SII has been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
The DCGI also directed Serum Institute of India to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Oxford/AstraZeneca vaccine is also being produced as part of a tie-up by the Serum Institute of India.
The global trials were halted after a study participant suffered a 'potentially unexplained illness, reports Sohini Das.
Health Minister Harsh Vardhan said the COVID-19 vaccine will be available in the next few months and it is estimated that by July-August 400-500 million doses will be made available for 25-30 crore people.
A Chennai-based man has demanded a compensation of Rs 5 crore from the SII after his health worsened allegedly after volunteering for the clinical trials for a COVID-19 vaccine.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
Indian Council of Medical Research Director General Balram Bhargava said the purpose of the COVID vaccine drive would be to break the chain of viral transmission.
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