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important Notifications I] Contraceptives and Disinfectants notified as drugs under Section 3 (b) (ii). Notification No. 1-20/60-D, Government of India, Ministry of Health, New Delhi-2, dated 3rd June, 1961.- In exercise of the powers conferred by sub-clause (ii) of clause (b) of Section 3 of the Drugs Act, 1940 (23 of 1940), the Central Government in supersession of the notifications of the Government of India in the Ministry of Health No. F.1-10/56-D, dated 20th October, 1956, F.1- 40/59-D, dated 2nd April 1960 and No. F.1-50/59 dated the 15th June, 1960, hereby specifies as drugs the following. 1. * Contraceptives 2. **Disinfectants (1)*** Disinfectant fluids made from coal tar oil, coal tar acids or similar acids derived from petroleum with or without hydrocarbons. (2)*** Disinfectant fluids made from synthetic or naturally occurring substance other than those mentioned in (1) above by virtue of their composition possessing disinfectant properties or with claim to possess disinfectant properties. * Amended by Govt. of India Ministry of Health Notification NO. F. 1-20/60-D, dated 29.09.1962. ** Amended by Notification No. X. 11013/2/72, dated 9-7-1975 *** Amended by Notification No. F. 1-49/68-D dated 11.6.1969. II - Medical Devices notified under Section 3 (b) (iv). Notification No.G.S.R. 365(E), dated March 17, 1989. In pursuance of the sub-clause (iv) of clause (b) Section 3 of the Drugs and Cosmetics Act, 1940, the Central Government hereby specify the following devices, after consultation with the Drugs Technical Advisory Board, as drugs with immediate effect:- (i) Disposable Hypodermic Syringes. (ii) Disposable Hypodermic needles. (iii) Disposable Perfusion sets. (iv) In –vitro diagnostic devices for HIV, HbsAg and HCV.] III - Aditional Medical Devices notified under Section 3 (b) (iv) Notification No. S.O. 1468(E) dated 6th October, 2005 In pursuance of the sub-clause(iv) of clause(b) of Section of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following sterile devices intended for external or internal use in human beings as drugs with immediate effect, namely :- i. Cardiac Stents ii. Drugs Eluting Stents iii. Catheters iv. Intra Ocular Lenses v. I.V. Cannulae vi. Bone Cements vii. Heart Valves viii. Scalp Vein Set ix. Orthopaedic Implants x. Internal Prosthetic Replacements. IV] Notification under Rule 68 A - Drugs within Purview of CLAA notified. Notification No. G.S.R. 86 (E), dated February 26, 1993 as corrected by Notification No. G.S.R. 374 (E), dated 13th April, 1993 In pursuance of the provisions of sub-rule (i) of Rule 68-A of part VII of the Drugs and Cosmetics Rules , 1945, the Central Government hereby specifies the following drugs to be licensed for manufacture for sale or distribution by the Central Licence Approving Authority appointed by the Central Government. (1) Whole Human Blood and Blood Products. (2) Large Volume Parenterals (Intravenous Fluids). (3) Sera and Vaccines. (4) Recombinant DNA (r-DNA) derived drugs.] V] Notification under Rule 68 A - Drugs within Purview of CLAA notified. Notifcation No. G.S.R. 627(E) dated 7th October 2005 In pursuance of provisions of sub-rule (i) of rule 68A of part VII of the Drugs and Cosmetics Rules, 1945, the Central Government hereby specifies the following drugs to be licensed for manufacture, for sale or distribution by the Central License Approving Authority appointed by the Central Government, namely:- i. Cardiac Stents ii. Drugs Eluting Stents iii. Catheters iv. Intra Ocular Lenses v. I.V. Cannulae vi. Bone Cements vii. Heart Valves viii. Scalp Vein Set ix. Orthopaedic Implants x. Internal Prosthetic Replacements.
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