MEDICAL DEVICES COMMITTEE

Chairman: Mr. Prabal Chakraborty
Vice President & Managing Director
Boston Scientific India Pvt. Ltd.

 

Secretariat: Mr. Gaurav Mendiratta
Sector Manager – Medical Devices
Email: gaurav@amchamindia.com

 

Sector Overview

 

The medical devices industry is estimated at USD 4.2 bn in 2014 and is expected to grow at a CAGR of 16% during 2014 – 2018[1]. Medical devices play a crucial role in diagnosing and managing diseases, particularly non-communicable diseases, by allowing people to live longer, healthier and more productive lives. Medical devices form an extremely diverse product category, with over 14,000 different types ranging in complexity from wound dressings, adhesive bandages and syringes to pacemakers, prosthetics and MRI machines.

 

The biggest challenge faced by the medical devices industry is that medical devices are not defined in the Drugs & Cosmetics act, 1940 and are treated as drugs. But, the government of India is slowly but surely recognising the significance of medical devices in India’s healthcare ecosystem. This is unequivocally clear from the fact that Government of India is deliberating on a separate regulatory regime for medical devices thereby differentiating them from drugs by making amendment to the Drugs and Cosmetics Act 1940. The Drugs & Cosmetics (Amendment) Bill 2015 is a big leap forward for healthcare delivery and allied sectors in India, and for the first time in India’s regulatory and legislative history, proposes to distinguish medical devices from pharmaceuticals.

 

Amcham has been working towards highlighting the critical role of Medical Device Industry in the Healthcare scenario and working on the policy frame work with the government for creating and improving the ecosystem for medical devices in delivery of world class treatment, preventive medicare and diagnostics.

 

Through Amcham and member companies, the Medical Device Committee aims to foster partnership with government and trade bodies, and promote policies that ensure sustainable access to the latest, highest quality medical technologies by healthcare professionals and their patients in India.

 

[1] Medical Technology Sector in India-Enabling Swastha Bharat, FICCI Report 2015

 

Letter from Weights & Measures Department

 

Meeting of committee members with Sh. Mukul Joshi, Secretary, Department of Pharmaceutical – 18 October 2011

 

Letter dated 23rd August 2010 to Mr. Vilasrao Deshmukh, Union Minister for Heavy Industries and Public Enterprises, regarding Regulation for Medical Devices