DRAP notified the Pharmacovigilance Rules, 2022, for active monitoring of safety of therapeutic goods across the country

The pharmacovigilance Rules, 2022, notified on 22nd April, 2022 , came into effect. This will provide a legal framework to monitor the safety of therapeutic goods throughout their use in the healthcare practice. This legislation details responsibilities of all stakeholders in active supervision of the product’ safety and monitoring, and provides a legal framework to implement and strengthen the pharmacovigilance system across the country. The newly approved rules will have a significant impact to improve pharmacovigilance system in the country, and provides responsibilities to be carried out by the National Pharmacovigilance Centre, Provincial or regional pharmacovigilance Centres, Public Health Programs (PHPs), and as well as, for the products’ registration holders (marketing authorization holders).

The Pharmacovigilance Rules,2022 are aimed at :-

  • Establishing the pharmacovigilance system for the collection and monitoring of Adverse Events, and related data on safety of therapeutic goods;
  • Review and assessment of safety data for effective regulatory actions to ensure the safe use of drugs, vaccines, medical devices, etc.;
  • Encourage reporting of Adverse Events by the Healthcare Professionals, Patients and Consumers of therapeutic goods;
  • Better communication and collaborative working among all stakeholders.

To know more about please navigate to “How DRAP Monitor Safety of Therapeutic Goods“, and “How to Report Adverse Events?”