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.;
Advertisement
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.
Read also:Russian COVID Vaccine Clinical Trial in India: DCGI asks Dr Reddys to submit fresh protocol
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 .
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.