The Drugs Controller General of India (DCGI) on Thursday granted conditional regular market approval for COVID-19 vaccines Covaxin and Covishield for restricted use in emergency situations in the adult population.
According to Union Health Ministry, the vaccines will not be available in medical stores but hospitals and clinics can now purchase the vaccines. Vaccination data has to be submitted to DCGI every six months. The data has to be updated on CoWIN app also.
According to Central Drugs Standard Control Organization (CDSCO), the proposals for regular market approval were reviewed by it in consultation with the Subject Expert Committee (SEC) for COVID-19. After detailed deliberation, the committee recommended updating the status of approval of COVID vaccines -- Covishied and Covaxin from Restricted use in an emergency situation to the New Drug permission as per rules in the adult population with conditions.
The vaccines are for sale or for distribution under New Drugs and Clinical Trials (NDCT) Rules, 2019 in adult population with the conditions that the Firm shall submit data of overseas ongoing clinical trials of the product with due analysis on a six-monthly basis or as and when available, whichever is earlier.
Secondly, the vaccine shall be supplied for programmatic setting and all vaccinations done within the country to be recorded on CoWIN platform and AEFI, AESI shall continue to be monitored. The firm shall submit the safety data including Adverse Events Following Immunization (AEFI) and Adverse Events of Special Interest (AESI) with due analysis on a six-monthly basis or as and when available. whichever is earlier as per NDCT Rules. 2019.
Covishield is manufactured by Pune-based Serum Institute of India while Covaxin is manufactured by Hyderabad-based Bharat Biotech.