Cipla receives DGCI nod to import Moderna’s COVID-19 vaccine for emergency use in India

Moderna’s COVID-19 vaccine will be the fourth vaccine and the first international vaccine to receive approval for restricted emergency use in India. 

Created On: Jun 30, 2021 11:08 ISTModified On: Jul 1, 2021 12:08 IST
Moderna Vaccine in India
Moderna Vaccine in India

Cipla, a multinational pharmaceutical company in Mumbai, was granted permission by the Drug Controller General of India (DGCI) on June 29, 2021, to import Moderna’s COVID-19 vaccine for the restricted emergency use in India.

Moderna’s COVID-19 vaccine will be the fourth vaccine to be available in India after Covishield, COVAXIN, and Sputnik. It will also be the first international vaccine that will be administered in two doses. 

Reportedly, DGCI has granted permission to Cipla to import Moderna’s COVID-19 vaccine for the restricted emergency use as per the provisions of the New Drugs and Clinical Trial Rules, 2019 under the Drugs and Cosmetics Act, 1940.

Moderna Vaccine: Check details

The Moderna COVID-19 vaccine, codenamed mRNA-1273, is a vaccine developed by Moderna, the United States National Institute of Allergy and Infectious Diseases, and the Biomedical Advanced Research and Development Authority.

Like Pfizer, the Moderna COVID-19 vaccine is an mRNA vaccine that has fragments of the genetic material known as RNA.

The mRNA Vaccine works by giving cells the temporary instructions to make Coronavirus spike protein. This protein is found on the surface of the COVID-19 virus.

As per the research data, the Moderna COVID-19 vaccine is said to be 90 percent effective against Coronavirus.

Moderna gets approval for restricted use: What will be the rules?

•  According to an official, permission to the Moderna vaccine is for the restricted use in emergency situations in the public interest.

•  The firm will have to submit 7 days safety assessment of the vaccine in the first 100 beneficiaries before rolling out of the vaccine for further immunization programme, as per the approval order.

•  Cipla had filed the application on June 28, 2021, seeking permission to import Moderna Vaccine referring to the DGCI notices dated April 15 and June 1, 2021, according to which if the vaccine has been approved by the USFDA for EUA, it can be granted marketing authorization without the bridging trial and assessment of the safety data of first 100 beneficiaries of vaccines will be submitted before rolling out in the immunization programme.

•  Also, the requirement of testing every batch by the Central Drug Laboratory (CDL), Kasauli, can be exempted if the batch/lot is released by the CDL of the country of origin. However, the summary lot protocol review and the scrutiny of the documents will be undertaken by the laboratory for batch release as per the standard procedures.

US to donate certain number Moderna vaccines to India:

Moderna, on June 27, 2021, informed that the United States Government has agreed to donate a certain number of doses of Moderna COVID-19 vaccine, mRNA-1273, through COVAX to India. The US Government has also sought approval from India's Central Drugs Standard Control Organisation (CDSCO) for the vaccines.

The firm added that the correspondence is to request the CDSCO to open a file for the approval of those urgently needed vaccines.

Background

On June 1, 2021, in a bid to speed up the rollout of COVID-19 vaccines, the Drug Controller General of India had decided to waive the testing of batches at CDL for the foreign manufactured vaccines that have already been approved by the International Drug regulators such as UK’s MHRA, US FDA or WHO.

The Central Government earlier in April 2021, had also issued the guidelines and had proactively eased the entry of the vaccines manufactured abroad and approved by the country's regulatory bodies.

 

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