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

MATERIOVIGILANCE PROGRAMME OF INDIA

• Launched on July 6, 2015, to monitor medical device safety in India.
• Aims to systematically collect and analyze data on adverse events related to medical devices for regulatory decisions.
• Includes electronic equipment, implants, consumables, surgical instruments, and in-vitro diagnostic reagents.
• Focuses on reporting adverse events, coordinated analysis, and regulatory recommendations.
• Coordination and Regulation
  • National Coordination Centre (NCC) operated by the Indian Pharmacopoeia Commission (IPC) since 2018.
  • Regulated by the Central Drugs Standards Control Organization (CDSCO) under the Ministry of Health and Family Welfare.
• Current Regulatory Framework
  • Medical devices regulated under the Drugs and Cosmetics Act, 1940, and Medical Device Rule, 2017.
  • India heavily dependent on imports, with approximately 80% reliance on imported medical devices.

DRUGS CONTROLLER GENERAL OF INDIA (DCGI)

• Head of the CDSCO responsible for approving licenses of specified drug categories.
• Sets standards for drug manufacturing, sales, import, and distribution in India.
• Approves licenses for drugs like blood products, IV fluids, vaccines, and sera.
• Ensures compliance with regulatory standards for drug quality and safety.