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Medical devices under public monitoring

The CDSCO, under the Ministry of Health and Family Welfare, regulates the safety, efficacy, and quality of 23 devices under the provisions of Drugs and Cosmetics Act, 1940 and rules there under, out of which 15 medical devices are notified under Section 3(b)(iv) of the Drugs and Cosmetic Act. Medical Devices Rules, 2017 have been implemented with effect from August 1, 2018 which have detailed provisions for regulation of 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 machines under the purview of section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 with the objective of ensuring their quality.

Out of the 23 medical devices, listed as drugs, four devices namely cardiac stents, drug eluting stents, condoms, and 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.

Further, the government has also notified the ceiling prices of orthopedic knee implants for a knee replacement system under paragraph 19 of the Drugs (Price Control) Order, 2013. 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 10 percent of the price during the preceding 12-month period.

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