On Friday, the Indian Drug Controller General (DCGI) authorised Reliance Life Sciences, owned by Mukesh Ambani, to conduct a phase I clinical trial with certain conditions of its indigenous COVID 19 vaccine.
They said that the phase-I clinical trial will assess SARS-CoV-2 vaccine for recombinant protein in healthy volunteers according to their safety, tolerability, and immunogenicity.
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 US firms Moderna and Johnson & Johnson.
