Expect a HNY with vaccines in hand: CDSCO, DG

Mumbai: India can expect some “good news” in the New Year on Covid-19 vaccines, said VG Somani, director-general of the Central Drugs Standard Control Organisation (CDSCO), which is responsible for approving vaccines in the country. Somani’s statement on Thursday comes on the day Prime Minister Narendra Modi said India is making preparations for the largest adult immunisation programme in the world.“Since March, along with the department of biotechnology, we have taken this challenge to hand-hold the development of vaccines of different platforms in the country...the drug industry and research organisations have stood the test of time and probably we will have a happy new year with something in hand — that is what I can hint at,” Somani said at a webinar organised by the DBT on the science of vaccine development.On Friday, the subject expert committee under CDSCO is expected to review data provided by the Serum Institute of India, which is testing and manufacturing a Covid-19 vaccine developed by AstraZeneca and the University of Oxford. The UK regulator approved the AZ/Oxford candidate this week, raising hopes that the vaccine will also be cleared for use in India.However, Somani said the Indian regulatory framework will scrutinise the data of the vaccine makers independently, too.“We have a panel of subject experts of immunologists, pharmacologists and pulmonologists who thoroughly scrutinise the data. And, in addition to us, the subject expert committee also reviews the data,” Somani explained. “The scrutiny is quite tough — it is not that just because some vaccine is approved outside it will be automatically approved in our country. It has to go through the tough scrutiny process. Of course, as a regulator, we will be looking at these data quickly and on a rolling basis.”Since the pandemic outbreak, the drug regulator has given “emergency approval” to drugs such as remdesivir and favipiravir as new therapy options to treat Covid-19. 80051304

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