India’s drug regulator to take a decision to grant Emergency Use Authorization (EUA) of Covid-19 vaccines within three working days of receiving the applications from the candidates, the union health ministry informed on Thursday.
The decision is a part of the fast track approval policy of the government for the foreign Covid-19 vaccine candidates in the country.
The ministry said: “The Central Drugs Standard Control Organisation (CDSCO) will process the applications by vaccine candidates to receive restricted use in an emergency situation and the Drug Controller General of India (DCGI) will consider and make a decision within 03 working days from date of submission of complete application”.
However, the ministry said that the DCGI will grant EUA, inter alia, certain conditions.
- a) Vaccine shall be used as per the guidelines prescribed under National Covid-19 Vaccination Programme.
- b) First 100 beneficiaries of such vaccines shall be assessed for 7 days for safety outcomes before it is rolled out for further Vaccination program.
- c) Applicant shall initiate conduct of post-approval bridging clinical trials within 30 days of such approval.
However, the CDSCO will also review the safety data of the vaccine seeking emergency approval and will authorise for emergency use only after the data is found satisfactory, the guidelines for EUA shared by the ministry stated.
Besides, the ministry of health and family welfare also informed that the CDSCO will approve the protocol for the bridging trial in consultation with the Subject Expert Committee (SEC) within 7 days of the receipt of the proposal.
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 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 a 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 pre-qualified by the WHO for emergency use.