The Pharmacovigilance Programme of India, (PvPI) was first introduced in the year 2010 to improve the safety of Indian population by monitoring drug-related Adverse Drug Reactions (ADRs) collected via ADR monitoring centres across the country and the data was further sent to National Coordinating Centre (NCC)-PvPI.
NCC-PvPI receive suspected ADRs from all stakeholders, including Marketing Authorization Holders (MAHs), and reviews the safety information on a regular basis. It supports the Central Drugs Standard Control Organization (CDSCO) for further regulatory actions in the following manner:
1) Signal Review Panel (SRP) of NCC-PvPI analyses the suspected ADRs and identifies India specific drug safety signals and recommends its findings to CDSCO for appropriate regulatory action.
2) Subject Expert Committee (SEC) of CDSCO reviews the SRP recommendations, and if agreed with SRP, the SEC recommends the same to CDSCO for implementation or for the inclusion of the ADRs in prescribing information (package inserts and drug safety labels). In case the SEC is not satisfied with SRP recommendations, it asks the NCC-PvPI to submit more Individual Case Safety Reports/signals to support their recommendation.
3) CDSCO after considering the recommendation of SEC, requests all State/UT Drugs Controllers to instruct all the manufacturers licensed for the said product/drugs to implement the same in prescribing information.
To know more about the suspected drugs, their adverse reactions and recommendations go through the file attached below.