According to the sources, The DCGI (The Drugs Controller General of India) granted permission to Mukesh Ambani-owned Reliance Life Sciences to conduct its COVID-19 vaccine trial on friday with certain conditions. The safety, tolerability and immunogenicity of the SARS-CoV-2 recombinant protein subunit vaccine in healthy volunteers will be evaluated in phase – 1 clinical trial according to a protocol, they said. According to a source, the firm is required to submit the revised clinical trial protocol for immunogenicity to be assessed on Day 42, instead of Day 14, as recommended by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation, citing the conditions set for the trial.

The DCGI gave the approval based on the recommendations given by the SEC which deliberated on the company’s application on August 26. The trials will be conducted at eight sites in Maharashtra. India’s drug regulator has issued emergency authorisation to six COVID-19 vaccines– Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s ZyCoV-D, Russian-made Sputnik V and the two made by US firms Moderna and Johnson & Johnson.

The DCGI granted permission to Mukesh Ambani-owned Reliance Life Sciences to conduct its COVID-19 vaccine trial.