Inclusion of Medical Colleges as Adverse Drug Reaction Monitoring Centers Under Pharmacovigilance Programme of India: Missing the Targets

Indian Pharmacopoeia Commission (IPC) is performing the functions of National Coordination Centre for Pharmacovigilance Programme of India (PvPI) since April 2011 under the aegis of Ministry of Health and Family Welfare, Government of India.[1] The goal of PvPI is to protect the health of the patients by assuring drug safety. The program started with the following objectives: to monitor adverse drug reactions (ADRs) in the Indian population, to create awareness among health-care professionals about the importance of ADR reporting in India, and to monitor benefit-risk profile of medicines.[2]

Under PvPI, ADR monitoring centres (AMCs) were to be established in Medical Council of India (MCI) approved medical colleges and hospitals, private hospitals, centers running public health programs, and autonomous institutes. Five-year roadmap of PvPI targeted to include 300 medical colleges as AMCs by the year 2014 only in a phase-wise manner of including 40 medical colleges in the year 2010–2011, 60 in the year 2011–2012, and then, an increment of 100 each for year 2012–2013 and 2013–2014.[3] Going by that rate, by now, all the MCI approved medical colleges in India should have been covered under PvPI and included as AMCs.

However, ground situation is different. As of September 2017, as per IPC website information, 250 centers have been marked as AMCs, and that include medical colleges and other hospitals too.[4] Of these 250 centers, 220 are medical colleges. As of now, there are 476 MCI approved medical colleges in India, imparting graduate medical degree.[5] Obviously, we are way behind the stated targets of PvPI. Even half of the medical colleges in India have not been covered under PvPI. To add to this, there are 683 MCI approved hospitals imparting internship training to students.[6] If all those hospitals are to be included in the PvPI too (all are MCI approved), it is desirable to say that currently, only one-fifth of the MCI approved medical colleges and hospitals have been covered under PvPI as AMCs, and we are way behind the intended targets.

Lack of sensitization on the part of authorities and nonmandatory clause on the part of medical colleges may be one of the reasons for lackluster approach on the part of the medical colleges to join PvPI. A letter of intent has to be submitted by the college authorities to initiate the process of establishing AMCs at the medical college. This optional clause may be one of the reasons of intentionally nonjoining the PvPI. It is right time that MCI be roped in and establishing AMCs at medical colleges be made obligatory to widen the base of the program.