Indian Pharmacopoeia Commission (IPC) in collaboration with Central Drugs Standard Control Organisation (CDSCO)  to conduct a workshop on basics of pharmacovigilance and establishment of pharmacovigilance systems in pharmaceutical companies on May 25 at Shantabai Devarao Shivaram Tuberculosis Research Centre (SDSTRC) and Rajiv Gandhi Institute Of Chest Diseases (RGICD), Bengaluru.

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.

As per the amendment in Drugs & Cosmetic Rules, Schedule Y and the notification dated March 8, 2016, setting up of PV system is mandatory for all market authorisation holders (MAHs).

Professionals working in PV, quality assurance and regulatory affairs in pharmaceutical industry will hugely benefit from the workshop towards establishment of PV system at MAHs thus resolving doubts about reporting of ADRs by MAHs to IPC.

In this workshop, IPC and CDSCO will also discuss current issues and challenges for reporting of ADRs by MAHs to IPC.

In this regard, IPC, which is also a WHO-Collaborative Centre for PV in collaboration with CDSCO has developed “PV Guidance Document for MAHs of Pharmaceutical Products”, which was released by the union health ministry on September 29, 2017 and has been effective from January 1, 2018

The union health ministry launched a nationwide Pharmacovigilance Programme of India (PvPI) in 2010 to monitor Adverse Drug Reactions (ADRs) thus ensuring the benefits of drugs outweighs the risks associated with its use. IPC is  autonomous institute under the Union health minsitry 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.