New Delhi: The Drugs Controller General of India (DCGI) on Thursday (July 1) denied Dr Reddy Laboratories the permission to carry out the Phase-III trials of the Covid-19 vaccine ‘Sputnik Light’. in India, sources told ANI. The new version of the Russian vaccine is a one-dose vaccine like the one from Johnson & Johnson. It was approved in Russia on June 2.
According to reports, the expert committee of the Central Drugs Standard Control Organisation (CDSCO) refused to allow the trials due to a lack of ‘scientific rationale’ behind it.
Earlier this month, sources had told ANI that the vaccine could be fast-tracked for approval in India which would have made it the first one dose Covid-19 vaccine to be approved in the country.
The vaccine’s efficacy was adjudged to be at 79.4 per cent and Phase-III trials were carried out in UAE, Ghana, and Russia.
Sputnik Light uses a recombinant human adenovirus like the Johnson & Johnson vaccine.
Deepak Sapra, CEO (API and Services) Dr Reddy’S Laboratories had said in May that the company was in talks with the Indian government to get approval for Phase-III trials for the one dose vaccine.
The researchers at the Gamaleya Research Institute of Epidemiology and Microbiology which has developed Sputnik Light have admitted that the vaccine is less effective against the Beta variant, first identified in South Africa but offers greater protection against all the other variants than any other vaccine.
India has granted Emergency Use Authorisation (EAU) to Serum Insititute’s Covishield, Bharat Biotech’s Covaxin, and Sputnik V all of which are two-dose vaccines.
With inputs from ANI