To sensitize manufacturers, importers, distributors and other stakeholders to develop and strengthen pharmacovigilance system as per the Good Pharmacovigilance Practices (GVP) across the user domain to monitor Adverse Drug Reactions (ADRs) aimed at establishing safer drug use in the country, the Indian Pharmacopoeia Commission (IPC) will organise a workshop on "Basics of Pharmacovigilance & Establishment of Pharmacovigilance System in Pharmaceutical Industries - A Way Forward" on March 23 at Metropole, RTO Circle in Ahmedabad.

This will be the 5th regional workshop being organised by the IPC which is aimed to discuss about setting up and strengthening of pharmacovigilance system at Market Authorisation Holders (MAHs) site. It will also discuss the current issues and challenges for reporting of ADRs by MAHs to the IPC.  The workshop will bring together regulatory authorities and pharma professionals and experts to discuss the practice of pharmacovigilance in the country. It will also widen the knowledge spectrum of pharma professionals in the field of pharmacovigilance.  

Professionals in pharmacovigilance, quality assurance (QA) and regulatory affairs (RA) in pharmaceutical companies and healthcare systems are the targeted audience of this workshop. And creation of an agreeable roadmap for  pharmaceutical companies and healthcare providers for the establishment of a harmonised and sustainable pharmacovigilance system for collection, collation and processing AEs/ADRs is the expected outcome of this workshop.

The IPC's initiative in organising workshops at different locations in the country is signigicant as pharmacovigilance 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. The Union Health Ministry, therefore, launched a nationwide Pharmacovigilance Programme of India (PvPI) in the year 2010 to monitor Adverse Drug Reactions ensuring the benefits of drugs outweighs the risks associated with its use. Indian Pharmacopoeia Commission (IPC), autonomous institute under the ministry 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 & Cosmetic Rules 1945, Schedule Y and the Gazette notification GSR 287 (E) dated March 8, 2016, the setting up of pharmacovigilance 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 ministry on September 29, 2017 and has been effective from January 1, 2018.