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Clinical trials have always been an emotive issue in the country, as they involve testing medicines on human volunteers to understand a drug’s safety profile.
And the Supreme Court’s statement that new trials would not be allowed in the country, until a system is put in place to monitor it and protect people participating in them – has surprised an industry that was bracing itself for more regulatory scrutiny.
The clinical trial industry had expected more rules to be brought upon it, but a complete halt is not good for research, said Arun Bhatt , President of ClinInvent Research.
Another industry representative, Suresh Menon with the Indian Society for Clinical Research, said the development was not expected. “Especially, since in the last two to three months the Government had taken steps to improve the mechanisms governing clinical trials.”
Menon felt that apart from the loss to the industry, “This doesn’t augur well for the country as a whole and for the average patient community.”
Health workers, who have been vocal about unethical practices in clinical trials too, were not entirely sure if halting all trials of new drugs was the solution.
“This is the culmination of what has been happening since 2005,” said Amit Sengupta of the People’s Health Movement, referring to the amendment in the Drugs and Cosmetics Act, which opened the floodgates for new clinical trials in the country. He said the Government had changed the laws without anticipating the regulatory challenges, which led to improper monitoring given the sudden rise in clinical trials in the country.
It is true that the situation on the ground is very serious, he said, adding that he was not sure if the remedy was to stop everything till monitoring mechanisms were put in place.
Tardy implementation
But the Swasthya Adhikar Manch, which filed the petition with the apex court in the first place, pointed out that of 475 New Chemical Entities (that may have become new drugs after they were successfully tested) only 17 were approved for marketing which comes to less than 4 per cent. But during these clinical trials 2,644 persons died, out of which only 80 deaths were attributed to clinical trials, they pointed out.
Giving a list of drug companies that conducted trials in the country, counsel for the Swasthya Adhikar Manch had pointed out that the reason for so many deaths is because New Chemical Entities were being tested on Indian citizens without following the regulations and taking necessary precautions taking advantage of poverty and tardy implementation including corruption.
Taking a middle ground though, S. Srinivasan with voluntary agency Locost, said what comes out of this process will benefit both industry and the patients, as it paves the way for a better regulated framework for clinical trials.
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