In a marked shift in its policy on regulatory approvals for foreign vaccine manufacturers, the Indian government fast-tracked approval for foreign vaccines, which can apply for emergency-use authorisation.
“It will also open up, eventually, doors for import of bulk or import of finished foreign vaccines in vials or import leading to fill and finish (of the vaccine) in the country,” Health Secretary Rajesh Bhushan told the media.
The decision comes at a time when India recorded the world’s biggest surge in infections. In addition, severe vaccines shortages are being reported from various parts of the country with several states indicating that just over five days of vaccine stocks are currently remaining, while another week of supplies is in the pipeline.
On Wednesday, India reported a total of 184,372 new Covid-19 cases pushing the tally of cases to 13.8 million, according to health ministry data. With 1,027 deaths in the last 24 hours, the death toll increased to 172,085.
India has already passed Brazil's tally, making it the country with the second-highest number of infections in the world.
The western state of Maharashtra, the epicentre of the second wave, alone accounts for 50 percent of the total active caseload of the country.
Under the new norms, instead of conducting a local clinical trial before seeking an emergency use authorisation, vaccine makers can conduct a bridging trial parallel to the rollout post-authorisation, the government said.
“The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation," the health ministry statement said.
“The plan is to increase the pace of vaccination with a bigger pool of vaccines because this second Covid wave is unprecedented and we need to be prepared,” virologist Jacob John told RFI.
A day prior to the announcement, Russia's Covid vaccine Sputnik V was cleared for emergency use by India's drug regulator, the Drugs Controller General of India.
Currently there are two approved vaccines – one developed by Oxford-AstraZeneca and made by the Pune-based Serum Institute of India (SII), and another developed by the Hyderabad-based Bharat Biotech.
The government reportedly failed to anticipate a higher demand for vaccinations when it opened up its first vaccination drive on January 16.
Officials also did not take into account the vaccines that the country had shipped out through its ambitious "Vaccine Maitri", or "vaccine friendship", initiative with other countries.
India has shipped more than 60 million doses to 76 nations, delivered either under the World Health Organization-backed Covax mechanism or as part of commercial deals.
Since the country started the world's largest vaccination programme, over 111 million people have received one dose of the vaccine so far.
With demand for vaccines suddenly spiking since 1 April due to the second surge in infections as well as the age threshold for vaccination being reduced to 45 plus, production capacity was unable to keep up.
Pfizer, which withdrew its application for importing its mRNA vaccine after the subject expert committee of India’s drug regulator rejected its request for a waiver for a local trial, is likely to be the biggest beneficiary of the relaxed rules in India.