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Materiovigilance
programme of India and its reporting tools
Mr. V. Hari Haran
Senior Materiovigilance Associate,
Materiovigilance programme of
India (MvPI), Indian pharmacopoeia
Commission (IPC) Posted in National
Institute of Mental Health and
Neurosciences (NIMHANS), Bengaluru.
(Ministry of Health & Family Welfare)
Govt of India |
Mrs Abirami N
Materiovigilance associate
Materiovigilance programme of
India Indian pharmacopoeia
commission Ghaziabad |
In India, the regulatory agency, the Central Drugs
Standard Control Organization (CDSCO), plays a crucial
role in maintaining compliance with Post-Market
Surveillance (PMS) specifications. They ensure that
medical device manufacturers undertake post-market
surveillance studies and submit regular PMS reports
detailing the results of their surveillance activities.
The Ministry of Health and Family Welfare, Government of
India, approved and commenced the Materiovigilance
Programme of India (MvPI) in the country with the sole
objective of monitoring the safety and ensuring the
quality of medical devices used in the country. MvPI has
established monitoring centers and has made available an
adverse event reporting form for use by manufacturers,
importers, distributors, healthcare professionals, and
others to comply with PMS requirements, which can result
in penalties, fines, or even product recalls.
The MvPI was formally launched at the Indian
Pharmacopeia Commission (IPC), Ghaziabad, by the Drugs
Controller General of India (DCGI) on July 6, 2015. The
Indian Pharmacopoeia Commission (IPC) is an autonomous
institution of the Ministry of Health and Family Welfare
and also functions as the National Coordination Centre (NCC)
for the Materiovigilance Programme of India (MvPI). Sree
Chitra Tirunal Institute of Medical Sciences &
Technology (SCTIMST), Thiruvananthapuram, functions as a
National Collaborating Centre for the MvPI. Technical
support for the program is being provided by the
Healthcare Technology Division of the National Health
System Resource Centre (NHSRC), New Delhi, which is also
a WHO-collaborating center for priority medical devices
and health technology policy.
.
The MvPI program aims to promote and facilitate adverse
event reporting of medical devices and subsequently
evaluate these events. The scientific and systematic
evaluation of these medical device adverse events and
reports fosters monitoring trends for improving and
protecting the health and safety of patients. The
Medical Device Rules 2017, effective since January 2018,
mandate the reporting of all medical device adverse
events in the country to ensure patient safety.
Post-market surveillance of medical devices under the
Medical Devices Rules 2017 is collected under the
Materiovigilance Programme of India. It is submitted to
subject experts for necessary recommendations and will
be discussed with partner organizations like SCTIMST,
IPC, and NHSRC to provide regulatory feed back to CDSCO
for necessary corrective and preventive action with the
support of marketing authorization holders. Currently,
there is low awareness among manufacturers, importers,
distributors, health facilities, and consumers regarding
the MvPI program and its reporting mechanism, which
needs to be developed further in active mode to address
public health concerns related to medical devices.
In this regard a D.O.No. X.11035/429/2022-DRS dated:
14th October 2022 written by Dr, Rajesh Bhushan Health
Secretory, GOI wrote to all the state & union
territories for implementing PvPI & MvPI program for
promoting formation of Adverse Drug Reaction Monitoring
centres (AMC) and Medical device adverse event
monitoring centres (MDMC). |
