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  • Setback to Dr Reddys:...

Setback to Dr Reddys: CDSCO panel rejects proposal to test Covid vaccine Sputnik-V due to inadequate data

Ruchika SharmaWritten by Ruchika Sharma Published On 2020-10-08T16:06:13+05:30  |  Updated On 19 Aug 2021 2:55 PM IST
Setback to Dr Reddys: CDSCO panel rejects proposal to test Covid vaccine Sputnik-V due to inadequate data
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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.

The recommendations by an expert panel of the CDSCO noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.
The regulatory move comes as a setback for Russia's plan to roll-out the vaccine even before full trials show how well it works while pushing back its efforts to win approval for the vaccine in the country that leads the world on an average number of new infections, reports Reuters.
Earlier this month the Hyderabad-based drugmaker had applied to the Drugs Controller General of India for permission to conduct phase-3 human clinical trials of the Russian vaccine Sputnik V against COVID-19 in India.

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

Also Read: Dr Reddys Seeks DCGI Approval To Conduct Sputnik V Phase-3 Clinical Trial

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.

Also Read: Russian COVID Vaccine Clinical Trial In India: DCGI Asks Dr Reddys To Submit Fresh Protocol

"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.

The Russian Direct Investment Fund (RDIF), which is marketing the Sputnik V, and Dr. Reddy's Laboratories last month announced their partnership to run clinical trials and distribute the vaccine in India.
Russia was the first country to grant regulatory approval for a novel coronavirus vaccine and did so before large-scale trials were complete, stirring concerns among scientists and doctors about the safety and efficacy of the shot.
RDIF and Dr. Reddy's did not immediately reply to Reuters' requests for comment outside business hours.
sputnik-vrussian covid vaccinecdscodr reddysdr reddydr reddys labsdr reddys laboratoriesdr reddys news
Source : with agency inputs
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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