Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. The objective of PV is to provide reliable, balanced information for the effective assessment of the risk-benefit profile of drugs to ensure patient safety in relation to the use of drugs.

Pharmacovigilance is an integral part of the clinical drug development process and plays a critical role in marketing approval/authorisation of drug by the regulatory authority. The pharmacovigilance activities (in form of pharmacovigilance plan) are built into the clinical trial protocols for each phase (phase I, II & III) of the trial. Subsequent to successful completion of all the clinical trial phases, the drug regulatory authority grants marketing approval /authorisation to the drug provided the risk-benefit assessment is favourable.

The knowledge regarding the safety profile of a product may change over time, through expanded use. Once the drug is approved for marketing, the pharmacovigilance activities continue in the post-marketing phase and until such time the drug remains available in the market. For instance, during the early post-marketing period, a larger population might use the product over a short period, resulting in new information that might impact the associated benefits and risks. Thus, pharmacovigilance is a dynamic process and requires safety information to be evaluated on a continuous basis for the assessment of the risk-benefit profile of the drug.

In India, the Central Drugs Standard Control Organization (CDSCO) is responsible for conducting the Pharmacovigilance Programme of India.  For this purpose, CDSCO has set up a National Coordinating Centre at Indian Pharmacopoeia Commission (IPC). The IPC has published guidance documents for pharmacovigilance requirements in India.

Marketing authorisation holders are required to set up appropriate pharmacovigilance system, to collect and assess adverse reactions and to submit Periodic Safety Update Reports (PSUR), for a period of at least four years to CDSCO. In consultation with expert committees, CDSCO may extend the duration of this data beyond 4 years. The PSUR data should be submitted to CDSCO in the prescribed format as per the Fifth Schedule (page 229) of the New Drugs and Clinical Trial Rules, 2019.

Resources and further reading:

• Pharmacovigilance guidance document for Market Authorisation Holders of Pharmaceutical Products, Indian Pharmacopoeia Commission in collaboration with Central Drugs Standard Control Organization, 2018, available online (last accessed on 26.02.2019).
• Guidance for Industry on Pharmacovigilance Requirements for Biological Products, Central Drugs Standard Control Organization, 2017, available online (last accessed on 26.02.2019).
• The Importance of Pharmacovigilance, Safety Monitoring of Medicinal Products, World Health Organization, 2002, available online (last accessed on 26.02.2019).
• Amale et al., 2018, Pharmacovigilance Process in India: an overview, Journal of Pharmacovigilance, available online (last accessed on 26.02.2019).
• New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 004.2019).