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Emergency use authorisation for COVID Vaccine

The Central Drugs Standard Control Organisation's Subject Expert Committee asked the Serum Institute of India and Bharat Biotech to submit more data and information to get emergency use authorisation (EUA) for the COVID vaccine.

In India, Vaccines and medicines, and even diagnostic tests and medical devices, require the approval of the Central Drugs Standard Control Organisation (CDSCO) before they can be administered to the general public. The fastest authorisation given to any vaccine is the mumps vaccine in the year 1960 which took about four-and-a-half years after it was developed.

In Emergency situations, many countries around the world have developed mechanisms to grant approvals to medical products and medicines after gathering positive responses from phase-3 trials.

EUA (Emergency Use Authorisation) is when an unapproved medical product has given marketing approval by a regulator in an emergency to diagnose, treat or prevent life-threatening diseases or conditions. EUA is granted in the USA after sufficient efficacy data from phase 3 trials had been generated.

In India, we do not have a provision related to a EUA, also the process of receiving it is not defined anywhere. Despite it, CDSCO had granted emergency or restricted use of some drugs in COVID-19 treatment like favipiravir, remedesivir and itolizumab. There will be several associated risks when a product is being granted EUA and not full approval.

With this new development in the medical field, the responsibility of doctors will be increased while administering these types of dosages to the public, Public need to be informed about the benefits and risks involved while signing a consent form that they understood all the implications.

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