The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) on Wednesday, i.e 19th January 2021 has granted regular market approval to Covid Vaccines of Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin with conditions for the adult population. A market authorisation label for a vaccine means that it can be authorised for use without reservations or conditions.
It is worth noting that since January last year when India’s largest vaccination drive commenced, Covishield and Covaxin have been made available under Emergency Use Authorisation (EUA). The EUA, termed as restricted use in emergency situations, is invoked due to public health emergencies, like that of a pandemic, and provided that the regulator, based on initial data from phase 3 of clinical trials, determines that the potential benefits of the vaccine, when used to prevent Covid-19, outweigh its potential risks.
Central Drug Standard Control Organisation (CDSCO) also took to Twitter to confirm that its SEC has recommended the upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant new drug permission with conditions in the adult population. DCGI will evaluate the recommendations and give its decision.
SEC OF CDSCO HAS RECOMMENDED FOR UPGRADE OF COVISHIELD AND COVAXIN STATUS FROM RESTRICTED USE IN EMERGENCY SITUATIONS TO GRANT OF NEW DRUG PERMISSION WITH CONDITIONS IN ADULT POPULATION ,DCGI WILL EVALUATE THE RECOMMENDATIONS AND GIVE ITS DECISION.
— CDSCO_INDIA_INFO (@CDSCO_INDIA_INF) JANUARY 19, 2022
Scientifically noting, the recommendations mean that the two Covid vaccines now meet the high standard of safety, effectiveness and manufacturing quality that the Drugs and Cosmetic Act required of a new vaccine.
It is pertinent to mention that the expert panel’s recommendations are based on long-term follow-up data of both vaccines. In addition to the successful completion of phase 2/3 clinical study in India, till Wednesday, 137 crore doses of the Covishield vaccine have been administered to the people of this country under the government’s vaccination drive and all the vials manufactured are tracked by the government.
Also, under the present situation of the EUA, the Covid vaccines cannot be sold in the retail market. On Wednesday, the regulator said the expert panel’s recommendations are based on certain conditions. When these vaccines are administered, the beneficiaries are monitored by trained health professionals and adverse events following immunisation are captured on the government’s CoWin platform, on a real-time basis. The regulator is also likely to impose post-marketing surveillance conditions, which are imposed on various approved drugs.
Vaccines approved in India till date
In India, eight Covid-19 vaccines have been licenced for emergency use in the past year, namely Covishield and Covovax from the Serum Institute of India, Covaxin and Corbevax from Bharat Biotech, Russia’s Sputnik V, Moderna, Johnson and Johnson’s single-dose vaccination, Zydus Cadila’s ZyCoV-D, from Biological E.
Covishield and indigenously developed Covaxin have been the backbone of India’s vaccination drive wherein Sputnik V failed to take off in the India pharma market while ZyCoV-D has not been rolled out yet. Moreover, Moderna has not entered the Indian market as an agreement has not yet been reached.
At present, Covaxin is the only vaccine being administered to children.
Last year in November, the World Health Organisation issued an emergency use listing for Bharat Biotech’s Covaxin, making it the eighth vaccine in the world to receive the global health body’s approval.
