Vigilance of medical devices and IVDs in the South East Asia Region –Safety Monitoring Systems in India and other Countries Dr. Madhur Gupta; MD, DM Technical Officer- Pharmaceuticals WHO India Country Office New Delhi, India guptamadh@who.int Disclaimer: No Conflict of Interest

South-East Asia Regulatory Network (SEARN) In 2016, 11 Member States of WHO South East Asia Region launched the South East Asia Regulatory Network (SEARN) to enhance information sharing, collaboration and convergence of medical products (medicines, vaccines, diagnostics, devices) regulatory practices across the region. The mission is to develop and strengthen regulatory collaboration, convergence and reliance in the South-East Asia region over shared regulatory issues and challenges that will build capacity and will enable National Regulatory Authorities to fulfil their mandates and better safeguard public health. Objectives of SEARN Information sharing Systems strengthening Convergence Collaboration

Working Group 3:Vigilance for medical products Engage in capacity building programmes in Vigilance such as workshops for principles, practice and causality assessment in compliance with good pharmacovigilance practices, including haemovigilance and fostering reporting. Provide information to set up safety monitoring system for medical devices and in-vitro diagnostics. Develop SEARN Vigilance Newsletter. Develop capacity for integrating Pharmacovigilance with National Health Programmes in South-East Asia Region through workshops on Regulatory aspects of Pharmacovigilance, including Pharmacovigilance Inspections and role of Drug Regulators for enforcement.

SEARN: Goals for Vigilance Group Short term Mid term Long term 1. Information sharing Drugs safety signals Bulletins Technical documents and guidelines 2. Building effective Communication Capacity building and strengthening of vigilance system Training & workshop Quality management system Region specific signal detection Self sustainability

Vigilance for Medical Products-Working Group of SEARN-Mapping of Existing Regulations for Pharmacovigilance, Practice, and Training Needs Assessment

Information Sharing and Technical Support Sharing of Vigilance guidance documents, newsletters as part of regulations of NRAs for countries revising their regulations for vigilance. All countries to share the, FAQs, factsheets, advocacy materials- newsletter to be available on SEARN platform for information sharing- link for vigilance materials to be created. Drug Safety Alerts; Lack of efficacy alerts (quality?) Share best practices including the guidance and support for testing of medical devices and medical device /Dx Vigilance guidance

National Institute of Biologicals (NIB) Indian Pharmacopoeia Commission (IPC) WHO Collaborating Centre (WHO CC) for Centre for Capacity-Building for Pharmacovigilance in Public Health Programmes and Regulatory Services in the WHO South-East Asia Region National Institute of Biologicals (NIB) WHO South East Asia Region Collaborating Centre for Quality Control of HIV, Hepatitis B & C and Syphilis In-Vitro Diagnostics National Health Systems Resource Centre(NHSRC) WHO Collaborating Centre for Priority Medical Devices & Health Technology Policy

Materiovigilance Programme of India (MvPI) Ministry of Health and Family Welfare, Government of India, has approved the commencement of "Materiovigilance Programme of India (MvPI)" vide approval dated 10/2/2015. Materiovigilance Program of India (MvPI) has been launched by DCG (I) on 6th July 2015 at Indian Pharmacopoeia Commission (IPC) Ghaziabad. IPC Ghaziabad functions as National Coordination Centre for MvPI. Sree Chitra Tirunal Institute of Medical Sciences & Technology (SCTIMST), Thiruvananthapuram, function as National Collaboration Centre for MvPI. National Health System Resource Centre (NHSRC) for Technical support & Resource Centre. Central Drugs Standard Control Organisation (CDSCO), New Delhi shall act as regulator.

Scope of MVPI To create a nation - wide system for patient safety monitoring. To analyse the benefit-risk ratio of medical devices. To generate evidence based information on safety of medical devices. To support CDSCO in the decision-making process on use of medical devices. To communicate the safety information on use of medical devices to various stakeholders to minimise the risk. To emerge as a national centre of excellence for Materiovigilance activities. To collaborate with other healthcare organisations for the exchange of information and data management.

13 Medical Device Adverse Event Monitoring Centers (MDMCs) Bengaluru: Department of Clinical Research, Narayna Hrudalaya Hospital, Karnataka Chandigarh: Department of Biomedical Engineering, Postgraduate Institute of Medical Education and Research (PGIMER)-Chandigarh, Delhi: Department of Pharmacology, All India Institute of Medical Sciences (AIIMS Delhi: Division of Health Care Technology, National Health System Resource Centre (NHSRC), National Institute of Health & Family Karnataka Department of Biomedical Engineering. National Institute of Mental Health & Neuro Sciences (NIMHANS) Kerala Biomedical Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Puducherry Department of Biomedical Engineering, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER) Punjab Department of Pharmacology, Dayanand Medical Colllege and Hospital, Ludhiana, Tamilnadu Department of Biomedical Engineering, Christian Medical College (CMC) Uttar Pradesh Department of Biomedical Engineering, Sanjay Gandhi Post Graduate Institute of Medical Science, Lucknow West Bengal Department of Clinical Science, Glocal Group of Hospitals, Kolkata Tamil Nadu: Royal Care Hospital Tamil Nadu: Ramakrishna Hospital, Coimbatore

Medical Device Adverse Event (MDAE) reporting

Ongoing developments Independent registry to track usage of medical devices in the country including a mechanism to be created through which online information could be made available about any withdrawal by regulatory agencies/voluntary withdrawal by the company of devices/safety issue of devices. Exhaustive draft of guidance document that describes fundamental design and manufacturing requirements for up to 594 medical devices, referred to as “Essential Principles for Safety and Performance” that when met, indicate a medical device is safe and performs to its specification. Registered Medical Devices –Information Sharing Portal