To help pharma industry develop pharmacovigilance system as per the good pharmacovigilance practices, the Indian Pharmacopoeia Commission (IPC) will soon roll out a series of workshops in Mumbai and Ahmedabad considering the fact that Market Authorisation Holders (MAHs) and regulators have to jointly implement Pharmacovigilance (PV).

PV improves patient care and safety in relation to the use of medicines and also play a major role in clinical practice and the development of public health policy.

“With the sensitisation of industry stakeholders, regulators can usher in stringent regulatory system to implement the same, which will lead compliance to percolate at the ground level through advisories, drug alerts and black box warnings,” according to a senior CDSCO official.

IPC is also in the process of drafting PV audit check list for the drug regulators to implement it effectively. IPC has recently been nominated as the 8th WHO collaborative centre to support World Health Organization (WHO) member countries to implement pharmacovigilance programme in their health systems.

A meeting with CDSCO officials and state drug controllers also took place recently in which state drug controllers were sensitised on PV and also were apprised about the recent developments.

The Ministry of Health and Family Welfare (MoHFW) launched a Nationwide Pharmacovigilance Programme of India (PvPI) in 2010 to monitor Adverse Drug Reactions (ADRs) ensuring that the benefits of drugs outweighs the risks associated with its use.

IPC, which is an autonomous institutes under the MoHFW has been functioning as National Coordination Centre (NCC) for PvPI since April 15, 2011.

To monitor ADRs, Adverse Drug Reactions Monitoring Centres (AMCs) under PvPI have  been established across the country. As per the recent amendment in Drugs and Cosmetic Rules 1945, Schedule Y and the notification dated March 8, 2016, setting up of PV system is mandatory for all MAHs.

In this regard, IPC in collaboration with CDSCO has developed “Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products”, which was released by the then Secretary Health on September 29, 2017 and has been effective from January 1, 2018.