DCGI reassures all protocols being followed in Serum's clinical trials

The regulator said ethics committees at sites and investigators play a key role in the process.
In the wake of reports of a serious adverse event in one 40-year-old Chennai volunteer in the Serum Institute-AstraZeneca vaccine trial, the Indian drug regulator on Friday reassured that all processes and protocols are being followed for clinical trials in the country.


Speaking to the media in a webinar on Friday, V G Somani, Drugs Controller General of India (DCGI), said India is one of the few countries that has stringent rules related to compensation in case of adverse event during a clinical trial that has a causal link to the investigational drug or vaccine candidate. In fact, Somani said compensation in excess of Rs 12 crore had been given to participants in clinical trials over the years.


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.

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