The Drugs Controller General of India (DCGI) on September 3 granted permission to the Mukesh Ambani-owned Reliance Life Sciences to conduct phase-I clinical trial of its indigenous COVID-19 vaccine with certain conditions, sources said.
The phase-I clinical trial will be conducted to evaluate safety, tolerability and immunogenicity of the SARS-CoV-2 recombinant protein subunit vaccine in healthy volunteers according to protocol, they said.
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, a source said, citing the conditions set for the trial.
The DCGI gave the permission 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 so far issued emergency use 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 U.S. firms Moderna and Johnson & Johnson.
