New Delhi: Two Covid-19 vaccines —Covaxin by Bharat Biotech and Covishield by the Serum Institute of India — have received “conditional market authorisation” from India’s drug regulator, Union Health Ministry announced on Thursday.
The approval was granted under the New Drugs and Clinical Trials Rules, 2019 after recommendations from the Subject Expert Committee (SEC) under the drug regulatory authority to upgrade the status for the vaccines from restricted use in emergency situations to grant of new drug permission with conditions in the adult population on Jan. 19, the Ministry informed.
The terms and conditions for the approval state both the firms to produce safety analysis and overseas clinical trial data for their vaccines every six months to the drug regulator, product supply in Government-approved centres, doses record on Co-WIN and monitoring of all adverse events.
“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 Immunisation [AEFI], Adverse Event of Special Interest [AESI] shall continue to be monitored,” it added.
“The firm shall submit the safety data including AEFI and AESI with due analysis on a six-monthly basis or as and when available, whichever is earlier as per NDCT Rules, 2019,” the Ministry said further.
The “Conditional Market Authorization” approved for the two vaccines is a new category of market authorisation that has emerged during the current global pandemic of Covid-19. 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. Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on Jan. 3 and were introduced in the nationwide Covid-19 vaccination program which was launched on Jan. 16 2021. Till date, more than 160 crore doses have been administered.