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India to roll out adverse event medical device monitoring

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India to roll out adverse event medical device monitoring

India’s health ministry said this week that it’s forming a program in the next 3 months to monitor adverse events in medical devices across the country, PharmaBiz.com reported.

The plan is slated to be coordinated by the Indian Pharmacopoeia Commission in Ghaziabad, while the biotechnology wing of the Sree Chitra Thirunal Institute of Medical Sciences and Technology in Thiruvananthapuram is set to be the collaborating center for the program, according to the website.

The aim is to enable systematic safety data collection so that regulatory decisions and recommendations for safe use of devices in India can be based on data generated within the country, according to the report. It will also generate independent, evidence-based recommendations on the safety of medical devices and communicate its findings to all key stakeholders.

Despite being a $3.1 billion medical device market, India currently has no regulatory scheme in place for tracking and recording adverse event data from medical devices, which leaves the country dependent upon other nations’ medical data.

The health ministry said it foresees "Materio-vigilance Program" centers in 10 medical colleges across India. According to officials, these medical colleges are already equipped to collect and disseminate adverse event information.

Ministry officials said that the program would operate along similar lines to its already running pharmaceutical and blood monitoring programs, the website reported.

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