The Drugs Controller General of India (DCGI) gave its nod to market authorization of two Covid-19 vaccines—Covaxin and Covishield—subject to certain conditions, the Union health ministry said on Thursday. The approval reflects India’s proactive and agile Covid-19 management, it said.
The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) had recommended for upgradation of status for the vaccines from restricted use in emergency situations to grant of new drug permission with conditions in the adult population on 19th January 2022.
For the market authorization, the firm should 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.
The vaccine should be supplied for programmatic setting and all vaccinations done within the country need to be recorded on CoWIN platform. Any adverse event following immunization (AEFI) and adverse event of special interest (AESI) should continue to be monitored.
The firm should 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.
“The latest approval accorded by DCGI for conditional market authorization to two Covid-19 vaccines in the country 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,” the ministry said in a statement.
It noted that only the United States Food and Drug Administration (USFDA) and Medicines and Healthcare products Regulatory Agency (MHRA) of the UK have granted “conditional market authorization” to Pfizer and AstraZeneca, respectively, for their Covid-19 vaccines.
According to the ministry, the “conditional market authorization” is a new category of market authorization that has emerged during the current global pandemic of Covid-19. “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 said.
