Cipla, a multinational pharmaceutical company headquartered in Mumbai, on Tuesday received the approval from the Drugs Controller General of India (DCGI) to import Moderna’s coronavirus vaccine for restricted emergency use in India.
At the health briefing on Tuesday, Niti Aayog (Health) member Dr VK Paul confirmed the development, saying an application received from Moderna through an Indian partner has received emergency use authorisation.
“This opens up likelihood of the vaccine being imported in near future. This is the fourth vaccine," he said, adding, “This is only the regulatory approval given. Indemnity issue is being examined."
News agency PTI quoted a source as saying, “Drugs Controller General of India has granted permission to Cipla to import Moderna’s Covid-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules, 2019 under Drugs and Cosmetics Act, 1940."
In separate communications, Moderna on June 27 informed DCGI that the US government has agreed to donate a certain number of doses of its coronavirus vaccine through COVAX to India for use here and sought an approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccines.
Cipla, meanwhile, said that it “supporting Moderna Inc with the regulatory approval and importation of vaccines to be donated to India". “At this stage, there is no definitive agreement on commercial supplies," the company added.
Moderna’s vaccine will be the fourth coronavirus vaccine to be available in India after Covishield, Covaxin and Sputnik.
Cipla on Monday sought the DCGI’s nod for importing the Moderna’s vaccine and submitted an application.
“This permission is for restricted use in emergency situations in public interest. The firm has to submit 7 days safety assessment of the vaccine in first 100 beneficiaries before rolling out of vaccine for further immunisation programme, according to the approval order," an official said.
Moderna’s method to protect against Covid-19 relies on messenger RNA (mRNA) to program cells to generate immunity to the coronavirus. This vaccine along with Pfizer are viewed as a preferred choice among wealthy countries, analysts said, based on clinical trial data showing they were more than 90% effective at preventing symptomatic coronavirus.
About 120 million Americans have received a Pfizer or Moderna shot so far with no major safety issue identified.
The United States and European Union are pushing to stock up on even more of the mRNA vaccines. Japan is also working to secure 100 million doses of Pfizer’s shot by the end of June.
(With inputs from PTI and Runjhun Sharma)