Official sources on Tuesday informed that India’s drug regulator DCGI has approved permission to Mumbai-based pharmaceutical company Cipla to import Moderna’s coronavirus vaccine for restricted emergency use in the country.
“Drugs Controller General of India (DCGI) 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,” a source told PTI.
After Covishield, Covaxin, and Sputnik, Moderna’s vaccine will be the fourth COVID-19 vaccine dose to be available in India. Cipla on Monday requested the drug regulator for import and marketing authorization of these doses on behalf of the US pharma major.
An official said, “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.”
On June 27, it was informed by Moderna to DCGI that the US government has agreed to donate a certain number of doses of its COVID-19 vaccine through COVAX to India for use. For the same it has also sought an approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccines.
Cipla filed the application on Monday seeking permission for import of Moderna’s vaccine referring to DCGI notices dated April 15 and June 1, according to which if the vaccine is granted permission by the USFDA for EUA that vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme.
Also, the requirement of testing of every batch by Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of the country of origin, however, Cipla said referring to the DCGI’s new revised rules summary that a lot of protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release according to standard procedures.
“This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines,” Moderna said.
Moreover, it has been informed by Moderna that the US government has agreed to provide a certain number of doses of the Moderna vaccine, mRNA-1273, through COVAX to the government of India for use in the country and has submitted the dossiers through e-mail.
The DCGI decided to abandon the testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators like the US FDA, the UK’s MHRA or the WHO.
Detailed guidelines have been issued by the central government in April that proactively alleviated entry of foreign made coronavirus vaccines approved by US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India.
According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.