Health Ministry Denies Reports Of Rejection Of SII, Bharat Biotech Emergency Use Authorisation

Both Serum Institute of India (SII) and Bharat Biotech have applied to the Drugs Controller General of India (DCGI) for emergency use authorisation of their Covid-19 vaccines.

New Delhi: The Health Ministry on Wednesday issued a statement in which it refuted the claims made by media outlets stating that the emergency use authorisation of vaccines by Serum Institute of India (SII) and Bharat Biotech have been rejected. “The media report about the rejection of Serum Institute and Bharat Biotech's emergency use authorization of vaccine is fake," news agency ANI quoted Health Ministry as saying.

The media report about the rejection of Serum Institute and Bharat Biotech's emergency use authorisation of vaccine is fake: Ministry of Health & Family Welfare pic.twitter.com/vysHrU43hi

— ANI (@ANI) December 9, 2020

The news of rejection for proposal to get emergency use authorisation for both indigenously made Covid-19 vaccines was reported by several media outlets on Wednesday evening. The media reports claime that vaccines were rejected as they failed to present data on safety and efficacy. Bharat Biotech, had on Monday, applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for its Covid-19 vaccine Covaxin, which is being indigenously developed by the Hyderabad-based pharmaceutical firm in collaboration with the Indian Council of Medical Research (ICMR). Likewise, the Serum Institute of India had also applied to the central drug regulator for emergency use authorisation of AstraZeneca-Oxford’s coronavirus vaccine. On contrary of the claims made by media houses, Health Ministry had on Tuesday said that three Covid-19 vaccines  developed by Bharat Biotech, Serum Institute of India and Pfizer, are under active consideration of India's drug regulator and there is hope that early licensure is possible for all or any of them. When asked about what steps would be followed by the DCGI in the absence of a water-tight emergency use authorisation law for granting licence to vaccine makers, Union Health Secretary Rajesh Bhushan said not all countries' regulatory framework or rules and acts mention emergency use authorisation. The New Drugs and Clinical Trials Rules, 2019, clearly specifies that under specific special situations, relaxation, abbreviation, omission, or deferment of data including local clinical trial data may be considered for approval. Giving a bird's-eye view of the Indian landscape of COVID-19 vaccines, Bhushan mentioned that eight vaccines are at different stages of development.