India developing federal medical device surveillance system

It will be run out of 10 Indian medical schools, led by the Sree Chitra Thirunal Institute of Medical Sciences and Technology in the South Indian city of Thiruvananthapuram, according to Indian news outlet  The Indian Pharmacopoeia Commission, located near New Delhi, will play a coordinating role, as well as the Central Drug Standard Control Organization, the country’s equivalent to the FDA.  In addition, a proposed World Health Organization center for crucial medical devices and health technology policy would provide technical support, according to the article.

Currently, a committee formed to implement the program is designing adverse event reporting forms and studying how to do to causality assessments.  The government has devoted about $15 million to setting up surveillance programs for pharmacovigilance, biovigilance, and haemovigilance, as well as medical device monitoring, or materiovigilance.  Among emerging markets, India is one of the most accepting of new devices because it has many modern, privately run hospitals, and lacks a strict process for device regulation or approval.

But this move shows the Indian government is looking to increase its oversight of a med tech market worth $3.1 billion annually.  The information gained from the monitoring system will help regulators’ make decisions and recommendations based on domestic use of devices.  China is also implementing systems to gather domestic data in the form of more invasive local clinical trials, which would be required as a condition for device approval.

The article alludes to the global metal-on-metal hip debacle, which left a stream of injured patients in its wake, and demonstrates the dangers of other countries’ reliance on the FDA and European regulators.  The plan to create an adverse event reporting and post-market monitoring system comes in the context of a federal proposal to create a separate medical device regulatory regime.  In India, they are currently regulated as drugs, in spite of the myriad differences between the two sets of products.

REFERENCE:  Fierce Medical Devices; 22 MAY 2015; Varun Saxena

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