Slow approvals put drug trials industry at risk

The domestic drugs trial market was worth about $485 million in 2011, according to consultants Frost & Sullivan, who predict that could double to $1 billion by 2016.

But the regulatory fog surrounding clinical trials means Asia's third-largest economy has failed to fulfil its potential to become a testing hub, companies and analysts said. Less than 1.5 percent of global trials take place in India, according to the Indian Society for Clinical Research (ISCR).

"We are concerned by delays in approval of clinical trials, and ambiguity in the processes, over the past two years," said a spokesman for MSD, the local unit of U.S. drugmaker Merck & Co.

ADDED LAYER

Two groups of activists filed cases last year alleging firms illegally conducted trials, exploiting poor people by testing potentially harmful drugs on them. The cases are being heard simultaneously in the Supreme Court.

"Putting patients first is at the heart of everything we do, and our clients share this same commitment to patients and their safety," said Quintiles, a clinical research services provider to various drugmakers around the world, including India.

"In the event of an injury in a clinical trial, the need for compensation for the patient and/or their dependent(s) is taken very seriously, and is handled by the sponsor of the trial in accordance with all applicable regulations and guidelines," Quintiles said.

The Supreme Court last month ordered the health ministry to supervise all clearances for new drug trials, creating an added layer of decision-making.

Two activists told Reuters they believed

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