The Serum Institute of India on Friday said that India’s drug controller has given it permission to manufacture Russia’s coronavirus vaccine Sputnik V, reported NDTV.
“We have got preliminary approval for Sputnik V,” the Serum Institute’s spokesperson told NDTV. “But actual manufacturing will take several months. In the meantime, our focus remains Covishield and Covovax [vaccines].”
The Serum Institute will manufacture the vaccine after testing and analysing it. The Drugs Controller General of India gave the Pune-based company a test licence, which means that the Serum Institute can only develop and manufacture the vaccine for testing but not sell it.
The Serum Institute has collaborated with Russia’s Gamaleya Research Institute, which has developed the vaccine, reported PTI. The Adar Poonawalla-led company will work on the vaccine with the Gamaleya Research Institute at its Hadapsar facility in Pune.
The Serum Institute had applied for permission to the Drugs Controller General of India on Thursday, an unidentified official told PTI. The drugs controller had set four conditions to grant approval, the official said.
The Serum Institute was asked to submit a copy of the agreement with the Gamaleya Research Institute for transferring cell bank and virus stock. It also needed to submit a copy of the agreement for technology transfer with the Russian institute.
Further, the drug controller asked Serum Institute to place before it a copy of Review Committee on Genetic Manipulation granting the Pune-based company the permission to import cell bank and virus stock. The Serum Institute also needed to give a copy of the committee’s permission for conducting research on and development of Sputnik V.
The Review Committee on Genetic Manipulation, working under the Ministry of Science and Technology, monitors the safety of ongoing research projects and activities on genetically engineered organisms.
The unidentified official said that the Serum Institute had applied for permission from the Review Committee on Genetic Manipulation on May 18. The safety committee had then raised some questions on the company’s application and sought a copy of the material transfer agreement with the Gamaleya Research Institute.
The drug controller had approved Sputnik V for emergency use in April, making the Russian product the third vaccine to be used in India. The vaccine was developed in India in partnership with Dr Reddy’s Laboratories in Hyderabad. Dr Reddy’s is also the local manufacturer of the vaccine.
Sputnik V has been given permission for emergency use in more than 65 countries. However, it is yet to be approved by the European Union or United States’ health authorities.
Meanwhile, India has so far administered 22,36,07,768 Covid-19 vaccine doses, with 4,44,34,820 getting both the shots, according to government data.
On Friday, India reported 1,32,364 new coronavirus cases over the past 24 hours, while deaths rose by 2,713. The country’s tally of infections now stands at 2,85,74,350 since the outbreak in January 2020, while the toll has reached 3,40,702.