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Oviya MedSafe offers Materio-Vigilance programme for assessing safety of medical devices in India

Peethaambaran Kunnathoor, Chennai
Thursday, March 19, 2015, 08:00 Hrs  [IST]

Subsequent to the approval of the Union health ministry for establishing Materio-Vigilance Programme of India (MvPI)  to ensure the safety of medical devices and report their adverse events, the Coimbatore based pharmacovigilance company, Oviya MedSafe,  has started discussions to offer their services to domestic and foreign companies manufacturing medical devices.

The company plans to create a platform of major medical devices manufacturers from India and abroad for sharing ideas and views about tracking of adverse events of medical devices and equipment  in line with pharmacovigilance programme, sources from the company informed.

The Union government was forced to set up the adverse events tracking programme due to several terrible incidents of malfunctioning of medical devices that happened recently in some hospitals in the country. Once MvPI is introduced, the adverse events of the medical devices, instruments and equipment can be registered with the concerned authorities. Currently, there is no such system for registration.

The programme will be made nationwide soon just as pharmacovigilance, bio-vigilance and haemovigilance programmes.

According to sources from health ministry, the bio-medical technology wing of the  Sree Chitra Thiunal Institute of Medical Sciences and Technology at Thiruvananthapuram will be the national collaborating centre for the programme and it will coordinate with the CDSCO. The programme is also aimed at creating awareness about the importance of medical device associated adverse events (MDAE) reporting in India and generate independent, evidence based recommendations on the safety of medical devices.

Dr Vijay Venkataraman, the CEO of Oviya MedSafe said there were reports initially that the MvPI will be established in 10 medical colleges in the country, and it will work in line with the ongoing pharmacovigilance programme of India (PvPI).

While speaking to Pharmabiz, he said “MvPI cells are to be established initially in 10 medical colleges in order to monitor the benefit-risk profile of medical devices. With these baby steps taken today towards achieving excellence in pharmacovigilance as well as materio-vigilance in India, we can be confident that the country is marching towards the right direction”.

The central government in 2013 had made a budget allocation of Rs. 100 crore for the four surveillance programmes of the country, pharmacovigilance, bio-vigilance, materio-vigilance and haemovigilance programmes.

 

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