Slow approvals put drug trials industry at risk

Feb 13 2013, 11:40 IST
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Slow approvals put drug trials industry at risk. (Reuters) Slow approvals put drug trials industry at risk. (Reuters)
SummaryDrugs firms complain that sluggish bureaucracy in New Delhi and a lack of legal clarity.

global drugmakers turning to Russia and Brazil for their trials as they struggle to get approval in India.

But moving drugs trials abroad could raise the cost for Indian companies. The $20,000 cost of trialling a drug in the United States is 10-20 times that in India, said Deepak Malik, a healthcare analyst at Emkay Global.


The relatively low cost of conducting trials and a fast-growing population of 1.2 billion should make India an attractive destination for companies to carry out tests. It is already a generic drug-making powerhouse whose exports to Latin America and Africa have earned it the sobriquet as "the developing world's pharmacy".

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.


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 the cases had stymied new drug trial approvals as senior government officials were too nervous to take decisions. "Unofficially they have decided not to sanction new clinical trials," said activist Amulya Nidhi.

However, G.N. Singh, the drugs controller general of India, said there had been no changes to the approvals process.

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