indore-based non-governmental organization Swasthya Adhikar Manch, revoked powers of Central Drugs Standard Control Organization to approve clinical trials.

The resultant delay in approvals caused the clinical research industry to work at a fifth of its capacity, industry executives estimate.

This has led to an estimated loss of $150-200 million this year alone on account of the regulatory uncertainty, they say.

Research firm 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, according to documents submitted by the Drugs Controller General of India in the Supreme Court.

The documents said 11,972 adverse effects, excluding deaths, were reported in the period, with 506 of these being directly attributable to the trials. They put deaths from trials at 2,644 in the past five years.

Source: http://www.livemint.com/Politics/VDBSdIqvHPd92OtTQ6Nx8I/Ministryprepares-response-to-SC-query-on-clinical-trial.html