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Materiovigilance programme goes through sticky patch as adverse events go unreported

Arun Sreenivasan, New Delhi
Wednesday, April 11, 2018, 08:00 Hrs  [IST]

Three years after receiving the health ministry’s green light, the Materiovigilance Programme of India (MvPI), an initiative to ensure the safety of medical devices, is progressing at a snail’s pace, thanks to lack of proper regulatory mechanism to make adverse event reporting mandatory and reluctance of manufacturers and healthcare institutions to report such incidents voluntarily.

The long-awaited Medical Devices Rules, 2017, the industry’s new rulebook that came into force in January this year, has provided among other things a risk-based classification of medical devices and a simplified process for obtaining registration or licence. However, the norms remain unclear about adverse event reporting though they have made it mandatory for manufacturers and importers to recall a product if it poses risk to a patient. Only those companies initiating recall are required to inform the licensing authority about the recall details.

The MvPI, being coordinated by the Indian Pharmacopoeia Commission (IPC) at Ghaziabad, was launched in 2015. The Commission functions as the national coordination centre and Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as the collaborating centre. Technical support is being provided by the National Health System Resource Centre in New Delhi. The purpose of the programme is to study and follow medical device associated adverse events (MDAE) and enables dangerous ones to be withdrawn from the market.

India has no proper system for registering MDAE or for tracking the safety record of medical devices despite being a $3 billion market and has been depending on data from the developed countries. “MvPI was envisaged as a nation-wide programme involving district hospitals, medical colleges and corporate healthcare institutions. Though three years have passed since its launch, only a few hospitals have MvPI cells. Some institutions have appointed research fellows to monitor MDAE, but this is a recent development. The programme is still in its infancy,” a senior scientist who was associated with the programme said on condition of anonymity.

“As per the current guidelines, it is the moral responsibility of the healthcare provider to report medical device-linked adverse events unlike in the developed nations were failure to report an incident is an offense. Moral responsibility is not an objective concept. As a result many equipment that are recalled by regulators across the globe continue to be sold in the Indian market,” a healthcare professional pointed out.

“A robust reporting structure is still missing. But the project has certainly helped increase awareness of MDAE among industry associations and healthcare providers. Last year only a handful of incidents were reported. But this year, on an average, 10 cases are reported every month to this facility,” a source at the SCTIMST said.

Keeping a close watch on MDAE and creating awareness among health care professionals are not the only goals of the project. It is also meant to generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.


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