Materiovigilance Programme of India

About Materiovigilance Programme of India: 

• It was launched on July 6, 2015 to monitor the safety of medical devices in the country.
• It aims to collect data on medical device related adverse events systematically and scientifically analyze them to aid in regulatory decisions and recommendations on safe use of medical devices.
• Objective: To improve Indian patient safety by monitoring, recording and analysing the root cause of adverse events or risks associated with the use of medical devices including in-vitro diagnostics by healthcare professionals or patients/users and suggesting regulatory bodies for appropriate action with the sole intention of improving patient safety.
• It is an important program for reporting of adverse events, coordinated analysis etc related to the medical devices including in-vitro diagnostic devices.
• The Indian Pharmacopoeia Commission (IPC) functions as National Coordination Centre (NCC) since 2018.
• It is regulated by the Central Drugs Standards Control Organization (CDSCO).
  • Medical devices consist of electronic equipment, implant, consumables and disposables, surgical instruments and in-vitro diagnostic reagents, among others.
  • Currently, all medical devices in India are regulated by the Drugs and Cosmetics Act, 1940 and Medical Device Rule, 2017.
  • At present, India is 80% dependent on imports for medical devices.
• Nodal Ministry: Ministry Of Health and Family Welfare

Key facts about Drugs Controller General of India

• Drugs Controller General of India is the head of the department of the CDSCO of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
• DCGI also sets standards for the manufacturing, sales, import, and distribution of drugs in India.

Q1: What is the Central Drugs Standard Control Organization (CDSCO)?

CDSCO is the National Regulatory Authority (NRA) of India for the medical devices industry under the provisions of the Drugs & Cosmetics Rules.It works under the Ministry of Health & Family Welfare.

Source: DCGI calls for strict reporting of side-effects related to medical devices

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