“Recent clinical trial regulations in India have affected some NIH studies,” the NIH said in a 19 July statement. “Some trials have stopped enrolment and some others have been postponed.”
The NIH, an arm of the US health department
, has cancelled approximately 40 ongoing clinical trials in the country, Mint
reported on 11 July. NIH had declined comment at that time.
The health ministry relaxed some of the new rules it put in place, after realizing that these could effectively kill India’s growing clinical trials industry, according to a note posted on its website on 10 July. These tighter laws were instituted following the Supreme Court
The clinical trials business in India is estimated to be worth around $500 million (Rs.2,970 crore), according to researcher Frost and Sullivan
, which projects that it will grow to $1 billion by 2016. Industry experts estimate a loss of $150-200 million in the past six months on account of regulatory changes.
After industry lobbying, the ministry has already relaxed norms—one concerning compensation and another that said the tests could have only the desired or intended effects, and no other.
The documents said that 11,972 adverse effects, excluding deaths, were reported in the period, with 506 of these being directly attributable to the trials. They put deaths from trials at 2,644 in the past five years.
In a 3 January ruling, the apex court revoked the powers of the Indian drug regulator to approve trials for new chemical entities, placing the responsibility on the health secretary, who was asked to personally vet all approvals. Since then, only six trials had been approved until this month, when the ministry cleared 50 trials at one go.
“We believe the protection of research participants involved in clinical trials is an ethical imperative and we commend the substantial efforts being made to review the oversight of clinical trials in India,” the NIH said in its statement. “We are following developments surrounding the amendments to the Drugs and Cosmetics Rules, and are hopeful that additional information and guidance surrounding their implementation will pave the way for our continued joint endeavours.”