Emergency Use Authorisation

In normal times, drugs and vaccines required to be tested and approved by regulatory authorities of a country before they can be commercially used. But Emergency Use Authorisation is a situation in which a drug or vaccine is given an early or emergency authorization to be used in case of any pandemic like COVID-19.

Key Points

  • In India, the central drug regulator is the Central Drugs Standard Control Organisation (CDSCO).
  • But during a pandemic and an emergent situation, Emergency Use Authorisation (EUA) is issued by the regulator.
  • It is an interim approval given to the drugs, provided the regulator is satisfied with the safety of the drug. After all, clinical trials are completed; the final approval for the drug/vaccine is issued by the regulator.
  • EUA is provided in the USA by the government’s Food and Drug Administration (FDA). Indian drug legislation does not contain provisions for EUA. CDSCO has been issuing emergency approvals to COVID-19 drugs.

Pfizer and Serum Institute of India seek Emergency Use Authorisation

After the parent company of Pfizer obtained emergency use authorisation in the UK and Baharain, Pfizer India recently applied for EUA from Drugs Controller General of India (DCGI).

After the EUA application of Pfizer India; the Serum Institute of India has also applied for emergency use authorization for its Oxford Covid-19 vaccine in India. Serum Institute of India is the first Indian company to seek EUA for the COVID-19 vaccine.

Drugs Controller General of India (DCGI)

DCGI is a department of the CDSCO. The department is responsible for issuing licenses to specified category drugs in India. The department also set the standard procedures for manufacturing, selling, distribution, and import of the drugs.

Food and Drug Administration (FDA)

It is a US federal agency that is responsible for controlling and supervising medications, vaccines, food safety, dietary supplements, biopharmaceuticals, tobacco products, medical devices, cosmetics, electromagnetic radiation emitting devices (ERED), veterinary products. The main aim of the agency is to protect and promote public health.