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

The ethics committee has seven members, including a chairperson who has to be from outside the institution where the trial is being conducted.

Coronavirus, vaccine, covid, drugs, clinical trials
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The regulator said ethics committees at sites and investigators play a key role in the process.

Sohini Das Mumbai
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