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 Amendments and Notifications


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Drugs and Cosmetics Rules, 1945
GSR 1041 (E) dtd 4.11.2016 - Drugs and Cosmetics (Seventh Amendment) Rules, 2016
In Schedule Y, in Appendix III relating to Animal Toxicology (non-clinical toxicity studies), in paragraph 1, in sub- paragraph 1.4 relating to Local Toxicity amended to carry out "non-animal alternative tests as given in Organisation for Economic Cooperation and Development Guidelines".
GSR 640 (E) dtd 29.6.2016 - Drugs and Cosmetics (Fourth Amendment) Rules, 2016
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Amends Rule 69, 69A, 75, 75A, 76 and substituted Schedule M-III
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GSR 532 (E) dtd 18.5.2016 - Drugs and Cosmetics (Third Amendment) Rules, 2016
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Substituted Rule 43-A
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Amended Rule 122DA, added a note in Schedule Y, Appendix I, item 4, after sub-item 4.8
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GSR 287 (E) dtd 8.3.2016 - Drugs and Cosmetics (First Amendment) Rules, 2016
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Amended Schedule Y
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GSR 11 (E) dtd 06.1.2016-The Drugs and Cosmetics (9th Amendment) Rules, 2016
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Draft rules to amend the Drugs and Cosmetics Rules, 1945, sub-rule (4) and (5) in Rule 122DA and a new Note is proposed in Schedule Y, Appendix I after item 4.8
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GSR 1011 (E) dtd 29.12.2015-The Drugs and Cosmetics (8th Amendment) Rules, 2015
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Draft rules to amend the Drugs and Cosmetics Rules, 1945, in respect to Rule 24 (1), 24-A (3), (5), (7), 34 (3), 34A(3), 59 (2), (3), (4), 62-C (1), (2), 67A (2), (3), 69 (2), (3), (4), 69A (1), (3), (4), 75 (1), (2), (3), (4), (5), 75A (1), (1A), (3), (4), 82, 85B (2), (3), (4), (5), 85ED, 90 (2), 122A (1), 122B (1), 122D (1), 122DA (2), 122 F (1), (2), (3) 122K, 129A(1), (5), 138 (1), (2), (3), 138A (1), (2), (5), (6) 150B (1), (2) & 151-I
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GSR 611 (E) dtd 31.7.2015-The Drugs and Cosmetics (Fifth Amendment) Rules, 2015
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In exercise of the powers conferred under section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 central Govt in consultation with DTAB, amended Drugs and Cosmetics Rules, 1945. A new para after clause (iii) in paragraph 2 under the heading "Clinical Trial" is added. In appendix V under the heading "Informed Consent", in sub-heading 1.1 relating to "Essential Elements" serial 14 is substituted with New Serial No. 14 to 16.
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GSR 558 (E) dtd 17.7.2015-The Drugs and Cosmetics (Sixth Amendment) Rules, 2015
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In exercise of the powers conferred under section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 central Govt in consultation with DTAB, amended Drugs and Cosmetics Rules, 1945. In rule 105, in sub-rule (2) second and third provisio are amended. Third provisio is substituted with "Provided also that Diclofenac injection for human use shall be in single unit dose pack only."
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GSR 289 (E) dtd 15.4.2015-Drugs and Cosmetics (Third Amendment) Rules, 2015
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In Rule 74, 74A, 74B, 78, 78A clause inserted not to advertise drugs specified in Schedule H, Schedule H1 or Schedule X without previous sanction of the Central Government. (Published in The Gazette of India, Extraordinary, PART II-Section 3-Sub-section (i), at No. 232)
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GSR 203 (E) dtd 18.3.2015-Drugs and Cosmetics (Second Amendment) Rules, 2015
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Liquid foundation make-up IS 14318, Cold Wax-Hair remover IS 15152, Face pack IS 15153, Kajal IS 15154, Oxidation Hair Dyes (Emulsion type) IS 15205, and Cream Bleach IS 15608 added in Schedule S.(Published in The Gazette of India, Extraordinary, PART II-Section 3-Sub-section (i), at No. 152)
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GSR 588 (E) dated 30.8.2013-Drugs and Cosmetics (Fourth Amendment) Rules, 2013
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Ministry of Health and Family Welfare, New Delhi on 30 Aug, 2013 vide GSR 588 (E) has notified Schedule H1 after consultation with DTAB. These Rules will come in force after six months of publication in official Gazette.

In Rule 65, in condition (3), (9), (11) (11A) wherever Schedule H is their “Schedule H and Schedule H1” shall be substituted.

In Rule 97 in sub rule (1) a provision is made that the formulation containing substance specified in Schedule H1, the drug formulation shall be labelled with symbol Rx which shall be in red and conspicuously displayed in the left top corner of the label and shall also be labelled with following Box warning:

“Schedule H1 Drug-Warning -It is dangerous to take this preparation except in accordance with the medical advice. -Not to be sold by retail without the prescription of a Registered Medical Practitioner,”

In Schedule H, Alprazolam, Cefdinir, Cefepime HCl, Cefetamet Pivoxil, Cefpirome, Cefpodoxime Poxetil, Ceftazidime Pentahydrate, Ceftizoxime Sodium, Chlordiazepoxide, Clofazimine, Codeine, Diazepam, Diphenoxylate and its salts, Ethambutol HCl, Ethionamide, Levofloxacin, Meropenam, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Pyrazinamide, Sparfloxacin, Thiacetazone, Tramadol HCl, Zolpidem entries are omitted.

In Schedule H1, following drug substances and their salts excluding those intended for topical or external use (Except ophthalmic and ear or nose preparations) Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefexime, Cefoperazone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Chlordiazepoxide, Clofazimine, Codeine, Cycloserine, Diazepam, Diphenoxylate, Doripenem, Ertapenem, Etambutol HCl, Ethinamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Ribabutin, Rafampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem are covered.

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GSR 72 (E) dtd 8.2.2013-The Drugs and Cosmetics (Third Amendment) Rules, 2013
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In the Drugs and Cosmetics Rules, 1945, after rule 122 DC, a new rule 122 DD inserted related to Registration of Ethics Committee.
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GSR 364 (E) dated 7.6.2013- Drugs and Cosmetics (Second Amendment) Rules, 2013
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In Schedule Y in sub-paragraph (4) after clause (iii), clause (iv) is inserted and in Appendix V under heading 1 in sub heading 1.1 relating to ‘Essential Elements’, the existing entry 14 is renumbered 16 & new entries 14 and 15 are inserted.
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GSR 53 (E) dtd 30.1.2013-The Drugs and Cosmetics (First Amendment) Rules, 2013
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Inserted Appendix XII-Compensation in case of injury or death during Clinical Trial, Rule 122-DAB, Clause (v) in Schedule Y, substitutes clause (iv) in Schedule Y
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GSR 63 (E) dtd 1.2.2013-The Drugs and Cosmetics (Second Amendment) Rules, 2013
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In the Drugs and Cosmetics Rules, 1945, in Part X-A, after rule 122 DAB, a new rule 122 DAC inserted-related to Permission of Clinical Trials.
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GSR 263 (E) dtd 30.3.2011 -Import registration date extended wef 1.10.2011 for GSR 426 (E) dtd 19.5.2010
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GSR 45 (E) dated 24.1.11-Drugs and Cosmetics (1st Amendment) Rules, 2011-Rule 122E (i) substituted
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In the Drugs and Cosmetics Rules, 1945 in rule 122E, in the Explanation for item (i) "(i) all vaccines and recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under rule 21" shall be substituted.
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GSR 426 (E) dated 19.5.2010 Hindi/ English-Drugs and Cosmetics (4th Amendment) Rules, 2010 (Wef 1.4.2012)(shall come into force with effect from 1.4.2013)
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In Part XIII, for the heading "Import of Cosmetics", The heading "Import and Registration of Cosmetics" shall be substituted. Rule 129 is substituted with Rule 129, 129A to 129H. After Form 41, Form 42 and 43 are inserted. After Schedule D (II), a new Schedule D(III) is inserted.
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NO.893(E) dated 24.12.2008-Guidelines for evaluation of Ayurveda, Siddha & Unani Drugs and other Traditional Medicines of India.
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GSR 755 (E) dated 23.10.2008-Notification reg. amendment in Drugs & Cosmetics Rules, 1945 to permitted Excipients etc in ASU Drugs
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S.O.297(E) dated 12.2.2008
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Notification of Dr. Surinder Singh, Drugs Controller (India) (In-charge) as the Licensing Authority under Rule 21 (b)
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GSR 579 (E) dated 20.9.2006- Drugs and Cosmetics (4th Amendment) Rules, 2006
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The Central Govt in exercise of the powers conferred by Sections 12 and 33 of the said Act, In Rule 2 for clause (b) a new clause reading ‘“Central Licence Approving Authority”, means the Drugs Controller, India, or the Joint Drugs Controller (India) or the Deputy Drugs Controller (India) appointed by the Central Government.’ is substituted.
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In pursuance of the provisions of clause (b) of Rule 21 of Drugs & Cosmetics Rules, 1945, the Central Government has appointet Dr. M. Venkateshwarlu, Drugs Controller (India) (In-charge) to be the Licensing Authority.
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GSR 352 (E) dated 1st/8th June, 2006-Drugs and Cosmetics (3rd Amendment) Rules, 2006
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Functions, Procedure for despatch of samples for test or analysis, Report of result of test or analysis, Fee Schedules and Forms are notified for Pharmacopoeial Laboratory for Indian Medicines to function as Central Drugs Laboratory for the purpose of testing or analysis of Ayurveda, Siddha and Unani drugs.
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GSR 160(E) Dated 16.3.2006- Drugs and Cosmetics (2nd Amendment) Rules, 2006
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The Central Govt has issued notification to substitute the existing Schedule H with a new Schedule-H containing 536 drugs with immediate effect.
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GSR 26 (E) dated 19.1.2006
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Central Govt vide this notification has substituted Rule 69 (5) with a fresh sub rule (5), in Rule 75, 76, Form 29-6H, 27D and 28D alongwith words " Large Volume Parenterals and Sera and Vaccines" " Recombinant DNA (r-DNA) derived drugs" are inserted. Rule 122 B is also amended and in Schedule P under the heading ' Sera, Toxin and Toxoid' against serial number 18, expiry of 36 months & storage In cold place shall be substituted. This shall come into force from 19.1.2006
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