The Drugs and Cosmetics Act, 1940


Act ID: 194023
Act Number: 23
Enactment Date: 1940-04-10
Act Year: 1940
Short Title: The Drugs and Cosmetics Act, 1940
Long Title: An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
Ministry: Ministry of Health and Family Welfare
Department: Department of Health and Family Welfare
Enforcement Date: 10-04-1940
Notification: Notification No. 3358-LSG., dated the 25th August, 1941.

YearDescriptionFiles
21.12.1945 The Drugs and Cosmetics Rules, 1945
31.01.2017 Medical Devices Rules, 2017
YearDescriptionFiles
YearDescriptionFiles
YearDescriptionFiles
23.07.1983 Prohibition of the manufacture, sale of the said FDCs_Section
31.01.1984 Amendment in the notification regarding Prohibition of import of Methaqualone_Section
31.01.1984 Amendment in the notification regarding Prohibition of the manufacture, sale of Methaqualone_Section
23.04.1984 Amendments in the Second Schedule_Class of drugs like vaccine, sera, toxines
03.05.1984 Amendment in the notification regarding Prohibition of the manufacture, sale of Oxytetracycline and Demeclocycline Liquid Oral Preparations_Section
28.08.1987 Amendment to First Schedule_Section
03.11.1988 Prohibition of the manufacture, sale of the Fixed Dose Combination of corticosteroidx with any other drug for internal use and fixed dose combination of Chloramphenicol with any other drug for internal use _Section
26.12.1990 Amendment in the notification regarding Prohibition of the manufacture, sale of said drugs_Section
13.02.1991 Amendment in the notification regarding Prohibition of the manufacture, sale of said drugs_Section
07.06.1991 Amendment in the notification regarding Prohibition of import ofChloral Hydrate_Section
07.06.1991 Amendment in the notification regarding Prohibition of the manufacture, sale fo FDC of crude Ergot preparation and Chloral Hydrate_Section
30.04.1992 Prohibition of the manufacture, sale of all Ayurvedic Drugs licensed as tooth pastes, tooth powders containing tobacco_Section
30.04.1992 Amendment of Rule 43A_Section
30.04.1992 Prohibition of the manufacture, sale of all Cosmetics Drugs licensed as tooth pastes, tooth powders containing tobacco_Section
19.10.1993 Amendment in the Rule 49_Section
31.08.1994 amendment to First Schedule_Section
30.09.1994 Amendment in the notification regarding Prohibition of the manufacture, sale of said drugs_Section
07.02.1995 Amendment in the notification regarding Prohibition of the manufacture, sale of ORS_Section
13.09.1995 Prohibition of the manufacture, sale and distribution of the said fixed dose combination_Section_Section
13.12.1995 Amendment in the notification regarding Prohibition of the manufacture, sale of Fixed dose combinationf ofHydroxyquinoline group of drugs with any other drug except for preparations meant for external use_Section _Section
04.12.1996 Amendment in the Rule 49_Section
25.02.1997 prohibits the manufacture and sale of parenteral preparations containing fixed dose combination of streptomycin with pencillins_Section
06.05.1998 Amendment in the Rule 3A_Ffunctions of laboratories in respect of IUD_Section
14.08.1998 Amendment to notification regarding Prohibition of import Hydrochloride, Fenfluramine and Dexfenfluramine_Section
14.08.1998 Amendment to notification regarding Prohibition of the manufacture and sale_Mepacrine Hydrochloride, Fenfluramine and Dexfenfluramine_Section
05.04.1999 Amendment of Rule 122_Requirements of blood bank_Section
27.05.1999 Amendment to notification regarding Prohibition of the manufacture and sale of Fixed dose combination of Metoclopramide_Section
14.10.1999 Prohibits the manufacture, sale or distribution of Fixed Dose Combination of Vitamin B, vitamin B6 and Vitamin B12 for human_Section
16.12.1999 Prohibits the manufacture, sale or distribution of Fixed Dose Combination of Pancreatin or Pancrelipase drugs for human_Section
12.03.2001 Amendment to notification regarding Prohibition of the manufacture and sale of Fixed dose combination of Diazcpam and Diphenhydramine Hydrochloride_Section
12.03.2001 Prohibits the manufacture, sale and distribution of the said drugs for human use_Section
24.08.2001 Amendment in the notification regarding Prohibition of the manufacture, sale of Fixed dose combinationf of Metoclopramide except combination of Metoclopramide with AspirinParacetamol_Section
24.08.2001 Amendment of Drugs and Cosmetics Rule, 1945_Section
04.04.2002 Amendment of Rule 3A_Section 12 and 33_D&C Act
01.05.2002 Amendment of Rule 69,71,75,76_Section
12.06.2002 Amendment of Rule 168_Section 33N_D&C Act
11.02.2003 Amendment in the notification regarding Prohibition of the manufacture, sale of FDC of Rifampicin, Isoniazide and pyraxinamide_Section
05.03.2003 Prohibition of the manufacture, sale or distribution of the Astemizole and Terfinadine for human_Section
01.10.2003 Prohibition of the manufacture, sale or distribution of the Phenoformin_Section
15.12.2004 Prohibits the manufacture, sale or distribution of the Rofecoxib and its formulation_Section
28.07.2005 Prohibits the manufacture, sale of distribution of the valdecoxib and its formulation_Section
21.12.2005 Amendment of Rule 122F, 122G, Schedule F_Section
21.12.2005 Amendment Schedule K-Production of Oxygen 93 percent_Section
19.01.2006 Amendment of Rule 69,75,76,122B Sch P_Section
16.03.2006 Amendment of Rule_Substitution of Schedule H_Section
31.10.2006 Amendment of Rule_Schedule M-I_Section12 and 33_D&C Act.
16.04.2008 Amendment in the notification regarding Prohibition of manufacture, sale Fixed dose combination of Salbutamol or any other drug having primarily bronchdilatory activity with centrally acting anti-tussive andor antithistamine_Section
10.11.2008 Amendment of Rule 74, 78, 150E_Imlementation of Sch_L1_Section
28.08.2009 Corrigendum to G.S.R 46E
09.09.2009 Amendment of Rule 3A_CDTL, Chennai notified for Condoms_Section
15.09.2009 restriction for Oseltamivir Phosphate and Zanamivir_Section
09.10.2009 Amendment in the notification regarding Prohibition of the manufacture, sale fo FDC of Corticosteroid_Section
11.12.2009 Amendment in the notification regarding Prohibition of the manufacture, sale of Rimonaband_Section
11.12.2009 Amendment in the notification regarding Prohibition of import of Rimonabant_Section
22.12.2009 Amendment Schedule K_addition of Homeopathic Hair Oils, omission of Arnica Montana hair oil_Sction
20.04.2010 Amendment in Schedule I_Ayurvedic, Siddha Pharmacopeia and its parts_Section
12.11.2010 Prohibits the manufacture, sale or distribution of the Rosiglitazone and its formulation_Section
24.01.2011 Amendment of Rule122E_Addition of Vaccines and r-DNA_Section
10.02.2011 Prohibits the manufacture, sale of distribution of hte said drugs_Section
30.05.2011 Amendment in G.S.R. 82 dt. 10.02.2011
12.10.2011 Suspension of Letrozole for induction of Ovulation_Section
17.01.2012 Amendment of Rule 97A-Lablelling requirements for Food producing Animals_Section
08.02.2012 Amendment of Rule 127_Addition of Titanium Dioxide coated mica pearlscent pigments_Section
30.03.2012 Corrigendum
07.06.2012 Prohibition of the manufacture, sale or distribution of the serodignostic kit for diagnosis of tuberculosis
07.06.2012 Prohibition of the imports fo the serodignostic kit for diagnosis of tuberculosis_Section
17.07.2012 Amendment of Rule 75A, 76A, 78A , 83A,83AA.Schedule A_Section
17.07.2012 Amendment of Rule 43A_Addition of mumugao sea port and Goa, Bengaluru air port_Section
29.09.2012 Corrigendum to G.S.R. 270E
30.01.2013 Insertion of Rule 122DAB, Appendix XII_Death Compensation_Section
08.02.2013 Insertion of Rule 122DD_Registration of Ethics Committee_Section
23.05.2013 Suspension of the manufacture for sale, sale and distribution of Detyropropoxyphene and formulations containing Detyropropoxyphene for human use_Section
18.06.2013 Suspension of the manufacture for sale, sale and distribution of analgin and all formutation containing Analgin for human use_Section
18.06.2013 suspension of the manufacture for sale, sale and distribution of Fixed dose combination of Flupenthixol+ Melitracen for human use_Section
18.06.2013 Suspension of the manufacture for sale, sale and distribution of Pioglitazone and all formulations containing Pioglitazone for human use_Section
11.07.2013 Insertion of Rule 122E,Sch D, Sch.H,Sch.S,Sch.X_Section
31.07.2013 Revoke GSR 379E_Reg. Pioglitazone Suspension
30.08.2013 Amendment of Rule 65A, Rule 97_Inclusion of Sch H1,Omission of said drugs from Sch H List_Section
25.10.2013 Amendment of Rule 157A_Ayurveda, Siddha, Unani_Section
17.01.2014 Regulation and restiction of the manufacture, sale & Distribution of Oxytocin_Section
13.02.2014 Revoke GSR 378E_Reg. Suspension of Analgin and all formulatins containing Analgin for human use.
21.05.2014 Insertion of Rule 148C_Prohibition of testing of cosmetics on animals_Section
11.07.2014 Prohibition of the manufacture, sale or distribution of FDC of Flupenthixole and Melitracen_Section
07.08.2014 Amendment of Rule 71, 71A, 71B 76, 76A_Active
25.09.2014 Amendment of Drugs and Cosmetics Rule, 1945_labelling requirements of Medical devices_Sectionn
13.10.2014 Insertion of Rule 134B_Prohibition of import of Cosmetics tested on animal_Section
12.12.2014 Amendment of Rule 122DAB, Schedule Y & Appendix XII_Section
22.12.2014 Amendment of Rule 3A_tests notified for NIB_Sectinon
17.02.2015 Revoke of suspension ondextropropoxyphene_Section 26_A D&C Act
17.02.2015 Amendment Schedule K_Words,figures, letters ommitted in form 20C_Sction
18.03.2015 Amendment of Sch S, SchQ_Section 12& 33
15.04.2015 Amendment of Rule 74, 74A, 74B,78,78A
18.05.2015 Amendment Rule 157A
17.07.2015 Amendment Rule 105A
31.07.2015 Amendment SchY_Relating to Informed Consent_Section
30.10.2015 Amendment of Rule 122DA_Substitution of Explanation_122DA omitted_Section
30.11.2015 Amendment of Rule 2,122A,122B_Data to be submitted for Phytopharmaceuticals for CT_Section
25.01.2016 Corrigendum to G.S.R 826E
08.03.2016 Amendment SchY_PMS, Sytematic Toxicity studies_Section
16.03.2016 Amendment of Rule 122DA
18.05.2016 Amendment of Rule 43A_Addition of Vishakhapatnam Sea and air port_Section
29.06.2016 Sch Mlll (Rule 69,69A, 75,75A)
21.09.2016 Amendment in Shedule D(I) and Schedule D(II)_Section
04.11.2016 Amendment of Shedule Y Apendix III_Animal Toxicity_Section
17.01.2017 Amendment of Rule 43A
19.01.2017 G.S.R 56E Amendment Rule 135A,145D
31.01.2017 G.S.R 78E Amendment devices Rule 2017_ Section 12 and 33 _ D & C Act.
31.01.2017 G.S.R 76E Amendment Schk_ Exemptions of Homeopathic hair oils, Cutom made devices, Zin sulphate Tabs
02.02.2017 Amendment of Rule 103A Additional of Rule
17.02.2017 regulation of Oseltamivir Phosphate and Zanamivir_ Section 26B_ D&C Act.
17.02.2017 Revoke of suspension on Letrozole_Section 26_A D&C Act
15.03.2017 Amendment of Rule 3A
30.03.2017 Amendment of Shedule H_Etizoam was included_Section
03.04.2017 BCS Classification and BABE studies_Section 12 and 33_D&C Act.
03.04.2017 Amendment to Form44
03.04.2017 Amendment of Rule 122P
27.10.2017 Amendment to D &C Rules_Perpetual Licensing and Joint Inspection_Section 12 and 33_D & C Act
10.11.2017 Amendment of drugs and Cosmetic Rules_Homoeopathy_Section
13.03.2018 Drugs and Cosmetics (First Amendment) Rules, 2018
19.03.2018 TB Reporting Notification
23.03.2018 Drugs and Cosmetics (Second Amendment) Rules, 2018
23.03.2018 Prohibition of test kits used in Antibody Detecting Rapid Diagnostic Test
10.04.2018 Drugs and Cosmetics (Third Amendment) Rules, 2018
12.04.2018 Drugs and Cosmetics (Amendment) Rules, 2018
18.04.2018 Drugs and Cosmetics (Amendment) Rules, 2018
19.04.2018 Drugs and Cosmetics (Fourth Amendment) Rules, 2018
24.04.2018 Amendment in GSR 577(E) dated 23.7.1983
26.04.2018 Drugs and Cosmetics (Fifth Amendment) Rules, 2018
27.04.2018 Manner of manufacture, sale, distribution of Oxytocin
15.05.2018 Reconstitution of Drugs Technical Advisory Board
01.06.2018 Drugs and Cosmetics (Sixth Amendment) Rules, 2018
01.06.2018 Designation of Laboratories under Medical Devices Rules, 2017
YearDescriptionFiles
YearDescriptionFiles
YearDescriptionFiles


Disclaimer: Updating and uploading of all Central Acts available on this web page is the proprietary of the Legislative Department in the Ministry of Law and Justice.
The updating and uploading of Rules, Regulations, Notifications, etc., and linking them with relevant sections of the respective Principal Act under which the said subordinate legislations have been made is the proprietary of the concerned Ministry/Departments in the Government of India administering subject matter of the Legislation.