New Delhi: India will strengthen a proposed law on human clinical research that would have an ethics guideline and tougher penalties for violators.
The department of health research of the Union health ministry has concluded a review of the long-pending Bill for Research on Human Subjects and a fresh draft would be ready in two months, said department head V.M. Katoch.
“If any violations occur in trials here, the punishment should be as stringent as it is in other countries where these (multinational drug) companies do research,” he said. “Human dignity in research is something we will tackle in this Bill.”
Katoch said the new draft would incorporate international standards on the ethics to be followed in human drug testing.
Experts say while a tougher law is necessary, the key is implementation.
“There are numerous research going on in India so such regulations are needed,” said Mira Shiva, founder member, People’s Health Movement, a health activist organization. “But the point is that even if there is a regulation, will it be implemented?”
“The issue is what is the nature of research going on, and how much of our health needs it is meeting, and is it ethical? How are the protocols made?” Shiva added.
Katoch said the Bill would have a provision for setting up a biomedical research authority to oversee the implementation of ethical standards in human drug trials involving stem cell research and genetic research as well.
India is among the fastest growing clinical research destinations in the world with a growth rate that is two-and-a-half times that of overall market growth, but human drug trials are not monitored closely.
The nation’s clinical trial market is valued at $300 million (Rs1,400 crore) with a compounded annual growth rate of 30%, according to a recent report by consultancy Ernst and Young and industry lobby group Federation of Indian Chambers of Commerce and Industry.
Since India is fast becoming an attractive location for human clinical trials, the government has taken swift steps in the past one year to strengthen regulations governing all such research.
For greater transparency in drug research, the government is making it mandatory for organizations conducting clinical trials on humans to register with it, having already made it mandatory to register all clinical trials with a registry of the Indian Council of Medical Research.
The health ministry is also looking to introduce the Central Drug Authority Bill with similar provisions.