Need For Constant Vigilance

An analysis on the progress of India’s pharmacovigilance programme

- Usha Sharma

In 2010, Dr Surinder Singh, Former DCG(I), launched the Pharmacovigilance Programme of India (PvPI) with the objective of studying the adverse effects of drugs, to strengthen the number of drug inspectors and to maintain quality parameters in countries from where India imported drugs. In observance of Pharmacovigilance Day, let’s examine the progress of the PvPI programme so far.

Improved ADR reporting

Commenting on the progress so far, Dr Renuka Munshi, Coordinator, AMC, TN Medical College & BYL Nair Hospital says, “In the last seven years, the programme has been progressing in leaps and bounds. Recently, PvPI has also taken the responsibility of reporting adverse events due to medical devices and has initiated the process of reporting adverse events due to drugs used for vector-borne diseases like Kala-azar. We have more than 250 ADR monitoring centres, which have been involved in the activity. Programmes like Revised National Tuberculosis Control Program (RNTCP) and ART and their respective centres have been roped in to report ADRs.”

Enhanced Data Collection

PvPI has contributed numerous data to the WHO-Uppsala Monitoring Centre (UMC) and Central Drugs Standard Control Organization (CDSCO). Quality checks of the submitted ADRs is done by National Coordinating Centre (NCC) and queries sent to respective ADR Monitoring Centre (AMC). There has been a positive impact on the quality of Indian Society for Clinical Research (ISCR) submitted to AMC at Uppsala. During 2014-2015, the completeness score of the ISCR reports submitted by India to Uppsala has been as high as 0.92 out of a total score of 1. The fact that the Medical Council of India (MCI) has also made it mandatory for medical colleges to incorporate ADR reporting to PvPI as a Minimum Standard Requirement (MSR) for those medical colleges seeking MCI recognition has given added impetus to the programme.