Guidance Document For Spontaneous Adverse Drug Reaction Reporting. Version: 1.0, 2014
(2014; 80 pages)


Adverse reactions of drugs continue to remain as an important public health issue. Safety monitoring of medicines is the responsibility of all stakeholders of the healthcare system since it continues to be an important cause of morbidity and mortality. In some countries adverse drug reactions are among the leading causes of mortality. The safety of patients and the safe use of medicines are crucial for health policy development and delivery of the best healthcare. To prevent or reduce harm to patients thereby improving public health, the safety of medicines in clinical use must be monitored and evaluated through specialised systems. This requires a well-organised pharmacovigilance system to be established. Thus, a pharmacovigilance system is defined as a system used by an organisation to monitor the safety of authorised medicinal products and detect any change to their benefit-risk balance. A pharmacovigilance system is characterised by its structures, processes and outcomes. To run an effective pharmacovigilance system, a protocol is required for reporting adverse reactions associated with drug use. Therefore National Coordination Centre (NCC) aims to ensure the systematic and effective functioning of PvPI by publishing and implementing its guidance document for reporting Adverse Drug Reactions (ADRs).

This guidance document lays down requirements and guidance for reporting ADR and significant safety issues related to drugs regulated by the Central Drugs Standard Control Organization (CDSCO). This document does not establish legally enforceable responsibilities. This has been prepared by the NCC and approved by Working Group. The purpose of this document is to present the importance of pharmacovigilance in India, to record the growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health. This document also highlights the importance of collaboration and communication at local, regional and international levels to ensure that pharmacovigilance delivers its full benefits. It also provides guidance to stakeholders on good pharmacovigilance practices, assessment of data regarding drugs including vaccines and blood products.

This document helps to expand the role and responsibilities of stakeholders under Pharmacovigilance Programme of India (PvPI) to identify, analyse and minimise the risk associated with drugs. Further it promotes better and broader use of pharmacovigilance data for patient safety by using the spontaneous reporting system.

The document is intended for the following stakeholders under PvPI:

  • Professional staff at NCC and ADR Monitoring Centres (AMCs)
  • Representatives of AMCs
  • National Health Programmes integrated with PvPI
  • Staff and consultants in CDSCO
  • Healthcare practitioners (clinicians, dentists, pharmacists, nurses and other healthcare professionals)
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