The Drugs Controller General of India (DCGI), on Tuesday, granted permission to Mumbai-based pharmaceutical firm Cipla to import Moderna’s COVID-19 vaccine.
Details of a rollout plan are not out yet. It is not clear how many doses will be available in India and when. Sources say for now, Cipla is only looking at receiving donated vaccines; commercial agreements are still being processed.
“Cipla Limited is supporting Moderna Inc with the regulatory approval and importation of vaccines to be donated to India. At this stage, there is no definitive agreement on commercial supplies,” Cipla said in a statement. Both Pfizer and Moderna have asked for an important concession – they want indemnity from liability in case of any adverse effect of the vaccine. India has, so far, not granted indemnity to any vaccine-maker.
Cipla received clearance to import Moderna vaccines within 24 hours of its application, due to the government’s revised policy on accelerated approvals for foreign vaccines. It had taken Sputnik two months for the same approval.
Cipla, in its application to the drug regulator, had referred to the government’s decision to waive bridging trials for foreign vaccines if it is cleared for emergency use in countries like the US and if the safety assessment data of the first 100 beneficiaries is submitted before mass rollout.