New Delhi: The Drugs Controller General of India (DCGI) on Friday gave its approval to Bharat Biotech for intranasal Covid-19 booster dose trials in the country.
The trials, as per reports, will be done on 900 subjects.
Earlier on Thursday, the DCGI gave its nod to market authorization of two Covid-19 vaccines, Covaxin and Covishield, subject to certain conditions.
The Union Health Ministry in a release said the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) had recommended for upgradation of status for the vaccines from restricted use in emergency situations to grant of new drug permission with conditions in the adult population on January 19, 2022.
The market authorization of the two Covid-19 vaccines is subject to the following conditions:
- Firm shall submit data of overseas ongoing clinical trials of the product with due analysis on six monthly basis or as and when available, whichever is earlier.
- The vaccine shall be supplied for programmatic setting and all vaccinations done within the country to be recorded on CoWIN platform and Adverse Event Following Immunization (AEFI), Adverse Event of Special Interest (AESI) shall continue to be monitored. The firm shall submit the safety data including AEFI and AESI with due analysis on six monthly basis or as and when available, whichever is earlier as per NDCT Rules, 2019.
The Health Ministry said “Conditional Market Authorization” is a new category of market authorization that has emerged during the current global Covid-19 pandemic.
“The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines,” the ministry added.