Dr Reddys submits revised protocol to DCGI for Sputnik V phase 2,3 trials

Recently, the expert panel of DCGI had recommended that Dr Reddy's Lab submit a fresh application to the top drug regulator seeking its consideration.;

Published On 2020-10-15 07:15 GMT | Update On 2020-10-15 07:26 GMT

New Delhi: Indian drug maker Dr Reddy's Laboratories (DRL) has submitted a revised application to the Drugs Controller General of India (DCGI) seeking his approval to conduct phase 2 and 3 clinical trials of the Russian COVID-19 vaccine Sputnik V in India, a government official said on Tuesday.

Recently, the expert panel of DCGI had recommended that Dr Reddy's Lab submit a fresh application to the top drug regulator seeking its consideration.

Last week, the Subject Expert Committee (SEC) did a thorough evaluation of the previous application submitted by Dr Reddy's lab. Thereafter, the SEC had directed the pharma company to apply with a revised protocol with more information.

Dr Reddy's Lab has joined hands with The Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.

As per RDIF, it will supply 100 million doses of its potential COVID-19 vaccine to Dr Reddy's Lab.

"Before giving permission, the drug regulator will conduct a technical evaluation of the application submitted by Dr Reddy's Lab to conduct phase 2,3 clinical trial in India of Russian Covid19 vaccine," said the official.

Last month, Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF) informed that Russia is in close dialogue with the Indian government and drug manufacturers of India regarding the localisation of production of its Sputnik V vaccine in India.

A prestigious medical journal, The Lancet, has also published the findings of clinical trials of the Russian vaccine demonstrating its safety and efficacy.

On August 11, the Sputnik V vaccine developed jointly by the RDIF and the Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19.

According to Russian researchers, Sputnik V is a human adenoviral vector vaccine that fights against coronavirus disease.

Article Source : ANI

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

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

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

JnJ seeks indication extension of Akeega from EMA for adults with metastatic hormone-sensitive prostate cancer, HRR gene alterations

2025-07-06 07:00 GMT

Dr Reddys submits revised protocol to DCGI for Sputnik V phase 2,3 trials

Recently, the expert panel of DCGI had recommended that Dr Reddy's Lab submit a fresh application to the top drug regulator seeking its consideration.;

Similar News

JnJ seeks indication extension of Akeega from EMA for adults with metastatic hormone-sensitive prostate cancer, HRR gene alterations

Govt Panel Proposes Braille Cards, Voice-Enabled QR Codes on Medicine Packs to Aid Visually Impaired

AstraZeneca Imfinzi approved in EU for muscle-invasive bladder cancer

Pfizer's Abrocitinib Phase III Data Accepted by CDSCO Expert Committee

COVID-19 Vaccine and Heart Attack: Biocon Chief, Karnataka CM get into war of words

Govt Panel Makes This Approval Mandatory For New Drug Licenses

CDSCO Panel Asks Glenmark To Justify BE Waiver for FDC Inhalation Suspension With Scientific Evidence

Sun Pharma Gets SEC Nod to Begin Phase III Trial of Cough Drug Gefapixant