Hetero Biopharma gets nod for Sputnik phase-3 trials

The government’s Central Drugs Laboratory (CDL), Kasauli has cleared the first batch of Indian-made Sputnik V vaccine doses manufactured by Hyderabad-based Hetero Biopharma, which the company will use to start its phase-3 clinical trial. The Russia Direct Investment Fund had entered into an agreement with Hetero to produce over 100 million doses of Russia's Covid-19 vaccine Sputnik V in India.

“The company will need to test the Indian version of the vaccine. The bridging trial will take around 2 months after which Hetero can start production of India-made Sputnik V,” said a senior government official. The Drugs Controller General of India (DCGI) norms require a phase-3 bridging trial to be conducted for all internationally-approved vaccines that are manufactured in India.

The RDIF has signed agreements with several companies to manufacture Sputnik V in India — Virchow Biotech (up to 200 million doses per year) Gland Pharma (252 million doses) and Stelis Biopharma (200 million doses). All these companies will have to conduct similar trials before rolling out their products.


The efficacy of Sputnik V was reported at 91.6%.