Slow approvals put drug trials industry at risk
its vice chairperson Swati Piramal said, warning that India was losing its "innovation edge".
The approval time for initiating drug trials in India typically stretches to 6-8 months, compared to just 28 days in Europe and Canada, said Piramal. "Post the Supreme Court case, certainly companies like us will look anywhere in the world to see if we get good trials," she said.
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
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