eCourtsIndia
IndiaCode Laws
Act23
Enacted 1940

The Drugs and Cosmetics Act and Rules

In force 168 sections Punjab

Act 23 of 1940

Preamble

i GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE diat (Department of Health) THE DRUGS AND COSMETICS ACT AND RULES THE DRUGS AND COSMETICS ACT, 1940 (23 OF 1940) (As amended up to the 30th June, 2005) and THE DRUGS AND COSMETICS RULES, 1945 (As amended up to the 30th June, 2005) LIST OF AMENDING ACTS AND ADAPTATION ORDERS 1. The Repealing and Amending Act, 1949 (40 of 1949). 2. The Adaptation of Laws Order, 1950 . 3. The Part B States (Laws) Act, 1951 (3 of 1951). 4. The Drugs (Amendment) Act, 1955 (11 of 1955). 5. The Drugs (Amendment) Act, 1960 (35 of 1960). 6. The Drugs (Amendment) Act, 1962 (21 of 1962) . 7. The Drugs and Cosmetics (Amendment) Act, 1964 (13 0f 1964). 8. The Drugs and Cosmetics (Amendment) Act, 1955 19 of 1972). 9. The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982). 10. The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982). 11. The Finance Act, 1993 (22 of 1995). 12. The Drugs and Cosmetics (Amendment) Act, 1995 (71 of 1995). LIST OF ABBREVIATIONS USED A.O. 1950 Adaptation of Laws Order, 1950 Cl. Clause Ins. Inserted P. Page Pt. Part Reg. ” Regulation Rep. ” Repealed Section S. Sch ” Schedule Sec. ” Section Subs. Substituted w.e.f. With effect from CONTENTS Pages The Drugs and Cosmetics Act, 1940 (23 of 1940) The Drugs and Cosmetics Rules, 1945 dto Colis THE DRUGS AND COSMETICE ACT, 1940 ARRANGEMENT OF SECTIONS CHAPTER I INTRODUCTORY Sections 1. Short title, extent and commencement. 2. Application of other laws not barred. 3. Definitions. 3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir. 4. Presumption as to poisonous substances. CHAPTER II THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY AND THE DRUGS CONSULTATIVE COMMITTEE 5. The Drugs Technical Advisory Board. 6. The Central Drugs Laboratory. 7. The Drugs Consultative Committee. 7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs. CHAPTER III IMPORT OF DRUGS AND COSMETICS 8. Standards of quality. 9. Misbranded drugs. 9A Adulterated drugs. 9B Spurious drugs. 9C. Misbranded cosmetics. 9D. Spurious cosmetics. 10. Prohibition of import of certain drugs or cosmetics. 10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest. 11. Application of law relating to sea customs and powers of Customs officers. 12. Power of Central Government to make rules. 13. Offences. 14. Confiscation. 15. Jurisdiction. iv Drugs and Cosmetics Act, 1940 CHAPTER IV MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS Sections 16. Standards of quality. 17. Misbranded drugs. 17A. Adulterated drugs. 17B. Spurious drugs. 17C. Misbranded cosmetics. 17D. Spurious cosmetics. 18. Prohibition of manufacture and sale of certain drugs and cosmetics. 18A. Disclosure of the name of the manufacturer, etc. 18B. Maintenance of records and furnishing of information. 19. Pleas. 20. Government Analysts. 21. Inspectors. 22. Powers of Inspectors. 23. Procedure of Inspectors. jaCode 24. Persons bound to disclose place where drugs or cosmetics are manufactured or kept. 25. Reports of Government Analysts. 26. Purchaser of drug or cosmetic enabled to obtain test or analysis. 26A. Power of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest. 27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter. 27A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter. 28. Penalty for non-disclosure of the name of the manufacturer, etc. 28A. Penalty for not keeping documents, etc., and for non-disclosure of information. 28B. Penalty for manufacture, etc. of drugs or cosmetics in contravention of section 26A. 29. Penalty for use of Government Analyst's report for advertising. 30. Penalty for subsequent offences. 31. Confiscation. 31A. Application of provisions to Government departments. 32. Cognizance of offences. 32A. Power of Court to implead the manufactur

Sections

Type to filter. 168 sections.

  1. 1Short title, extent and commencement
  2. 2Application of other laws not barred
  3. 3Definitions
  4. 4
  5. 6
  6. 8
  7. 9
  8. 10
  9. 11
  10. 12
  11. 13
  12. 14
  13. 15
  14. 16
  15. 17
  16. 18Prohibition of manufacture and sale of certain drugs and cosmetics
  17. 19Pleas
  18. 21Inspectors
  19. 23Procedure of Inspectors
  20. 24Persons bound to disclose place where drugs or cosmetics are manufactured or kept
  21. 25Reports of Government Analysts
  22. 26Purchaser of drug or cosmetic enabled to obtain test or analysis
  23. 27APenalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter
  24. 28BPenalty for manufacture, etc., of drugs or cosmetics in contravention of section 26A
  25. 29Penalty for use of Government Analyst's report for advertising
  26. 31Confiscation
  27. 32Cognizance of offence
  28. 33Power of Central Government to make rules
  29. 33BApplication of Chapter IVA
  30. 33C
  31. 33EMisbranded drugs
  32. 33EEAdulterated drugs
  33. 33FGovernment Analysts
  34. 33GInspectors
  35. 33HApplication of provisions of sections 22, 23, 24 and 25
  36. 33JPenalty for subsequent offences
  37. 33KConfiscation
  38. 33LApplication of provisions to Government departments
  39. 33MCognizance of offences
  40. 33NPower of Central Government to make rules
  41. 34Offences by companies
  42. 35Publication of sentences passed under this Act
  43. 36Magistrate's power to impose enhanced penalties
  44. 37Protection of action taken in good faith
  45. 39
  46. 47
  47. 48
  48. 49
  49. 50
  50. 51
  51. 52
  52. 53
  53. 54Form of order not to dispose of stock
  54. 56Form of intimation of purpose of taking samples
  55. 57Procedure for despatch of sample to Government Analyst
  56. 59
  57. 62Sale at more than one place
  58. 65Condition of licences
  59. 66Cancellation and suspension of licences
  60. 67B
  61. 67CForms of licences to sell drugs
  62. 68Manufacture on more than one set of premises
  63. 68BDelegation of Powers by the Central Licence Approving Authority
  64. 74AConditions for licence in Form 25-B
  65. 81Procedure of Licensing Authority
  66. 83Renewal
  67. 84
  68. 84AA
  69. 85AManufacture on more than one set of premises
  70. 85B
  71. 85C
  72. 85E
  73. 85EBReport by Inspector
  74. 85ECGrant or refusal of licence
  75. 85EDFurther application after rejection
  76. 85EEAppeal to the State Government
  77. 85FDuration of licence
  78. 85GCertificate of renewal
  79. 85HConditions of licence
  80. 86Conditions relating to manufacture for examination, test or analysis
  81. 87Labelling
  82. 88Labelling of drugs supplied to other persons
  83. 89Licence
  84. 90Form of application
  85. 91Duration of licence
  86. 92Conditions of licence
  87. 93
  88. 94Exemption of certain drugs from certain provisions of this Part
  89. 95Prohibition of sale or distribution unless labelled
  90. 97Labelling of medicines
  91. 103
  92. 108Container
  93. 110Prohibition of sale of substance after prescribed date
  94. 111Standards
  95. 115Application of tests for sterility
  96. 119
  97. 120
  98. 122Substances specified in Schedule C(1)
  99. 122DA
  100. 122DBSuspension or cancellation of Permission/Approval
  101. 122DCAppeal
  102. 122EDefinition of new drug
  103. 122G
  104. 122HDuration of licence
  105. 122I
  106. 122JReport by Inspector
  107. 122KFurther application after rejection
  108. 122LDelegation of powers by the Central Licence Approving Authority
  109. 122M
  110. 123
  111. 127List of colours permitted to be used in drugs
  112. 128
  113. 129Statement to accompany imported cosmetics
  114. 130Documents to be supplied to the Collector of Customs
  115. 131Procedure for the import of cosmetics
  116. 132
  117. 133
  118. 135Import of cosmetic containing Lead or Arsenic compound prohibited
  119. 136
  120. 137
  121. 138Application for licence to manufacture cosmetics
  122. 139
  123. 139ABReport by Inspector
  124. 139ACGrant or refusal of licence
  125. 139ADFurther application after rejection
  126. 139AEAppeal to the State Government
  127. 140Duration of licence
  128. 141Certificate of renewal
  129. 141AADuration of a loan licence
  130. 142
  131. 143Cancellation and suspension of licence
  132. 145Use of Lead and Arsenic compounds for the purpose of colouring cosmetics prohibited
  133. 145BForm of receipt for seized cosmetics
  134. 146Prohibition of sale or distribution
  135. 148Manner of labelling
  136. 149
  137. 150Report of result of test or analysis of cosmetics
  138. 150DDuration of approval
  139. 150E
  140. 150FInspection before grant of approval
  141. 150GReport of Inspection
  142. 150HProcedure of approving authority
  143. 150J
  144. 150KWithdrawal and suspension of approvals
  145. 151Manufacture on more than one set of premises
  146. 152Licensing Authorities
  147. 153Application for licence to manufacture Ayurvedic (including Siddha) or Unani drugs
  148. 154Form of licence to manufacture Ayurvedic (including Siddha) or Unani drugs
  149. 155
  150. 156
  151. 157Conditions for the grant or renewal of a licence in Form 25-D
  152. 158Conditions of licence
  153. 159Cancellation and suspension of licences
  154. 160Identification of raw materials
  155. 160B
  156. 160CDuration of approval
  157. 160DConditions of approval
  158. 160FReport of inspection
  159. 160GProcedure of approving authority
  160. 160HApplication after rejection
  161. 160JWithdrawal and suspension of approvals
  162. 161
  163. 162
  164. 163
  165. 164
  166. 165Qualifications of Government Analyst
  167. 166Duties of Government Analys.t
  168. 168

Provenance. Read from the Government's own scanned gazette with Azure Document Intelligence, then split into sections by their numbering. India Code publishes no text for this Act. The scan itself is mirrored into our own storage and served at /scan/053728db-416d-4003-acca-99b3d6b7df6f.pdf, so the reading here can be checked against the page it came from without depending on India Code's own copy staying where it is (it was at https://indiacode.gov.in/server/api/core/bitstreams/2cd6c2e9-226a-4ecd-badb-d1db92507328/content).

Source and method. Compiled from the enactments of Parliament and of the State legislatures as published on India Code, and republished together with commentary and other original matter under section 52(1)(q)(ii) of the Copyright Act, 1957. Structured, cross-referenced and maintained by eCourtsIndia. Every one of the 168 sections of this Act has its own page. This page is not a substitute for legal advice.