Medilytix News Bureau:
Bharat Biotech and Serum Institute of India (SII) will have to submit data of overseas ongoing clinical trials of their COVID-19 vaccines Covaxin and Covishield with due analysis on six monthly basis or as and when available, whichever is earlier, the government said on Thursday.
he provision is a part of the market authorization status that both the vaccines have received from the Drugs Controller General of India (DGCI). Despite over 160 crore doses of both the vaccines have been administered in India, the manufacturers will have to be under a strict screening of the government for safety profiles and efficacy of their vaccines.
“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,” the Union Health Ministry said in a statement.
Of the global Stringent 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-19 Vaccines. India has followed the suit. The national drug regulator, DCGI has given nod to market authorization of two COVID-19 vaccines, Covaxin and Covishield being administered under the national COVID-19 vaccination program subject to certain conditions on Thursday.