Covid-19 vaccines Covaxin and Covishield get market authorization for use in adults
All vaccinations done within the country will need to be recorded on the CoWIN platform
The Drugs Controller General of India (DCGI) has given its nod to market authorization of two Covid-19 vaccines, Covaxin and Covishield. The national regularator's clearance on Thursday is subject to certain conditions.
The move is likely to make the vaccines available at private clinics across the country, thus making it more accessible to the people.
This follows last week's recommendation of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO).
The committee recommended the upgradation of status for the vaccines from restricted use in emergency situations to grant of new drug permission with conditions in the adult population.
According to the Ministry of Health and Family Welfare, the market authorization of Covaxin and Covishield in the country is subject to the following conditions:
1. Firm shall submit data of overseas ongoing clinical trials of the product with due analysis on six monthly basis or as and when available, whichever is earlier.
2. The vaccine shall be supplied for programmatic setting and all vaccinations done within the country to be recorded on CoWIN platform and Adverse Event Following Immunization [AEFI], Adverse Event of Special Interest [AESI] shall continue to be monitored. The firm shall submit the safety data including AEFI and AESI with due analysis on six monthly basis or as and when available, whichever is earlier as per NDCT Rules, 2019.
Of the global regulatory Authorities, only the United States Food and Drug Administration (USFDA) Medicines and Healthcare products Regulatory Agency (MHRA) of the UK have granted “conditional market authorization” to Pfizer and AstraZeneca, respectively, for their Covid-1919 vaccines.
The health ministry pointed out that “Conditional Market Authorization” is a new category of market authorization that has emerged during the current global pandemic of COVID19.
"The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines," it added.
Describing the government's approach as "proactive and agile", the health ministry said the latest approval accorded by DCGI indicates the promptness and timeliness with which the public response strategy and decision making apparatus of the country has responded to the emerging needs during the pandemic.
India’s nation-wide Covid-19 vaccination program was launched on January 16, 2021 and more than 163 crore doses have been administered.