New Delhi: Till date registrations of more than 15 institutional ethics committee have been suspended or cancelled after they failed to report serious adverse events to the CDSCO within 30 days," said DCGI Dr VG Somani here in New Delhi.
Somani was addressing a webinar on Regulatory Pathways for Covid 19 vaccines, clinical trials, ruling reviews and adverse event monitoring.
He said that the ethics committee plays an important role during vaccine trial process.
"The ethics committee review and approve clinical trial protocol to safeguard the rights, safety and well being of all trial subjects. It analyses the report of serious adverse event including deaths and forwards its opinion to DCGI. It also reports all serious adverse events to the CDSCO within 30 days. In case of non-compliance, DCGI may suspend or cancel the registration of the ethics committee," said Somani.
It may be mentioned here that the ethics committee of the Chennai based hospital where a Covid19 vaccine volunteer faced adverse event, the committee reportedly told the DCGI that there was no connection between the deteriorating condition of the patient and vaccine administered.
Somani informed that till that Rs 12 crore have been dispersed to the kind of the victims as compensation in previous trials.
The DCGI said that subjects or patients are enrolled in the clinical trial by the investigator based on the fulfilment of inclusion and exclusion criteria, as per the protocol approved by the respective ethics committee and CDSCO.
"Subject voluntarily decides to participate in the trial, and required to sign a consent form, approved by the respective ethics committee detailing all the information and objectives of the trial, possible adverse reactions, provision for free medical management, compensation end," Somani said.
He said that the investigator is also responsible for the overall conduct of the clinical trial. "Investigator should provide medical care to participants and report all serious adverse events to the CDSCO, the sponsor and the ethics committee, within 24 hours of their occurrence," Somani informed.
He said that the sponsor (company/organisation conducting trial) also report all serious adverse events, after analysis to the ethics committee, expert committee, DCGI and the head of the institution within 14 days. "The sponsor also pay compensation in case of trial-related injury or deaths of the patient. In case of failure to pay compensation, DCGI can debar or restrict the sponsor from conducting any clinical trials in future," Somani said.
He informed that before March 2019, clinical trials and new drugs regulated under Part X-A of the drugs and cosmetics rules, 1945 and schedule Y of the rules.
"At present clinical trials and new drugs are regulated under the new drugs and clinical trials rule 2019...The rules contain various provisions for ensuring ethical conduct of clinical trials and provides for inspection, compensation, accelerated review process and regulatory action in case of non-compliance," Dr Somani said.
Admitting the fact that it takes 4-5 years for rolling out a vaccine, Dr Somani said that when such a pandemic occurs it's the response of the scientific community and regulators to see that we get the vaccine at the earliest.
"For Covid19 vaccine, some of the phases of vaccine trials are allowed to run parallelly. Interim analysis of clinical trial data at pre-defined stages is conducted by the CDSCO to facilitate early decision in an emergency situation," said Dr Somani.
Echoing the same view, Dr Sheela V Godbole, Scientist G and Head-epidemiology at ICMR said that all procedures are followed for vaccine trials.
"In the first 3-4 months of this year, scientists have accelerated the identification of existing vaccine which were used for other purposes," said Dr Godbole.
Terming the present pandemic situation as unique, Dr Renu Swarup, secretary in the department of biotechnology said that the government is looking at multiple vaccines coming in. The DBT has identified 11 vaccine trial sites across India.
Stating that there is a separate vaccine expert committee in DBT, Swarup said, "There have been a lot of efforts for vaccine development though it's very tough to say at present which vaccine will be the best."
"We also have excellent collaboration with international agencies for vaccine development," Swarup added.
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