Drug regulator 'goes slow' on clinical trials

Files related to clinical trial applications have stopped moving at the drug regulator’s office, according to sources.

This is in the wake of stringent directives from the Supreme Court asking the government and the regulatory agency to take measures to ensure safety of patients participating in clinical trials for testing of new medicines.

Sources in the know told Business Standard the health ministry and the Central Drugs Standard Control Organization are cautious while approving any clinical trial or even new drugs in the country.

“There are over 150 applications pending, seeking approvals for clinical trials. But all are at evaluation stage and no file is moving,” said an industry official.

He added that ever since the matter had come under the SC scanner, it has been like this.

According to industry officials, hardly any applications were cleared through this year. In fact, only five clinical trials were granted approval around August-September and these applications were pending from the previous year.

The apex court has already blocked as many as 157 clinical trials, approved by the government in 2012.

The court has asked the government to wait for its nod while the cases are being re-examined under the new regulatory regime, which was framed following earlier directives from the apex court.

The court had earlier asked the secretary to Ministry of Health and Family Welfare to monitor approval of every clinical trial himself until a proper system was in place.

Following many such stringent directives, the health ministry has put in place a three-tier system to scrutinise applications for clinical trials.

However, the industry, although supportive of a transparent mechanism, is concerned about the impact of the ongoing developments on the regular business.

“There is certainly an impact on the business because the normal work has suffered and the Indian industry is losing opportunity,” said Suneela Thatte, president of Indian Society of Clinical Research.

According to Thatte, the timeline of approvals and other procedures has become unpredictable because of the ongoing litigation and proceedings.

“Globally, one has to make a proper plan with estimated timelines etc to conduct clinical trials, but because of regulatory uncertainties, planning has become so much difficult.”

Officials pointed out that earlier, an approval used to take 12-16 weeks.

However, there are no timelines for a regulatory clearance now, directly hitting pharmaceutical companies as well as clinical research organisations.

According to market research firm Frost & Sullivan, the Indian clinical trial industry was worth $450 million in 2010–11.

At present, it is growing at 12 per cent a year and is predicted to pass the $1-billion mark in 2016.

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