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Covid-19 Vaccine: Pfizer, Bharat Biotech, and Serum Institute Applications To Be Reviewed Today


The Central Medicines Standard Control Organization (CDSCO), which is the National Regulatory Authority of India, will review applications from Pfizer, Serum Institute of India and Bharat Biotech, the three pharmaceutical companies that have applied for emergency use authorization for their vaccine. Covid-19. candidates.

On December 4, the Indian arm of the US pharmaceutical giant Pfizer applied for approval of its vaccine to the central drug regulator, after the firm obtained such authorization in the United Kingdom and Bahrain. On December 6, the Serum Institute of India in Pune sought a go-ahead for its Oxford Covid-19 vaccine. Subsequently, Bharat Biotech requested the same on December 7.

What does India’s regulatory framework say about emergency authorization?

There is no law by the name of Emergency Use Authorization Act for licensing vaccine manufacturers in India. But there are provisions in this regard. The Union’s health secretary, Rajesh Bhushan, has said that the exact phrase – emergency use authorization – is not used but the 2019 New Drugs and Clinical Trials Rules clearly specify that, in specific special situations, relaxation, abbreviation, omission or deferral of data, including data from clinical trials may be considered for approval.

How will India review applications?

It will be a very deep scrutiny, said ICMR CEO Balram Bhargava. “It involves looking at voluminous data. We hope that the decision is quick, but it will never compromise the scientific rigor and the processes in it, ”he said. The experts will grant authorization only when they are satisfied with the risk-benefit ratio, that is, if the benefit is greater than the risk.

At a press meeting revealing details of the proposed vaccination campaign in India, the Health Secretary said that some vaccine manufacturers will obtain licenses in the coming weeks. But it is difficult to predict which one will be obtained or when. Most vaccines consist of two or three doses and there will be a few weeks interval between doses. Even after vaccination, precautions should be taken, ”said Bhushan.

Hindustan Times