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Slow approvals put drug trials industry at risk

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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.

"There hasn't been any halt in approving new clinical trials," Singh said. "We cannot suddenly wake up one day and decide 'Ok, no more clinical trials in this country'."

V.M. Katoch, the head of the state-run Indian Council of Medical Research (ICMR), which advises the drugs regulator on approvals, also disputed that approval times had slowed.

Referring to the allegations made in the Supreme Court, he said trials conducted without the patient's consent were a small number of aberrations. "That creates the impression that everything is wrong all around, which is not true actually," he said. "The ethical practices every year have become stronger and stronger."

However, Katoch acknowledged that recent negative publicity around drug trials in India had put the government "on the defensive" for a while.

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