Why is it in the News?

The DCGI recently issued a directive to all medical device license holders and manufacturers, instructing them to report any adverse events associated with life-saving medical equipment on the government's Materiovigilance Programme of India (MvPI) platform.

What is the Materiovigilance Programme of India?

• The Materiovigilance Programme of India was launched on July 6, 2015, that monitors and evaluates the safety of medical devices across the country.
• It aims to systematically collect and scientifically analyze data on adverse events related to medical devices, offering guidance on their safe usage and supporting regulatory decision-making processes.

Objectives and Importance:

• The primary goal of the Materiovigilance Programme is to enhance patient safety in India by carefully recording, assessing, and determining the root causes of adverse events or risks associated with medical devices, including in-vitro diagnostics.
• By coordinating the reporting and analysis of such events, the programme seeks to inform regulatory bodies and healthcare professionals, promoting the appropriate use of medical devices and ultimately improving patient safety.

Governance and Regulation:

• Since 2018, the Indian Pharmacopoeia Commission (IPC) has served as the National Coordination Centre (NCC) for the programme.
• The Materiovigilance Programme is regulated by the Central Drugs Standards Control Organization (CDSCO), operating under the Ministry of Health and Family Welfare.
  • The Drugs and Cosmetics Act, 1940, and Medical Device Rule, 2017, currently govern all medical devices in India.
• Given that the country is 80% dependent on imports for medical devices, the programme's role in ensuring the safety and efficacy of these essential healthcare tools is crucial.

About Drugs Controller General of India (DCGI):

• The Drugs Controller General of India (DCGI) leads the Central Drugs Standard Control Organization (CDSCO), ensuring the quality of drug supply nationwide.
• Nodal Ministry: Ministry of Health & Family Welfare

Functions:

• Approving new drugs and overseeing clinical trials.
• Establishing standards for drug manufacturing, sales, import, and distribution in India.
• Granting licenses for specific drug categories such as blood products, IV fluids, vaccines, and sera.
• Ensuring uniform implementation of the Drugs & Cosmetics Act, 1940, and its associated rules to safeguard patient safety, rights, and well-being.