Explained: What is 'conditional market authorisation'? Covishield, Covaxin get nod; Read

Drugs Controller General of India (DCGI) on Thursday, January 27, granted 'conditional market authorisation' approval for COVID vaccines, Serum Institute of India’s Covishield, and Bharat Biotech’s Covaxin. This is applicable for the COVID vaccine to the adult population only. 

Earlier on January 19, a Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation recommended permitting regular market approval for use of the vaccines in the adult population subject to certain conditions to both the COVID vaccines, Covishield and Covaxin. 

What is conditional market authorisation?

Both Covishield and Covaxin are available under Emergency Use Authorisation (EUA) since January 2021. In India, the EUA route is termed as emergency situations usage only. This state is approved based on initial data from phase 3 of clinical trials when public health emergencies like a pandemic are witnessed in the country. 

And as both COVID vaccines meet the standard of safety by showing potential benefits of the vaccine, when used to prevent Coronavirus infections, outweighing its potential risks, they have now been upgraded to 'conditional market authorisation'. All important factors including safety, effectiveness, and manufacturing quality that the Drugs and Cosmetic Act required has been met by both Covishield and Covaxin. 

This up-gradation serves as a relaxation concerning the regulatory requirements on monitoring the safety of the vaccine. Manufacturers are directed to submit safety and efficacy data every 15 days or a month under EUA while under the conditional market authorisation, every six months, they have to submit the data on safety and efficacy.

India's COVID vaccine approval

It is to be mentioned that conditional market authorisation is different from full market authorisation. According to sources, only during the pandemic, the concept of conditional authorisation has gained momentum across the globe.  

It is said that India’s conditional market authorisation for Covishield and Covaxin will be similar to the conditional market authorisation of other countries including the United States Food and Drug Administration (FDA) has granted to Pfizer’s mRNA COVID vaccine, or the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has granted to AstraZeneca’s COVID vaccine.

(Image: PTI)