In order to help Indian pharmaceutical companies adopt good pharmacovigilance practices in the country towards patient safety, state drug controllers from across the country are scheduled to meet in February this year at Indian Pharmacopoeia Commission (IPC), Ghaziabad.
Central Drugs Standard Control Organisation (CDSCO) and Pharmacovigilance Programme of India (PvPI) have recently come out with a set of exhaustive guidelines on par with existing global guidelines and features pertinent areas like signal detection for risk-benefit evaluation and risk management programmes towards drug safety.
IPC is the national coordinating centre (NCC) for the PvPI. Since the initiation of PvPI in 2010, adverse drug reactions (ADRs) are reported from all over the country to NCC-PvPI, which work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base.
IPC in collaboration with CDSCO also developed pharmacovigilance guidance document for marketing authorization holders of pharmaceutical products to ensure smooth functioning of PV activities by pharmaceutical companies.
This pharmacovigilance guidance document has been introduced for pharmaceutical companies and aimed to establish an effective pharmacovigilance system at their sites as per recent amendment in drugs and cosmetics rules, 1945, Schedule Y through a gazette notification published on 8 March 2016.
Government has mandated market authorisation holders (MAH) to set up pharmacovigilance (PV) cell in their companies in accordance with the Drugs and Cosmetics Rules, 1945. MAH have been mandated to collect, process and forward the report to licensing authority for information on ADRs emerging from the use of drug manufactured or marketed.
Under the present set of rules, the drug exporting pharmaceutical companies have to set up a PV system to fulfill its legal tasks in relation to pharmacovigilance, design to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
A pharmaceutical company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with contract research organizations (CROs) specializing in pharmacovigilance function.
“Within a span of seven years, PvPI has become a formidable force at international level for the best pharmacovigilance practices including ADR reporting and providing skill development. The Individual Case Safety Reports (ICSRs) are collected in a scientific way and analysed to facilitate appropriate decisions at CDSCO,” explains Dr GN Singh, secretary-cum-scientific director, IPC, Ghaziabad.
Activities in PV department include ADR case processing and reporting (electronic or hard copy), Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER), product quality complaints management, medical inquiries management, safety data exchange agreement management, signal detection for risk-benefit evaluation, training of company employees on ADR reporting, global compliance monitoring, audits and inspections among others.