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Consider the following statements with reference to the Materiovigilance Programme of India (MvPI) platform:
1. It is launched to monitor the safety of medical devices.
2. The Indian Pharmacopoeia Commission functions as National Coordination Centre.
Which of the statements given above is/are correct?
- a)1 only
- b)2 only
- c)Both 1 and 2
- d)Neither 1 nor 2
Correct answer is option 'C'. Can you explain this answer?
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Most Upvoted Answer
Consider the following statements with reference to the Materiovigilan...
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.
- 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.
Hence both statements are correct.
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Consider the following statements with reference to the Materiovigilan...
Explanation:
Importance of Materiovigilance Programme of India (MvPI) platform:
- The Materiovigilance Programme of India (MvPI) platform is indeed launched to monitor the safety of medical devices in India. It aims to ensure the safety and effectiveness of medical devices by collecting, analyzing, and responding to reports of adverse events associated with these devices.
Role of Indian Pharmacopoeia Commission:
- The Indian Pharmacopoeia Commission (IPC) functions as the National Coordination Centre for the Materiovigilance Programme of India (MvPI). It plays a crucial role in coordinating the activities of the programme, including the collection and evaluation of adverse event reports related to medical devices.
Therefore, both the statements given in the question are correct. The Materiovigilance Programme of India (MvPI) platform is an important initiative in ensuring the safety of medical devices in the country, with the Indian Pharmacopoeia Commission serving as the National Coordination Centre for the programme.
Importance of Materiovigilance Programme of India (MvPI) platform:
- The Materiovigilance Programme of India (MvPI) platform is indeed launched to monitor the safety of medical devices in India. It aims to ensure the safety and effectiveness of medical devices by collecting, analyzing, and responding to reports of adverse events associated with these devices.
Role of Indian Pharmacopoeia Commission:
- The Indian Pharmacopoeia Commission (IPC) functions as the National Coordination Centre for the Materiovigilance Programme of India (MvPI). It plays a crucial role in coordinating the activities of the programme, including the collection and evaluation of adverse event reports related to medical devices.
Therefore, both the statements given in the question are correct. The Materiovigilance Programme of India (MvPI) platform is an important initiative in ensuring the safety of medical devices in the country, with the Indian Pharmacopoeia Commission serving as the National Coordination Centre for the programme.
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Consider the following statements with reference to the Materiovigilance Programme of India (MvPI) platform:1. It is launched to monitor the safety of medical devices.2. The Indian Pharmacopoeia Commission functions as National Coordination Centre.Which of the statements given above is/are correct?a)1 onlyb)2 onlyc)Both 1 and 2d)Neither 1 nor 2Correct answer is option 'C'. Can you explain this answer?
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