Drug Regulator Seeks More Data Over Approval For Covishield Booster: Report

On December 1, Prakash Kumar Singh, director, Government and Regulatory affairs at Serum Institute of India (SII), had sought approval from the Drugs Controller General of India (DCGI) for Covishield as booster dose.

An expert panel of India's central drug authority which reviewed Serum Institute's application for approval of Covishield as booster dose against COVID-19 on Friday recommended that the firm submit local clinical trial data and proposal along with justification for the booster dose approval, official sources said.

On December 1, Prakash Kumar Singh, director, Government and Regulatory affairs at Serum Institute of India (SII), had sought approval from the Drugs Controller General of India (DCGI) for Covishield as booster dose, citing adequate stock of the vaccine in the country and a demand for a booster shot due to the emergence of new coronavirus variants.

Mr Singh had referred to the UK's Medicines and Healthcare products Regulatory Agency giving a go-ahead to the booster doses of AstraZeneca ChAdOx1 nCoV-19 vaccine in the application.

"The subject expert committee (SEC) on COVID-19 at CDSCO reviewed SII's application and following detailed deliberation recommended that the Pune-based firm should submit local clinical trial data and proposal along with the justification for booster dose approval," a source said.