The company will seek emergency use authorisation in May or June, its managing director told Reuters.
India's Cadila Healthcare has started producing its potential COVID-19 vaccine for which it will seek emergency use authorisation in May or June, its managing director told Reuters, with an aim to make up to 240 million doses a year.
Government officials said they are eagerly waiting for Cadila to seek approval for ZyCoV-D soon, as a record rise in coronavirus infections have led to a public health disaster in the world's most populous country after China, reported Reuters.
"We have just started producing doses," Sharvil Patel said in a Microsoft Teams interview on Friday. "But it is not meaningfully large."
He said the aim was to produce 10 million doses a month starting June, taking the in-house annual capacity to 120 million. The rest of the production, as required, will mainly come from third-party producers.
"We are already talking with two other manufacturers. We will slowly add more manufacturers," Patel said.
Patel said unlike some other drugmakers hit by U.S. curbs on exports of vaccine raw material, Cadila was sourcing its ingredients domestically. "We did anticipate those challenges," he said. "Everything for us is done in India. Our supply chain is secure. We don’t have any issues for the next 14-15 months."
Its DNA plasmid product - which involves the injection of a small part of the virus's genetic code (DNA or RNA) to stimulate immune response in the recipient - is currently meant to be given in three doses but the company is also doing trials on a two-dose regimen, he said.
On Friday, Zydus Cadila announced that it has received restricted emergency use approval from the Drug Controller General of India (DCGI) to use antiviral drug Virafin for the treatment of moderate COVID-19 infections.
When administered early on during COVID, Virafin will help patients recover faster and avoid much of the complications. Virafin will be available on the prescription of medical specialist for use in hospital/institutional setup, the company said in an exchange filing.
In order to ramp up the coronavirus vaccination drive in the country, the Indian government announced a "liberalised and accelerated" Phase 3 strategy of COVID-19 vaccination from May 1, under which everyone above the age of 18 will be eligible to get Covid-19 vaccine.