Indian Drug Regulator asks Dr. Reddy’s for more data on Sputnik V vaccine

The committee asked the company to submit a comparative analysis of late-stage immunogenicity data

88
Medicine Injection Vaccine
Picture: Pixabay

Bengaluru: An expert panel of India’s drug regulator on Friday sought additional data from drug maker Dr. Reddy’s Laboratories on its Sputnik V C-19 vaccine trial, in its second such request after an initial evaluation in February.

The committee asked the company to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported till date.

Dr. Reddy’s has been conducting small clinical trials with Sputnik V in India under a deal with Russia’s wealth fund. Several Indian companies have signed deals to produce and supply over half a billion doses of the vaccine.


Also read:

List of Laboratory Instruments for Pharma & Cosmetics Industry

Remdesivir’s price must not cross Rs 1400: Maha Govt

J&J in discussions with Indian Govt single dose vaccine trial

Remdesivir: 2 held for black marketing, 284 vials seized

E-Pharmacies & OTC Drugs: High time for regulation

IPC invites bids for supply of Ref Std, Impurities from Pharma…


Enter your email address:

Delivered by FeedBurner

Latest updates

The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.

Go to main website, click here

Follow and connect with us on Facebook and Linkedin

For daily free updates on WhatsApp, click here

Subscribe here for daily updates
Loading