Covaxin, Covishield Vaccines Given ‘Conditional’ Market Approval By DCGI
Mumbai: Covaxin and Covishield COVID-19 vaccines have received conditional market authorisation from DCGI.
Earlier, the CDSCO committee recommended up-gradation of the status from restricted use in emergency situations with conditions in adults.
The subject expert committee of the Central Drugs Standard Control Organization has previously recommended routine market approval of these COVID-19 vaccines for the adult population, subject to certain conditions.
However, market approval does not mean that the vaccine will be available at medical stores. People have to buy Covishield and Covaxin from hospitals and clinics.
Union Health Minister Dr Mansukh Mandaviya tweeted following the grant of market approval: “The Central Drugs Standard Control Organisation (CDSCO) has now upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions.
“The conditions include supply for programmatic settings including registration on the CoWIN platform and to continue to submit safety data on a six-monthly basis.”
https://twitter.com/mansukhmandviya/status/1486641071434055684?s=20
Vaccination data has to be submitted to DCGI every six months. Data will have t to be updated on CoWIN app also.
Earlier, it was reported that the Centre was planning to cap the price of the vaccines at ₹275 per dose.
What are the conditions?
- The approval has been granted under the New Drugs and Clinical Trials Rules, 2019.
- The firms, in this case, Bharat Biotech (Covaxin) and Serum Institute of India (Covishield), shall submit data of ongoing clinical trials
- All vaccination data will be recorded on the CoWIN platform.
- The approval is only for adult population.
- Adverse events following immunisation will continue to be monitored as part of the conditions.
Prakash Kumar Singh, director of government and regulatory affairs at SII, had submitted an application to DCGI on October 25 seeking regular market authorization for Covishield. Singh had recently submitted a response with more data and information after DCGI sought more data and documents from the Pune-based company.
In an application sent to V Krishna Mohan, whole-time director of DCGI, Hyderabad-based Bharat Biotech, seeking pre-clinical and clinical data, chemistry as well as regular market authorization for Covaxin Presented complete details about manufacturing and control.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
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