Should Surgical gowns and drapes come under Drugs and Cosmetics Act? CDSCO invites Public Comments

New Delhi: Through a recent public notice, the Central Drugs Standard Control Organisation(CDSCO) has informed about the proposal of bringing surgical gowns and drapes under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 as Medical Devices

In this connection, it has invited all the stakeholders to forward their comments and suggestions within 45 days of issue of the notice through email at dci@nic.in and ddcimd-cdsco@nic or in hard copies to the O/o DCG(I), CDSCO, FDA Bhawan, Kotla Road, New Delhi-110002. The public notice to this effect was published on 27th November, 2018.

Section 3 of the Drugs and Cosmetics Act, 1940 gives various definitions under the act. Section 3 (b) defines the word "DRUG" under the act, and section Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 means to include medical devices as Drug adding such devices* intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;

The said section gives power to the government to bring medical devices under the purview of the act. Ministry of Health & Family Welfare, Government of India has notified the Medical Devices Rules 2017 vide G.S.R. 78(E) dated 31.01.2017 under the provisions of the Drugs and Cosmetics Act, 1940. At present, 15 notified medical devices are regulated under the said act.

In the meeting held on 05.10.2018 at Nirman Bhawan, New Delhi under the chairmanship of DGHS w.r.t. the implementation of the decisions taken by the Committee of Secretaries (Cos) on Technical Textiles, it proposed that surgical gowns and drapes can be considered for notification under the said Act.

In this connection, all the stakeholders are requested to forward their comments/suggestions within 45 days of issue of this notice through email at dci@nic.in and ddcimd-cdsco@nic or in hard copies to the O/o DCG(I), CDSCO, FDA Bhawan, Kotla Road, New Delhi-110002

Also Read: CDSCO invites comments on New Drugs and Clinical Trials Rules, 2018