PremiumIndia's drug regulator will grant emergency use licences to coronavirus vaccine candidates under review, after analysing all aspects of safety and efficacy, said Dr Vinod Paul, member of Niti Aayog and the head of a panel advising the prime minister on the country’s efforts to produce and roll-out the inoculation. Pfizer, Serum Institute of India and Bharat Biotech have applied for market authorisation for their vaccines.
“We have three applications today for the emergency use authorisation on sound principles. We have Pfizer, we have Bharat Biotech and we have Serum and they have not only met the deadline, they have overtaken the deadline," Paul said.
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The decisions regarding the COVID-19 vaccine will roll out in a matter of a few days, Paul added. "Importantly, these decisions will be science-based, evidence based, rules based. Our regulator will make the right decision. Safety, immunogenicity and efficacy will drive the decision," Paul noted.
"We have absolutely no pressure on the regulator to do the decision one way or the other; I can say this with authority. We have insulated that system. We respect their decision making process." he further added.
Paul said taking the right decision was important for the nation. "There is a reputation to be kept. Our vaccines go to half of the world. If we compromise today we will be hurting ourselves," he noted.
Drugs Controller General of India (DCGI) was in touch with the United Kingdom regulator, he said. "We are trying to work together irrespective of a particular vaccine which is common to both the nations," Paul said.
On starting the process of imparting the vaccine, he added that the process would have to be regulated so that the most needy get the dosage first. Paul said that conventional cold chains have been built up to store the vaccine and so has been the capacity of syringes and needles.
"We have vaccinators being lined up, partly from the government system because we don't want to load the government system because if we depend totally on the government system their other priorities like primary health care, particularly immunisation will suffer, so therefore additional elements are being brought up," he added.
“We have also built a strong IT platform which will be doing the logistics management..it will also give messages for appointments and inform which day a person needs to go for the vaccination. It is almost ready, testing is being done. We also believe that once ready we will also offer it to the world for any country which would like to adopt it," he added.
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