The Drugs Controller General of India has granted restricted emergency use authorisation to Moderna for its Covid-19 vaccine. It has also allowed Cipla to import donated doses of vaccine.
US vaccine manufacturing giant Moderna has secured restricted emergency use authorisation for its Covid-19 vaccine in India. The approval was granted by the Drug Controller General of India (DCGI), the government said on Tuesday.
Besides this, Indian drug manufacturer Cipla has been given permission to import Moderna’s Covid-19 vaccine. However, at present, Cipla is allowed to import only those doses that Moderna has committed to donate to India.
Following today’s developments, Moderna has become the fourth Covid-19 vaccine that will be used in India’s vaccination drive. The vaccines that India is currently using are:
- Covishield: It was developed by the Oxford University and AstraZeneca and is manufactured in India by the Pune-based Serum Institute of India.
- Covaxin: It was developed and manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
- Sputnik V: It was developed and manufactured by Gamaleya Research Institute of Epidemiology and Microbiology in Russia.
“An application was received from Moderna through their Indian partner Cipla following which Moderna’s Covid-19 vaccine has been granted restricted emergency use authorisation by the drug regulator. This new permission for restricted emergency use potentially opens up a clear possibility of this vaccine being imported to India in the near future,” NITI Aayog Member (Health) Dr VK Paul said.
Dr Paul added that the government’s is continuing with its efforts to invite and to have other internationally developed vaccines, specifically Pfizer and J&J.
“Those processes are on. We are also looking at increasing the production of availability of vaccines that are being manufactured in our country.”
Besides seeking regulatory approval in India, Moderna has also informed that the US government has agreed to donate a certain number of doses of the Moderna Covid-19 vaccine through COVAX to India use and has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines.
It is these donated doses of the Moderna vaccines that Cipla will be currently importing.
“I want to thank the government of India for this authorisation, which marks an important step forward in the global fight against the pandemic,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are committed to making our Covid-19 vaccine available around the world.”
Cipla filed its application to import and market Moderna’s Covid-19 vaccine on Monday. In its application, Cipla referred to DCGI notices dated April 15 and June 1, which state that if a vaccine is approved by the USFDA for EUA, it can be granted marketing authorisation in India without bridging trial.
