Govt. speeds up approval for more vaccines

Nod for drugs developed abroad with emergency use consent will allow imports in bulk

In a major shift in vaccine approval policy, the government has decided to fast track approvals for COVID-19 vaccines that have been developed outside India and have been granted the emergency use authorisation (EUA) by other drug regulatory agencies. The decision was taken based on the recommendation made by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) at a meeting held on April 11, to “expand the basket of vaccines for domestic use and hasten the pace and coverage”. The vaccines that would be eligible for the fast-track approval will include those that have been granted an EUA by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, or those that have been prequalified by the WHO for emergency use. This would mean that Pfizer, Moderna and Johnson and Johnson vaccines would be eligible for fast-track approval.