Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics Act, 1940

ओषधि और प्रसाधन सामग्री अधिनियम,1940

Rules Regulations Notifications Orders Circulars Ordinance Statutes

Act ID:	194023
Act Number:	23
Enactment Date:	1940-04-10
Act Year:	1940
Short Title:	The Drugs and Cosmetics Act, 1940
metadata.dc.title.hindi:	ओषधि और प्रसाधन सामग्री अधिनियम,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.


Schedule 1. THE FIRST SCHEDULE. Order Appendix Forms
Schedule 2. THE SECOND SCHEDULE. Order Appendix Forms

Title	Files

Title	Files

Title	Files

Show all section The Drugs and Cosmetics Act, 1940

CHAPTER I

INTRODUCTORY

CHAPTER II

THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY AND THE DRUGS CONSULTATIVE COMMITTEE

CHAPTER III

IMPORT OF DRUGS AND COSMETICS

CHAPTER IV

MANUFACTURE. SALE AND DISTRIBUTSION OF DRUGS AND COSMETICS

CHAPTER IVA

PROVISIONS RELATING TO AYURVEDIC, SIDDHA AND UNANI DRUGS

CHAPTER V

MISCELLANEOUS


Section 1. Short title, extent and commencement.
Section 2. Application of other laws not barred.
Section 3. Definitions.
Section 3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir.
Section 4. Presumption as to poisonous substances.
Section 5. The Drugs Technical Advisory Board.
Section 6. The Central Drugs Laboratory. Show Related Subordinates
Section 7. The Drugs Consultative Committee.
Section 7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs
Section 8. Standards of quality.
Section 9. Misbranded drugs.
Section 9A. Adulterated drugs.
Section 9B. Spurious drugs
Section 9C. Misbranded cosmetics.
Section 9D. Spurious cosmetics.
Section 10. Prohibition of import of certain drugs or cosmetics.
Section 10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest.
Section 11. Application of law relating to sea customs and powers of Customs officers.
Section 12. Power of Central Government to make rules. Show Related Subordinates
Section 13. Offences
Section 14. Confiscation
Section 15. Jurisdiction.
Section 16. Standards of quality.
Section 17. Misbranded drugs
Section 17A. Adulterated drugs.
Section 17B. Spurious drugs.
Section 17C. Misbranded cosmetics
Section 17D. Spurious cosmetics.
Section 17E. Adulterated cosmetics
Section 18. Prohibition of manufacture and sale of certain drugs and cosmetics
Section 18A. Disclosure of the name of the manufacturer, etc.
Section 18B. Maintenance of records and furnishing of information.
Section 19. Pleas.
Section 20. Government Analysts.
Section 21. Inspectors
Section 22. Powers of Inspectors.
Section 23. Procedure of Inspectors.
Section 24. Persons bound to disclose place where drugs or cosmetics are manufactured or kept.
Section 25. Reports of Government Analysts.
Section 26. Purchaser of drug or cosmetic enabled to obtain test or analysis.
Section 26A. Powers of Central Government to regulate, restrict or prohibit manufacture, etc., of drug and cosmetic in public interest.
Section 26B. Powers of Central Government to regulate or restrict, manufacture, etc., of drug in public interest.
Section 27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.
Section 27A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter.
Section 28. Penalty for non-disclosure of the name of the manufacturer, etc
Section 28A. Penalty for not keeping documents, etc., and for non-disclosure of information.
Section 28B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of section 26A.
Section 29. Penalty for use of Government Analyst’s report for advertising.
Section 30. Penalty for subsequent offences.
Section 31. Confiscation.
Section 31A. Application of provisions to Government departments.
Section 32. Cognizance of offences.
Section 32A. Power of Court to implead the manufacturer, etc.
Section 32B. Compounding of certain offences.
Section 33. Power of Central Government to make rules. Show Related Subordinates
Section 33A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs.
Section 33B. Application of Chapter IVA
Section 33C. Ayurvedic and Unani Drugs Technical Advisory Board.
Section 33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee
Section 33E. Misbranded drugs.
Section 33EE. Adulterated drugs
Section 33EEA. Spurious drugs.
Section 33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs
Section 33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs.
Section 33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interest.
Section 33F. Government Analysts
Section 33G. Inspectors.
Section 33H. Application of provisions of sections 22, 23, 24 and 25.
Section 33-I. Penalty for manufacture, sale, etc., of Ayurvedic. Siddha or Unani drug in contravention of this Chapter
Section 33J. Penalty for subsequent offences
Section 33K. Confiscation
Section 33KA. Disclosure of name of manufacturer, etc
Section 33KB. Maintenance of records and furnishing of informantion.
Section 33L. Application of provisions to Government departments
Section 33M. Cognizance of offences.
Section 33N. Power of Central Government to make rules. Show Related Subordinates
Section 33-O. Power to amend First Schedule
Section 33P. Power to give directions.
Section 34. Offences by companies.
Section 34A. Offences by Government departments.
Section 34AA. Penalty for vexatious search or seizure.
Section 35. Publication of sentences passed under this Act
Section 36. Magistrate’s power to impose enhanced penalties.
Section 36A. Certain offences to be tried summarily.
Section 36AB. Special Courts.
Section 36AC. Offences to be cognizable and non-bailable in certain cases
Section 36AD. Application of Code of Criminal Procedure, 1973 to proceedings before special Court.
Section 36AE. Appeal and revision
Section 37. Protection of action taken in good faith.
Section 38. Rules to be laid before Parliament.


Schedule 1. THE FIRST SCHEDULE. Order Appendix Forms
Schedule 2. THE SECOND SCHEDULE. Order Appendix Forms

Year	Description	Hindi Description	Files(Eng)	Files(Hindi)
21-12-1945	The Drugs and Cosmetics Rules, 1945
31-01-2017	Medical Devices Rules, 2017
19-03-2019	New Drugs and Clinical Trials Rules, 2019

Year	Description	Hindi Description	Files(Eng)	Files(Hindi)
23-07-1983	Prohibition of the manufacture, sale of the said FDCs_Section
31-01-1984	Amendment in the notification regarding Prohibition of the manufacture, sale of Methaqualone_Section
31-01-1984	Amendment in the notification regarding Prohibition of import 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 the manufacture, sale fo FDC of crude Ergot preparation and Chloral Hydrate_Section
07-06-1991	Amendment in the notification regarding Prohibition of import ofChloral 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	Amendment to Form44
03-04-2017	BCS Classification and BABE studies_Section 12 and 33_D&C Act.
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

Schedule 1. THE FIRST SCHEDULE.

Schedule 2. THE SECOND SCHEDULE.