In order to create an enabling ecosystem for manufacturing, research and innovation for medical device sector, NITI Aayog conducted a stakeholders consultation for drafting a medical devices bill in Delhi recently.
The purpose of the draft bill is to ensure that medical devices in India are safe and effective.
This follows the union health ministry directive in August this year for medical device manufacturers to register at the Medical Devices Information Sharing Portal through hyperlink – www.mvpi.co.in to effectively implement the Materiovigilance Programme of India (MvPI).
This portal would serve the purpose as an India specific tool to help Indian Pharmacopoeia Commission (IPC) facilitate baseline study of products available with medical devices companies in India and assure patient safety.
IPC in consultation with Central Drugs Standard Control Organisation (CDSCO) developed the portal to ensure that safe medical devices are available in the country.
According to NITI Aayog officials, “Appropriate, affordable and good quality medical devices are indispensable in healthcare services. Access to safe, effective and innovative medical devices is critical to ensuring healthy lives and promote well being for all. India is a booming market for consumption of medical technology.”
Ayushman Bharat Prime Minister Jan Aarogya Yojana (PMJAY) has further triggered an unprecedented demand for medical devices. It is also the government’s endeavor to make India a medical products manufacturing and innovation hub for the world. Hitherto, a select group of medical devices in India have been regulated through the Drugs and Cosmetics (D&C) Act 1940.
However, there is a long felt need for establishing a more enabling regulatory system in India to nurture and boost the medical devices sector.
IPC has been keenly working on the development of resource material and reporting tools as the National Coordination Centre (NCC) for MvPI which was launched in 2015.
Other reporting tools and reference documents for manufacturers available on IPC website are an updated medical devices adverse event reporting (MDAER) Form (version 1.1), a field safety corrective action (FSCA) form, a reference manual for medical devices and a handbook for MvPI.
Union health ministry is also planning to create a Registry of High Risk Medical Devices to effectively study and follow medical device associated adverse events (MDAE) and enable dangerous ones to be withdrawn from the market.
The registry would track usage of high risk medical devices in India mandatorily. The same would be worked out taking reference of international scenario so that serious adverse events (SAE) can be prevented soon before it arises from the manufacturer’s end.
The National Health Policy (NHP) 2017 envisages strengthening regulations of medical devices and establishing a regulatory body for medical devices to unleash innovation and the entrepreneurial spirit for manufacture of medical devices in India.