India has amended its clinical trials laws, adding new rules that will oblige pharma companies sponsoring trials to pay compensation in cases where volunteers suffer trial-related death or injury.
The Ministry of Health & Family Welfare ruling comes a month after the Supreme Court of India, based in New Delhi, criticised the country’s government for poor regulation of clinical trials.
Compensation will be decided on a case-by-case basis, according to a local report in The Economic Times, and failure to pay up could see pharma firms and clinical research organisations (CROs) face suspension of trials and even a permanent ban on their activities.
However, the Indian Society of Clinical Research (ISCR) criticised sections of the new amendment on compensation, which they believe will have “a far-reaching impact on organisations and academic institutes, both Indian and multination”.
The ISCR said: “The clauses stating that compensation needs to be paid for injury or death due to failure of investigational product to provide intended therapeutic effect and use of placebo in placebo controlled trials contradict the scientific base of a clinical trial.”
The institute added: “It is ironical that the Ministry notification has come around the same time that the US FDA is holding a hearing to discuss with industry experts how a speedier pathway to approve drugs and biologics for serious and life-threatening conditions with unmet medical needs can be constructed.”