Enhancing Patient Safety: IPC Issues Urgent Call for Strict Materiovigilance Compliance Among Medical Device Makers

The Indian Pharmacopoeia Commission (IPC), acting as the National Coordination Centre for the Materiovigilance Programme of India (MvPI), has issued a high-priority directive to all Medical Device Marketing Authorisation Holders (MAHs). The Commission is urging immediate and rigorous adherence to adverse event reporting protocols, warning that under-reporting by domestic manufacturers poses a significant risk to public health and regulatory efficiency.

The Vital Role of MvPI in Public Health

Launched in 2015 and managed by the IPC since 2018, the Materiovigilance Programme of India (MvPI) is the nation’s primary defense against faulty medical devices and in-vitro diagnostics (IVDs). By systematically collecting and analyzing device-related adverse events, the IPC and the Central Drugs Standard Control Organisation (CDSCO) can identify “signals”—early warnings of potential malfunctions or safety hazards.

Why Reporting Matters:

Early Risk Detection: Identifies emerging safety concerns before they become widespread.
Regulatory Action: Supports decisions on field safety corrective actions (FSCAs), design modifications, and labeling updates.
Continuous Improvement: Provides manufacturers with data to refine device performance and reliability.
Building Trust: Ensures that healthcare providers and patients have confidence in the safety of medical technology used in India.

Bridging the “Under-Reporting” Gap

The IPC expressed specific concern regarding the low volume of reports coming from domestic medical device manufacturers. Under current regulations—specifically the Medical Devices Rules, 2017, and the Drugs and Cosmetics Act, 1940—monitoring and reporting the safety of medical products is a statutory and ethical obligation.

“Adverse event reporting is not merely a regulatory checkbox; it is the cornerstone of patient safety. Timely data allows us to act before harm occurs.” — Extract from the IPC Public Notice

Modernizing the Ecosystem: Digital Reporting Channels

To eliminate barriers to reporting, the IPC has introduced several user-friendly, real-time platforms. MAHs are encouraged to report both serious and non-serious, as well as known and unexpected adverse events through these channels:

ADRMS Platform: The Adverse Drug Reactions Monitoring System, launched in August 2024, serves as a unified digital portal for medicines, vaccines, and devices.
MvPI Mobile App: Available on the Google Play Store, this allows for “on-the-go” reporting by healthcare professionals and manufacturers.
Toll-Free Helpline: Stakeholders can dial 1800-180-3024 for guidance and telephonic reporting support.

The Bottom Line for Manufacturers

The IPC has reiterated that all license holders must establish robust internal post-market surveillance systems. Failure to report adverse events not only violates policy directives issued by the Ministry of Health but also hinders the development of a safe medical device ecosystem in India. To assist companies, the MvPI continues to offer technical training and support to enhance understanding of the reporting workflow.