The Central Drugs Standard Control Organisation (CDSCO), which is the National Regulatory Authority of India, will review the applications of Pfizer, Serum Institute of India and Bharat Biotech — the three pharma companies that have sought emergency use authorisation for their Covid-19 vaccine candidates.
The Indian arm of US pharmaceutical giant Pfizer had on December 4 sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain. On December 6, Pune’s Serum Institute of India sought a nod for its Oxford Covid-19 vaccine. Subsequently, Bharat Biotech applied for the same on December 7.
What does India’s regulatory framework say about emergency authorisation?
There is no law by the name of emergency use authorisation law for granting licence to vaccine makers in India. But there are provisions for the purpose. Union health secretary Rajesh Bhushan has said that the exact phrase — emergency use authorisation — is not used but the New Drugs and Clinical Trials Rules, 2019, clearly specify that under specific special situations, relaxation, abbreviation, omission, or deferment of data including local clinical trial data may be considered for approval.
How will India review the applications?
It will be a very deep scrutiny, ICMR director-general Balram Bhargava has said. “It involves looking at voluminous data. We hope the decision would be expeditious but it will never compromise on scientific rigour and the processes therein,” he said. The experts will grant the authorisation only when they will be satisfied with the risk-benefit ratio that is if the benefit is more than the risk.
Addressing a press meet in which the details of India’s proposed vaccination drive were revealed, Health secretary said that in the next few weeks some vaccine-makers will get licences. “But it is difficult to foretell which one will get or when. Most of the vaccines consist of two to three doses and there will be a gap of a few weeks between doses. Even after vaccination, precaution must be taken,” Bhushan said.