Drug Res (Stuttg) 2020; 70(09): 429-436
DOI: 10.1055/a-1195-1945
Opinion Paper

Materiovigilance: Concept, Structure and Emerging Perspective for Patient’s Safety in India

Farazul Hoda
1  Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India
,
Rishabh Verma
1  Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India
,
Mawrah Arshad
1  Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India
,
Ali Nasir Siddiqui
2  Department of Pharmaceutical Medicine, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India
,
Mohammad Ahmed Khan
1  Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India
,
1  Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India
,
Abul Kalam Najmi
1  Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India
› Author Affiliations
Funding This review did not receive any specific grant from funding agencies in the public, commercial or non-for profit sectors.

Abstract

There has been an escalation in the number, diversity, and complexity of medical devices. Regulation of these devices has also advanced due to the requirement of better regulatory perspective induced due to elevation in the number of adverse events associated with medical devices. All over the globe, various measures are undertaken to provide better safety to the patients along with attempts to improve the standard of medical devices. The initial and ultimate objective of the concept happens to be unfailingly to ensure patient safety as well as impart required guidance for both manufacturers and adept authorities enabling them to superintend cases coherently and appropriately. Materiovigilance programme of India (MvPI) was launched by the Drug Controller General of India at the Indian Pharmacopoeia commission (IPC) in Ghaziabad in 2015. The main purpose of this initiative is to monitor adverse events associated with medical devices in order to generate safety data, create awareness among the various stakeholders, and prescribe best practices for patient safety. Whilst the reforms in regulations have proposed policies and designs to elucidate, consolidate and accelerate the processes involved in manufacturing and importing medical devices to India, they consistently carry their challenges and limitations. To eliminate such complications the guidelines and regulations are anticipated to be implemented appropriately with the efficacious conclusion. India has been evident in matching with advancements in the World Medical Device regulation scenario, the current review at hand takes upon the question of ‘how successful has it been so far’?



Publication History

Received: 07 February 2020

Accepted: 29 May 2020

Publication Date:
03 August 2020 (online)

© Georg Thieme Verlag KG
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