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S.N.KATJU'S
Encyclopaedia on
LAWOFDRUGS (With The Drugs & Cosmetics Amendments Rules, 2009)
The Drugs & Co.smetics Amendment Act, 2008 (w.e.f. 10.08.2009)
CONTAINING
+ IHE DRUGS & COSMETICS ACT, 1940 with RULES, 1954
+ IHE DRUGS & MAGIC REMEDIES (Objectionable Advertisments) ACT, 1954
+ IHE DRUGS (Control)ACT, 1950
+ THE DRUGS (Price Control) ORDER, 1955
+ IHE NEW DRUGS POLICY, 1994
+ IHE INDIAN MEDICAL CENTRAL COUNClL, 1970
+ THE NARCOTICS DRUGS AND PSYCHOTROPIC SCBSTANCES ACT, 1985 with RULES and NOTIFlCA TIONS
+ THE MEDICI:\IAL & TOlLET PH.EPARA TlONS (EXCISE DUTIES) Ace 1955 with RCLES, 1955
+ IHE MENTAL HEALTH ACT, 1987 with CENTRAl MENTAL HEAlTH AUTHORITY RULES, 1990
+ IHE PHARMACY ACT, 1948
+ THE BIO- MEDICAL WASTE (MANAGEMENT & HANDLING) RULES, 1998
+ THE MEDICAL TERMINATION OF PREGNANCY ACT,1971 with RULES, 1975 alongwith REGULA TIONS, 1975
+ DIE PRE-NATAL DIOGNOSTIC TECHNIQUES (REGULATION & I'HEVFNTION OE MISUSF) ACl,1994 with HULES, 1
t DIE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994 with HCUS, 1995
WITH LATEST AMENDMENTS ON DRUGS AND COSMETICS ACT,1940 ALONGWITH NARCOTICS DRUGS AND PSYCHOTROPIC
SUBSTANCES ACT AND NOTIFICATIONS
Ravi Kant Asst. Dmgs Co1ttroller, (;;ovt. o[ N.c.r. ofDelhi
Revised by
5th Edition
2010
K.C.Agarwal Drugs Illspector,
Gout o{ N.\.1'. ojDellJi
CONTENTS PREFACE TO THE FIFTH EDITION
PREFACE TO THE FOURTH EDITION
PREFACE TO THE THIRD EDITION
CONTENTS
TABLE OF CASES
Sectio71
ENCYCLOPAEDIA ON
LAWOFDRUGS PART I
THE DRUGS AND COSMETICS ACT, 1940 CHAPTER I
INTRODUCTORY
1. Short title, extent and commencement 2. Application of other laws not barred 3. Definitions
3-A. Construction of refcrC'ncl'~ to an\' \,1\\' not in forcl' or
functionary not in ('\i~t('nl'l' in tlw Stcltl' of L1 111!11 1I ,md
\'
VII
IX
XI
1
2
K<1shmir lJ
4. Prl'sl1mption dS to p()i~()n(l\I~ ~lIb",L1l1n'~ q
C 11 1\ 1'1 F 1\ II
THE DRUGS TECHNICAL ADVISORY BOARD, '1'111" CI·:NTIV\L DRUGS LABORATORY AND THE DRUCS CONSUITATIVL
COMMITTEE
5.
6.
7.
7-A.
8.
9. 9-A. 9-B.
Thc Drugs Tcchnical !\d\'i~()I"\' J)oc1l'd
Thc Ccnt1'al Drugs Lahoratl)r~'
The Drugs Consultative Committcc
Seetions 5 and 7 not to clpplv to [A yurn:dic,
Siddha 01' UnaniJ drugs CHAPTER III
IMPORT OF DRUGS AND COSMETICSJ
Standards of q uali ty Misbrandcd drugs Adultcratpd drugs
Spurious drugs
q
11
12
12
1~
12
ENCYCLOPAEDIA ON LAW OF DRUGS
on Page I_C. Misbranded cosmetics 14
-D. Spurious cosmetics 14
10. Prohibitious on import of certain drugs or cosmetic 14 I-A. Power of Central Government to prohibit import of
drugs and cosmetics in public interest 15
1l. Application of law relating to sea customs and powers of Customs Officers 16
12. Power of Central Government to make rules 16
13. Offences 20
14. Confiscation 20
15. J urisdiction 20
CHAPTER IV IANUFACTURER, SALE AND DISTRIBUTION OF [DRUGS AND
COSMETICS] 16. Standards of quality 20 17. Misbranded drugs 20
7_A. Adulterated drugs 22 7-B. Spurious drugs 23 7 -co Misbranded cosmetics 23 7_D. Suprious cosmetics 24 7-E. Adulterated cosmetics 24 18. Prohibition of manufacture and sale of certain drugs
and cosmetics 25 ,-A. Disclosure of the name of the manufacturer, etc. 41 ~-B. Maintenance of records and furnishing of information 42 19. Pleas 42 20. Government Analysts 45 21. Inspectors 45 22. Powers of Inspectors 46 23. Procedure of Inspectors 49 24. Persons bound to disclose place where drugs or
cosmetics are manufactured or kept 52 25. Reports of Government Analysts 52 26. Purchaser of drug or cosmetic enabled to obtain
test or analysis 65 -A. Power of Central Government to regulate,
restrict or prohibit manufacture, etc. of drug and cosmetic in public interest 65
CONTENTS xiii
Seetion Page 26-B. Power of Central Government to regulate or
restriet, manufacture, ete., of drug in public interest 66
27. Penalty for manufacture, sale, etc. of drugs in contravention of this Chapter 67
27-A. Penalty for manufacture, sale, ete. of cosmeties in contravention of this Chapter 78
28. Penalty for non-disclosure of the name of the manufacturer, ete. 79
28-A. Penalty for not keeping doeuments, ete. and for non-disclosure of information 79
28-B. Penalty for manufaeture, ete. of drugs or eosmetics in eontravention of Sec. 26-A 79
29. Penalty for use of Government Analyst's report for advertising 80
30. Penalty for subsequent offences 80 31. Confiscation 81
31-A. Application of provisions to Government departments 82
32. Cognizance of offences 82 32-A. Power of Court to implead the manufaeturer, ete. 84 32-B. Compounding of eertain offences 85
33. Power of Central Government to make rules 85 33-A. Chapter not to apply to Ayurvedic, Siddha or
Unani Drugs 89 CHAPTER IV-A
PROVISIONS RELATING TO A YURVEDIC, SIDDHA AND UNANI DRUGS
33-B. Applieation of Chapter IV-A 89 33-C. Ayurvedic and Unani Drugs Technical Advisory
Board 89 33-D. The A yurvedic Siddha and Unani Drugs
Consultative Committee 91 33-E. Misbranded drugs 92
33-EE. Adulterated drugs 92 33-EEA. Spurious drugs 93 33-EEB. Regulation of manufacture for sale of Ayurvedic,
Siddha and U nani drugs 93
xiv ENCYCLOPAEDIA ON LAW OF DRUGS
Sectioll Page
33-EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs 93
33-EED. Power of Central Government to prohibit manufacture etc. of Ayurvedic, Siddha or Unani drugs in public interest 94
33-F. Government Analysts 95 33-G. Inspectors 95 33-H. Application of provisions of Sees. 22, 23, 24 and 25 95 33-I. Penalty for manufacture, sale, etc. of Ayurvedic,
Siddha or Unani drug in contravention of this chapter 95
33-J. Penalty for subsequent offences 96 33-K. Confiscation 97
33-KA. Disclosure of name of manufacturer, etc. 97 33-KB. Maintenance of records and furnishing of
informa tion 97 33-L. Application of provisions to Government
departments 98 33-M. Cognizance of offences 98
33-N. Power of Central Government to make rules 98 33-0. Power to amend First Schedule 99
CHAPTER V MISCELLANEOUS
33-P. Power to give direction 100 34. Offen ces by companies 100
34-A. Offences by Government departments 106 34-AA. Penalty for vexa tious search or seizure 107
35. Publication of sentences passed under this Act 107 36. Magistrate's power to impose enhanced penalties 107
36-A. Certain offences to be tried summarily 108 36-AB. Special Courts 109 36-AC. Offences to be cognizable and non-bailable in
certain cases 110 36-AD. Application of Code of Criminal Procedure, 1973
to proceedings before Special Court 110 36-AE. Appeal and revision 111
37. Protecting of action taken in good fai th 111 38. Rules to be laid before Parliament 111
Rules CONTENTS
THE DRUGS AND COSMETICS RULES, 1945 PART I
PRELIMINARY 1. Short title, extent and commencement 2. Definitions
PART II THE CENTRAL DRUGS LABORATORY
3. Functions 3-A.
VDRL Antigen
4. Despatch of sampies for test or analysis 5. Recording of condition of seals 6. Report of result of test or analysis 7. Fees 8. Signature of certificates
2l. 22. 23. 24.
24-A.
[PART III (Rules 9 to 20) [* * *]
PART IV IMPORT AND REGISTRATION
Import licences Form and manner of application for import licence Form and manner of application for Registration Certificate
25. Licences for import of drugs manufactured by one
25-A.
25-B.
26.
27. 27-A.
28.
28-A. 29.
29-A.
30.
manufacturer Condition to be satisfied before a licence in Form 10 or Form 10-A, granted Registration Certificate for import of drugs manufactured by one manufacturer Condition of import licence Grant of import licence Grant of Registration Certificate Duration of import licence Duration of Registration Certificate Suspension and cancellation of import licence Suspension and cancellation of Registration Certificate
Prohibition of import after expiry of potency
xv
Page
116
116
119 120
121 121 122 122 122
122 123 123 123
123
125
125
125 126 127 128 128
128
128
129
129
x xvi ENCYCLOPAEDIA ON LAW OF DRUG~
Rules Page
30-A. [* * *]. 129 :3
30-AA. Import of new Homeopathic medicines 129
'J 30-B. Prohibition of import of certain drugs 130 ~
31. Standard for certain imported drugs 130
32. Packing and labelling of imported drugs 130
32-A. Packing and labelling of Homeopathic medicine 130
33. Import of drugs for examination, test or analysis 130
33-A. Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients 131
34. Application for licence for examination, test or analysis 132
34-A. Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients 132
35. Cancellation of licence for examination, test or analysis 133
35-A. Cancellation of licence for import of small quantities of new drugs 133
36. Import of drugs for personal use 133
37. Packing of patent or proprietary medicines 134
38. Statement to accompany imported drugs 134
39. Documents to be supplied to the Customs Collector 134
40. Procedure for the import of drugs 135
41. 135
[42. * * *] 136
43. 136
43-A. 136
43-B. 136
PARTY GOVERNMENT ANAL YSTS, INSPECTORS, LICENSING
AUTHORITIES AND CONTROLLING AUTHORITIES 44. Qualifications of Government Analyst 137 45. Duties of Government Analysts 138 46. Procedure on receipt of sampie 139 47. Report of result of test or analysis 140 48. Fees 140 49. Qualifications of Inspectors 140
CONTENTS xvii
Rules Page
49-A. Qualifieation of Lieensing Authority 140
50. Controlling authorj: . 140
50-A. Qualification of a Controlling Authority 140
5l. Duties of Inspeetors of premises lieensed for sale 141
52. Duties of inspectors speeially authotised to inspeet the manufacture of drugs or eosmeties 142
53. Prohibition of disclosure of information 142
54. Form of order not to dispose of stock 142
54-A. Prohibition of sale 143
55. Form of receipts for seized drug, cosmetic, reeord, registered, document or any other material object 143
55-A. Manner of eertifying eopies of seized doeuments 143 56. Form of intimation of purpose of ta king sampies 143
56-A. Form of receipt for sampies of drugs where fair price tendered is refused 143
5~ , Procedure for despatch of sampie to Government Analyst 143
58. Confiseation of drugs, implements, machinery, ete. 144 58-A. Procedure for disposal of eonfiscated drugs 144
PART VI SALE OF DRUGS OTHER THAN HOMEOPATHIC
MEDICINES 59. 145 60. 146 6l. Forms of licenees to seIl drugs 146 62. Sale at more than one place 146
62-A. Restrieted licences in Forms 20-A and 21-A 146 62-B. Conditions to be satisfied before a licenee in
Form 20-A or Form 21-A is granted 147 62-C. Applieation for lieence to sen drugs by wholesale
or to dis tribute the same from a motor vehicle 147 62-D. Form of lieences to sell drugs by wholesale or
distribute drugs from a motor vehicle 148 63. Duration of licence 148
63-A. Certificate of renewal of a sale licenee 148 63-B. Certifieate of renewal of licence 148
64. Conditions to be satisfied before a licenee in Form 20, 20-B, 20-F, 20-G, 21 or 21-B is granted or renewed 148
xviii ENCYCLOPAEDIA ON LAW OF DRUGS
Rules Page
65. Condition of licences 154
65-A. Additional information to be furnished by an applicant for licence or a licensee to the licensing authority 164
66. Cancellation and suspension of licences 166
66-A. Procedure for disposal of drugs in the event of cancellation of licence 166
[67. * * *] 166
PART VI-A SALE OF HOMEOP ATHIC MEDICINES
67-A. 166
67-B. 167
67-C. Forms of licences to seIl drugs 167
67-D. Sale at more than one place 167
67-E. Dura tion of licences 167
67-EE. Certificate of renewal 167
67-F. Condition to be satisfied before a licence in Form 20-C or Form 20-D is granted 167
67-G. Conditions of licence 168
67-GG. Additional information to be furnished by an applicant for licence or a licensee to the licensing authority 168
67-H. Cancellation and suspension of licences 169
PART VII MANUFACTURE FOR SALE OR FOR DISTRIBUTION
OF DRUGS OTHER THAN HOMEOPATHIC MEDICINES
68. Manufacture on more than one set of premises 169
68-A. Grant or renewal of licences by the Central Licence Approving Authority 169
68-B. Delegation of powers by the Central Licence Approving Authority 170
69. Application for licence to manufacture drugs other than those specified in Schs. C and C (1) to the Drugs and Cosmetics Rules 171
69-A. Loan licence 172 69-B. [* * *] 174
70. Form of licence to repack or manufacture drugs other than those specified in Schs. C and C(l) 174
CONTENTS xix
Rules Page 70-A. Form of Ioan Licence to manufacture for sale or
for distribution] of drugs other than those specified in Schs. C, C (1) and X 174
71. Conditions for the grant or renewal of a licence in Form 25 or Form 25-F 174
71-A. Conditions for the grant or renewal of a licence in Form 25-B 177
71-B. Conditions for the grant or renewal of a licence in Form 25-A 178
72. Duration of licence 179 73. Certificate of renewal 179
73-A. A certificate of renewal of a loan licence 179 73-AA. Duration of Ioan licence 179
73-B. Certificate of renewal of licence in Form 25-B 179 74. Conditions of licence in Form 25 and Form 25-F 179
74A. Condition of licence in Form 25-B 182 74B. Londition of licence in Form 25-A 183
75. Forms of application for licence to manufacture for sale or distribution of drugs specified in Schs. C, C (1) and X excluding those specified in Part XB 184
75-A. Loan licences 185 75-B. [* * *] 186
76. Forms of licences to manufacture drugs specified in Schs. C and C(l), excluding those specified in Part XB ,md Sch. X, or drugs specified in Schs. C, C(l) and X ,md the conditions for the grant or renewal of such licences 190
76-A. Form of loan licence to manufacture for sale or for distribution of drugs specified in Schs. C and C (1) excluding the drugs specified in Sch. X and conditions for the grant or renewal of such licence 190
77. Duration of licence 190 78. Conditions of licence 190
78-A. Condi tions of licence in Form 28-A 194 79. Inspection before grant or renewal of licence 195
80. Report by Inspector 195
8I. Procedure of licensing authority 195 82. Further application after rejection 196
xx ENCYCLOPAEDIA ON LAW OF DRUGS
Rules Page 83. Renewal 196
83-A. Certificate of a renewal of a loan licence 196 83-AA. Duration of loan licence 196
84. 196 84-A. Provisions for appeal to the State Government
or Central Government by party whose licence has not been granted or renewed 197
84-AA. Additional information to be furnished by an applicant for licence or a licensee to the licensing authority 197
84-B. Prohibition for the manufacture for sale of cyclamates and preparations containing cyclamates 197
85. Cancellation and suspension of licences 197 PART VII-A
MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF HOMEOPATHIC MEDICINES
85-A. Manufacture in more than one set of premises 198 85-B. Application for licence to manfuacture
Homeopathic medicines 198
85-C. Application to manufacture "New Homeopathic medicines ." 198
85-D. Form of licence to manufacture Homeopathic medicines 200
85E. Conditions for the grant or renewal of a licence in Form 25-C. 200
85EA. Inspection before or renewal of licence 201 85-EB. Report by Inspector 201 85-EC. Grant or refusal of licence 202 85-ED. Further application after rejection 202 85-EE. Appeal to the State Government 202
85-F. Duration of licence 202 85-G. Certificate of renewal 202 85-H. Condi tions of licence 202
85-HH. Additional information to be furnished by an applicant for the licence or a licensee to the licensing authority 204
85-1. Cancellation and suspension of licences 204
CONTENTS xxi
Rules Page PART VIII
MANUFACTURE FOR EXAMINATION, TEST OR ANALYSIS
86. Conditions relating to manufacture for examination, test or analysis 204
87. Labelling 204 88. Labelling of drugs supplied to other persons 204 89. Licence 204 90. Form of application 205 91. Duration of licence 205 92. Conditions of licence 205 93. Cancellation of licences 206
PART IX LABELLING AND PACKING OF DRUGS OTHER THAN
HOMEOPATHIC MEDICINES 94. Exemption of certain drugs from certain
provisions of this Part 206 95. Prohibition of sale or distribution unless labelled 207 96. Manner of labelling 207 97. Labelling of medicines 213 98. Manner of labelling.- [***] 214 99. Labelling with the name and address of seller-[***] 214
10l. Labelling with the statement of quantity of alcohol or a substance specified in Sch. E 214
102. Non-sterile surgical ligature and suture 214 103. (1) *** 214 104. Use of letters LP. ete. 215
104-A. Prohibition against altering inscriptions on containers, labels or wrappers of drug 215
105. Packing of drugs 215 105-A. Packing of drugs specified in Sch. X 216
106. Diseases whieh a drug may not purport to prevent or eure 216
PART IX-A LABELLING AND PACKING OF HOMEOPATHIC
MEDICINES 106-A. Manner of labelling of Homeopathie medicines 216 106-B. Probation of quantity and pereentage 216
xxii ENCYCLOPAEDIA ON LAW OF DRUGS
Rufes Page PART X
SPECIAL PROVISIONS RELATING TO BIOLOGICAL AND OTHER SPECIAL PRODUCTS
107. Name of substance 108. Container 109. Labelling
109-A. Labelling of medical devices 110. Prohibition of sale of substaI1Ce after prescribed
date 111. Standards 1 f2. Tests for strength and quality 113. (***] 114. [***] 115. Application of tests for sterility 116. [***] 117. [***]
218 218 219 220
220 220 221 221 221 221 221 221
118. [***] 221 119. 221 120. 221
121. Test for freedom from abnormal toxicity 222 121-A. Test for pyrogens 222
122. Substances specified in Sch.C.(I) 222 PARTX-A
IMPORT OR MANUFACTURE OF NEW DRUG FOR CLINICAL TRIALS OR MARKETING
.. 122-A. Application for permission to import new drug 122-B. Application for approval to manufacture new
drug [***]. 122-C. [****]. 122-D. Permission to import or manufacture fixed dose
223
224 225
combination 225 122-DA. Application for permission to conduct clinical trials
for New Drugs/Investigational New Drug 225 122-DAA. Defindition of Clinical trial 226
122-DB. Suspension or Cancellation of Permission/ Approval 226
122-DC. Appeal 227 122-E. Definition of new drug 227
CONTENTS Rules
PART-X-B
xxiii
Page
REQUIREMENT FOR THE COLLECTION, STORAGE, PROCESSING AND DISTRIBUTION OF WHOLE HUMAN BLOOD, HUMAN BLOOD COMPONENTS BY BLOOD BANKS [***] OF BLOOD
PRODUCTS 122-EA. Definitions
122-F. Form of application for licence for operation of blood bank/processing of whole human blood for components/manufacture of blood produts for sale or distribution
122-G. From of licence for the operation of a blood bank/ processing of whole human blood for components and manufacture of blood products and the conditions for the grant or renewal of such licence
122-H. Duration of licence 122-1. Inspection before grant or renewal of licence
for operation of blood bank, processing of whole human blood for components and manufacture of blood products
122-J. Report by Inspector 122-K. Further application after inspection 122-L. Delegation of power by the Central Licence
Approving Authority 122-M. Provision for appeal to the State Government by
a party whose licence has not been granted or renewed
122-N. Additional information to be furnished by an applicant for licence by a licensee to the licensing authority
122-0. Cancellation and suspension of licences 122-P. Conditions of licence
123.
124. Standards of drugs
PART XI EXEMPTIONS
PART XII STANDARDS
124-A. Standards for veterinary drugs 124-B. Standards for patent or proprietary medicines
227
228
230 231
231 232 232
232
232
232 233 233
235
237 238 238
xxiv ENCYCLOPAEDIA ON LAW OF DRUGS
Rules Page 124-C. Standards for surgical dressings 238 124-D. Standards for sterilised umbilical tapes 238
125. Standards for substances (other than food) intended to affect the structure or any function of human body-Contraceptives 238
125-A. Standards for medical deviees 239 126. Standards for substanees intended to be used for
the destruetion of vermin or inseets whieh eause disease in human beings or animals-Disinfeetants 239
126-A. Standards for ophthalmie preparatilons 239 127. List of colours permitted to be used in drugs 239 128. 241
PART XIII IMPORT OF COSMETICS
129. Statement to aeeompany imported eosmeties 242 130. Doeuments to be supplied to the Collector of
Customs 242
131. Proeedure for the import of eosmetics 242
132. Exemption of cosmetics 242
133. Import through points of entry 243
134. Cosmetic to contain dyes, colours and pigments 243
134-A. Prohibition of import of cosmetic containing hexacholorophene 243
135. Import of cosmetic containing lead or arsenic compound prohibited 243
135-A. Import of eosmetics containing mercury compounds priohibited 243
136. Import of cosmetic for personal use 244
PART XIV MANUFACTURE OF COSMETICS FOR SALE OR FOR
DISTRIBUTION 137. Manufacture on more than on set of premises 244
138. Applieation for licence to manufacture cosmetics for sale or for distribution 244
138-A. Application for loan licence to manufacture cosmetics 245
139. Conditions for the grant or renewal of a licence in Form 32 246
139-A. Form of licence to manfuacture cosmetics for sale for distribution 246
CONTENTS xxv
Rules Page 139-AA. Inspection before grant or renewal of licence 247 139-AB. Report by Inspector 247 139-AC. Grant or refusal of licence 247 139-AD. Further application after rejection 247 139-AE. Appeal to the State Government 247 139-B. Form of 10an or for distribution licence to manufacture
cosmetics for sale or for distribution 247 140. Duration of licence 247 141. Certificate of renewal 247
141-A. Certificate of renewal of 10an licence 248 141-AA. Dura tion of 10an licence 248
142. Conditions of licence 248 142-A. Additional information to be furnished by an applicant
for licence or a license to the licensing authority 249 142-B. Conditions of licence in Form 32-A 249
143. Cancellation and suspension of licence 250 144. Prohibition of manufacture of cosmetics containing
colours other than those prescribed 250 144-A. Prohibition of manufacturer of cosmetic containing
hexachlorophene 250 145. Use of lead and arsenic compounds for the purpose of
colouring cosmetics prohibi ted 250 145-A. Form of intimation for purpose of taking sampIes of
cosmetics 250 145-AA. Form of receipt of sampIes of cosmetics where fair
price tendered is refused 251 145-B. Form of receipt for seized cosmetics 251
145-BA. Manner of certifying copies of seized documents 251 145-C. Form of order not to dispose of stocks of cosmetics 251 145-D. Prohibition of manufacture of cosmetic containing
mercury compounds 251 PART XV
LABELLING, PACKING AND STANDARDS OF COSMETICS
146. Prohibition of sale or distribution 252 147. Exemption of cosmetics and manufaetured for
consumption or sale in India from the provisions of this Part 252
148. Manner of labelling 252
xxvi ENCYCLOPAEDIA ON LAW OF DRUGS
Rules Page 148-A. Prohibition against altering inscriptions on containers, labels
or wrappers of cosmetic 253 148-B. Prohibition against false or misleading claims 253
149. Labelling of hair dyes containing dyes, colours and pigments 253
149-A. Special provisions relating to toothpaste containing fluoride 253
150. Report of result of test or analysis of cosmetics 254 150-A. Standards of cosmetics 254
PART XV-A APPROVAL OF INSTITUTIONS FOR CARRYING OUT TESTS ON
DRUGS/ COSMETICS AND RAW MATERIAL USED IN THEIR MANUFACTURE ON BEHALF OF LICENSEE FOR MANUFACTURE
FOR SALE OR DRUGS/COSMETICS 150-B. Application for grant of approval for testing drugs/
cosmetics 254 I50-C. Form in which approval to be granted for carrying out
tests on drugs or cosmetics on behalf of licensees for manufacture of drugs or cosmetics and conditions for grant or renewal of such approval 254
150-D. Duration of approval 255 150-E. Conditions of approval 257 150-F. Inspection before grant of approval 258
150-G, Report of inspection 258 150~H. Procedure of a approving authority 258 150-1. Further application after rejection 258 150-J, Renewal 259
150-K. Withdrawal and suspension of approvals 259 PART XVI
MANUFACTURE FOR SALE OF A YURVEDIC (INCULUSIVE SIDDHA) OR UNANI DRUGS
151. Manufacture on more than one set of premises 259 152. Licensing authority 259 153. Application for licence to manufacgture Ayurvedic
(including Siddha) or Unani drugs 259 153-A. Loan licence 260
154. Form of licence to manufacture Ayurvedic (including Siddha) or Unani drugs 260
154-A. Form of 10an licence to manufacture for sale Ayurvedic (including Siddha) or Unani drugs 260
CONTENTS
Rules 155. Certificate of renewal
155-A. Certificate of renewal of a 10an lieenee 155-B. Certificate of award of G.M.P. of Ayurveda, Siddha
and Unani Drugs 156. Duration of lieence
156-A. Duration of 10an lieenee 157. Conditions for the grant or renewal of a lieenee in
Form 25-D 157-A.
158. Conditions of lieenee 158-A. Conditions of loan lieenee
xxvii
Page 261 261
~ 261 261 261
261 262 262 263
159. Cancelling and suspension of lieenees 263 160. Identifieation of raw materials 263
PART XVI (A) APPROV AL OF INSTITUTIONS FOR CARRYING OUT TESTS ON
AYURVEDIC, SIDDHA AND UNANI DRUGS AND RAW MATERIALS USED IN THEIR MANUFACTURE ON BEHALF OF LICENSEES FOR MANUFACTURE FOR SALE OF AYURVEDIC,
SIDDHA AND UNANI DRUGS 160-A. Applieation for grant of approval for testing Ayurvedie,
Siddha and Unani drugs 264 160-B. Form in which approval to be granted for earrying out
tests on Ayurvedic, Siddha and Unani drugs on behalf of licensees for manufacture of Ayurvedic, Siddha and Unani drugs and eonditions for grants or feneWill of such approval 265
160-C. Duration of approval 267 160-D. Conditions of approval 268 160-E. Inspection before grant of approval 268 160-F. Report of inspection 268
160-G. Procedure of Approving Authority 268 160-H. Application after rejection 268 160-1. Renewal 268 160-J. Withdrawal and suspension of approvals 268
PART XVII LABELLING PACKING AND LIMIT OF ALCOHOL IN A YURVEDIC
(INCLUDING SIDDHA) OR UNANI DRUGS 161. Labelling, packing and limit of alcohol 270
161-A. Exemption in labelling and packing provisions for export of Ayurvedic (including Siddha) and Unani Drugs 272
xxviii
Rules
ENCYCLOPAEDIA ON LAW OF DRUGS
PART XVIII GOVERNMENT ANAL YSTS AND INSPECTORS FOR A YURVEDIC
(lNCLUDING SIDDHA) OR UNANI DRUGS 162. Duties of Inspectors specially authorised to inspect the
manufacture of Ayurvedic (including Siddha) or Unani drugs 272
162~A.
163. Procedure for despatch of sampie to Government Analyst and its receipt by the Government Analyst
163·A. Functions 163·B.
273
273 274 274
163-C. Despatch of sampies for test or analysis 274 163-D. Recording of condition of seals 274 163-E. Report of result of test or analysis 274 163-F. Fees 275 163-G. Signature on certificates 275
164. Method of test or analysis to be employed in relation to Ayurvedic (including Siddha) or Unani drugs
165. Qualifications of Government Analyst 275 166. Duties of Government Analyst 275 167. Qualifications of Inspector 275
168.
PART XIX STANDARDS OF A YURVEDIC, SIDDHA AND
UNANI DRUGS]
169. Permitted Excipients
Section
PART II THE DRUGS AND MAGIC REMEDlES
(OBJECTIONABLE ADVERTISEMENTS) ACT, 1954
1. Short title, extent and commencement 2. Definitions 3. Prohibition of advertisement of certain drugs for
treatment of certain diseases and disorders 4. Prohibition of misleading advertisements relating
276 276
729 729
731
to drugs 732 5. Prohibition of advertisement of magie remedies for
treatment of certain diseases and disorders 733 6. Prohibition of import into, and export from, India of
certain advertisements 733
CONTENTS xxix Secti011 Page
7. Penalty 734 8. Powers of entry, search, etc. 735 9. Offences by companies 735
9-A. Offences to be cognizable 735 10. J urisdiction to try offences 735
10-A. Forfeiture 735 1l. Officers to be deemed to be public servants 735 12. Indemnity 735 13. Other laws not affected 735 14. Savings 735 15. Power to exempt from application of Act 736 16. Power to make rules 736
THE DRUGS AND MAGIC REMEDlES (OBJECTIONABLE ADVERTISEMENTS)
RULES, 1955 Rules
l. Short title and commencement 739 2. Definitions 739 3. Scrutiny of misleading advertisement relating to
drugs 739 4. Procedure to be followed in prohibited import
into, and export from India of certain ad vertisemen ts 740
5. Manner in which advertisements may be sent confidentially 740
6. Prohibition of advertisement of drugs for treatment of disease, etc. 740
THE DRUGS (CONTROL) ACT, 1950 l. Short title and extent 741 2. Interpretation 742 3. Drugs to wh ich this Act applies 742 4. Fixing of maximum prices and maximum quantlties
which may be held or sold 742 5. Restrictions on sale, etc. where maximum is fixed
under Sec. 4 742 6. General limitation on quantity which may be
possessed at any one time 742
7. Duty to declare possession of excess stocks 742
8. Refusal to sell 743
9. Cash memorandum to be given of certain sales 743
xxx ENCYCLOPAEDIA ON LAW OF DRUGS
Rules Page 10. Marking of prices ,md exhibiting list of prices
and stocks 743 1l. Obligation to state price separatelyon composite
offer 743 12. Prohibition or regulation of the disposal of drugs 743 13. Penalties 744 14. Offences by Corporation 744 15. Produce 744 16. Power of search and seizure 744 17. Power to make rules 744 18. Protection of action taken in good faith 745 19. Savings of other laws 745 20. Repeal of Ordinance 26 of 1949 745
THE DRUGS (PRICES CONTROL) ORDER, 1995 Order
1. Short title and commencement 746 2. Defini tions 746 3. Power to fix the maximum sale prices of bulk drugs
specified in the First Schedule 750
4. Information to be furnished by the manufacturer in relation to the Scheduled bulk drugs 751
5. Information to be furnished by the manufacturer in relation to the non-Scheduled bulk drugs 751
6. Power to direct manufacturers of bulk drugs to seIl bulk drugs to other manufacturers of formulations 752
7. Calculated of retail price of formulatior: 752
8. Power to fix retail price of Scheduled formulations 753
9. Power of fix ceiling price of Scheduled formulations 754
10. Power to revise price of bulk drugs and formulations 754
1l. Fixation of price under certain circumstances 755
12. Power to re cover dues accrued under the Drugs (Prices Control) Order, 1979 and to deposit the same into the Drugs Prices Equalisation Account 755
13. Power to recover overcharged amount 755
14. Carrying into effect the price fixed or revised by the Government, its display and proof thereof 756
15. Display of prices of non-Scheduled formulations and price list thereof 756
16. Control of sale prices of bulk drugs and formulations 757 17. Sale of split quantities of formulations 757
CONTENTS xxxi
Order Pa;.?c 18. Manufacturer, distributor or dealer not to refuse
sale of drug 757 19. Price of formulations sold to the dealer 758 20. Maintenance of records and production therefore
for inspection 758 2l. Power of entry, search and seizure 758 22. Power to review 759 23. Power to issue guidelines and directions 759 24. Penalties 759 25. Power to exempt 760 26. Delegation of powers 760 27. Repeal and saving 761
THE NEW DRUGPOLICY, 1994 l. In trod uction 777 2. 777 3. Present status and approach adopted in review 777 4. 777 5. 777 6. Industrial licensing 778 7. Research and development 778 8. Investment 778 9. Pricing 779
10. 779 11. 779 12. 780 13. Quality Control and Rational Use of Drugs 780 14. 780 15. 780 16. National Drug Authority 780 17. 781 18. 781 19. 782 20. 782 21. Indigenous and other systems of medicines 782 22. Decisions in regard to modifications in Drug
Policy, 1986 782 22.1 Licensing 782
22.1.1 782 22.1.2 783
xxxii ENCYCLOPAEDIA ON LAW OF DRUGS
Order 22.1.3 22.1.4
22.2 Basic stage production 22.3 Review of items reserved for the public sector
22.4 Foreign investment 22.4.1 22.4.2
22.5 Foreign technology agreements 22.6 Encouragement to research and development (R & D)
efforts 22.6.1 22.6.2 22.6.3
22.7 Pricing 22.7.1 Single list of price controlled drugs and "Mape 22.7.2 Span of control 22.7.3 Ceiling Prices 22.7.4 Simplified Procedure 22.7.5 Encouragement to Production from Basic Stage
22.8 Setting up of National Drug Authority 22.8.1 22.8.2
22.9 Coordination between Ministries 22.10 Other matters
THE INDIAN MEDICINE CENTRAL COUNCIL ACT, 1970 CHAPTER I
PRELIMINARY Section
1. Short title, extent and commencement 2. Definitions
CHAPTER II THE CENTRAL COUNCIL AND ITS COMMITTEES
3. Constitution of Central Council 4. Mode of election 5. Restriction on elections and membership 6. Incorporation of Central Council 7. Term of office of President, Vice-President and
members of Central Council 8. Meetings of Central Council
Page 783 783 783 783 783 783 783 783
783 783 783 783 784 784 784 784 785 785 785 785 785 785
790 791
793 794 794 794
794 795
CONTENTS xxxiii
Sectioll Page 9. Committees for Ayurveda, Siddha and Unani 795
10. Other committees 795 1l. Meetings of committees 795 12. Officers and other employees of Central Council 795 13. Vacancies in the Central Council and committees
thereof not to invalidate acts, etc. 797 CHAPTER HA
PERMISSION FOR NEW MEDICAL COLLEGE, CO URS E, ETC.
13-A. Permission for establishment of new medical college, new course of study, etc. 797
13-B. Non-recognition of medical qualifications in certain cases 799
13-C. Time for seeking permission for certain existing medical college 799
CHAPTER IH RECOGNITION OF MEDICAL QUALIFICATIONS
14. Recognition of medical qualifications granted by certain medical institutions in India 799
15. Recognition of medical qualifications granted by certain medical institutions whose qualifications are not included in Second Schedule 799
16. Recognition of medical qualifications granted by medical institutions in countries with which there
is a scheme of reciprocity HOO 17. Rights of persons possessing qualifications included
in Second, Third and Fourth Schedule to be enrolled HOO 18. Power of require information as to courses of study
and examinations 802
19. Inspectors at examinations 802
20. Visitors at examinations 803
2l. Withdrawal of recognition 803
22. Minimum standards of education in Indian medicine 804
CHAPTER IV THE CENTRAL REGISTER OF INDIAN
MEDICINE 23. The Central Register of Indian Medicine 804
24. Supply of copies of State Register of Indian Medicine 80S
25. Registration in the Central Register of Indian
Medicine 80S
xxxiv
Seetion
ENCYCLOPAEDIA ON LAW OF DRUGS
26. Professional conduct 27. Removal of names from the Central Register of
Indian Medicine 28. Provisional registration for practice 29. Privileges of persons who are enrolled on the
Central Register of Indian Medicine 30. Registration of additional qualifications 31. Persons enrolled on Central Register of Indian
Medicine to notify change of place of residence and practice
CHAPTER V MISCELLANEOUS
32. Information to be furnished by Central Council and publication thereof
33. Commission of inquiry 34. Protection of action taken in good faith 35. Power to make rules 36. Power to make regulations
PART IU THE MEDICINAL AND TOlLET PREPARATIONS
(EXCISE DUTIES) ACT, 1955 PRELIMINARY
1. Short title, extent and commencement 2. Definitions
LEVY AND COLLECTION OF DUTIES 3. Duties of excise to be levied and collected on certain
Page
805
805 805
806 806
806
806 807 808 808 808
843 843
goods 847 4. Rebate of duty on alcohol, etc., supplied for
manufacture of dutiable goods 849 5. Recovery of sums due to government 850 6. Certain operations to be subject to licences 850 7. Offences and penalties 851 8. Power of Courts to order forfeiture 852
POWERS AND DUTIES OF OFFICERS AND LANDHOLDERS 9. Power to arrest 852
10., Power to summ on persons to give evidence and produce documents in inquiries under this Act. 853
11. Officers required to assist Excise Officers 8J;3
CONTENTS xxxv Section Page
12. Owners or oeeupiers of land to report manufaeture of eontraband dutiable goods 853
13. Punishment for eonnivanee at offenees 854 14. Searehes and arrests how to be made 854 15. Disposal of persons arrested 854 16. Inquiry how to be made by Exeise Officers against
arrested person forwarded to them 8S5 17. Vexatious seareh, seizure, ete., by Exeise Offker 855 18. Failure of Excise Offieers on duty 856
SUPPLEMENTARY PROVISIONS 19. Power to make rules H56 20. Bar of suits and limitation of suits and other legal
proeeedings 859 21. Repeals and savings 859
THE MEDICINAL AND TOlLET PREPARATIONS (EXCISE DUTIES) RULES, 1956
CHAPTER I PRELIMINARY
Rufes
1. 5hort title 863 2. Definitions 863 3. Agent or owner of goods, manufaetory or
warehouse to be deemed owner for eertain purposes 866
CHAPTER II APPOINTMENT OF OFFICERS
4. Appointment of officers and delegation of powers to them 866
5. Excise Commissioner may exercise the powers of any officer 866
CHAPTER III LEVY AND RUFUND OFf AND EXEMPTION
FROM DUTY 6. Recovery of duty 867 7. Exemption from duty on medicinal preparation for
Government and eharitable institutions 867 8. Power to exempt from duty in special eases 867 9. Time and manner of paymcnt of duty 868
10. Alteration of duty 869
xxxvi ENCYCLOPAEDIA ON LAW OF DRUGS
Rules Pt/Xl'
11. Recovery of duties or charges short-levied or erroneously refunded
12. Residuary powers for recovery of sums due to
Government 871
13. No refund of duties or charges erroneously paid, unless claimed within six months 871
14. Rebate of duty on goods exported 872
15. Export under bond of goods on which duty has not been paid 872
16. General bond by an exporter 872
17. Penalty for failure to furnish proof of export within the prescribed period 872
MANUFACTURE 18. Supply of rectified spirit for manufacture of
medicinal and toilet preparations 873
19. Wastage in transit of rectified spirit 873
20. Mode of manufacture 873
21. Issue of rectified spirit without payment of duty 873
22. Entry into and exist from a bonded manufactory 873
23. Essential of a bonded manufactory 874
24. No additions or alterations to be made without orders .. , 874 25. Arrangement of receptacles in a bonded manufactory 875 26. Indent for rectified spirit 875 27. Verification of rectified spirit received 875 28. Storage of rectified spirit 875 29. Issues of rectified spirit from the spirit store 876 30. Indent for opium, Indian hemp and other narcotic
drugs and narcotics, their storage and issue for manufacture 876
31. Manufactured dutiable goods 876 32. Manufacturing vessels to bear labels 876 33. Sampie to be taken 877 34. Storage of finished products 877 35. Deficiency noticed in the finished store 878 36. Disposal of sub-standard preparations 879 37. Disposal of recovered alcohol 879 38. Wastage in manufacture 880 39. Remission of duty in case of loss due to accident 881 40. Issue from a bonded manufactory 881
CONTENTS xxxvii
Rules Page 41. The licensee to maintain proper accounts, etc. 881 42. Size of establishment 881 43. Accounts 881 44. Collection of duty 882 45. Scope of duties 882 46. Opening and closing hours 882 47. Building arrangements 883 48. Receptacles 883 49. Indent for rectified spirit-duty paid 284 50. Indent for opium, Indian hemp and other narcotic
drugs and narcotics, their storage and issue for manufacture 885
SI. Restrictions on manufacture 885 52. Manufacture, storage and sale to be carried on only
in the licensed premises of the non-bonded manufactory 886
53. Sampies to be taken by the Excise Officer at least onee a month for analysis 886
54. Proeedure to be followed in taking sampies 887 55. No eompensation to manufaeturer of sampie
taken for analysis 887 56. Correct and up-to-date accounts in preseribed
printed registers to be maintained 887 57. Employees 888 58. Inspection 888 59. Allopathie preparations 888
Restricted and unrestricted medicinal preparations 60. Maintenance of restricted list of preparations 889
Homeopathic preparations 6L Mode of manufacture 890 62. [* * * *] 890
Preparation with narcotic ingredients 63. Preparations containing opium, Indian temp and other
narcotic drugs and narcotics 890 Ayurvedic preparations
64. Types of preparations 890 65. Pharmacopoeia for A yurvedic prepara tions 890 66. Classification of preparations containing self-
genera ted alcohol for purpose of levy of duty 890
xxxviii ENCYCLOPAEDIA ON LAW OF DRUGS
Rules 67. Levy of duty on Ayurvedic preparations made by
distillation or to which alcohol is added at any stage of manufacture
67-A. [*****] Standing Committee
68. Standing Committee and its functions CHAPTER V
WAREHOUSING 69. Establishment of bonded warehouses 70. Licensing of warehouses 71. Licensee to enter into a bond 72. Receipt of goods at warehouse 73. Owner's power to deal with warehoused goods 74. Goods not to be taken out of warehouse except as
provided by these rules 76. Mode for calculating quantity of goods warehoused 77. Power to re mit duty on warehoused goods lost or
destroyed 78. Responsibility of the licensee of the warehouse 79. Offences with respect to warehousing 80. Monthly returns 81. Clearance on payment of duty
CHAPTER VI LICENSING
82. Procedure for obtaining licence 83. Form of application 84. Grant of a licence 85. Form of licence-Limitations 86. Alteration or substitution of licence 87. Revocation and suspension of licence 88. Refund of licence-fee 89. Licence to be exhibited 90. Regulation of business of licensee 91. Additional rules specially applicable for applying
for a licence to manufacture medicinal and toilet preparations in a bonded/non-bonded manufactory
92. Plan of the manufactory to accompany the application
Page
891 891
891
892 892 893 893 893
894 894
894 894 894 895 895
895 896 897 899 899 900 901 901 901
901
902
CONTENTS xxxix
Rules Page 93. In case of a firm cert, ~n particulars to accompany
the application 902 94. The applicant to be in possession of the requisite
licence under the Drugs and Cosmetics Act, 1940 903 95. Disposal of application for licence to manufacture
medicinal and toilet preparation in a bondedl non-bonded manufactory by the licensing authority 903
96. Security 904 CHAPTER VII
EXPORT UNDER CLAIM FOR REBATE OF DUTY OR UNDER BOND
97. Method of export 904 98. Application to be submitted 904 99. Examination of goods prior to despatch 904
100. 905 10l. Examination at the place of export 906 102. Further procedure in respect of goods exported by
parcel post 906 103. Presentation of claim for rebate 906
CHAPTER VIII INTER-STATE MOVEMENT OF MEDICINAL AND TOlLET
PREPARATIONS CONTAINING ALCOHOL, OPIUM, INDIAN HEMP AND OTHER NARCOTIC DRUGS
AND NARCOTICS 104. Mode of Inter-State movement 906 105. Bond for due arrival and re-warehousing 907 106. Remover may enter into a general bond 907 107. Procedure in respect of goods removed from one
warehouse to another 907 108. Failure to present triplicate application 908 109. Procedure on failure to pay duty 908
CHAPTER IX ENTRY, SEARCH, SEIZURE AND INVESTIGATION
110. Authorized officers to have free access to premises, equipment, stocks and accounts of dealers in dutiable goods 909
111. Penalty for obstruction or giving false or misleading information 909
xl ENCYCLOPAEDIA ON LAW OF DRUGS
Rules Page
112. Power to detain person and examine goods 910
113. Power to stop, enter and se ar eh 910
114. Seizure 910
115. Power to require aeeess to place, vessel or conveyance of inspection or examination of goods 910
116. Police to take charge of articles seized 910
117. Summons and notices : manner of service 910
118. Service of notice : notice not void for error 911
119. Disposal of things seized 911
120. Prosecution 911
121. Arrests 912
122. Provisions of arrests and seizures to be in conformi ty with the Act 912
CHAPTERX PENALTIES, CONFISCATIONS AND APPEALS
123. Powerof adjudication of confiscation and penalty 912 124. General penalty 912 125. Composition of offences 912 126. Confiscation 912 127. Appeal 913 128. Revision petitions 913 129. Appeal and applications for revision to be accompanied
by copy of decision or order appealed against 913 CHAPTER XI
MISCELLANEOUS 130. Excise Commissioner may require a fresh declaration 914 131. Stocks of dutiable goods to be stored in an orderly
manner 914 132. Account of stock of goods in a manufactory or
warehouse to be taken and balance to be struck 914 133. Restriction of rem oval of goods 915 134. Licensee' s liability for removal of goods by any
person 915 135. How registers and stock accounts to be maintained 915 136. Provision and maintenance of weighing and
measuring apparatus 916 137. Provision and maintenance of locks 916
137-A. Duplicates of documents may be gran ted on payment of fees 917
CONTENTS xli
Rules Page 138. Goods, plant and machinery chargeable with duty
not paid 917 139. Dutiable goods not to be sold except in prescribed
containers bearing a label 917 140. Officer not to disclose information learned in his
official capacity 918 141. Provisions of lodgings for the excise staff posted
to the bonded manufactory or warehouse 918 142. Power to issue supplementary instructions 1000 143. Cancel1ation of former rules, order and notifications 1000
Rufes
THE MEDICINAL AND TOlLET PREPARTIONS (EXCISE DUTIES) CONSTRUCTION OF
REFERENCES RULES, 1976
1. Short title 2. Construction of references to certain expressions
PART IV THE NARCOTIC DRUGS AND PSYCHOTROPIC
SUBST AN CES ACT, 1985 CHAPTER I
PRELIMINARY
1000 1000
Seetion 1. Short title, extent and commencement 2. Definitions 3. Power to add to or omit from the list of
1001 1003
psychotropic substances 1010 CHAPTER II
AUTHORITIES AND OFFICERS 4. Central Government to take measures for
preventing and combating abuse of and illicit traffic in narcotics drugs, ete. 1011
5. Officers of Cen1tal Government 1012 6. The Narcotic Drugs and Psychotropic Substances
Consultative Committee 1013 7. Officers of State Government 1013
CHAPTER II-A NATIONAL FUND FOR CONTROL OF DRUG ABUSE
7-A. National Fund for control of Drug Abuse 1014 7-B. Annual report of activities financed under thc Fund 1014
xlii
Seetion
ENCYCLOPAEDIA ON LAW OF DRUGS
CHAPTER In PROHIBITION, CONTROL AND REGULATION
Page
8. Prohibition of certain operations 1015 8-A. Prohibition of Certain activities relating to property
derived from offence 1021 9. Power of Central Government to permit, control and
regulate 1022 9-A. Power to control and regulate controlled substances 1024
10. Power of State Government to permit, control and regulate 1025
11. Narcotic Drugs and Psychotropic Substances, etc., not liable to distress or attachment 1026
12. Restrictions over external dealings in Narcotic Drugs and Psychotropic Substances 1027
13. Special provisions relating to coca plant and coca leaves for use in the preparation of flavouring agent 1027
14. Special provision relating to cannabis 1027 CHAPTER IV
OFFENCES AND PENALTIES 15. Punishment for contravention in relation to poppy
straw 16. Punishment of contravention in relation to coca plant
1027
and coca leaves 1031 17. Punishment for contravention in relation to prepared
opium 1031 18. Punishment for contravention in relation to opium
poppy and opium 1031 19. Punishment for embezzlement of opium by cultivator 1038 20. Punishment for contravention in relation to cannabis
plant and cannabis 1038 21. Punishment for contravention in relation to
manufactured drugs and prepara tions 1050 22. Punishment for contravention in relation to
psychotropic substances 1056 23. Punishment for illegal import into India, export from
India or tanshipment of narcotic drugs and psychotropic substances 1058
24. Punishment for external dealings in narcotic drugs and psychot .. opic substances in contravention of Sec. 12 1059
Sectiml 25.
25-A.
26. 27.
27-A.
28. 29. 30. 31.
31-A.
32.
32-A.
32-B.
33.
34. 35. 36.
36-A 36-B. 36-C.
36-D. 37. 38. 39.
40.
CONTENTS
Punishment for allowing premises, etc., to be used for commission of an offence Punishment for contravention of orders made und er Sec. 9-A Punishment for eertain acts by lieensee or his servants Punishment for eonsumption of any narcotic drug or psyehotropic substance Punishment for financing illicit traffic and housing offenders Punishment for attempts to commit offene es Punishment for abetment and criminal conspiracy Preparation Enhanced punishment for offences after previous eonviction Death penalty for certain offences after previous eonviction Punishment for offence for which no punishment is provided No suspension, remission or commutation in any sentence awarded under this Act Pactors to be taken into account for imposing higher than the minimum punishment Application of Sec. 360 of the Code of Criminal Procedure, 1973 and of the Probation of Officers Act, 1958 Security for abstaining from commission of offence Presumption of culpable mental state Constitution of Special Courts Offences triab le by Special Courts Appeal and revision Application of code to proceedings before a Special Court Transitional provisions Offences to be cognizable and non-bailable Offences by companies Power of Court to release certain offenders on probation
Power of Court to publish names, place of business, etc., of certain offenders
xliii
Page
1059
1060 1060
1060
1063 1063 1065 1065
1066
1066
1068
1068
1070
1071 1071 1071 1072 1074 1077
1078 1078 1079 1090
1090
1091
xliv ENCYCLOPAEDIA ON LAW OF DRUGS
Sectiol1 Pa"c (~
CHAPTER V PROCEDURE
4l. Power to issue warrant and authorisation 1091
42. Power of entry, seareh, seizure and arrest without warrant or authorisation 1095
43. Power of seizure and arrest in public place 1107
44. Power of entry , search, seizuIe and arrest in offences relating to coca plant, opium poppy and cannabis plant 1110
45. Procedure where seizure of goods liable to confiscation not practicable 1110
46. Duty of landholder to give information of illegal cultivation 1110
47. Duty of certain officers to give information of illegal cultivation 1110
48. Power of attachment of crop illegally cultivated 1110 49. Power to stop and search conveyance 1111 50. Conditions under which search of person shall be
conducted 1111 50-A. Power to under take controlled delivery 1130
51. Provisions of the Code of Criminal Procedure, 1973 to apply to warrants, arrests, searches and seizures 1130
52. Disposal of persons arrested and articles seized 1131 52-A. Disposal of seized narcotic drugs and psychotropic
substances 1133 53. Power to invest officers of certain departments with
powers of an officer-in-charge of a police station 1135 53-A. Relevancy of statements under certain drcumstances 1136
54. Presumption from possession of illidt articles 1137 55. Police to take charge of articles seized and delivered 1138 56. Obligation of officer to assist each other 1142 57. Report of arrest and seizure 1142 58. Punishment for vexatious entry, search, seizure or
arrest 1144 59. Failure of officer in duty or his connivance at the
contravention of the provisions of this Act 1144 60. Liability of illidt drugs, substances, plants, articles
and conveyances to confiscation 1145
CONTENTS xlv Secti011 Page
61. Confiscation of goods used for cancelling illicit drugs or substances 1146
62. Confiscation of sale proceeds of illicit or drugs substances 1147
63. Procedure in making confiscations 1147 64. Power to tender immunity from prosecution 1148
64-A. Immunity from prosecution to addict voluteering for treatment 1149
65. [* * *] 1150 66. Presumption as to documents in certain cases 1150 67. Power to call for information, etc. 1151 68. Information as to commission of offences 1155
CHAPTER V-A FORFEITURE OF PROPERTY DERIVED FROM, OR
USED IN, ILLICIT TRAFPIC 68-A. Application 1155
68-B. Defini tions 1159
68-C. Prohibition of holding illegally acquired property 1159
68-D. Competent authority 1159
68-E. Identifying illegally acquired property 1160
68-F. Seizure or freezing of illegally acquired property 1160
68-G. Management of properties seized or forfeited under this Cha pter 1161
68-H. Notice of forfeiture of property 1161
68-1. Forfeiture of property in certain cases 1162
68-J. Burden of proof J 163
68-K. Fine in lieu of forfei ture 1164
68-L. Procedure in relation to certain trust properties 1164
68-M. Certain transfers to be null and void 1165
68-N. Constitution of Appellate Tribunal 1165 68-0. Appeals 1165
68-P. Notice or order not to be invalid for error in
description 1166
68-Q. Bar of jurisdiction 1166
68-R. Competent Authority and Appellate Tribunal to have powers of Civil Court 1166
68-S. Information to Competent Authority 1167
68-T. Certain officers to assist Administrator, competent
authority and Appellate Tribunal 1167
xlvi ENCYCLOPAEDIA ON LAW OF DRUGS
Section Page 1167 1168
68-U . Power to take possession 68-V. Rectification of mistakes
68-W. Finding under other laws not conclusive for proceedings under this Chapter
68-X. Service of notices and orders 68-Y. Punishment for acquiring property in relation to
which proceedings have been taken, under this Chapter
68-2. Release of property in certain cases CHAPTER VI
MISCELLANEOUS
1168 1168
1168 1169
69. Protection of action taken in good faith 1169 70. Central Government and State Government to have
regard to international conventions while making rules 1169
71. Power of Government to establish centres for identification, treatment, etc., of addicts and for supply of narcotic drugs and psychotropic substances 1169
72. Recovery of sums due to Government 1170 73. Bar of jurisdiction 1170 74. Transitional provisions 1171
74-A. Power of Central Government to give directions 1171 75. Power to delegate 1171 76. Power of Central Government to make rules 1173 77. Rules and notifications to be laid before Parliament 1173 78. Power of State Government to make rules 1174 79. Application of the Customs Act, 1962 1174 80. Application of the Drugs and Cosmetics Act, 1940
not barred 1174 81. Saving of State and speciallaws 1174 82. Repeal and savings 1174 83. Power to remove difficulties 1174
Rules
THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES RULES, 1985
CHAPTER I PRELIMINARY
1. Short title and commencement 2. Definitions
1181 1181
CONTENTS xlvii
Rules Page CHAPTER II
POWERS OF OFFICERS 3. Delegation of powers 1183 4. Narcotics Commissioner and other officers to
exercise the powers of their subordinate 1183 CHAPTER III
OPIUM POPPY CULTIVATION AND PRODUCTION OF OPIUM AND POPPY STRAW
5. Opium poppy cultivation and production of opium or poppy straw 1183
6. Fee for grant of lieenee 1183 7. Form of lieenee for eultivation of the opium poppy 1183 8. Issue of lieenee 1183 9. Lieence to specify the area, ete. 1183
10. Designating of Lambardar 1183 1l. Withholding or cancellation of licenee 1184 12. Proeedure with regard to measurement of land
cultivated with opium poppy 1184 13. Proeedure with regard to preliminary weighment 1184 14. Delivery of opium produeed 1185 15. Opium to be weighed, examined and classified 1185 16. Proeedure where cultivator is dissatisfied with
classification of opium 1185 17. Procedure for sending opium suspeeted to be
adulterated 1185 18. Drawing of sam pIes from opium sent to Government
Opium Factory under rule 16 or rule 17 1185 19. Fixation of price of opium 1185 20. Provisional payment of price 1185 21. Weighment and examination of the opium at the
Government Opium Faetory 1185 22. Confiseation of adulterated opium 1186 23. Adjudication of eonfiscation of adulterated opium 1186 24. Determination of final price of opium 1186 25. Adjustment of cultivator's account and recovery
of dues from the cultivators 1186 26. Weights and scales 1186 27. Cultivation of opium poppy for exclusive production of
poppy straw 1186
xlviii ENCYCLOPAEDIA ON LAW OF DRUGS
Rules Page
28. Appeals to the Deputy Narcotics Commissioner and Narcotics Commissioner 1186
29. Appeals to the Chief Controller of Factories 1187
30. Procedure for appeal 1187 CHAPTER IV
MANUFACTURE, SALE AND EXPORT OF OPIUM 31. Manufacture of opium 1188
32. Export of opium 1188 33. Sale to State Governments or manufacturing chemists 1188 34. Fixation of sale price of opium 1188
CHAPTER V MANUFACTURED DRUGS
35. General prohibition 1189 36. Manufacture of natural manufactured drugs 1189 37. Manufacture of synthetic manufactured drugs 1189 38. Application for licence 1190 39. Conditions for issue of licences 1190 40. Manufacture only from materials lawfully possessed 1190 41. Limits of manufacture 1190 42. Security arrangements 1191 43. Advance notice for commencement and cessation of
manufacture 1191 44. Cessation of manufacture 1191 45. Possession, sale and distribution 1191 46. Maintenance of accounts and submission of returns 1192 47. Inspection of stocks, etc. 1192 48. Suspension and revocation of licence 1192 49. Appeal 1193 50. Procedure for appeal 1193 sI. Surrender of licence 1193 52. Disposal of stocks of drugs on cancellation of licence,
etc. 1193 CHAPTER VI
IMPORT, EXPORT AND TRANSHIPMENT OF NARCOTIC DRUGS AND PSYCHOTROPIC
SUBSTANCES 53. General prohibition 1193
53-A. 1193 54. Import of opium, etc.-The ilmpore of 1194 55. Application for import certificate 1194 56. Issue of import certificate 1194
CONTENTS xlix
Rules Page 57. Transit 1195 58. Application for export authorisation 1195
59. Isslit-: of export authorisation 1196
60. Translüpment 1196
61. Procedure for transhipment 1196
62. Diversion of consignment 1196
63. Prohibition of import emd export of consignment through a post office box, etc. 1197
CHAPTER VII PSYCHOTROPIC SUBSTANCES
64. Ceneral prohibition 1197 65. Manufacture of p','!chotropic substances 1197 66. Possession etc., of psychotropic substances 1198 67. Transport of psychotropic substances 1199
CHAPTER VII-A SPECIAL PROVISIONS REGARDING MANUFACTURE,
POSSESSION, TRANSPORT, IMPORT-EXPORT, PURCHASE AND CONSUMPTION OF NARCOTIC DRUGS AND PSYCHOTROPIC
SUBST AN CES FOR MEDICAL AND SCIENTlFIC TRAINING PURPOSES
67-A. Notwithstanding anything contained in the foregoing provisions of these rules 1200
67-B. 67-C.
CHAPTER VIII MISCELLANEOUS
1200 1201
68. Repeal and savings 1201 THE NARCOTIC DRUGS AND PSYCHOTROPIC
SUBSTANCES (EXECUTION OF BOND BY CONVICTS OR ADDICTS) RULES, 1985
1. Short title and commencement 1219 2. Form of bond to be executed under Sec. 34 1219 3. Forms of bonds to be executed under Sec. 39 1219
THE ILLEGALL Y ACQUIRED PROPERTY (RECEIPT, MANAGEMENT AND DISPOSAL) RULES, 1989
CHAPTEl~ I PRELIMINARY
1. Short title and commencement 2. Definitions
1222
1222
ENCYCLOPAEDIA ON LAW OF DRUGS
Rules Page
CHAPTER II ASSISTANCE TO THE ADMINISTRATORS
3. Assistance to the Administrators 1222
CHAPTER III DESIGNATION OF GODOWNS, RECEIPT AND
MANAGEMENT OF PROPERTY
4. Designation of godowns 1222
5. Proper accounting of properties 1223
6. Godown register 1223
7. Godown register for valuable 1223
8. Storage of property 1223
9. Management of land and building 1223
10. Occupation of land or building 1223
11. Recordof land or buildings 1223
12. Storage of property other than valuables 1224 13. Placement of stock-cards 1224
14. Opening and re-selling of the packages 1224 15. Maintenance of seized/ confiscated conveyances 1224
CHAPTER IV DISPOSAL OF PROPERTY
16. Disposal of livestocks, perishables, etc. 1224 17. Disposal of valuables 1224 18. Disposal of currency 1225 19. Disposal of the property 1225 20. Disposal of land or building 1225 2l. Disposal of conveyances 1225 22. Furnishing of Reports and Returns 1225
CHAPTER V MISCELLANEOUS
23. Periodical Reports 1225 24. Periodical Inspection 1225 25. Record of Receipt and Disposal 1225
THE APPELLATE TRIBUNAL FOR FORFEITED PROPERTY (CONDITIONS OF SERVICE OF CHAIRMAN AND MEMBERS) RULES, 1989
l. Short title and commencement 1228 2. Definitions 1228 3. Remuneration, allowances, etc. of the Chairman 1228 4. Remuneration, allowances, etc. of Members 1229
CONTENTS li
Rules Page 5. Retirement during the term of Member 1229 6. Travelling allowances 1229 7. Leave 1230 8. Vacation 1230 9. Accommoda tion 1230
10. Medical A ttendance ..... 1231 11. Tenure
ll-A. Contributions of General Provident Fund and Contributory Provident Fund
12. Oath of office 13. Terms and conditions of service of Chairman and
Members who are Chairman and Member of th Appellate Tribunal for Forfeited Property constituted
1231
1232 1232
under SAFEMFOP A 1232 14. Saving 1232
THE APPELLATE TRIBUNAL FOR FORFEITED PROPERTY (FE ES) RULES, 1989
1. short title and commencement 1233 2. Sc ale of fees for inspection of re cords and registers
of the Appellate Tribunal 1233 3. seale of fees for obtaining certified copies of records
and registers of the Appellate Tribunal 1233 4. saving 1233 THE APPELLATE TRIBUNAL FOR FORFEITED PROPERTY
(PROCEDURE) RULES, 1989 1. short title and eommeneement 1234 2. Definitions 1234 3. Language of the Tribunal 1235 4. Headquarters of the Tribunal, ete. 1235 5. Proeedure for fHing appeals and petitions 1236 6. Proeedure for registration of appeals 1237 7. Proeedure after registration of appeal 1238 8. Joint hearing anddisposal of appeals 1239 9. Grounds whieh may be taken in appeals 1239
10. Adjournment 1239 11. Dismissal of appeal for appellant's default 1239 12. Effect of death, insolveney, ete, on appeal 1240
13. Remand of case by the Tribunal 1240 14. Produetion of additional evidenee before the Tribunal 1240
lii ENCYCLOPAEDIA ON LAW OF DRUGS
~~ ~~ 15. Hearing of appeals 1240 16. Pronouncement of order 1241 17. Order to be communicated to parties 1241 18. Signing of orders 1241 19. Publication of orders 1241 20. Orders and directions in certain cases 1241
Order
THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES (AUTHENTICATION OF
DOCUMENTS) RULES, 1992 1. Short title and commencement 1244 2. Authority for authentication and the manner of
duthentication of documents 1244 THE NARCOTIC DRUGS AND PSYCHOTROPIC
SUBSTANCES (REGULATION OF CONTROLLED SUBSTANCE) ORDER, 1993
1. Short title and commencement 2. Defini tions 3. Manufacture, distribution, sale, imports, exports and
1245 1245
consumption of controlled substances 1245 4. Transport of controlled substance 1245 6. Labelling of consignment for export or import 1247 7. Filing of returns 1247
Notifications under the Narcotic Drugs and Psychotropic Substance Act, 1985 1255
ESTABLISHMENT OF NEW MEDICAL COLLEGE, OPENING OF NEW OR HIGHER COURSE OF STUDY
OR TRAINING AND INCREASE OF ADMISSION CAPACITY BY A MEDICAL COLLEGE
REGULATIONS, 2003 Regulation
l. Short title and commencement 1314 2. Definition 1314 3. The permission for establishment of a medical college,
opening of new or higher course of study or training and increase fo admission capacity 1314
4. Application Form of scherne 1314
5. Authority to whom the schemes and applications is to be submitted 1314
6. Eligibility for making an application 1315 7. Recommendation of the Central Council 1317
CONTENTS Regulations
liii !Jage
Rufes
8. Fee to be submitted alongwith application 9. Permission order
THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES (NATIONAL FUND FOR CONTROL
OF DRUG ABUSE) RULES, 2006
1317 1317
1. Short title and commencement 1335 2. Definitions 1335 3. Procedure for remittance of grant to the Fund 1.135 4. Receipt of money 1336 5. Procedure for grant of money from the Fund 1336 6. Grant of money from the Fund 1336 7. Communication of sanctions 1337 8. Accounts and audit 1337 9. Publication of annual report and statement of accounts 1337
10. Application of the provisions of General Financial ~ules, 2005 1337
THE PREVENTION OF ILLICIT TRAFFIC IN NARCOTIC DRUGS AND PSYCHOTROPIC
SUBST ANCES ACT, 1988 Section
1. Short title, extent and commencement 1347 2. Definitions 1347
3. Power to make order detaining certain persons 1347
4. Execution of detention order 1350 5. Power to regulate place and condition of detention 1352
6. Grounds of detention severable 1352 7. Detention orders not to be invalid or inoperative
on certain grounds 1353
8. Powers in relation to absconding person 1353
9. Advisory Boards 1354 10. Cases in which and circumstances under which
person may be detained for periods longer than three months without obtaining the opinion of Advisory Board 1355
11. Maximum period of detention orders 13,')6
12. Revocation of detention orders 1356
13. Temporary release of person detained 1357 14. Proteetion of action taken in good faith 1357
15. Amendment of Act 52 of 1974 1357
liv ENCYCLOPAEDIA ON LAW OF DRUGS
Section Page 1358 16. Repeal and saving
PARTY THE MENTAL HEALTH ACT, 1987
CHAPTER I PRELIMINARY
1. Short title, extent and eommeneement 2. Definitions
CHAPTER II MENTAL HEALTH AUTHORITIES
3. Central Authority for Mental Health Services 4. State Authority for Mental Health Services
CHAPTER III PSYCHIATRIC HOSPITALS AND PSYCHIATRIC
NURSING HOMES 5. Establishment or maintenance of psychiatrie hospitals
1360 1360
1362 1363
and psychiatrie nursing hornes 1364 6. Establishment or maintenanee of psychiatrie hospitals
or psychiatrie nursing hornes only with lieenee 1364 7. Application for licence 1365 8. Grant or refusal of lieenee 1365 9. Duration and renewal of lieenee 1366
10. Psychiatrie hospital and psychiatrie nursing horne to be maintained in accordance with prescribed conditions 1367
11. Revocation of licence 1367 12. Appeal 1367 13. Inspection of psychiatrie hospitals and psychiatrie
nursing homes and visiting of patients 1367 14. Treatment of out-patients 1368
CHAPTER IV APMISSION AND DETENTION IN PSYCHIATRIC HOSPITAL OR
PSYCHIATRIe NURSING HOME Part I
Admission on voluntary basis 15. Request by major for admission as voluntary patient 1368 16. Request by guardian for admission of a ward 1368 17. Admission of, and regulation with respect to,
voluntary patients 1368
CONTENTS Iv Section Page
18. Discharge of voluntary patients 1369 Part II
Admission under special circumstances 19. Admission of mentally ill persons under certain
special circumstances 1369 Part III
Reception orders A.-Reception order on applications
20. Application for reception order 1370 21. Form and contents of medical certificates 1371 22. Procedure upon application for reception order 1372
B.-Reception order on production of mentally ill persons before Magistrate
23. Powers and duties of police officers in respect of certain mentally ill persons 1373
24. P -cedure on production of mentally ill persons 1374 25. Order in case of mentally ill person cruelly treated or
not under proper care and control 1375 C.-Further provisions regarding admission and detention
of certain mentally ill persons 26. Admission as inpatient after inquisition 1375 27. Admission and detention of mentally i1l prisoner 1376 28. Detention of alleged mentally ill person, pending
report by medical officer 1376 29. Detention of mentally ill person pending his
removal to psychiatrie hospital or psychiatrie nursing horne 1376
D.-Miscellaneous provisions in relation to order undcr this Chapter
30. Time and manner of medical examination of mentally ill person 1376
31. Authority for reception order 1377 32. Copy of reception order to be sent to medical officer
in charge 1377 33. Restriction as to psychiatrie hospitals and psychiatrie
nursing hornes into which reception order may direct
admission 1377 34. Amendment of order or document 1378
lvi
Section
ENCYCLOPAEDIA ON LAW OF DRUGS Pagt'
35. Power to appoint susbtitute for person upon whose application reception order has been made 1378
36. Officers cornpetent to exercise powers and discharge functions of Magistrate und er certain sections 1379
CHAPTER V INSPECTION, DISCHARGE, LEAVE OF ABSENCE AND REMOVAL
OF MENTALL Y ILL PERSONS Part I
Inspection 37. Appointment of Visitors 1379 38. Monthly inspection by Visitors 1379 39. Inspection of mentally ill prisoners 1380
Part II Discharge
40. Order of discharße by medieal officer in charge
41. Discharge of mentally ill persons on application
4~. Order of discharge on the undertaking of relatives or friends, etc., for due care of rnentally ill person
43. Discharge of person on his request 44. Discharge of person subsequently found on inquisition
to be of sound rnind Part UI
Leave of Absence
45. Leave of absence 46. Grant of leave of absence by Magistrate
Part IV Removal
47. Removal of rnentally i1l person frorn one psychiatric hospital or psychiatrie nursing ho me to any other
1381 1381
1381 1382
1382
1382 1382
psychiatrie hospital or psychiatrie nursing horne 1383 48. Admission, detention and re-taking in certain cases 1384 49. Appeal from orders of Magistrate 1384
CHAPTER VI JUDICIAL INQUISITION REGARDING ALLEGED
MENTALLY ILL PERSON POSSESSING PROPERTY, CUSTODY OF HIS PERSON AND MANAGEMENT
OF HIS PROPERTY 50. Application for judicial inquisition 1385 51. lssues on which finding should be given by Distriet
Court after inquisition 1386
CONTENTS lvii
Section Page 52. Provision for appointing guardian of mentally ill
person and for manager of property 1386 53. Appointment of guardian of mentally ill person 1387 54. Appointment of manager for management of
property of mentally ill person 1387 55. Appointment of manager by Collector 1387 56. Manager of property to execute bond 1388 57. Appointment and remuneration of guardians and
managers 1388 58. Duties of guardian and manager 1388 59. Powers of manager 1388 60. Manager to furnish inventory and annual accounts 1389 61. Manager' s power to execute conveyances under
orders of District Court 1389 62. Manager to perform contracts directed by
District Court 1389 64. Manager may dispose of leases 1390 65. Power to make order concerning any matter
connected with mentally ill person 1390 66. Proceeding if accuracy of inventory or accounts is
impugned 1390 67. Payrnent into pubEc trE'ClSury Clnd investrnl'nt of
proceeds of estate 1390
68. Rdcüivc may sue fm ac count 13l)()
69. Rcmoval of manClgers ,md guardians }391
70. Dissulution and disposal of propert)' of partnership on a member becoming mentally ill 1391
71. Power to apply property fm maintenance of mentally ill person without appointing ITlanager in certain cases 1391
72. Power to order transfer to stock, seCllri ties or shares belonging to mentally i1l person in certClin G\ses 1391
73. Pov,rer to order transfer of stock, securities or shClres of mentally ill person residing out of India 13l)2
74. Pow('r to apply property for mentally ill person':; maintenance in case of temporary mcntcd illness 1392
75. Action taken in respect of mentally ill person to be set aside if District Court finds that his mental illness has ceased 1392
lviii ENCYCLOPAEDIA ON LAW OF DRUGS
Section Page
76. Appeals 1392
77. Power of District Court to make regulations 1392
CHAPTER VII LIABILITY TO MEET COST OF MAINTENANCE OF
MENT ALL Y ILL PERSONS DET AINED IN PSYCHIATRIC HOSPITAL OR PSYCHIATRIe
NURSING HOME 78. Cost of maintenance to be borne by Government in
certain cases 1393
79. Application to District Court for payment of cost of maintenance out of estate of mentally i1l person or from a person legally bound to maintain hirn hospital or psychia tric 1393
80. Persons legally bound to maintain mentally ill person not absolved from such liability 1393
CHAPTER VIII PROTECTION OF HUMAN RIGHTS OF MENT ALL Y
ILL PERSONS 81. 1394
CHAPTER IX PENALTIES AND PROCEDURE
82. Penalty for establishment or maintenance of psychiatrie hospital or psychiatrie nursing home in contravention of Chapter III 1394
83. Penalty for improper reception of mentally i1l person 1394 84. Penalty for contravention of Sees. 60 and 69 1395 85. General provision for punishment of other offences 1395 86. Offences by companies 1395 87. Sanction for prosecutions 1395
CHAPTERX MISCELLANEOUS
88. Provision as to bonds 1395 89. Report by medical officer 1396 90. Pension, etc., of mentally ill person payable by
Government 1396 9l. Legal aid to mentally ill person at State expense in
certain cases 1396 92. Protection of action taken in good faith 1397 93. Construction of reference to certain laws, ete. 1397
CONTENTS IIx Secti011 Page
94. Power of central Government and State Government to make rules 1397
95. Rules made by Central Government or the State Government to be laid before the Legislature 1399
96. Effect of Act on other laws 1399 97. Power to remove difficulty 1399 98. Repeal and saving 1399
THE CENTRAL MENTAL HEALTH AUTHORITY RULES, 1990
CHAPTER I PRELIMIN ARY
1. Short title and commencement 1401 2. Definitions 1401
CHPTER H CENTRAL MENTAL HEALTH AUTHORITY
3. Constitution of the Authority 1401 4. Disqualifica tion 1402 5. Chairman 1402 6. Term of office of members 1402
CHAPTER III PROCEEDINGS OF THE AUTHORITY
7. Meetings of the Authority 1403 8. Subjects for special meetings 1403 9. Subjects for the Annual Meeting 1403
10. Proced ure for holding meetings 1403 11. Proceedings of the Authority 1404 12. Approval by circulation 1404 13. Secretary to the Authority 1404 14. Forwarding of copies of the proceedings of the
Authority to the Central Government 1405 THE STATE MENTAL HEALTH RULES, 1990
CHAPTER I PRELIMINARY
1. Short title and commencement 1406 2. Defini tions 1406
CHAPTER H.
STATE MENTAL HEALTH AUTHORITY 3. Constitution of the Authority 1407 4. Disqualifica tion 1407 5. Chairman 1407
Ix ENCYCLOPAEDIA ON LAW OF DRUGS
Secti011 Page
6. Term of offiee of members 1407
CHAPTER III PROCEEDINGS OF THE AUTHORITY
7. Meetings of the Authority HOB
8. Subject for Special Meetings 1408
9. Subjects for the Annual Meeting H08
10. Proced ure for holding meeting 1408
11. Proceedings of the Authority 1409
12. Approval by circulation 1409
13. Secretary to the Authority 1409
14. Forwarding of co pies of the proceedings of the Authority to the State Government 1410
CHAPTER IV LICENCE
15. Application for licence 1.+10
16. Grant of licence 1410
17. Refusal of licence and manner of communicating thc order 1410
18. Application for renewal 1410
19. Refusal of licence 1411
20. Manner and conditions of maintaining psychiatrie hospitals or psychiatrie nursing homes 1411
21. Time for appeal 1411
CHAPTER V
22. Minimum facilities for treatment of out-patients 1412 23. Revocation of licence 1412 24. Maintenance of records 1413
CHAPTER VI NIISCELLANEOUS
25. Admission and detention in psychiatrie hospital or psychiatrie nursing horne 1413
26. The qualifications and functions of the Visitors 1413 27. Leave of absence 1414 28. Interception of the letters and other communications
addressed to the mentally ill persons 1414 PART VI
THE COST ACCOUNTING RECORDS (BULK DRUGS) RULES, 1974
1. Short title and commencement 1423
CONTENTS lxi
Rules Page 2. Application 1423 3. Definitions 1423 4. Maintenance of records 1424 5. Penalty 1424
THE COST ACCOUNTING RECORDS (COSMETICS AND TOILETRIES) RULES, 1993
l. Short tide and commencement 1442 2. Application 1442 3. Maintenance of records 1443 4. Penalty 1444
THE COST ACCOUNTING RECORDS (FORMULATIONS) RULES, 1988
l. Short title and commencement 1464 2. Application 1484
2-A. Definition 1484 3. Maintenance of records 1484 4. Penalty 1485
PART VII THE PHARMACY ACT, 1948
CHAPTER I INTERLOCUTORY
Section 1. Short title, extent and commencement 1531 2. Interpretation 1532
CHAPTER II THE PHARMACY COUNCIL OF INDIA
3. Constitution and composition of Central Council 1534 4. Incorporation of Central Council 1535 5. President and Vice-President of Central Council 1535 6. Mode of elections 1536 7. Term of office and casual vacancies 1536 8. Staft remuneration and allowances 1537 9. The Executive Committee 1537
9-A. Other Cornrnittees 1537 10. Education Regulations 153R 1l. Application of Education Regulation to States 1539 12. Approved courses of study imd examination 1539 13. Withdrawal of approval 1541
lxii ENCYCLOPAEDIA ON LAW OF DRUGS
Seetion Pa;;;c
14. Qualifications granted outside the territories to which
this Act extends 1541
15. Mode of dec1arations 1542
15-A. The Central Register 1542
15-B. Registration in the Central Register 1543
16. Inspection 1543
17. Information to be furnished 1543
17-A. Accounts and audit 1543
18. Power to make regulations 1544
CHAPTER III STATE PHARMACY COUNCILS
19. Constitution and composition of State Councils 1545
20, Inter-State agreements 1547
21. Composition of Joint State Councils 1547
22. Incorporation of State Councils 1548
23. President and Vice·President of State Council 1548
24. Mode of elections 1550
25. Term of office and casual vacancies 1550
26. Staft remuneration and allowances 1550
26-A. Inspection 1551
27. The Executive Comrnittee 1551
28. Inforrna tion to be furnished 1551
CHAPTER IV REGISTRATION OF PHARMACISTS
29. Preparation and maintenance of register 1552 30. Preparation of first register 1552 31. Qualifications for entry on first register 1553 32. Qualifications for subsequent registration 1553
32-A. Special provisions for registration of certain persons 1554 32-B. Special provisions for registration of displaced
persons, repatriates and other persons 1556 33. Scrutiny of applications for registration 1557 34. Renewal fees 1557 35. Entry of additional qualifications 1558 36. Removal frorn register 1558 37. Restoration to register 1559 38. Bar of other jurisdiction 1559 39. Issue of duplicate certificate of registration 1559 40. Printing of register and evidentiary value of entries
therein 1560
CONTENTS lxiii
Seetiot! Page CHAPTER
MISCELLANEOUS
41. Penalty for falsely claiming to be registered 1560
42. Dispensing by unregistered persons 1561
43. Failure to surrender certificate of registration 1562
44. Payment of part of fees to Central Council 1562
45. Appointment of Commission of Enquiry 1562
46. Power to make rules 1563
THE MATERNITY BENEFIT ACT, 1961
1. Short title, extent and commencement 1565
2. Application of Act 1565
3. Definitions 1566
4. Employment of or work, by women prohibited during certain periods 1568
5. Right to payment of maternity benefit 1569
5-A. Continuance of payment of maternity benefit in certain cases 1570
5-B. Payment of maternity benefit in certain cases 1570
6. Notice of claim for maternity benefit and payment thereof 1570
7. Payment of maternity benefit in ca se of death of a woman 1571
8. Paym~nt of medical bonus 1571 9. Leave for miscarriage etc. 1571
9-A. Leave with wages for tubectomy operation 1572 10. Leave for illness arising out of pregnancy, delivery,
premature birth of child, miscarriage, medical termination of pregnancy or tubectomy operation 1572
11. N ursing breaks 1572 12. Dismissal during absence or pregnancy 1572 13. No deduction of wages in certain cases 1573 14. Appointment of Inspectors 1573 15. Powers and duties of Inspectors 1573 16. Inspectors to be public servants 1573 17. Power of Inspector to direct payment to be made 1574 18. Forfeiture of maternity benefit 1574 19. Abstract of Act and Rules thereunder to be exhibited 1574 20. Registers, etc. 1575 2l. Penalty for contravention of Act by employer 1575
lxiv ENCYCLOPAEDIA ON LAW OF DRUGS
Sectio11 Pagt
22. Penalty for obstructing Inspector 1575
23. Cognizance of offences '1575
24. Protection of action taken in good faith 1576
25. Power of Central Government to give directions 1576
26. Power to exempt establishment 1576
27. Effect of laws and agreements inconsistent with this Act 1576
28. Power to make rules 1576
29. Amendment of Act LXIX of 1951 1577
30. Repeal 1577
THE MATERNITY BENEFIT (MINES AND CIRCUS) RULES, 1963
Rules 1. Short title and commencement 1578
2. Defini tions 1578
3. Muster-roll 1579
4. Proof 1579
5. Payment of maternity and other benefit 1580
6. Break for nursing child 1580
7. Duties and powers of the Competent AL.thority ap:1 Inspectors 1581
8. Act which constitute gross misconduct 1581
9. Appeal under Sec. 12 1581
10. Complaint under Sec. 17 1582
11. Appeal under Sec. 17 1582
12. Supply of forms 1582 13. Non-submission of notices, appeals or complaints in
the prescribed forms 1582 14. Records 1582 15. Abstract 1583 16. Ann ual returns 1583
PART VIII THE BIO-MEDICAL WASTE (MANAGEMENT AND
HANDLING) RULES, 1998 1. Short title and commencement 1598 2. Application 1598 3. Definitions 1598 4. Duty of Occupier 1599 5. Treatment and DisDosal 1599
:::) ~'JTENTS
l<-l1/es
6, Segregation, Packaging, Transportation and Storage 7. Prescribed Authority 8. Authorisation 9. Advisory Committee
9A. Monitoring of implementary of the rules in Armed Forces Health Care Establishment
10. Annual Report 11, Maintenance of Records 12, Accident Reporting 13. Appeal
14, Common disposal/ uncineration sites THE MEDICAL WASTE DISPOSAL THE VECTOR CONTROL THE WORLD HEALTH REPORT, 1996
PART IX THE MEDICAL TERMINATION OF PREGNANCY ACT, 1971
Sectiol1 l. Short title, extent and commencement 2. . Definitions 3. When pregnancies may be terminated by registered
medical practitioners 4. PI ace where pregnancy may be terminated 5, Sections 3 and 4 when not to apply 6, Power to make rules 7. Power to make regulations 8. Proteetion of action taken in good faith
THE MEDICAL TERMINATION OF PREGNANCY REGULATIONS, 2003
l. Short ti tle and commencement 2. Definitions 3. Form of certifying opinion or opinions 4. Custody of forms 5. Maintenance of Admission Register 6. Admission Register not to be open to inspection 7. Entries in register maintained in hospital or
approved place THE MEDICAL TERMINATION OF PREGNANCY
RULES, 2003 l. Short title and commencement 2. Definitions
lxv
Page lSqq
l6()t)
1601
1601
1602 !hll2 ]6()'2
160~
1603 1603 161:;
1621
1626
1638 1638
1638 1b411 1641 1M! 1642 1M2
1643 164:\ 1643 1M3 1644 IM:;
Ih--l:r;
!h--l:t)
164Y
lxvi ENCYCLOPAEDIA ON LAW OF DRUGS
Rules Page
3. Composition and tenure of District Level Committl'l> 1649
4. Experience and training under Cl. (d) of Sec. 2 1650
5. Approval of a place 1651
6. Inspection of a place 1652
7. Cancellation or suspension of certificate of appro\'al 1652
8. Review 1652
9. Form of consent 1652
10. Repeal and saving 1652 PART X
THE PRE-NATAL DIAGNOSTIC TECHNIQUES (PROHIBITION OF SEX SELECTION) ACT, 1994
CHAPTER I PRELIMINARY
Seetion L Short title, extent and commencement 1656 2. Definitions 1656
CHAPTER II REGULATION OF GENETIC COUNSELLING CENTRES,
GENETIC LABORATORIES AND GENETIC CLINICS 3. Regulation of Genetic Counselling Centres, Genetic
Laboratories and Genetic Clinics 1659 3-A. Prohibition of sex selection 1659 3-B. Prohibition on sale of ultrasound machine, ete., to
persons, laboratories, dinics, ete., not registered under the Aet 1659
CHAPTER III REGULAITON OF PRE-NATAL DIAGNOSTIC
TECHNIQUES 4. Regulation of pre-natal diagnostic teehniques 1659 5. Written eonsent of pregnant woman and prohibition
of eommunicating the sex of foetus 1659 6. Determination of sex prohibited 1661
CHAPTER IV CENTRAL SUPERVISORY BOARD
7. Constitution of Central Supervisory Board 1661 8. Term of offiee of members 1662 9. Meetings of the Board 1663
10. Vaeancies ete., not to invalidate proceedings of the Board 1663
11. Temporary association of persons with the Boards for partieular purposes 1663
CONTENTS SectiOll
12. Appointment of otiicert:> (\lld OÜ1l:'1 elllpjuyees of the
lxvii
Page
Board 1664 13. Authentication of orders and other instruments of the
Board 1664 14. Disqualificaitons for appointment as member 1664 15. Eligibility of member for re-appointment 1 ll65 16. Functions of the Board 1665
16-A. Constitution of State Supervisory Board and Union territory Supervisory Board 1665
CHAPTER V APPROPRIATE AUTHORITY AND ADVISORY
COMMITTEE 17. Appropriate authority and Advisory Committee 1667
17-A. Powers of Appropriate Authorities 1669 CHAPTER VI
REGISTRAITON OF GENETIC COUNSELLING CENTRES, GENETIC LABORATORIES AND GENETIC CLINICS
18. l{egistraiton of Genetic Counselling Centres, Genetic Laboratories or Genetic Clinics 1669
19. Certificate of registration 1670 20. Cancellaiton or suspension of registration 1670 21. Appeal 1671
CHAPTER VII OFFENCES AND PENALTIES
22. Prohibition of advertisement relating to pre-conception and pre-natal determination of sex and punishment for contravention 1671
23. Offences and penalties 1672 24. Presumption in the case of conduct of pre-natal
diagnostic techniques 1672 25. Penalty for contravention of the provisions of the Act
or rule for which no specific punishment is provided 1672 26. Offences by companies 1673 27. Offence to be cognizable, non-bailable and non-
compoundable 1673 28. Cognizance of offences 1673
29. 30. 3l.
31-A.
CHAPTER VIII MISCELLANEOUS
Main tenance of records Power to search and seize records, etc. Proteciton of action taken in good faith Removal of difficulties
1674 1674 1675 1675
__ VII) ENCYCLOPAEDIA ON LAW CA m~U( J:--::
Rules Pi/ge
32. Power to make rules 1675
33. Power to make regulatiuns 1676
34. Rules and regulations to be bid betorl' ]',nlJr1IlH'nt 1677
THE PRE-NATAL DIAGNOSTIC TECHNIQUES [PROHIBITION OF SEX SELECTION) RULES, 1996
l. Short title and commencement 1678
2. Definitions 1678
3. Minimum requirements 1678
3-A. Sale of ultrasound machines/imaging machines 1678
4. Registration of Genetic Counselllng Centre, Genetic Laboratory and Genetic Clinics 1682
5. Application Fee 1682
6. Certificate of registration 1683
7. Validity of registration 1683
8. Renewal of registration 1684 9. Maintenance and preservation of records 1685
10. Conditions for conducitng pre-natal diagnostic procedures 1686
11. Facilities for inspection 1686
12. Procedure for search and seizure 1687 13. Intimation of changes in employees, place or
equipment 1688 14. Conditions for analysis or test and pre-natal
diagnostic procedures 1689 15. Meetings of the Advisory Committees 1689 16. Allowances to members of the Central Supervisory
Board 1689 17. Public Information 1689 18. Code of conduct to be observed by persons
working at Genetic Counselling Centre, Genetic Laboratories, Genetic Clinic, Ultrasound Clinics, Imaging Centres etc. 1689
19. Appeals 1690 THE PRE-NATAL DIAGNOSTIC TECHNIQUES
(REGULATION AND PREVENTION OF MISUSE) (ADVISORY COMMITTEES) RULES, 1996
l. Short title and cornmencement 1705 2. Definitions 1705 3. Terms and conditions of appointment as a member
of an Advisory Cornmittee 1705 4. Meetings of the Advisory Committees 1706 5. Notice of Meeting 1707
CONTENTS lxix
Rules Page 6. Business ordinarily to be transacted at meetings 1707 7. Quorum 1707 8. Chairman of the meeting 1707 9. Assistancc to be rendered by the Appropriate Authority
to the Advisory Committee 1707 10. Decision on question before the Advisory Committee 1707 11. Vacancies etc., not to invalidate proceedings of the
Advisory Committee 1707 12. Record of proceedings of the Advisory Committee 170R
THE TRANSPLANTATION OF HUMAN ORGANS ACT,1994
CHAPTER I PRELIMIN ARY
Sectiol1 1. Short title, application and commeneement 170Q
2. Definitions 1709 CHAPTER II
AUTHORITY FOR THE REMOVAL OF HUMAN ORGANS
3. Authority for removal of human organs 1711 4. Removal of human organs not to be authorised in
certain eases 1712
5. Authority for removal of human organs in case of unclaimed bodies in hospital or prison 1712
6. Authority for removal of human organs form bodies sent for post-mortcm eXi:1mination for mpdieo legal or pathological purposes 1713
7. Preservation of human organs 1713
8. Savings 1713
9. Restrictions on removal and transplantation of human organs 1713
CHAPTER III REGULATION OF HOSPITALS
10. Regulation of hospitals conducting the removal, storage of transplantation of human organs 1715
11. Prohibition of removal or transplantation of human organ for any purpose other than therapeutic purposes 1716
12. Explaining effects, ptc. to donor emd recipient 171h I CHAPTER IV
APPROPRIATE AUTHORITY 13. Appropriate Authority 171\)
lxx ENCYCLOPAEDIA ON LAW OF DRUGS
Secti011 Page
CHAPTER V REGISTRATION OF HOSPITALS
14. Registration of hospitals engaged in removal, storage or transplantation of human organs 1717
15. Certificate of registration 1717
16. Suspension or cancellation of registration 1718
17. Appeals 1718
CHAPTER VI OFFENCES AND PENALTIES
18. Punishment for removal of human organ without authority 1718
19. Punishment for commercial dealings in human organs 1719
20. Punishment for contravention of any other provision of this Act 1719
2l. Offen ces by companies 1719 22. Cognizance of offence 1720
CHAPTER VII MISCELLANEOUS
23. Proteetion of action taken in good faith 1720 24. Power to make rules 1720 25. Repeal and savings 1722
THE TRANSPLANTATION OF HUMAN ORGANS RULES, 1995
l. Short title and commencement 1723 2. Definitions 1723 3. Authority for removal of Human Organ 1723 4. Duties of the medieal practitioner 1723
4A. Authorisation Committee 1725 5. Preservation of organs 1726 6. 1726
6-A. Composition of Authorisation Committees 1726 7. Registration of Hospital 1731 8. Renewal of registration 1731 9. Conditions for grant of certificate of registration 1731
INDEX 1(1)
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