The issue of clinical trials in the country has been a controversial one. Investigations revealing exploitation, procedural irregularities and breaches of ethics in several cases have lowered the credibility of such trials in the public’s mind and led to an overhaul of the regulatory system.
But has the overhaul erred too far on the side of caution? That was one of the questions explored by Y.K. Gupta, national scientific coordinator, Pharmacovigilance Programme of India, on Tuesday.
Dr. Gupta was speaking at a lecture at Sri Ramachandra University (SRU). Ranjit Roy Chaudhury, national professor of pharmacology and advisor, Department of Health and Family Welfare, Government of NCT, Delhi, who was due to give the lecture, died early on Tuesday morning.
“Clinical trials are a must for drug development,” Dr. Gupta said. India, he explained, had become a hub for clinical trials for a number of reasons: the large population and the relative low costs being major factors. This had led to a number of institutes conducting trials with international funding and often with international investigators. This led to a number of deviations from ethics and principles.
After exposes by the press and civil society, an expert committee was set up and a number of recommendations were made, almost all of which were accepted by the government, making the regulations in India on a par with international standards and more stringent than those in many other countries, he said.
Today, for instance, giving patients in clinical trials the standard treatment is the norm — the placebo trials, where one group of patients do not get any medication — are only used as a last resort, said Dr. Gupta.
“The issue is, sometimes when there is pressure on the government, an overcorrection takes place. And then correcting this is a tremendous job,” he said, citing the example of investigators being only allowed to perform three clinical trails each.
While the future may lie in experiments on parts of organs, as of now, it is impossible to truly know the effect of a drug unless tried on a human being, he said, making such trials essential.
Middle path
N. Ram, chairman, Kasturi and Sons Ltd., quoting an expert, said the middle path needed to be followed — too much restriction and innovation would be lost and too lax and there could be exploitation. While lauding the media for exposing unsavoury practices, he said they had to be careful not to damn the whole field. “This debate has to be taken up and the public and healthcare professionals educated. In a field like medicine, it is intolerable if the laws fail to protect vulnerable people and the field itself,” he said.
After exposes by the press and civil society, an expert committee was set up and most of its recommendations for regulating the practice were accepted
