Sheela Godbole, head, division of epidemiology at the Indian Council of Medical Research (ICMR), also said India has the most stringent guidelines on clinical trials
and compensation. The regulator said in case compensation isn’t paid after DCGI direction it can restrict or debar the sponsor from conducting future trials.
Central Drugs Standard Control Organisation (CDSCO) sources claimed that a detailed investigation into the adverse event in Serum’s trial did not found any causal link between the illness and the investigational candidate. Hence, the question of compensation has been ruled out.
Explaining the checks in place for ensuring a fair and objective trial, the regulator said ethics committees at sites and investigators play a key role in the process. The registration of institutional ethics committee with the CDSCO is mandatory, Somani said.
The ethics committee has seven members, including a chairperson who has to be from outside the institution where the trial is being conducted. Members need to be trained in rules and good clinical practices to safeguard rights, safety and well-being of subjects. “If not trained, the ethics committee shall be disqualified,” said Somani, adding that in the past 10-15 ethics committee registrations have been cancelled. The ethics committee is also expected to report all serious adverse events to the CDSCO within 30-days. Somani also said it is the investigator’s responsibility to inform subjects about the trial through a consent process.
A Chennai participant had reported ill during participation in Serum’s trial on 1,600 subjects. He sent a legal notice to the sponsor, Serum, seeking Rs 5 crore in damages. Terming his allegations “malicious and misconceived”, Serum said it would seek damages worth Rs 100 crore from the subject.
While initial investigations did not find the incident to be linked, the DCGI conducted an in-depth investigation by an independent expert committee.
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.