Mumbai: The Indian Pharmacopoeia Commission (IPC) has registered 44 small-scale medtech firms under ADR Monitoring System (ADRMS) to help them report medical devices related serious adverse events (SAEs) for patient and consumer safety.
IPC has couple of months back rolled out a Pan-India programme to train small-scale pharma & medtech firms in strengthening pharmacovigilance (PV) & materiovigilance (MV) reporting. The initiative aims to make PV and MV practices more accessible, efficient, and compliant for smaller industry players as per the regulatory requirements.
“As a part of the programme, IPC has started extending support to small-scale pharmaceutical and medical device manufacturers to register and subscribe to the ADRMS, which is a dedicated digital platform to streamline the reporting of medicines related adverse drug reactions (ADRs) and medical devices related SAEs,” informed Dr Vivekanandan Kalaiselvan, secretary-cum-scientific director, IPC.
Developed as an online, user-friendly reporting portal, ADRMS enables seamless submission of safety-related data. Recognising that small-scale industries often face challenges in meeting regulatory reporting requirements, IPC will not only provide access to the portal but also offer hands-on training to manufacturers. This training will guide them through the process of registering ADRs and SAEs on the platform, ensuring accurate and timely reporting for improved patient safety.
The data received through ADRMS will help IPC to make regulatory recommendations to the Central Drugs Standard Control Organisation (CDSCO) in making informed regulatory decisions and promotes the safe use of medicines among healthcare professionals and the public. The Weblink of Online ADRMS Software is www.adrmsipc.in.
The digital support offered through ADRMS is expected to enhance the industry’s overall participation in safety monitoring programmes, thereby strengthening compliance with the Pharmacovigilance Programme of India (PvPI) and the Materiovigilance Programme of India (MvPI). By simplifying reporting workflows, the platform helps manufacturers meet their obligations under the Drugs and Cosmetics Act, 1940, its associated Rules of 1945, the NDCT Rules 2019, and the Medical Device Rules 2017.
IPC, which is also the National Coordination Centre (NCC) of the PvPI and MvPI, has introduced this first-of-its-kind initiative implemented across the country as part of Prime Minister Narendra Modi’s vision of ‘Digital India’.
With ADRMS, IPC is positioning itself as a facilitator and guide for small-scale industries, enabling them to adopt robust PV and MV practices while ensuring aligned and responsible participation in India’s patient safety ecosystem.
The ADRMS software of PvPI is India’s first medical product safety database tailored to meet the needs of the Indian population. It facilitates the users (healthcare professionals, consumers and ADR monitoring Centres (AMCs)/Medical Device Monitoring Centres (MDMCs) under PvPI to report adverse events related to medicines and medical devices. This software will not only streamline the reporting process by patients/their caregivers and healthcare professionals but also empower Indian Pharmaceutical Industries/Marketing Authorizations Holders (MAHs) to report adverse events through direct User Gateway.
