The Central government has moved forward with its plan to bring all implantable medical devices and other critical medical equipment under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics (D&C) Act 1940 to ensure quality and reliability.
The list also includes CT scan equipment, MRI equipment, Defibrillators, Dialysis machine, PET equipment, X-Ray machine and Bone marrow cell separator. The step, which is expected to address concerns regarding patient safety, was backed by the Drug Technical
Advisory Board at its 79th meeting held on May 16, this year.
These devices will be defined as ‘drugs’ under the D&C Act for the purpose of price and quality control and regulated using the Medical Device Rules 2017.
This will be notified in the official Gazette of India and it will come into force after a period of twelve months from the date of its publication.
The Central Drugs Standard Control Organisation (CDSCO), the national pharmaceutical regulatory body, has notified the list of devices to be regulated under the D&C Act and asked stakeholders to submit their suggestions within 21 days of issue of notice .
