Mr. Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD) responded on the recent investigation into the Indian medical devices industry which has revealed a number of serious problems, including companies lobbying and bribing doctors, and patients being duped into unnecessary operations. It has revealed some glaring loopholes in the regulatory framework that governs the medical devices industry.
Global majors Medtronic and Stryker, Abbott and Bayer, all operating in a regulatory regime where there is no oversight for medical devices — either for their quality, clinical testing, pricing or performance.
It has been found that from coronary stents and pacemakers to breast and knee implants, from pelvic meshes to intrauterine devices — almost every medical device is advertised, sold, surgically implanted in a regulatory system that, effectively, doesn’t exist.
India’s medical device industry is estimated to be worth $5.2 billion – the fourth largest in Asia. The market at retail and institutional level is estimated to be over 10000 Cr Rs.
The number of cases of a medical device implant going wrong in a patient have increased from 40 in 2014 to 556 in 2018.
Mr. Rajiv …