EMERGENCY USE AUTHORISATION (EUA)

Subject: Science & tech

Context: Moderna said it was applying for emergency use authorisation for its Covid-19 vaccine. In India, Serum Institute of India, which is trialling a version of the AstraZeneca-Oxford vaccine, has said it expects to seek emergency use authorisation within the next two weeks.

Concept:

• Vaccines and medicines, and even diagnostic tests and medical devices, require the approval of a regulatory authority before they can be administered. In India, the regulatory authority is the Central Drugs Standard Control Organisation (CDSCO).
• For vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials. This is a long process, designed to ensure that a medicine or vaccine is absolutely safe and effective.
• In emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals if there is sufficient evidence to suggest a medical product is safe and effective.
• Final approval is granted only after completion of the trials and analysis of full data; until then, emergency use authorisation (EUA) allows the medicine or the vaccine to be used on the public.

CDSCO :

• The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
• Functions: Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
• CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.