Govt fast-tracks approval for foreign-produced vaccines

With an aim to expand the basket of COVID-19 vaccines and enhance the pace of inoculation in India, the central government on Tuesday said it has decided to fast-track emergency approvals for all coronavirus jabs that have been given a similar nod by the World Health Organization or regulators in the United States, Europe, Britain or Japan.

The move is significant as it may make available several vaccines, including those made by Pfizer, Moderna and Johnson & Johnson, in India with certain conditions. The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before they are rolled out for further immunization programme within the country, the Union Health Ministry said.

Terming it a significant development and a liberal regulatory step that will increase the access to vaccines manufactured outside, NITI Aayog member (Health) Dr V K Paul said, “We hope and we invite vaccine makers such as Pfizer, Moderna, Johnson and Johnson and others…To be ready to come to India as early as possible.”

The government has decided that COVID-19 vaccines which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by authorities in the US, Europe, the UK, Japan or which are listed in the WHO Emergency Use Listing may be granted emergency use approval in India.

They will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of a local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019, the ministry said.

“This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports, including import of bulk drug material, optimal utilization of domestic fill and finish capacity, etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic (use),” the ministry said.

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