List of medical devices under public monitoring: Minister Apprises parliament

New Delhi: The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey stated in a written reply in the Rajya Sabha that 4 devices namely (i) Cardiac Stents, (ii) Drug Eluting Stents (iii) Condoms and (iv) Intra Uterine Devices have been included in the National List of Essential Medicines and are under price control by virtue of being included in Schedule-I to the Drugs (Price Control) Order, 2013.

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, regulates the safety, efficacy, and quality of 23 devices under the provisions of the Drugs and Cosmetics Act, 1940 and Rules thereunder, out of which 15 medical devices are notified under Section 3(b)(iv) of the Drugs and Cosmetic Act.

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Medical Devices Rules, 2017 have been implemented with effect from 01.01.2018 which have detailed provisions for the regulation of the manufacture, import, sale, and distribution of medical devices covered under the said Act to ensure their quality.

Further, the DTAB has agreed to include all implantable medical devices, CT scan equipment, MRI equipment, Defibrillators, Dialysis Machine, PET equipment and X-Ray Machine under the purview of section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 with the objective of ensuring their quality.

Read also: Pacemaker, X-rays, MRI machines soon under Drugs and Cosmetics Act

Out of the 23 medical devices, listed as drugs, 4 devices namely (i) Cardiac Stents, (ii) Drug Eluting Stents (iii) Condoms and (iv) Intra Uterine Devices have been included in the National List of Essential Medicines and are under price control by virtue of being included in Schedule-I to the Drugs (Price Control) Order, 2013 and their ceiling prices have been fixed.

Read also: After Stents, NPPA shifts its focus to 19 other Medical Devices, Check out details

Read also: 4 more medical devices to be added to price control list, document shows

Further, the Government has also notified the ceiling prices of Orthopedic Knee Implants for knee replacement system under paragraph 19 of the Drugs (Price Control) Order, 2013.

Read also: Knee Surgery Implants now under Price Ceiling, Effective Immediately

The MRPs of remaining medical devices, being under the non-scheduled category, are monitored to ensure that no manufacturer increases the maximum retail price by more than ten percent of the price during the preceding 12 month period.