French drugmaker Sanofi is working on getting approval from the Drugs Controller General of India (DCGI) to conduct Phase 3 trial of its COVID-19 vaccine in the country.
Sanofi is looking to conduct a part of its 35,000-participant global Phase 3 trial of the jab in India, Mint has reported.
"Applications are being made to the regulator. The batches for clinical trial have to undergo testing at CDL (Central Drugs Laboratory) in Kasauli and the DCGI's approval has to be got soon before the trial begins," a source told the publication.
Moneycontrol could not independently verify the story.
"Sanofi is currently assessing a broad mix of clinical sites in several countries to participate in our phase 3 study. Recruitment has already started in the US and we expect to bring several countries on board in the coming weeks," a spokesperson for Sanofi told Mint.
"This phase 3 trial is expected to enrol more than 35,000 adult participants from several countries across the world," the spokesperson said.
Sanofi has partnered with British pharmaceutical giant GlaxoSmithKline (GSK) to develop an adjuvanted recombinant-protein COVID-19 vaccine candidate.
The company plans to initiate the recruitment process for the trial in several countries in Asia, Africa and Latin America in the coming weeks, the report said.
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