Mumbai-based Cipla gets DCGI nod to import Moderna vaccine for emergency use

Indias drug regulator DCGI has granted permission to Mumbaibased pharmaceutical company Cipla to import Modernas Covid19 vaccine for restricted emergency use in the country official sources said on TuesdayModernas vaccine will be the fourth Covid19 jab to be available in India after Covishield Covaxin and SputnikDrugs Controller General of India DCGI has granted permission to Cipla to import Modernas Covid19 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 PTIIn separate communications Moderna on June 27 informed DCGI that the US government has agreed to donate a certain number of doses of its Covid19 vaccine through COVAX to India for use here and sought an approval from the Central Drugs Standard Control Organisation CDSCO for the vaccinesAlso Read Five Covid19 patients at Delhi hospital suffered rectal bleeding due to CMV infection one diesOn Monday Cipla on behalf of the US pharma major requested the drug regulator for import and marketing authorisation of these jabsThis 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 saidOn Monday Cipla filed the application seeking permission for import of Modernas vaccine referring to DCGI notices dated April 15 and June 1 according to which if the vaccine is approved by the USFDA for EUA the 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 immunisation programmeAlso the requirement of testing of every batch by Central Drugs Laboratory CDL Kasauli can be exempted if the batchlot is released by the CDL of country of origin however summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release according to standard procedures Cipla said referring to the DCGIs new revised rulesFurther Moderna through a separate communication has informed that the US government has agreed to donate a certain number of doses of the Moderna vaccine mRNA1273 through COVAX to the government of India for use in the country and has submitted the dossiers through emailThis correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines Moderna saidOn June 1 in a bid to expedite the rollout of vaccines the DCGI decided to waive testing of batches at CDL for foreignmanufactured vaccines that have been approved by international drug regulators such as the US FDA the UKs MHRA or the WHOThe central government in April issued detailed guidelines and proactively eased entry of foreign made COVID19 vaccines approved by US FDA EMA UKs MHRA and Japans PMDA and WHOs Emergency Use Listing into IndiaAccording 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 wellestablished vaccines manufactured in other countriesThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever