The Central Drugs Standard Control Organisation (CDSCO) granted Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin “conditional market authorisation” for the adult population on January 27.
- Since both the vaccines now meet the high standard of safety, effectiveness, and manufacturing quality that the Drugs and Cosmetic Act required of a new vaccine, they have now been upgraded to “conditional market authorisation”.
What is Emergency Use Authorisation (EUA)?
- In January 2020, Covishield and Covaxin were granted Emergency Use Authorisation (EUA). The EUA route is termed as restricted use in emergency situations and it is invoked in public health emergencies like a pandemic.
What is conditional market authorisation?
- Under EUA, manufacturers have to submit safety and efficacy data every 15 days or a month but under conditional market authorisation, they have to submit the data on safety and efficacy every six months.
- Still, these two vaccines will not be available in regular pharmacies or chemist shops and one will not be able to buy them as a retail product, with or without a prescription.
- The vaccines will be available for private hospitals and private clinics to procure, against required documentation and payment.
(Source: IE)
