New Delhi, Jun 29 (PTI) India's drug regulator DCGI has granted permission to Mumbai-based Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, officials said on Tuesday.
Moderna's vaccine will be the fourth COVID-19 jab to be available in India after Covishield, Covaxin and Sputnik.
'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 V K Paul said at a press conference.
It became the fourth vaccine, he said.
'Our efforts to invite and to have other internationally developed vaccines specifically Pfizer and J&J also continue. Those processes are on. We are also looking at increasing the production of availability of vaccines that are being manufactured in our country,' Paul added.
On whether a commercial deal has been struck with Moderna or it is a donation and goodwill gesture by the US, he said, 'It is important for us to say that a regulatory step has been taken in the matter and it opens pathways for import in technically any of the modalities you are referring to. Let us see how these opportunities will be used for importing vaccines into our country.' He clarified that there will be no need for bridging study and said this modification in the regulations happened several weeks ago. First 100 people who will be administered the doses will be watched, he said.
On temperature of storage of Moderna, Paul said, 'Up to seven months storage is -25 to -15 degrees so medium term storage is -20 degrees. An unopened vial can be kept in 2 to 8 degrees in a normal cold chain for 30 days. So seven months storage - long term is -20 degrees and normal cold chain conditions for a period of 30 days. It has two doses which are given 28 days apart.' 'Moderna is coming as a ready to inject form there is no manufacturing base as of now in India. We also hope Moderna will produce this vaccine on Indian soil going forward,' he said.
On the issue of indemnity, Paul said, 'It is being addressed and being taken up for examination. It is under consideration.' In separate communications, Moderna on June 27 informed 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 here and sought an approval from the Central Drugs Standard Control Organisation (CDSCO).
On Monday, pharmaceutical company Cipla, on behalf of the US pharma major, requested the drug regulator for import and marketing authorisation of these jabs. '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.
On Monday, Cipla filed the application 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 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 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 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 DCGI's new revised rules.
Further, Moderna through a separate communication has informed that the US government has agreed to donate 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.
'This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines,' Moderna said.
During two rounds of high-level meetings chaired by the Cabinet Secretary held on May 19, it was discussed that Cipla hadevinced interest in procuring 5 crore doses from Moderna for 2022 .
Cipla had earlier also told the government it is close to committing over USD 1-billion as advance to the US major while seeking indemnification as well as waiver from price capping and bridging trials, sources had said.
Asked about the status of Pfizer, Paul said, 'We have had discussions of multiple sessions with Pfizer, interactions have been held, going through the agreements that are required for such an arrangement to be operationalised and exchange of thoughts inputs are going back and forth that is very much on... we had one intensive meeting last week and we are looking to receiving feedback there and now.' On June 1, in a bid to expedite the rollout of vaccines, the DCGI decided to waive testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK's MHRA or the WHO.
The central government in April issued detailed guidelines and proactively eased entry of foreign made COVID-19 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 the trial requirement altogether for the well-established vaccines manufactured in other countries. PTI PLB UZM ZMN