Slow approvals put drug trials industry at risk

Lupin Ltd. India's fourth-largest drugmaker by sales, said it had wanted to conduct an NCE trial in India last year, but the $5 billion firm eventually went overseas as the approval process was too slow and made more uncertain by the ongoing Supreme Court case.

"I think the intention is right but the implementation is so slow, that it's hampering in the near term," said Nilesh Gupta, Lupin's group president. "For NCEs in particular in India, the process is extremely long."

ECCRO, a contract research organisation that focuses on India, sees 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.

INDUSTRY "AT RISK"

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.

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