NMC Mandate: Medical Colleges, standalone PG institutions now required to enrol as Adverse Drug Reactions Monitoring Centers under PvPI

New Delhi: Aiming to uplift regulatory standards for the overall collection, analysis and monitoring of Adverse Drug Reactions (ADRs) from the public, the National Medical Commission (NMC) has directed all medical colleges and standalone PG institutions to enrol themselves as Adverse Drug Reactions Monitoring Centers.

The mandate to this effect issued under the authority of the Secretary I/C at NMC, Dr Pulkesh Kumar, calls for the enrollment of recognised Medical Colleges, hospitals and standalone PG institutes as Adverse Drug Reactions (ADR) Monitoring Centers with Indian Pharmacopoeia Commission (IPC) under the Pharmacovigilance Programme of India (PvPI) at the earliest.

Indian Pharmacopoeia Commission (IPC) is functioning as the National Co-ordination Centre, Pharmacovigilance Programme of India (PvPI) to collect, analyze and monitor the adverse drug reactions (ADRs) from the Indian population to promote patient safety & safeguard the health of patients by ensuring that the benefits of the use of medicines outweigh the risk associated with its use.

The collected ADRs data is a significant source of evidence for recommendations of regulatory interventions regarding the safety of medicines to the Central Drugs Standard Control Organization (CDSCO).

The NMC notification mentions that to achieve the above objective, "IPC has enrolled 652 Adverse Drug Monitoring Centres (AMCs) so far."

Further into execution, during the 22nd Meeting of the Governing Body of India, Pharmacopoeia Commission held on 14.10.2022 under the chairmanship of the Secretary (HFW), it has been decided that all Medical colleges/ hospitals under the National Medical Commission should also be enrolled as AMCs with IPC.

Hence, the NMC has issued the said notification directing all medical Colleges, hospitals and standalone PG institutes to enrol themselves Adverse Drug Reactions (ADR) Monitoring Centers with the Indian Pharmacopoeia Commission (IPC) under the Pharmacovigilance Programme of India (PvPI).

“Accordingly, all medical colleges/hospitals under the National Medical Commission are directed to enrol themselves with Indian Pharmacopoeia Commission (IPC) as AMCs at the earliest.” stated the NMC.

To view the NMC notification, click here