BANGALORE — After a series of revelations last month about instances of unethical clinical trial practices in India, the country's lawmakers are pledging to enact stringent laws to punish violators. “I am pushing very hard to make existing guidelines into a stringent law this year,” Vishwa Mohan Katoch, secretary to the Indian Department of Health Research, which is responsible for overseeing clinical trials, told Nature Medicine.
The push for harsher penalties is the second major legal development in recent months to improve the integrity of trials. The first came on 18 November when the Drug Controller General of India (DCGI), the country's main medical regulator, announced new rules regarding compensation for trial victims. Under the new legal rule, expected to go into force in the coming months, failure to pay compensation in the event of an adverse effect or death will result in the companies being barred from conducting any further clinical trial in India. “Only when these two laws are enacted will the menace of illegal trials stop,” says Prathap Tharyan, a psychiatrist and medical ethicist at the Christian Medical College in Vellore, India.
This is a preview of subscription content, access via your institution
