The Drugs Controller General of India has declined the proposal of pharma company Dr Reddy’s laboratories to conduct the third phase trial of Russia’s Sputnik V vaccine as the early trials have been condicted on a small group of overseas population.
After Russia became the first country that claimed to have come up with an effective Covid-19 vaccine, Dr Reddy’s Lab joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.
However, global experts raised concerns over the safety of the vaccine as it was rolled out in a short time. Union health minister Harsh Vardhan recently hinted that India has not given its nod to Dr Reddy’s to go ahead with the trial of the vaccine among Indian population yet.
The phase-3 trial of Sputnik V is underway in Russia on around 40,000 subjects since September 1.
“After detailed deliberation, the committee recommended that the firm should follow the regulatory requirements and conduct phase 2/3 trial in the country with proper monitoring for humoral and cell mediated immune response,” the committee that looked into Dr Reddy’s proposal said.
What next?
Instead of jumping straight to a large-scale trial, Dr Reddy’s has been advised to consider a small trial.
Other vaccine updates
Three vaccine candidates are at present under trial in India. The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford Covid-19 vaccine candidate, is conducting phase 2 and 3 human clinical trials. The vaccine developed by Bharat Biotech in collaboration with ICMR and the other developed by Zydus Cadila Ltd. are in the second phase of human trials.
