Last Updated on November 3, 2024 by The Health Master
DTAB
The Drugs Technical Advisory Board (DTAB) has proposed significant amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, to bolster drug safety and oversight.
These changes aim to ensure that marketing companies provide more frequent and comprehensive safety updates for their products, enhancing post-marketing surveillance.
Proposed Amendments to PSUR Submission
One of the key recommendations is to mandate annual submission of periodic safety update reports (PSURs) for drug products throughout their marketing lifespan.
Currently, PSURs are required only for the third and fourth years after approval.
This change will enable more vigilant monitoring of potential safety issues.
Moreover, the DTAB has suggested including the Pharmacovigilance System Master File (PSMF) as part of the required documents for PSUR submission.
The PSMF provides a detailed overview of the pharmacovigilance system used by the marketing company, ensuring transparency and accountability.
Enhanced Post-Marketing Surveillance
The post-marketing surveillance of new drugs through PSURs is a crucial component of ensuring drug safety.
The DTAB’s recommendations will strengthen this process by requiring more frequent and comprehensive reporting.
Key points of the proposed changes:
- Annual PSUR submission: Mandatory for the entire marketing lifespan of a drug.
- PSMF inclusion: Required as part of PSUR submission.
- Enhanced oversight: More vigilant monitoring of potential safety issues.
Central Licencing Authority’s Role
The Central Licencing Authority will play a pivotal role in overseeing these changes.
They will have the authority to extend the duration of PSUR submission if deemed necessary in the interest of public health.
Additionally, serious unexpected adverse reactions must be reported within fifteen days of initial receipt of information.
In conclusion, the DTAB’s recommendations, if implemented, will significantly enhance drug safety in India.
By requiring more frequent and comprehensive safety updates, the government aims to protect public health and ensure that only safe and effective drugs are available in the market.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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