Last Updated on February 23, 2022
Emergency Use Authorizations
A drug or vaccine with adequate quality, safety and efficacy data is considered for Emergency Use Authorization (EUA) by Registration Board of DRAP constituted under Section 7 of the Drugs Act, 1976. This particular authorization for use of a drug or vaccine is granted by keeping in view of the public health need mostly in pandemics.
Evaluation of EUA applications is done on priority and certain conditions are imposed on EUA holder of a drug or vaccine for compliance. These conditions are decided by Registration Board keeping in view of scientific data submitted to demonstrate quality, safety and efficacy of a drug product or a vaccine.
Is an EUA product available for use in market?
Any drug or vaccine which holds an EUA is not intended for marketing to the public. Keeping in view of its urgent requirement in a public health emergency, such drugs or vaccines are only supplied to healthcare facilities and are used under strict supervision of qualified specialist physicians.
How DRAP monitors EUA drugs or vaccines?
Apart from submitting sufficient data that establishes quality, safety and efficacy profile of a drug or vaccine, an applicant must also fulfil certain requirements after grant of an EUA. DRAP ensures that:
- periodic quality monitoring by DRAP through its inspectorates and testing laboratories is done;
- the firm holding EUA must submit quality data on quarterly basis;
- the firm distributes authorized labeling to hospitals and healthcare facilities;
- the appropriate storage and cold chain facility during manufacturing and distribution cycle is maintained;
- the firm reports serious adverse events and all medication errors associated with EUA product to DRAP’s pharmacovigilance center;
- proper recall procedures are followed in case of any quality issues or any adverse decision by the reference regulatory authorities.