India's drug regulator meets to discuss Oxford vaccine

CDSCO expert panel to reconvene on Jan 1 to consider emergency use authorisation for Covid-19 vaccines

SII, the world's biggest producer of vaccines, has already stockpiled about 50 million doses, enough for 25 million people

Representative Image. Credit: AFP Photo

Indian drug regulators on Wednesday did not grant emergency approval to any of the three vaccine manufacturers who approached the Central Drug Standards Control Organisation (CDSCO) seeking such permission for the early roll out of their Covid-19 vaccine in India.

The applications of Pfizer; Serum Institute of India, Pune; and Bharat Biotech, Hyderabad, were reviewed by a subject expert committee of the CDSCO.

While Pfizer sought more time to present their case, additional data submitted by the SII and Bharat Biotech were perused by the panel, but no decision was taken.

"The Subject Expert Committee (SEC) in the CDSCO met today in the afternoon to consider the emergency use authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt. Ltd," Union health ministry said in a statement.

“The analysis of the additional data and information is going on. The SEC will convene again on January 1, 2021,” the ministry said.

"Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech Pvt. Ltd was perused and analysed by the SEC. The analysis of the additional data and information is going on. The SEC will convene again on January 1, 2021," it said.

The CDSCO meeting took place on the same day when the UK Medicine and Healthcare Products Regulatory Agency gave its approval to the Oxford University-AstraZeneca Covid-19 vaccine.

This is the same vaccine that would be manufactured and sold by Serum Institute of India (SII), the world's biggest producer of vaccines, with the brand name 'Covishield'.

While the Hyderabad-based Bharat Biotech is halfway through the third phase of the clinical trial, the Serum Institute has not published the results of its clinical evaluation on 1,600 Indians. Pfizer, on the other hand, sought a waiver from an Indian trial.

SII had applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for Covishield on December 6 while the Bharat Biotech had sought a similar nod for its indigenously developed Covaxin on December 7. Pfizer had applied for a similiar approval for its vaccine on December 4.


(With inputs from PTI)