The Indian Pharmacopoeia Commission (IPC), which is the national coordination centre for Pharmacovigilance Programme of India (PvPI), in association with the CDSCO will conduct a regional workshop on 'Basics of Pharmacovigilance & Establishment of Pharmacovigilance System in Pharmaceutical Industries - A Way Forward' on June 23,  at AIIMS, Rishikesh.  

The main objective of this one-day programme is to sensitize manufacturers, importers, distributors and other stakeholders about the need for a properly-designed pharmacovigilance system across the user domain, to monitor Adverse Drug Reactions (ADRs) aimed at establishing safer drug use in the country.

The pharmaceutical products are primarily approved by CDSCO and subsequently licensed for either manufacturing and/or import by drug regulatory authorities at centre and states for marketing in the country.  The workshop is significant as during pre-market test and trials many adverse reactions related to such medicines may remain unnoticed. When a larger section of population belonging to various age groups and socio-economic strata are exposed to such medicines, many undesirable AEs/ADRs may emerge. This has necessitated the strengthening of pharmacovigilance standards and realization of the importance of a properly-designed pharmacovigilance system in the pharmaceutical companies as well as healthcare system.

The field of pharmacovigilance is on the path of rapid growth and its development has impacted the field of health sciences. The workshop is aimed at bringing together regulatory authorities and pharma professionals/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 target audience of this workshop which will create an agreeable roadmap for pharmaceutical companies and healthcare providers for the establishment of a harmonized and sustainable pharmacovigilance system for collection, collation and processing of AEs/ADRs.

Medicines’ safety-monitoring is an essential element of the healthcare system. The Ministry of Health & Family Welfare, therefore, launched a nationwide PvPI in 2010 to monitor the ADRs ensuring that the benefits of medicine outweigh the risks associated with its use. This helps safeguard the health of every citizen of India. Indian Pharmacopoeia Commission (IPC), an autonomous institution under the MoHFW, has been functioning as National Coordination Centre (NCC) for PvPI since April 15, 2011. To monitor the ADRs, Adverse Drugs Monitoring centres (AMCs) have been established across the country under the PvPI. The PvPI has taken a leap forward during the last five years. The programme has broadened its scope of activities and influence, providing a stage for interaction and partnership in the sphere of Pharmacovigilance.

In compliance with the recent amendment to Schedule Y, Drugs & Cosmetics Rules, 1945, vide Gazette Notification No. G.S.R. 287 (E) dated March 8, 2016, Pharmacovigilance has been mandate for Marketing Authorization Holders (MAHs) in India. To ensure the effective implementation, there is an urgent need for the MAHs to set up a Pharmacovigilance system at their site.