New Delhi: India's drug regulator, Central Drugs Standard Control Organisation (CDSCO), may soon grant restricted emergency use authorization for Moderna's Covid-19 vaccine. Moderna had earlier sought regulatory approval for its Covid-19 vaccine in India.
Moderna has also agreed to donate a number of vaccine doses to the Government of India for use through WHO's COVAX.
According to a PTI report, the US-based pharmaceutical company has sought approval from the Central Drugs Standard Control Organisation (CDSCO) for these vaccines. Mumbai-based pharmaceutical firm Cipla, on behalf of the US pharma major, has requested for import and marketing authorisation of these jabs.
The PTI report stated that an approval is likely to come anytime as the CDSCO is in favour of doing so.
On Monday, Cipla filed an application seeking permission for import of Moderna Covid-19 vaccine referring to DCGI notices dated April 15th and June 1st stating that "if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorization without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme".
Earlier this month, sources in the Union Health Ministry revealed that the central government is likely to provide indemnity against legal proceedings. When asked if India is close to giving indemnity to foreign vaccine makers like Pfizer and Moderna, Dr Paul said that the issue has multiple dimensions and it is not wise to give a timeline for such issues.
"The discussion for paving the way for internationally developed vaccines to India, is going on. The issue has multiple dimensions and we are trying to find an agreed way forward at the earliest. We are trying to expedite the progress in every possible way," he said.