New Delhi: The country’s apex drug regulatory agency, the Central Drugs Standard Control Organisation (CDSCO), has started conducting an internal review of the applications submitted by the Serum Institute of India (SII) and Pfizer, seeking emergency authorisation of their vaccine candidates in India, ThePrint has learnt.
The recommendations on granting of authorisation, which will help in making Covid-19 vaccines available in India, will be made on the basis of three parameters — safety, quality and efficacy.
The recommendations will be given by the Subject Expert Committee (SEC), which advises the Drug Controller General of India (DCGI), who heads the CDSCO, on applications seeking approvals for new drugs, vaccines and clinical trials. The DCGI will take the final decision on the approval.
“The decision to give emergency authorisation will solely be based on three parameters of safety, quality and efficacy. We will go by merit,” said a source, who is part of the developments at the CDSCO.
“The company, which has submitted strong and convincing data points in its application to establish safety, quality and efficacy of the vaccine, will be considered for grant of emergency authorisation,” he added.
The source said that at present the “internal review” of the vaccines is going on.
“We will be making note of some points, which will be given to the expert committee for an independent consideration along with their overall assessment of the application,” the source said, adding that the SEC is yet to be formed by the CDSCO.
The SEC is formed based on expertise required to evaluate certain important proposals or applications.
“The meeting of the committee will be planned within the next 15 days. This matter is of high importance and we won’t rush the decision-making process. Each data point matters here,” the source added.
The source also said the side-effect reported by a trial participant, which had sent a legal notice to Serum seeking a compensation of Rs 5 crore, “will not be considered” as the DCGI had clarified that there was no relation between the vaccine and side-effect reported.
ThePrint reached DCGI V.G. Somani through calls and text messages for a comment on the matter, but there was no response till the publication of this report.
Serum versus Pfizer
The Serum Institute of India Sunday applied to the DCGI, seeking emergency use authorisation of its vaccine, while the Indian arm of US pharmaceutical giant Pfizer applied for a similar approval on 5 December.
The Pune-based SII is conducting the phase-three clinical trial of the Oxford University’s Covid-19 vaccine, Covishield, which is co-sponsored by Indian Council of Medical Research. It is being done in various parts of the country along with studies in Oxford-AstraZeneca in the UK and Brazil.
Pfizer hasn’t conducted the local trials yet in India. However, its vaccine was recently approved by the UK and Bahrain governments. It will be made available in Britain from Monday, according to a statement from the UK government. The shots have shown 90 per cent efficacy in trials.
Health experts, meanwhile, said there will be concerns with both the applications.
“For Pfizer, the UK approval was an EUA (emergency use authorisation) and not a full licensure. The data from the trial, which is still ongoing, is not yet published. There is no clinical trial data from India, and in the absence of that, it’s difficult to see on what basis an approval would be given in India,” said Anant Bhan, doctor and researcher in the fields of global health, health policy and bioethics.
For Serum, Bhan said, “there has been no approval (even an EUA) anywhere in the world, and the clinical trials in India are still ongoing, with no comprehensive reporting on safety and efficacy yet from the phase 3 studies”.
“In either case, any regulatory approval for mass use will need a strong justification, and transparent laying out of the rationale, and the conditions under which such a decision is being made,” he told ThePrint.