The Ahmedabad-based firm is looking to hire contract manufacturers for an additional 50 million to 70 million doses of its plasmid DNA vaccine, on top of the 100 million that will come from its own capacity, according to Managing Director Sharvil Patel. He declined to name the companies and the amount Cadila has invested in developing the vaccine.

“We’re just waiting for phase II to push that part of the process,” Patel, the 42-year-old, third-generation head of family-owned Cadila, said in a phone interview. “We have a lot of interest from people who want to use it for other countries and we will license it out for other markets and countries so we can have more manufacturing beyond India.”

Obtaining and delivering a safe vaccine is a major priority for Prime Minister Narendra Modi in a nation with the world’s largest number of infections after the U.S. While a government-backed scientific panel last week predicted that the South Asian country is past the peak of infections and may contain the spread by February, many are concerned of further spikes as a festival season commences ahead of densely populated north India’s cold and polluted winter.

Cadila, which also produces coronavirus treatments such as remdesivir, is among a number of Indian companies holding vaccine trials.

While Cadila’s plasmid DNA candidate doesn’t use an infectious agent, like other vaccines, and instead introduces the DNA sequence encoding the antigen, the other tests being done are for traditional delivery methods.

The Serum Institute of India Pvt., the world’s largest vaccine manufacturer, is conducting tests for the candidate developed by Oxford University. Dr Reddy’s Laboratories Ltd. plans to distribute the Russian vaccine in India after conducting final-stage human trials and receiving regulatory approval.

Trial Recruitment

Both Cadila and Bharat Biotech International Ltd., the other Indian drugmaker developing its own indigenous vaccine, are currently conducting second-phase human trial stages. By the end of November, Patel expects to see data from the tests that have enrolled more than 1,000 people.

If the results are promising, Cadila will begin recruitment in December of more than 30,000 people for final-stage trials. Patel said that process will likely take two to three months and that he doesn’t expect many delays from Indian regulators.

“The regulators themselves are working faster, which is a good thing,” Patel said.

Vaccine Distribution

The government has also set aside about 500 billion rupees ($7 billion) to vaccinate the world’s second-most populous country, according to people with knowledge of the matter.

Adar Poonawalla, the head of the Serum Institute, has predicted India would need about 800 billion rupees to procure and inoculate people across the South Asian nation. Apart from buying the treatment, industry executives and experts have also voiced concern over India’s ability to store and transport vaccines across the vast country of about 1.3 billion people.

Patel declined to comment on whether he thought 500 billion rupees would suffice, but said he wasn’t worried about potential delivery and cold-chain storage bottlenecks given that vaccine supply will initially be restricted to priority areas and those at high risk.

“It should be manageable,” he said, noting that Cadila’s shots will have low cold-chain storage requirements making them easier to transport. “It’s going to be a couple of years process,” Patel said. “Once it becomes open markets, then we have to see whether it can reach every nook and cranny of every part of the country.”