New Delhi: With an aim to expand the basket of COVID-19 vaccines and enhance the pace of inoculation in India, the Centre said Tuesday it has fast-tracked emergency approval for foreign-produced jabs. However, these COVID-19 vaccines must have similar clearances in other countries. The move is significant as it may make available several other vaccines. Among those are vaccines made by Pfizer, Moderna and Johnson & Johnson. However, certain conditions will be applicable for their use in India.
The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes. Then only will it be rolled out for further immunization programme within India, the Union Health Ministry said.
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 conduct of 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 utilisation 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 in a statement.
The decision came following the recommendations of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
Currently, two vaccines – Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII) – are are being used for inoculation in India.