Setback to Dr Reddys: CDSCO panel rejects proposal to test Covid vaccine Sputnik-V due to inadequate data
The recommendations by an expert panel of the Central Drugs Standard Control Organisation (CDSCO) noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.
New Delhi: The Subject Expert Committee (SEC) of the Indian regulator, the Central Drugs Standard Control Organisation (CDSCO) has knocked back a proposal from Dr Reddy's Laboratories Ltd to conduct a large study in the country to evaluate Russia's Sputnik-V Covid-19 vaccine and has asked it to first test the vaccine in a smaller trial.
Had the firm secured permission from the regulator, the Russian Direct Investment Fund (RDIF) would have supplied to Dr Reddy's 100 million doses of the vaccine
In response to the frim's submission, the Drugs Controller General of India (DCGI) expert panel noted that the firm presented Phase III clinical trial protocol before the committee along with overseas Phase I/II clinical trial & non-clinical toxicity data before the committee.
However, in wake of the fact that the safety and immunogenicity data in overseas Phase I/II studies were small and there was no data available on Indian subjects it directed the pharma giant Dr. Reddy's Laboratories (DRL) to submit a revised protocol for performing phase 2,3 clinical trials of the Russian Covid-19 vaccine (Sputnik V) in India.
"After detailed deliberation, the committee recommended that the firm should follow the regulatory requirements and conduct Phase II/III clinical trial in the country with proper monitoring for humoral & cell-mediated immune response," the committee noted.
It added that accordingly, the firm should submit the protocol for consideration of the committee.
A recent report by Reuters states that India is expected to overtake the United States over the next several weeks as the country with the world's largest number of cases.