Covaxin, Covishield Vaccines Allowed To Be Sold In Hospitals, Clinics: But Under These Conditions

Covaxin and Covishield are now available for the general public to purchase as the Drug Controller General of India (DCGI) has given conditional market approval to the two vaccines.

The approval has been granted under the New Drugs and Clinical Trials Rules, 2019. 

Both vaccines were granted Emergency Use Authorisation (EUA) on January 3, 2021.

What Changes?

The difference between EUA and market approval is the frequency in which safety and efficacy data has to be submitted. 

Data for drugs under EUA will have to be submitted every 15 days or a month.

Manufacturers of those given the market approval will have to submit data every six months.

What It Means For The Public

However, the market approval is conditional in this case. 

It does not mean that they can be bought in regular medical stores.

Adults can purchase them from hospitals and clinics.

It was reported earlier that the government may cap the price at Rs 275 per dose with an extra service charge of Rs 150.

‘Conditional’ Approval

As per conditions, Bharat Biotech (Covaxin) and Serum Institute of India (Covishield) will have to submit vaccination data to DCGI every six months and update it on the CoWIN app as well.

They will also have to submit data of ongoing clinical trials.

Adverse events following immunisation will continue to be monitored.

Timeline Of Approvals

The DCGI approval comes after a Subject Expert Committee of the CDSCO on COVID-19 on January 19 recommended regular market approval for use in the adult population, subject to certain conditions.

Union health minister Mansukh Mandaviya had tweeted that CDSCO or Central Drugs Standard Control Organisation had upgraded the permission of the vaccines from restricted use in emergency situations to normal permission in the adult population with certain conditions.

Serum Institute Applies For Approval

Last year on October 25, Director, Government and Regulatory Affairs at SII Prakash Kumar Singh had submitted an application to DCGI requesting regular market authorisation for Covishield.

The DCGI asked for more data and documents which Singh provided. 

He vouched for the safety and efficacy of Covishield especially with its use in the nationwide vaccination drive against the virus.

Bharat Biotech’s Application

Bharat Biotech’s whole-time director V Krishna Mohan also sent an application with the required information and data, seeking regular market authorisation for Covaxin.

Mohan wrote that his company rose to the occasion and developed, produced and clinically evaluated a vaccine from SARS-CoV-2 strains isolated from patients in India.