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A day after the Supreme Court (SC) stopped permissions to 157 clinical trials, pharmaceutical companies said Tuesday they may be forced to move trials out of India.
Dhananjay Bakhle, Executive Vice-President (Medical Research), Novel Drug Discovery & Development, Lupin Limited, said, “The regulatory environment and volatility therein, the uncertainty over the last two years was already discouraging and we started conducting clinical trials in other geographies such as Europe. If granted approvals are also being cancelled, there is no sanctity of governance. One has already noticed a sizeable decline in the number of trials and applications over the last 2 years.”
The uncertainty, companies say, will impact the availability of new drugs in India in the long run.
“The Supreme Court ruling that halts clinical trials till a monitoring system is in place is a deterrent to drug innovation that can have an irretrievable impact on the ability of India to partake in new drug development as it will lead to an exodus of innovators,” said Biocon CMD Kiran Mazumdar-Shaw.
The 157 trials are now subject to SC nod once a decision is taken on the safety recommendations by a committee headed by professor Ranjit Roy Choudhury. The committee set up earlier this year has recommended that clinical trials should be carried out only in facilities approved by a central accreditation council. It, however, dismissed as without a sound basis a recent compensation proposal by a committee set up by the Drug Controller General of India.
The proposal was a sore point for drug companies, who interpreted it as a compulsion to compensate trial subjects even if they died of completely unrelated exigencies.
Anjali Nayyar, senior vice-president of NGO Global Health Strategies, said: “Appreciate the SC decision. All clinical trials should be conducted as per ICMR ethical guidelines and human lives should not be jeopardised. India has always provided cheaper and quality solutions, be it drugs or vaccines. For a country with a such a large burden of disease, especially affecting the poor and disadvantaged, we have to acknowledge the cost of delay in research and development.”
Her concerns were echoed by others in the industry who said if Indian companies had to leave for a favourable regulatory ambience and global MNCs too could not conduct trials here, flow of new drugs would dry up.
On the other hand, trials require adherence to good clinical practices and standard treatment protocols generally absent in India. Bulk of the trials stopped were for diabetes and anti-cancer drugs, diseases that are a major concern in India.