| Introduction: Briefly describe what is EUA process. Body: What is its importance in the context of antibiotics? Conclusion: Way forward |
EUA or Emergency Use Authorisation as the name suggests is a regulatory mechanism used by many countries to allow the use of medical products or treatments during public health emergencies, such as pandemics or natural disasters, before they receive full approval. The traditional process to approve new drugs or vaccines is subject to a long clinical process which is very long and it takes years for such products to receive commercial approval. It’s crucial to understand that EUA does not equate to full approval. It opens a door for the quick use of medical devices in times of need, but the maker must still submit further information and apply for full clearance later. Recent notable examples of EUA include approval of AstraZeneca’s COVISHIELD, Pfizer, and Moderna COVID vaccine.
What is its importance in the context of essential antibiotics?
- Access to Life-saving vaccines/drugs: As seen during COVID and other life-threatening diseases like Cancer, EUA proved to be a life-saving intervention that made products easily accessible bypassing the lengthy process. Eg, AstraZeneca’s COVISHIELD and antibiotic, cefepime/zidebactam to combat drug-resistant gram-negative pathogens including Pseudomonas aeruginosa.
- Efficacy and Safety not compromised: Due diligence is maintained before granting EUA approval in terms of reviewing data and analysing the risks and benefits associated with the drugs. Scientific reports have suggested that the potential benefits of EUA outweigh the known potential risks.
- Limiting the spread of pathogens: Experience of COVID shows that the EUA process was responsible to limit or slow the spread of the virus particularly in developing nations. This led to a reduced fatality in the later stage when vaccines were available.
- Medical Ethics: EUA helps to bring a framework where regulatory agencies have to establish a balance between the need for timely access to interventions during public health emergencies with the imperative of protecting public health and safety by way of giving quick approval to drugs.
- Post-Authorization Monitoring: There are proper safeguards regarding post-authorization monitoring and surveillance of programs receiving EUA approval. The data of authorized products are collected and used to improve the safety, and efficiency of the product and publish their findings to make people aware of the performance of such drugs/vaccines.
Conclusion:
India must frame a law dealing explicitly with EUA to deal with the use and regulation of drugs during public health emergencies. EUA process must follow regular scrutiny, issues of safety and efficacy adequately addressed, and complete transparency and accountability of regulatory agencies be maintained concerning the whole process.
