Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

What is the Emergency Use Authorization (EUA) for Drugmakers?

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Vaccine for COVID

Mains level : Universalization of vaccines and associated challenges in India

The US drugmaker Moderna said it was applying for emergency use authorisation for its vaccine in India.

Practice question for Mains:

Q. What is Vaccine Nationalism? Discuss various ethical issues involved and its impact on vulnerable populations across the globe.

Emergency Use Authorisation (EUA)

  • 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).
  • The approval is granted after an assessment of their safety and effectiveness, based on data from trials. In fact, approval from the regulator is required at every stage of these trials.
  • This is a long process, designed to ensure that medicine or vaccine is absolutely safe and effective.
  • The fastest approval for any vaccine until now — the mumps vaccine in the 1960s — took about four-and-a-half years after it was developed.

Exceptions for emergency

  • In emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals.
  • However, there should 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, EUA allows the medicine or the vaccine to be used on the public.

What is the process of getting a EUA in India?

  • India’s drug regulations do not have provisions for a EUA, and the process for receiving one is not clearly defined or consistent.
  • Despite this, CDSCO has been granting emergency or restricted emergency approvals to Covid-19 drugs during this pandemic — for remdesivir and favipiravir in June, and itolizumab in July.

Associated risks

  • The public has to be informed that a product has only been granted a EUA and not full approval.
  • In the case of a Covid-19 vaccine, for example, people have to be informed about the known and potential benefits and risks.

Not a compulsion

  • There has been an ongoing debate over whether people have the option of refusing to take the vaccine.
  • Incidentally, no country has made vaccination compulsory for its people.
  • Initially, all vaccines are likely to be deployed on emergency use authorizations only. Final approval from may take several months, or years.
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