Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Drugs Rules, 1945

S.no Title Release Date Download Pdf Pdf Size
1 THE DRUGS RULES 1945 2022-Nov-22 4983 KB
2 DR_G.S.R. 654(E) dt_24.08.2022_Parallel submission in Form 28-D 2022-Aug-24 1242 KB
3 DR_G.S.R. 623(E) dt_10.08.2022_To include colour of disinfectants in rule 127 of Drugs Rules 1945 2022-Aug-10 1033 KB
4 DR_G.S.R. 502(E) dt_30.06.2022_Proviso to Sr.no 39 in Sch K for Liquid Antiseptics in Drugs Rules 2022-Jun-30 1289 KB
5 DR_G.S.R. 357(E) dt_18.05.2022_Inclusion of Acitretin in Sch H of Drugs Rules 1945 2022-May-18 1314 KB
6 DR_G.S.R. 158(E) dt_24.02.2022_Inclusion of allura red colour in rule 127 of the Drugs Rules 1945 2022-Feb-24 1423 KB
7 DR_G.S.R. 30(E) dt_20.01.2022_Amendment of Sch K for Liquid Antiseptics at Sr. no 39 in Drugs Rules 2022-Jan-20 1367 KB
8 DR_G.S.R. 20(E) dt_18.01.2022_QR code for active pharmaceutical ingredients 2022-Jan-18 1549 KB
9 DR_G.S.R. 258(E) dt_07.04.2021_ Inclusion of Tapentadol in Sch H1 at S.No. 48 2021-Apr-07 1225 KB
10 DR_G.S.R. 255(E) dt_07.04.2021_For substitution at entry no 14. of GSR 578(E) dt 23.07.1983 reg FDC of tamsulosin+Deflazacort 2021-Apr-07 1508 KB
11 DR_G.S.R. 140(E) dt_26.02.2021_Schedule K at serial number 23 to include Anganwadi worker 2021-Feb-26 1369 KB
12 DR_G.S.R. 47(E) dt_25.01.2019_Exemption of 100mL single use sterile parenteral solutions for export under Schedule K 2021-Jan-25 2426 KB
13 DR_G.S.R. 219(E) dt_26.03.2020_Sale of Hydroxychloroquine as per Schedule H1_Section 26B 2020-Mar-26 1190 KB
14 DR_G.S.R. 220(E) dt_26.03.2020_Doorstep delivery of the drugs by retail _Section 26B 2020-Mar-26 1343 KB
15 DR_G.S.R. 166(E) dt_18.03.2020_Amendment in Part X B & Part XII B pertains to Blood centre and Blood components 2020-Mar-18 2014 KB
16 DR_G.S.R. 180 (E) dt_16.03.2020_Banning of Chenodeoxycholic acid & Ursodeoxycholic acid extracted and prepareunder Section 10A 2020-Mar-16 773 KB
17 DR_G.S.R. 101(E) dt_13.02.2020_Definition, Responsibility & labelling requirements for marketer of the drugs 2020-Feb-13 787 KB
18 DR_G.S.R. 52(E) dt_27.01.2020_Exemption of Import of Oxytocin reference standards from Prohibition 2020-Jan-27 745 KB
19 DR_G.S.R. 653(E) dt_13.09.2019_Notification of ICD Dhannad Indore in MP for import of drugs under Rule 43A 2019-Sep-13 242 KB
20 DR_G.S.R. 499(E) dt_17.07.2019_Consesquential amendments to GSR 1337(E) Dt. 27.10.2017 2019-Jul-17 361 KB
21 DR_G.S.R. 317(E) dt_18.04.2019_Amendment in Form 45 and Form 46 under Schedule-A of D&C Rules, 1945 2019-Apr-18 322 KB
22 DR_G.S.R. 231(E) dt_20.03.2019_Addition of Rule 97A 2019-Mar-20 306 KB
23 DR_G.S.R. 205(E) dt_08.03.2019_Omission of provision for writing brand name in brackets in Rule 96 of D &C Rules, 1945 2019-Mar-08 302 KB
24 DR_G.S.R. 153(E) dt_26.02.2019_Date of implementation for G.S.R. 277(E) dated 23.03.2018 2019-Feb-26 315 KB
25 DR_G.S.R. 20(E) dt_10.01.2019_Notification of Mundra port and Kamarajar Port under Rule 43A 2019-Jan-10 292 KB
26 DR_G.S.R. 19(E) dt_10.01.2019_Provosion for information to be uploaded by licensee on SUGAM portal 2019-Jan-10 328 KB
27 DR_G.S.R. 521(E) dt_01.06.2018_Form12B_Extended validity of personal import licence 2018-Jun-01 1757 KB
28 DR_G.S.R. 602(E) dt_29.06.2018_Extention of implementation date for GSR 411(E) dated 27.04.2018 2018-Apr-27 1749 KB
29 DR_G.S.R. 411(E) dt_27.04.2018_ Regulation and restriction of the manufacture, sale & distribution of Oxytocin under Section 26A 2018-Apr-27 1756 KB
30 DR_G.S.R. 408 (E) dt_26.04.2018_amendment of Rule 96, Rule 97 , Sch H & Sch K 2018-Apr-26 1795 KB
31 DR_G.S.R. 390(E) dt_24.04.2018_Prohibit the import of Oxytocin under Section 10A 2018-Apr-24 1721 KB
32 DR_G.S.R. 385(E) dt_19.04.2018_Amendment of Sch-K to exempt Oxygen 93% IP 2018-Apr-19 1780 KB
33 DR_G.S.R. 360(E) dt_10.04.2018_Stability study of drugs & Sch.D exemption 2018-Apr-10 1730 KB
34 DR_G.S.R. 277(E) dt_23.03.2018_Inclusion of drugs in Sch. H 2018-Mar-23 1707 KB
35 DR_G.S.R. 222(E) dt_13.03.2018_ Rule 96_Amendment of proper name font size 2018-Mar-13 1689 KB
36 DR_G.S.R. 367(E) dt_13.04.2017_Revoke of suspension on dextropropoxyphene 2017-Apr-13 1157 KB
37 DR_G.S.R. 329(E) dt_03.04.2017_Form44_Particulars of new drug entries omitted 2017-Apr-03 1202 KB
38 DR_G.S.R. 328(E) dt_03.04.2017_Rule 122P_Blood banks and Blood Donation Camps 2017-Apr-03 299 KB
39 DR_G.S.R. 327(E) dt_03.04.2017_BCS Classification and BABE studies 2017-Apr-03 1205 KB
40 DR_G.S.R. 303(E) dt_30.03.2017_Shedule H_Etizolam was included 2017-Mar-30 1149 KB
41 DR_G.S.R. 250(E) dt_15.03.2017_Insertion to Rule 3A_Added tests notified for NIB 2017-Mar-15 1156 KB
42 DR_G.S.R. 145(E) dt_17.02.2017_Revoke of suspension on Letrozole 2017-Feb-17 1131 KB
43 DR_G.S.R. 144(E) dt_17.02.2017_Regulation of Oseltamivir Phosphate and Zanamivir 2017-Feb-17 1132 KB
44 DR_G.S.R. 103 (E) dt_02.02.2017_Addition of Rule 36A_Import of drugs by charitable hospital for free of cost 2017-Feb-02 1121 KB
45 DR_G.S.R. 76(E) dt_31.01.2017_Amendment SchK_Exemptions of Homeopathic hair oils,Custom made devices,Zinc sulphate Tabs 2017-Jan-31 1125 KB
46 DR_G.S.R. 56(E) dt_19.01.2017_Amendment Rule 135A, 145D_Limit of Mercury in cosmetics 2017-Jan-19 1107 KB
47 DR_G.S.R. 41(E) dt_17.01.2017_Notification for Hazira port and ICD Khodiyar Gandhi nagar 2017-Jan-17 1136 KB
48 DR_G.S.R. 640(E) dt_29.06.2016_Sch MIII(Rule 69, 69A,75,75A,76)_Quality management system for notified Medical devices 2016-Jun-29 495 KB
49 DR_G.S.R. 532(E) dt_18.05.2016_Addition of Vishakhapatnam Sea and air port 2016-May-18 164 KB
50 DR_G.S.R. 313 (E) dt_16.03.2016_Amendment Rule 122DA_Ethics Committee 2016-Mar-16 131 KB
51 DR_G.S.R. 287(E) dt_08.03.2016_Amendment SchY_PSUR, Systemic Toxicity studies 2016-Mar-08 151 KB
52 DR_G.S.R. 104 (E) dt_25.01.2016_corrigendum to GSR 826 2016-Jan-25 66 KB
53 DR_G.S.R. 611(E) dt_31.07.2015_Amendment SchY_Relating to Informed Consent 2015-Jul-31 93 KB
54 DR_G.S.R. 558(E) dt_17.07.2015_Amendment Rule 105_amendment in proviso and proviso added for Diclofenac Inj 2015-Jul-17 140 KB
55 DR_G.S.R. 390(E) dt_18.05.2015_Amendment Rule 157_No prefix & suffix for Aurvedic siddha unanitibb 2015-May-18 155 KB
56 DR_G.S.R. 289(E) dt_15.04.2015_Amendment Rule 74,74A,74B, 78,78A_No Advertisement for Sch H, H1, X Drugs 2015-Apr-15 147 KB
57 DR_G.S.R. 203(E) dt_18.03.2015_Amendment Sch S, SchQ 2015-Mar-18 68 KB
58 DR_G.S.R. 107(E) dt_17.02.2015_Amendment Schedule K_Words ommited in Form 20C 2015-Feb-17 1121 KB
59 DR_G.S.R. 570(E) dt_07.08.2014_Ammendment Rule 71, 71A, 71B,76, 76A_API in proper or generic name 2014-Aug-07 180 KB
60 DR_G.S.R. 498(E) dt_11.07.2014_Prohibition of FDC_Flupenthixole and Melitracen 2014-Jul-11 82 KB
61 DR_G.S.R. 498(E) dt_11.07.2014_26A_reg FDC of Flupenthixol and Melitracen 2014-Jul-11 82 KB
62 DR_G.S.R. 346(E) dt_21.05.2014_Insertion of 148C_ Prohibition of testing of cosmetics on animals 2014-May-21 69 KB
63 DR_G.S.R. 86(E) dt_13.02.2014_Revoke GSR378(E)_Reg. Suspension of Analgin 2014-Feb-13 83 KB
64 DR_G.S.R. 29 (E) dt_17.01.2014_26A_Oxytocin supply to licensed Mfgrers and to Vet hospitals 2014-Jan-17 90 KB
65 DR_G.S.R. 588(E) dt_30.08.2013_Amendment Rule 65, Rule 97_Inclusion of Sch H1, Labelling requirements, Sch H list 2013-Aug-30 182 KB
66 DR_G.S.R. 520(E) dt_31.07.2013_Revoke GSR 379(E)_Reg.Pioglitazone Suspension 2013-Jul-31 164 KB
67 DR_G.S.R. 379 (E) dt_18.06.2013 _Suspension of manufacture, sale, distribution of Pioglitazone 2013-Jun-18 55 KB
68 DR_G.S.R. 377(E) dt_18.06.2013_26A_ Flupenthixol + Melitracen for human use 2013-Jun-18 85 KB
69 DR_G.S.R. 332(E) dt_23.05.2013_26A_reg Dextropropoxyphene 2013-May-23 56 KB
70 DR_G.S.R. 590(E) dt_08.30.2013_Corrigendum to GSR 332(E) 23.05.2013 2013-May-23 55 KB
71 DR_G.S.R. 72(E) dt_08.02.2013_Addition of Rule 122DD_Registration of Ethics Committee 2013-Feb-08 415 KB
72 DR_G.S.R. 53(E) dt_30.01.2013_Addition Rule 122 DAB, Appendix XII_Death Compensation 2013-Jan-30 596 KB
73 DR_G.S.R. 575(E) dt_17.07.2012_Amendment to rule 43A_Addition of mumugao sea port and Goa , Bengaluru air port 2012-Jul-17 56 KB
74 DR_G.S.R. 574(E) dt_17.07.2012_amendment Rule 75A, 76A,78A, 83A, 83AA,Schedule A 2012-Jul-17 131 KB
75 DR_G.S.R. 433(E) dt_07.06.2012_Amendment to GSR 577E_Addition of prohibition of Import of Serodiagnostic test kit for TB 2012-Jun-07 25 KB
76 DR_G.S.R. 432(E) dt_07.06.2012_26A_Banning of SeroDiagnostic Kits for diagnosis of tuberculosis 2012-Jun-07 21 KB
77 DR_G.S.R. 270(E) dt_30.03.2012_Corregendum to GSR 733(E) dt 29.09.2011 2012-Mar-30 25 KB
78 DR_G.S.R. 76(E) dt_08.02.2012_Amendment in Rule 127_Addition of Titanium Dioxide coated mica pearlscent pigments 2012-Feb-08 45 KB
79 DR_G.S.R. 28(E) dt_17.01.2012_Amendment in Rule 97_Labelling requirements for Food producing Animals 2012-Jan-17 51 KB
80 DR_G.S.R. 418(E) dt_30.05.2011_26A_reh Human Placental Extracts (HPE) 2011-May-30 79 KB
81 DR_G.S.R. 82(E) dt 10.02.2011_26A_Reg Nimesulide, Cisapride, Phenylpropanolamine, HPE and Sibutramine 2011-Feb-10 41 KB
82 DR_G.S.R. 45(E) dt_24.01.2011_Amendment Rule 122E_Addition of Vaccines and r-DNA 2011-Jan-24 79 KB
83 DR_G.S.R. 337(E) dt_15.04.2010_Amendment in Schedule I_Ayurvedic , Siddha Pharmacopoeia and its parts 2010-Apr-15 81 KB
84 DR_G.S.R. 86(E) dt_19.02.2010_Recruitement rules for DIs 2010-Feb-19 229 KB
85 DR_G.S.R. 677(E) dt_15.09.2009_Restriction for Oseltamivir Phosphate and Zanamivir 2009-Sep-15 1314 KB
86 DR_G.S.R. 651(E) dt_09.09.2009_Amendment Rule 3A_CDTL, chennai notified for Condoms 2009-Sep-09 68 KB
87 DR_G.S.R. 607(E) dt_28.08.2009_corregendum of GSR 46(E) dt 22.01.2009 2009-Jan-22 31 KB
88 DR_G.S.R. 499(E) dt_04.07.2008_26A_Diclofenac and its formulations 2008-Jul-04 478 KB
89 DR_G.S.R. 290(E) dt_16.04.2008_26A_reg FDCs of Salbutamol or any other drug 2008-Apr-16 116 KB
90 DR_G.S.R. 160(E) dt_16.03.2006_Schedule H inclusion of drugs sr. no 1 to 536 2006-Mar-16 300 KB
91 DR_G.S.R. 26(E) dt_19.01.2006_Amendment Rule 69, 75,76, 122B& Sch A_Additional Fee, Addition of r-DNA 2006-Jan-19 88 KB
92 DR_G.S.R. 510(E) dt_25.07.2005_26A_reg Valdecoxib and its formulations 2005-Jul-25 55 KB
93 DR_G.S.R. 431(E) dt_30.06.2005_Amendments in Schedule M 2005-Jun-30 772 KB
94 DR_G.S.R. 191(E) dt_05.03.2003_26A_reg Astemizole and Terfinadine 2003-Mar-05 35 KB
95 DR_G.S.R. 100(E) dt_11.02.2003_26A_Reg FDC of Rifamicin, INH and Pyrazinamide 2003-Feb-11 29 KB
96 DR_G.S.R. 422(E) GSR 423(E) dt_11.06.2002_Rule 168& First Scedule 2002-Jun-11 187 KB
97 DR_G.S.R. 311(E) dt_01.05.2002_Amendment Rule 69,71,75,76_New Drug Approval 2002-May-01 129 KB
98 DR_G.S.R. 249(E) dt_04.04.2002_Amendment to Rule 3A_addition of NIB 2002-Apr-04 107 KB
99 DR_G.S.R. 603(E) dt_24.08.2001_26A_Reg FDC Metoclopramide and Aspirin+Paracetamol 2001-Aug-24 68 KB
100 DR_G.S.R. 604(E) dt_24.08.2001_Amendment to Part IV(rules)_Import and Registration 2001-Aug-24 27182 KB
101 DR_G.S.R. 170(E) dt_12.03.2001_26A_reg certain FDCs 2001-Mar-12 83 KB
102 DR_G.S.R. 169(E) dt_12.03.2001_26A_reg FDC of Diazepam and Diphenhydramine HCL 2001-Mar-03 75 KB
103 DR_G.S.R. 395(E) dt_19.05.1999_26A_reg FDC of Metoclopramide and Aspirin, Paracetamol 1999-May-19 75 KB
104 DR_G.S.R. 245(E) dt_05.04.1999_Amendment to Rule 122_Requirements of blood bank 1999-Apr-05 2627 KB
105 DR_G.S.R. 498(E) dt_14.08.1998_10A_reg Mepacrine HCl and Fenfuramine & Dexfenfluramine 1998-Aug-14 69 KB
106 DR_G.S.R. 499(E) dt_14.08.1998_26A_reg Mepacrine HCl and Fenfuramine & Dexfenfluramine 1998-Aug-14 93 KB
107 DR_G.S.R. 242(E) dt_18.03.1998_Substitution Rule 3A_Functions of laboratories in respect of IUD 1998-Mar-18 104 KB
108 DR_G.S.R. 93(E) dt_25.02.1997_26A_Reg FDC of Streptomycin and Penicillins 1997-Feb-25 66 KB
109 DR_G.S.R. 552(E) dt_04.12.1996_Amendment to Rule 49_Proviso included 1996-Dec-04 244 KB
110 DR_G.S.R. 633(E) dt_13.09.1995_26A_Reg certain FDCs(Oxyphenbutazone, Analgin etc) 1995-Sep-13 103 KB
111 DR_G.S.R. 57(E) dt_07.02.1995_26A_Reg ORS solution 1995-Feb-07 140 KB
112 DR_G.S.R. 658(E) dt_31.08.1994_Amendment to First Schedule_Substitution Book name 1994-Aug-31 218 KB
113 DR_G.S.R. 658(E) dt_19.10.1993_ Rule 49_Qulaification of Inspectors 1993-Oct-19 214 KB
114 DR_G.S.R. 444(E) dt_30.04.1992_26A_reg all cosmetics licensed as tooth pastes, tooth powders containing tobacco 1992-Apr-30 96 KB
115 DR_G.S.R. 445(E) dt_30.04.1992_Substitution Rule 3A_functions of laboratories in respect of drugs and OPV 1992-Apr-30 197 KB
116 DR_G.S.R. 443(E) dt_30.04.1992_33 (EED))reg prohibition of all Ayuvedic drugs licensed as toothpastes, tooth powders containign tobacco 1992-Apr-30 59 KB
117 DR_G.S.R 303 (E) dt_07.06.1991_10A_Prohibition of import of Chloral Hydrate as a drug 1991-Jun-07 76 KB
118 DR_G.S.R 304 (E) dt_07.06.1991_26A_Prohibition of Mfr of (i) FDC ergot preps and (ii) Chloral Hydrate 1991-Jun-07 91 KB
119 DR_G.S.R. 69(E) dt_11.02.1991_26A_reg certain FDCs 1991-Feb-11 131 KB
120 DR_G.S.R. 365(E) dt_17.03.1989_Notifying Disposable hypodermic syringes needles and perfusion set as drugs 1989-Mar-17 166 KB
121 DR_G.S.R. 322(E) dt_03.05.1984_26A_reg Oxytetracycline liquid oral prep and Demeclocycline Liqiod oral prep 1984-May-03 77 KB
122 DR_G.S.R. 299(E) dt_23.04.1984_Substitution in Second schedule_Class of drugs like vaccines, sera, toxines 1984-Apr-23 103 KB
123 DR_G.S.R. 48(E) dt_31.01.1984_10A_Prohibition of import of Methaqualone 1984-Jan-31 62 KB
124 DR_G.S.R. 49(E) dt_31.01.1984_26A_Prohibition of manufacture of Methaqualone 1984-Jan-31 68 KB
125 DR_G.S.R. 578(E) dt_23.09.1983__26A_Reg certain drugs and FDCs(amidopyrine, vit+tranquilisers etc 1983-Sep-23 123 KB
126 DR_G.S.R. 478(E) dt 06.08.1981_insertion of rule 43A 1981-Aug-06 80 KB