First meeting today on regulating medical devices

First meeting today on regulating medical devices
#ImplantFiles: Govt’s new council on medical devices will tackle patient safety and pricing

MORE THAN two months after The Indian Express published the Implant Files, a series of investigative reports on the unregulated medical bazaar in India, the government will hold its first meeting Friday to discuss the “road map” for regulating the sale and use of medical devices.

The meeting will be held by the Central Drugs Standard Control Organization, the national medical device regulator, with major stakeholders of the medical device industry. It will discuss regulatory measures, including safety of patients and pricing, sources said.

A notice send by Drugs Controller General of India Dr S Eswara Reddy states that the meeting is “in pursuance of the order by Ministry of Health and Family Welfare and in order to prepare road for regulations of all medical devices”.

Sources said the meeting will also discuss key findings of the 10-month investigation by The Indian Express.

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The investigation highlighted how the first Bill to regulate medical devices was drafted 12 years ago but was still not enacted. And how global pharma majors are pushing such devices — from coronary stents and pacemakers to breast and knee implants — into markets via a dubious nexus with hospitals and doctors.

It found breast implants being done in basement Operating Theatres; an out-patient department at AIIMS to conduct revision surgeries for faulty orthopaedic implants; and global majors, such as Johnson & Johnson, Medtronic, Stryker, Abbott and Bayer, pushing devices without adequate oversight for quality or clinical testing.

The investigation also revealed that more than half of the medical and diagnostic medical equipment used in private clinics and hospitals are imported as “pre-owned” or “second hand” with no assessments done on their levels of accuracy or safety.