Materiovigilance Programme of India

Context: Recently, all medical device licence holders and manufacturers were directed by the Drugs Controller General of India (DCGI) to report any adverse events related to life-saving medical equipment on the government’s Materiovigilance Programme of India (MvPI) platform.

About:

Topic	Details
Materiovigilance Programme of India (MvPI)
Launch Date	July 6, 2015
Aim	To monitor the safety of medical devices in the country
Objective	To improve Indian patient safety by monitoring, recording, and analyzing the root cause of adverse events or risks associated with the use of medical devices, including in-vitro diagnostics, and suggesting regulatory actions to improve patient safety.
Function	Collects data on medical device-related adverse events, systematically and scientifically analyzes them to aid in regulatory decisions and recommendations.
Coordination and Analysis	An important program for reporting adverse events and coordinated analysis related to medical devices, including in-vitro diagnostic devices.
National Coordination Centre (NCC)	Indian Pharmacopoeia Commission (IPC) since 2018.
Regulation	Regulated by the Central Drugs Standards Control Organization (CDSCO).
Medical Devices Covered	Electronic equipment, implants, consumables and disposables, surgical instruments, and in-vitro diagnostic reagents, among others.
Current Regulation	All medical devices in India are regulated by the Drugs and Cosmetics Act, 1940, and Medical Device Rule, 2017
Dependence Nodal Ministry	India is currently 80% dependent on imports for medical devices. Ministry of Health and Family Welfare

Key Facts about Drugs Controller General of India (DCGI)
Role	Head of the department of the CDSCO of the Government of India.
Responsibilities	Approval of licences for specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
Standards	Sets standards for the manufacturing, sales, import, and distribution of drugs in India.

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