India approves Moderna's vaccine for emergency use; Cipla to import jab

Cipla had filed an application on Monday seeking permission for import of Moderna's vaccine.

Drug major Cipla has been approved by India's drug regulator to import Moderna's coronavirus vaccine for restricted emergency use in the country, the government has said on Tuesday.

Moderna is said to have applied for the emergency use approval in India following the US agreement to donate doses to India via Covax. Cipla on behalf of the US pharma giant has requested for import and marketing authorisation of these jabs.

According to Drug Controller General of India (DCGI)'s new policy, vaccines approved by the US for EU drug regulators can be granted approval without bridging trials in India. The assessment of safety data of the first 100 beneficiaries of vaccines will be submitted before rolling out in the immunisation programme.

In a bid to expedite the roll out of vaccines, the Drug Controller General of India (DCGI) on June 1 decided to waive off bridge-testing for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK's MHRA or the WHO.

Moderna's vaccine, which employs the revolutionary messenger-RNA technology, has been approved by the US and UK health regulators. The jab has very high efficacy of over 90 per cent in preventing the infection.

The Indian government has been engaged with Moderna for quite sometime now to bring the shot to the country, but both parties were reportedly stuck on the issue of granting indemnity to the firm.