OBJECTIVES • To prevent substandard in drugs, presumably for treatment, maintaining high standards of medical • To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing. • Manufacture, distribution and sale of drugs and cosmetics by qualified persons only. • Act has nothing to do with the Excise duty • To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs. • To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs and cosmetics.

1. DRUGS AND COSMETICS ACT
1940 AND RULES 1945
OBJECTIVES
 To prevent substandard in drugs, presumably for treatment,
maintaining high standards of medical
 To regulate the import, manufacture, distribution and sale of
drugs & cosmetics through licensing.
 Manufacture, distribution and sale of drugs and cosmetics by
qualified persons only.
 Act has nothing to do with the Excise duty
 To regulate the manufacture and sale of Ayurvedic, Siddha and
Unani drugs.
 To establish Drugs Technical Advisory Board (DTAB) and Drugs
Consultative Committees (DCC) for Allopathic and allied drugs
and cosmetics.
DEFINITIONS-
(a) Ayurvedic, Siddha or Unani drug –
It includes all medicines intended for internal or external use for or in
the diagnosis, treatment, mitigation or prevention of disease or
disorder in human beings or animals, and manufactured exclusively in
accordance with the formulae described in, the authoritative books of
Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in
the First Schedule
(b) The Board means—

2. (i) in relation to Ayurvedic, Siddha or Unani drug, the Ayurvedic,
Siddha and Unani Drugs Technical Advisory Board constituted under
section 33C; and
(ii) in relation to any other drug or cosmetic, the Drugs Technical
Advisory Board constituted under section 5.
(c). COSMETIC –
It means any article intended to be rubbed, poured, sprinkled or
sprayed on, or introduced into, or otherwise applicated to, the human
body or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and includes any article
intended for use as a component of cosmetic.
(d) DRUG –
(I) All medicines for internal or external use of human beings or
animals and all substances intended to be used for or in the diagnosis,
treatment, mitigation or prevention of any disease or disorder in
human beings or animals, including preparations applied on human
body for the purpose of repelling insects like mosquitoes;
(II) Such substances (other than food) intended to affect the structure
or any function of human body or intended to be used for the
destruction of (vermin) or insects which cause disease in human
beings or animals, as may be specified from time to time by the Central
Government by notification in the Official Gazette
(III) All substances intended for use as components of a drug including
empty gelatin capsules
(IV) Such devices intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human
beings or animals, as may be specified from time to time by the Central
Government by notification in the Official Gazette, after consultation
with the Board

3. (e). Misbranded drugs:
(a) if it is so colored, coated, powdered or polished that damage is
concealed or if it is made to appear of better or greater therapeutic
value than it really is; or
(b) If it is not labeled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears
any statement, design or device which makes any false claim for the
drug or which is false or misleading in any particular.
(f). Adulterated drug:
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed
substance; or
(b) if it has been prepared, packed or stored under insanitary
conditions whereby it may have been contaminated with filth or
whereby it may have been rendered injurious to health; or
(c) if its container is composed in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to
health; or
(d) if it bears or contains, for purposes of colouring only, a colour other
than one which is prescribed; or
(e) if it contains any harmful or toxic substance which may render it
injurious to health; or
(f) if any substance has been mixed therewith so as to reduce its
quality or strength.
(g). Spurious drugs :
(a) if it is imported under a name which belongs to another drug; or
(b) if it is an imitation of, or a substitute for, another drug or resembles
another drug in a manner likely to deceive or bears upon it or upon its
label or container the name of another drug unless it is plainly and

4. conspicuously marked so as to reveal its true character and its lack of
identity with such other drug; or
(c) if it has been substituted wholly or in part by another drug or
substance; or
(d) if it purports to be the product of a manufacturer of whom it is not
truly a product.
(h). Manufacture :
In relation to any drug or cosmetic, it includes any process or part of a
process for making, altering, ornamenting, finishing, packing,
labelling, breaking up or otherwise treating or adopting any drug or
cosmetic with a view to its sale or distribution but does not include
the compounding or dispensing of any drug, or the packing of any drug
or cosmetic, in the ordinary course of retail business.
(i). Patent or Proprietary medicine :
A drug which is a remedy or prescription presented in a form ready for
internal or external administration of human beings or animals and
which is not included in the edition of the Indian Pharmacopoeia for
the time being or any other Pharmacopoeia authorized in this behalf
by the Central Government.
(j). Government Analysts-
(1) The State Government may, by notification in the Official Gazette,
appoint such persons as it thinks fit, having the prescribed
qualifications, to be Government Analysts for such areas in the state
and in respect of such drugs or [classes of drug or such cosmetics or
classes of cosmetics] as may specified in the notification.
(2) The Central Government may also, by notification in the Official
Gazette, appoint such persons as it thinks fit, having the prescribed
qualifications, to be Government Analysts in respect of such drugs or

5. [classes of drugs or such cosmetics or classes of cosmetics] as may be
specified in the notification
(3) Notwithstanding anything contained in sub-section (1) or sub-
section (2), neither the Central Government nor a State Government
shall appoint as a Government Analyst any official not serving under it
without the previous consent of the Government under which he is
serving.
(4) No person who has any financial interest in the import,
manufacture or sale of drugs or cosmetics shall be appointed to be a
Government Analyst under sub- section (1) or subsection (2) of this
section.
(k). Inspectors-
(1) The Central Government or a State Government may, by
notification in the Official Gazette, appoint such person as it thinks fit,
having the prescribed qualification, to be Inspectors for such areas as
may be assigned to them by the Central Government or State
Government, as the case may be.
(2) The powers which may be exercised by an Inspector and the duties
which may be performed by him, the drugs or [classes of drugs or
cosmetics or classes of cosmetics] in relation to which and the
conditions, limitations or restrictions subject to which, such powers
and duties may be exercised or performed shall be such as may be
prescribed.
(3) No person who has any financial interest [in the import,
manufacture or sale of drugs or cosmetics] shall be appointed to be
an Inspector under this section.
(4) Every Inspector shall be deemed to be public servant within the
meaning of section 21 of the Indian Penal Code (45 of 1860), and shall
be officially subordinate to such authority [having the prescribed

6. qualification] as the Government appointing him may specify in this
behalf.
(l). STANDARDS OF QUALITY-
(a) in relation to a drug, that the drug complies with the standard set
out in [the Second Schedule], and
(b) in relation to a cosmetic, that the cosmetic compiles with such
standard as may be prescribed.
SCHEDULES TO THE ACT
First schedule – Names of books under Ayurvedic and Siddha systems
Second schedule – Standard to be complied with by imported drugs
and by drugs manufactured for sale, sold, stocked or exhibited for sale
or distribution
SCHEDULES TO THE RULES
“A” Performa For Forms( Application, Issue, Renewal, Etc.)
“B” Rates Of Fee For Test Or Analysis By CDL Or Govt. Analysts
“C” List Of Biological And Special Products (Injectable) Applicable To
Special Provisions.
“C1” List Of Biological And Special Products (Non parenteral)
Applicable To Special Provisions.
“D” List Of Drugs That Are Exempted From Provisions Of Import
“E1” List Of Poisonous Substances Under The Ayurvedic , Siddha And
Unani Systems
“F” Provisions Applicable To Blood Bank

7. “F1” Special Provision Applicable To Biological And Special Products,
Eg. Bacterial And Viral Vaccines, Sera From Living Animals, Bacterial
Origin Diagnostic Agents
“F2” Standards For Surgical Dressings
“F3” Standards For Umbilical Tapes
“Ff” Standards For Ophthalmic Preparations
“G” List Of Substances Required To Be Used Under Medical
Supervision And Labelled Accordingly
“H” List Of Substances (Prescription) That Should Be Sold By Retail
Only On Prescriptions Of R.M.P.
“J” List Of Diseases And Ailments That Drug Should Not Claim To Cure
“K” List Of Drugs That Are Exempted From Certain Provisions
Regarding Manufacture
“M” Requirements Of Manufacturing Premises, GMP Requirements Of
Factory Premises, Plants And Equipment
“M1” Requirements Of Factory Premises For Manufacture Of
Homeopathic Medicines
“M2” Requirements Of Factory Premises For Manufacture Of
Cosmetics
“M3” Requirements Of Factory Premises For Manufacture Of Medical
Devices
“N” List Of Equipment To Run A Pharmacy “O” Standards For
Disinfectant Fluids
“P” Life Period(expiry) Of Drugs
“Q” Coal Tar Colors Permitted To Be Used In Cosmetics
“R” Standards For Mechanical Contraceptives
“R1” Standards For Medical Devices

8. “S” Standards For Cosmetics
“T” Requirements (GMP) Of Factory Premises For Ayurvedic, Siddha,
Unani Drugs
“U” Manufacturing And Analytical Records Of Drugs
“U1” Manufacturing And Analytical Records Of Cosmetics
“V” Standards For Patent Or Proprietary Medicines
“W” List Of Drugs Marketed Under Generic Names- Omitted
“X” List Of Narcotic Drugs And Psychotropic Substances
“Y” Requirement And Guidelines On Clinical Trials For Import And
Manufacture Of New Drugs
IMPORT OF DRUGS
CLASSES OF DRUGS PROHIBITED TO BE IMPORTED INTO INDIA
No person can import-
1. Any drug/cosmetic which is not of standard quality
2. Any misbranded, spurious or adulterated drug
3. Any misbranded or spurious cosmetic
4. Any drug/cosmetic for import for which license is prescribed
otherwise than under & in accordance with such license.
5. Any patent or proprietary medicine unless there is displayed in the
prescribed manner on the label the true formulae or list of active
ingredients in it.
6. Any drugs which purports to claim or mitigate any such disease or
ailment specified in Schedule J in the rules

9. 7. Any cosmetic which contains an ingredient which may render it
unsafe for use.
8. Drugs whose manufacture sale & distribution are prohibited in the
country of origin,
9. Drugs not labelled & packed in prescribed manner
10. Biologicals & other special products after the date of their expiry
as mentioned in label or those not complying with the standards of
strength, quality, purity as may be specified.
11. Any new drug expect with express permission of licensing
authority.
12. Any drug/cosmetic, the import which is prohibited under the rules.
SUBSTANCES EXEMPTED FROM PROVISION RELATING TO IMPORT
OF DRUGS (SCHEDULE D)
The substances specified in Schedule D are exempted from provisions
relating to import of drugs as follows:
1) Substances imported in bulk not for medicinal use and the importer
certified that these have been imported for non-medicinal use. If
imported otherwise than in bulk, each container should contain a label
indicating not for medicinal use
2) The following substances which are used both as articles of food as
well as drugs.
a) All condensed or powdered milk whether pure, skimmed or malted
fortified with minerals and vitamins.
b) Ginger, cinnamon, cumin, pepper and other related species unless
they are specifically labelled under the standards of Indian
Pharmacopoeia and other official pharmacopoeias and official
compendia of drug standards prescribed under Acts and Rules.

10. c) Virol, Bovril, Chicken essence and other similar pre-digested foods.
d) Farex, cerelac and lactose and other similar cereal preparations
whether fortified with vitamins or otherwise except those for
parenteral use.
IMPORT UNDER LICENSE OF THE BIOLOGICAL DRUGS (SCHEDULE
C/C1)
Conditions to be fulfilled:
 Licensee must have adequate facility for the storage-
Storage space or area must meet the minimum requirements set by
the authority
 Licensee must maintain a record of the sale-
Licensee must maintain and produce the record of sale when asked by
a governing authority
 Licensee must allow an inspector to inspect premises and to
check the records-
Licensee must always allow an inspector to inspect the premises and
must be liable to answer if found any discrepancies. Licensee must
allow the inspector to inspect the premises at all time with or without
any notice from the authority.
 Licensee must furnish the sample to the authority-
licensee must furnish and produce the samples if asked by the
inspector to carry out his inspections to check if the requirements are
met or not.
 Licensee must not sell drugs from which sample is withdrawn-
licensee must not sell the drugs from which sample is withdrawn by
the inspector for the inspection and he is advised not to sale, and

11. recall the batch from the market if the inspector marks the sample
unsafe or not suitable for sale.
IMPORT UNDER LICENSE OF DRUGS OTHER THAN C, C1 AND X.
Import of small quantities of drug for examination, test or analysis-
• Small quantities of drugs, the import of which is prohibited
under the act may be imported for the purpose of examination,
test or analysis, subject to the following conditions.
• The licensee must use imported drug exclusively for the purpose
for which they are imported & specified in the license.
• Licensee must maintain the records of imported drugs, showing
particulars of their quantities, names of manufacturer & date of
import.
• Licensee must allow the inspector to inspect the premises where
imported drugs are kept & to check the record & to take the
samples for test or analysis.
• Licensee must comply with other conditions as prescribed.
• Import of drugs for personal use-
• Small quantities of drugs, the import of which is otherwise
prohibited may be imported for personal use without any license
subject to the following conditions.
a. The drug shall form the passenger’s bonafide luggage & shall
exclusively be for personal use of the passenger.
b. The drug shall be declared to the customs authority, if they
direct so.
c. The quantity of any single drug so imported shall not exceed
100 doses.
• The licensing authority may in an exceptional case, sanction the
import of large quantity. Drug is not forming a part of bonafide
personal luggage if
a. The drug is for bonafide personal use.

12. b. The quantity to be imported is reasonable & is covered by
prescription of RMP.
Import of new drug-
• No new drugs are allowed to imported without the sanction of
the licensing authority
• The importer of new drug when applying for permission, shall
produce all documentary evidence & other evidences relating to
its standards, standards of quality & purity, strength, and such
other information including the clinical trials; to the licensing
authority.
Import of drug without license or permit-
• Drugs other than those discussed above, may be imported
without any permit or license.
• However, before such drugs are imported into the country, the
importer should submit a declaration to the custom collector
that they comply with all the provisions of chapter III of D&C Act
OFFENCES AND PENALTIES RELATED TO IMPORT OF DRUG-
1) Import of any Drugs or cosmetics which have been prohibited by
the Central Government on public interest under section 10A, shall be
punishable with three years imprisonment or up to 5000 INR fine or
both on first conviction and 5 years imprisonment or up to 10000 INR
fine or both on subsequent conviction.
2) Import of any adulterated drugs or spurious cosmetics or drugs or
containing ingredients under section 9A, 9B and 9D which are unsafe
or harmful for use shall be punishable with imprisonment of up to 3
years and with fine up to 5000 INR on first conviction and with 5 years
imprisonment and up to 10000 INR fine or both on subsequent
conviction

13. 3) Import of any drug or cosmetics mentioned other than in clause (a),
but prohibited to be imported under section 10, shall be punishable
with 6 months’ imprisonment or up to 500 INR fine or both on first
conviction and 1-year imprisonment or up to 1000 INR fine or both on
subsequent conviction.
4) The punishment provided under this section shall be in addition to
any penalty to which the offender may be liable under the provisions
of section 11.
MANUFACTURE OF DRUGS-
CONDITIONS FOR GRANT OF LICENSE TO MANUFACTURE OF DRUGS
SPECIFIED IN SCHEDULE C, C1 AND X.
 Application for the license of manufacturing drugs specified in
Schedule C, C1 and X should be made to the licensing authority
in the form 27B for which the licence is issued in form 28B.
 Application for including any additional drug in the license
should be accompanied by a fee of Rs.50 for each drug subject
to a maximum of Rs.500
Conditions for the grant of license:
Before the grand of license, the following conditions must be complied
by the applicant-
1. The manufacture will be conducted under the active direction of a
competent technical staff consisting at least one person who is a full
time employee & who is-
 A graduate in pharmacy with 18 months experience after
graduation in manufacture of drugs to which the license applies

14.  A graduate in Medicine, Chemical engineering or science with
chemistry or microbiology as principal subject and had at least 3
years of experience in manufacture of drugs to which the license
applies
2. The factory conditions must comply with the conditions prescribed
in Schedule M and M3
3. Applicant should provide adequate space, plant & equipment for
any or all manufacturing operations as prescribed in Schedule M & M3
4. Applicant should provide adequate staff, premises and laboratory
equipment for carrying out such tests for strength, quality & purity of
substances as required under the rules.
5. Adequate facilities for the storage of manufactured drugs should be
provided.
6. Data on stability of drugs that may deteriorate, for fixing the date
of expiry shall be furnished to licensing authority.
7. Licensee shall comply with requirements of GMP.
8. For manufacture of patent or proprietary medicines, data should be
provided to licensing authority that justifies that the medicines are
stable under conditions of recommended storage. contains such
ingredients & in such quantities for which there is therapeutic
justification
 License in form 28 & 28B remains valid for a period of 5 years on
and from the date on which it is issued.
 If application for renewal is made before its expiry, or application
made within 6 months of expiry, after payment of additional fee,
the license shall continue to be valid
 License shall deem to have expired if the application for its
renewal is not made within 6 months of its expiry.

15. Schedule G
Schedule G Warning:
Products or Substances that are included in this list should mention
below lines at label:
‘Caution: It is dangerous to take this preparation except under medical
supervision’ – conspicuously printed and surrounded by a line within
which there shall be no other words;
List of drugs and active pharmaceutical ingredients come under
Schedule G is as below:
 Aminopterin
 L-Asparaginase
 Bleomycin
 Busulphan; its salts
 Carbutamide
 Chlorambucil;its salts
 Chlorothiazide and other derivatives of 1, 2, 4 benzothiadiazine
 Chlorpropamide; its salts
 Chlorthalidone and other derivatives of Chlorobenzene
compound.
 Cis-Platin
 Cyclophosphamide; its salts
 Cytarabine
 Daunorubicin
 Di-Isopropyl Eluorophosphate
 Disodium Stilboestrol Diphosphate
 Doxorubicin Hydrochloride
 Ethacrynic Acid, its salts
 Ethosuximide
 Glibenclamide
 Hydantoin; its salts; its derivatives, their salts

16.  Hydroxyurea
 Insulin, all types
 Lomustine Hydrochloride
 Mannomustine; its salts
 Mercaptopurine; its salts
 Metformin; its salts
 Methsuximide
 Mustine, its salts
 Paramethadione
 Phenacemide
 Phenformin; its salts
 5-Phenylhydantoin; its alkyl and aryl derivatives; its salts
 Primadone
 Procarpazine Hydrochloride
 Quinthazone
 Sarcolysine
 Sodium-2-Mercaptoethanesulfonate Tamoxiten Citrate
 Testolactone
 Thiotepa
 Tolbutamide
 Tretamine; its salts
 Troxidone
 Antihistaminic substances the following, their salts, their
derivatives, salts of their derivatives
 Antazoline
 Bromodiphenhydramine
 Buclizine
 Chlorcyclizine
 Chlorpheniramine
 Clemizole
 Cyproheptadine
 Diphenhydramine
 Diphenylpyraline
 Doxylamine Succinate

17.  Isothipendyl
 Mebhydrolin Napadisylate
 Meclozine
 Phenindamine
 Pheniramine
 Promethazine
 Thenalidine
 Triprolidine
 Substances being tetra-N-Subs. derivatives of Ethylene Diamine
or Prophylenediamine.
Note – Preparations containing the above substances excluding those
intended for topical or external use are also covered by this Schedule.]
Schedule H
Schedule H includes drugs that shall be sold by retailer on prescription
of the registered medical practitioners.
Labeling Requirements:
If product contains a substance specified in Schedule H be labelled
with the symbol Rx and conspicuously displayed on the left top corner
of the label and be also labelled with the following words in Red color
base:
‘Schedule H drug – Warning: To be sold by retail on the prescription
of a Registered Medical Practitioner only’
If product contains a substance specified in Schedule H and comes
within the purview of the Narcotic Drugs and Psychotropic Substances
Act, 1985 (61 of 1985) be labelled with the symbol NRx which shall be
in red and conspicuously displayed on the left top corner of the label,
and be also labelled with the following words with Red Color Base:

18. ‘Schedule H drug – Warning: To be sold by retail on the prescription
of a Registered Medical Practitioner only’.
Dispensing:
The person dispensing a prescription containing a drug specified in
Schedule H and Schedule H1 and Schedule X shall comply with the
following requirements in addition to other requirement of these
rules.
The prescription must not be dispensed more than once unless the
prescriber has stated thereon that it may be dispensed more than
once
If the prescription contains a direction that it may be dispensed a
stated number of times or at stated intervals it must not be dispensed
otherwise than in accordance with the directions;
At the time of dispensing there must be noted on the prescription
above the signature of the prescriber the name and address of the
seller and the date on which the prescription is dispensed.
No person dispensing a prescription containing substances specified
in Schedule H and Schedule H1 or X, may supply any other
preparation, whether containing the same substance or not, in lieu
thereof.
Conditions:
Substances specified in Schedule H and Schedule H1 or Schedule X
shall not be sold by retail except on and in accordance with the
prescription of a Registered Medical Practitioner
The supply of drugs specified in Schedule H and Schedule H1 or
Schedule X to Registered Medical Practitioners, Hospitals,
Dispensaries and Nursing Homes shall be made only against the signed
order in writing which shall be preserved by the licensee for a period
of two years

19. Advertisement:
No advertisement of the drugs specified in Schedule H, Schedule H1
and Schedule X shall be made except with the previous sanction of the
Central Government.
1. Abacavir
2. Abciximab
3. Acamprosate calcium
4. Acebutol hydrochloride
5. Aclarubicin
6. Albendazole
7. Alclometasone dipropionate
8. Actilyse
9. Acyclovir
10. Adenosine
11. Adrenocorticotrophic hormone (acth)
12. Alendronate sodium
13. Alopurinol
14. Alphachymotrypsin
15. 2[Alprazolam
16. Alprostadil
17. Amantadine hydrochloride
18. Amifostine
19. Amikacin sulphate
20. Amiloride hydrochloride
21. Amineptine
22. Aminoglutethimide
23. Amino salicylic acid
24. Amiodarone hydrochloride
25. Amitriptyline
26. Amlodipine besylate
27. Amoscanate
28. Amoxopine
29. Amrinonelactate
30. Analgin
31. Androgenic anabolic, oestrogenic
& progestational substances
32. Antibiotics
33. Apraclonidine
34. Aprotinin
35. Organic compound of arsenic
36. Arteether
37. Artemether
38. Artesunate
39. Articaine hydrochloride

20. 40. Atenolol
41. Atracurium besylate injection
42. Atorvastatin
43. Auranofin
44. Azathioprine
45. Aztreonam
46. Bacampicillin
47. Baclofen
48. Balsalazide
49. Bambuterol
50. Barbituric acid
51. Basiliximab
52. Benazepril hydrochloride
53. Benidipine hydrochloride
54. Benserazide hydrochloride
55. Betahistine dihydrochloride
56. Bethanidine sulphate
57. Bezafibrate
58. Bicalutamide
59. Biclotymol monohydrate /lactate
60. Bifonazole
61. Bimatoprost
62. Biperiden hydrochloride
63. Biphenyl acetic acid
64. Bitoscanate
65. Bleomycin
66. Primonidine tartrate
67. Bromhexine hydrocloride
68. Bromocriptine mesylate
69. Budesonide
70. Bulaquine
71. Bupivacaine hydrochloride
72. Bupropion
73. Buspirone
74. Butenafine hydrochloride
75. Butorphanol tartrate
76. Cabergoline
77. Calcium dobesilate
78. Candesartan
79. Capecitabine
80. Captopril
81. Carbidopa
82. Carbocisteine
83. Carboplatin
84. Carboquone
85. Carisoprodol
86. L-carnitine

21. 87. Carteolol hydrochloride
88. Carvedilol
89. Cefadroxyl
90. Cefatoxime sodium
91. Cefazolin sodium
92. 2[Cefdinir
93. Cefepime hydrochloride
94. Cefetamet pivoxil
95. Cefpirome
96. Cefpodoximepoxetil
97. Ceftazidime pentahydrate
98. Ceftizoxime sodium]
99. Cefuroxime
100. Celecoxib
101. Centchroman
102. Centbutindole
103. Centpropazine
104. Cetirizine hydrochloride
105. 2[Chlordiazepoxide
106. Chlormezanone
107. 3 [ * * *]
108. Chlorpromazine
109. Chlorzoxazone
110. Ciclopiroxolamine
111. Cimetidine
112. Cinnarizine
113. Ciprofloxacin hydrochloride
114. Cisplatin
115. Citalopram hydrobromide
116. Clarithromycin
117. Clavulanic acid
118. Clidiniumbromide
119. Clindamycin
120. Clobazam
121. Clobetasol propena
122. Clobetasone 17-butyrate
123. 2[Clofazimine]
124. Clofibrate
125. Clonazepam
126. Clonidine hydrochloride
127. Clopamide
128. Clopidogrel bisulphate
129. Clostebolacetate
130. Clotrimazole
131. Clozapine
132. 2[Codeine]
133. Colchicine

22. 134. Corticosteroids
135. Cotrimoxazole
136. Cyclandelate
137. Cyclosporins
138. Daclizumab
139. Danazole
140. Dapsone
141. Desloratadine
142. Desogestrol
143. Dexrazoxane
144. Dextranomer
145. 2[* * *]
146. Dextropropoxyphene
147. 2[Diazepam]
148. Diazoxide
149. Diclofenac sodium/potassium/acid
150. Dicyclomin hydrochloride
151. Didanosine
152. Digoxine
153. Dilazep hydrochloride
154. Diltiazem
155. Dinoprostone
156. 2[Diphenoxylate, its salts]
157. Dipivefrin hydrochloride
158. Di-sodiumpamidronate
159. Disopyramide
160. Docetaxel
161. Domperidone
162. Donepezil hydrochloride
163. Dopamine hydrochloride
164. Dothiepin hydrochloride
165. Doxapram hydrochloride
166. Doxazosin mesylate
167. Doxepin hydrochloride
168. Doxorubicin hydrochloride
169. Drotrecogin-alpha
170. Ebastine
171. Econozole
172. Efavirenz
173. Enalapril meleate
174. Enfenamic acid
175. Epinephrine
176. Epirubicine
177. Eptifibatide
178. Ergot, alkaloids of whether hydrogenated or not, their homologoues, salts
179. Esomeprazole
180. Estradiol succinate

23. 181. Estramustine phosphate
182. Etanercept
183. Ethacridine lactate
184. 2[Ethambutol hydrochloride]
185. Ethamsylate
186. Ethinyloestradiol
187. 2[Ethionamide]
188. Etidronate disodium
189. Etodolac
190. Etomidate
191. Etoposide
192. Exemestane
193. Famciclovir
194. Famotidine
195. Fenbendazole
196. Fenofibrate
197. Fexofenadine
198. Finasteride
199. Flavoxate hydrochloride
200. 5-fluorouracil
201. Fludarabine
202. Flufenamic acids
203. Flunarizine hydrochloride
204. Fluoxetine hydrochloride
205. Flupenthixol
206. Fluphenazine enanthate and decanoate
207. Flurazepam
208. Flurbiprofen
209. Flutamide
210. Fluticasone propionate
211. Fluvoxamine maleate
212. Formestane
213. Fosfestril sodium
214. Fosinopril sodium
215. Fossphenytoin sodium
216. Fotemustine
217. Gabapentin
218. Galanthamine hydrobromide
219. Galamine, its salts, its quaternary compound
220. Gancyclovir
221. Ganirelix
222. Gatifloxacin
223. Gemcitabine
224. Gemfibrozil
225. Gemtuzumab
226. Genodeoxycholic acid
227. Gliclazide

24. 228. Glimepiride
229. Glucagon
230. Glycopyrrolate
231. Glydiazinamide
232. Goserelin acetate
233. Granisetron
234. Guanethidine
235. Gugulipid
236. Halogenated hydroxyquinolines
237. Haloperidol
238. Heparin
239. Hepatitis b. Vaccine
240. Hyaluronidase
241. Hydrocorisone 17-butyrate
242. Hydrotalcite
243. Hydroxizine
244. Ibuprofen
245. Idebenone
246. Indapamide
247. Imipramine
248. Indinavir sulphate
249. Indomethacin
250. Insulin human
251. Interferon
252. Intravenous fat emulsion
253. Iobitridol
254. Iohexol
255. Iopamidol
256. Iomeprol
257. Iopromide
258. Irbesartan
259. Irinotecan hydrochloride
260. Iron preparation for parenteral use
261. Isepamicine
262. Isocarboxside
263. Isoflurane
264. Isonicotnic acid hydrazine and other-hydragine derivatives of isonicotinic acid
265. Isosorbide dinitrate/ mononitrate
266. Isotretinoin
267. Isoxsuprine
268. Itopride
269. 4[***]
270. Ketoconazole
271. Ketoprofen
272. Ketorolactromethamine
273. Labetalol hydrochloride
274. Lacidipine

25. 275. Lamivudine
276. Lamotrigine
277. Latanoprost
278. Lefunomide
279. Lercanidipine hydrochloride
280. Letrozole
281. Leuprolide acetate
282. Levamesole
283. Levarterenol
284. Levobunolol
285. Levocetirizine
286. Levodopa
287. 2[Levofloxacin]
288. Levovist
289. Lidoflazine
290. Linezplid
291. Lithium carbonate
292. Lofepramine decanoate
293. Loperamide
294. Lorazepam
295. Losartan potassium
296. Loteprednol
297. Lovastatin
298. Loxapine
299. Mebendazole
300. Mebeverine hydrochloride
301. Medroxyprogesterone acetate
302. Mefenamic acid
303. Mefloquine hydrochloride
304. Megestrol acetate
305. Meglumine iocarmate
306. Melagenina
307. Elitracenhydrochloride
308. Meloxicam
309. Mephenesin, its esters
310. Mephentermine
311. 2[Meropenam]
312. Mesterolone
313. Metaxalone
314. Methicillin sodium
315. Methocarbamol
316. Methotraxate
317. Metoclopramide
318. Metoprolol tartrate
319. Metrizamide
320. Metronidazole
321. Mexiletine hydrochloride

26. 322. Mianserin hydrochloride
323. Miconazole
324. 2[Midazolam]
325. Mifepristone
326. Milrinone lactate
327. Miltefosine
328. Minocycline
329. Minoxidil
330. Mirtazapine
331. Misoprostol
332. Mitoxantrone hydrochloride
333. Mizolastine
334. Moclobemide
335. Mometasone furoate
336. Montelukast sodium
337. Morphazinamide hydrochloride
338. Mosapride
339. 2[Moxifloxacin]
340. Mycophenolate mofetil
341. Nadifloxacin
342. Nadolol
343. Nafarelin acetate
344. Nalidixic acid
345. Naproxen
346. Narcotics drugs listed in Narcotic Drugs & Psychotropic Substances Act, 1985
347. Natamycin
348. Nateglinide
349. N-butyl-2-cyanoacrylate
350. Nebivolol
351. Nebumetone
352. Nelfinavir mesilate
353. Netilmicin sulphate
354. Nevirapine
355. Nicergoline
356. Nicorandil
357. Nifedipine
358. Nimesulide
359. Nimustine hydrochloride
360. 2[Nitrazepam]
361. Nitroglycerin
362. Norethisterone enanthate
363. Norfloxacin
364. Octylonium bromide
365. Ofloxacin
366. Olanzapine
367. Omeprazole
368. Ornidazole

27. 369. Orphenadrine
370. Orthoclone sterile
371. Oxazepam
372. Oxazolidine
373. Oxcarbazepine
374. Oxethazaine hydrochloride
375. Oxiconazole
376. Oxolinic acid
377. Oxprenolol hydrochloride
378. Oxybutynin chloride
379. Oxyfedrine
380. Oxymetazoline
381. Oxyphenbutazone
382. Oxytocin
383. Ozothine
384. Paclitaxel
385. Pancuronium bromide
386. Pantoprazole
387. Para-amino benzene sulphonamide, its salts & derivatives
388. Parp-amino salicylic acid, its salts, its derivatives
389. Parecoxib
390. Paroxetine hydrochloride
391. D-penicilamine
392. 2[Pentazocine]
393. Pentoxifylline
394. Pepleomycin
395. Phenelzineh sulphate
396. Phenobarbital
397. Phenothiazine, derivatives of and salts of its derivatives
398. Phenylbutazine
399. Pimozide
400. Pindolol
401. Pioglitazone hydrochloride
402. Piracetam
403. Piroxicam
404. Pituitory gland, active principles of, not otherwise specified in this schedule and their
salts
405. Polidocanol
406. Polyestradiol phosphate
407. Poractant alfa
408. Praziquantel
409. Prednimustine iothalamates
410. Prednisolone stearoylglycolate
411. Prenoxdiazinhydro-chloride
412. Promazine hydrochloride
413. Promegestone
414. Propafenon hydrochloride

28. 415. Propanolol hydrochloride
416. Propofol
417. Protristyline hydrochloride
418. 2[Pyrazinamide]
419. Pyrvinium
420. Quetiapine fumerate
421. Quinapril
422. Quinidine sulphate
423. Rabeprazole
424. Racecadotril
425. Raloxifene hydrochloride
426. Ramipril hydrochloride
427. Ranitidine
428. Rauwolfia, alkaloids of, their salts, derivatives of the alkaloids or rauwolfia
429. Reboxetine
430. Repaglinide
431. Reproterol hydrochloride
432. Rilmenidine
433. Riluzone
434. Risperidone
435. Ritonavir
436. Ritodrine hydrochloride
437. Rituximab
438. Rivastigmine
439. Rocuronium bromide
440. Ropinirole
441. Rosoxacin.
442. Rosiglitazone meleate
443. Salbutamol sulphate
444. Salicyl-azo-sulphapyridine
445. Salmon calcitonin
446. Saquinavir
447. Satranidazole
448. Secnidazole
449. Septopal beads & chains
450. Serratiopeptidase
451. Sertraline hydrochloride
452. Sibutramine hydrochloride
453. Sildenafil citrate
454. Simvastatin
455. Sirolimus
456. Sisomicin sulphate
457. S-neominophagen
458. Sodiumpico sulphate
459. Sodium cromoglycate
460. Sodium hyaluronate
461. Sodium valproate

29. 462. Sodium and maglumine iothalamates
463. Somatostatin
464. Somatotropin
465. Sotalol
466. 2[Sparfloxacin]
467. Spectinomycin hydrochloride
468. Spironolactone
469. Stavudine
470. Sucralfate
471. Sulphadoxine
472. Sulphamethoxine
473. Sulphamethoxypyridazine
474. Sulphaphenazole
475. Sulpiride
476. Sulprostone hydrochloride
477. Sumatriptan
478. Tacrine hydrochloride
479. Tamsulosin hydrochloride
480. Trapidil
481. Tegaserod maleate
482. Teicoplanin
483. Telmisartan
484. Temozolamide
485. Terazosin
486. Terbutaline sulphate
487. Terfenadine
488. Terizidone
489. Terlipressin
490. Testosteroneun decoanoate
491. Teratolol hydrochloride
492. Thalidomide
493. 2[Thiacetazone]
494. Thiocolchicoside
495. Thiopropazate, its salts
496. Thymogene
497. Thymosin-alpha1
498. Tiaprofenic acid
499. Tibolone
500. Timolol maleate
501. Tinidazole
502. Tizanidine
503. Tabramycin
504. Tolfenamic acid
505. Topiramate
506. Topotecan hydrochloride
507. 2[Tramadolhydrochloride]
508. Tranexamic acid

30. 509. Tranylcypromine, its salts
510. Trazodone
511. Tretinoin
512. Trifluperazine
513. Trifluperidol hydrochloride
514. Triflusal
515. Trimetazidine dihydrochloride
516. Trimipramine
517. Tripotassium dicitrate bismuthate
518. Tromantadine hydrochloride
519. Urokinase
520. Valsartan
521. Vasopressin
522. Vecuronium bromide
523. Venlafaxine hydrochloride
524. Verapamil hydrochloride
525. Verteporfin
526. Vincristine sulphate
527. Vinblastine sulphate
528. Vindesine sulphate
529. Vinorelbine tatrate
530. Xipamide
531. Zidovudine hydrochloride
532. Ziprasidone hydrochloride
533. Zoledronic acid
534. 2[Zolpidem]
535. Zopiclone
536. Zuclopenthixol
Schedule M:
Schedule M describes Good Manufacturing Practices and
Requirements of Premises.
Schedule M provides the insights to achieve the objectives listed in
schedule, each licensee shall evolve appropriate methodology, system
and procedures which shall be documented and maintained for
inspection and reference; and the manufacturing premises shall be
used exclusively for production of drugs.
Part 1: Describes Good Manufacturing Practices For Premises and
Material

31. Part 1A: Describes the Specific requirement for manufacture of sterile
products. Parenteral preparations (Small Volumn Injections and Large
Volumn Parenterals) and Sterile Ophthalmic Preparations
Part 1B: Describes the Specific requirements for manufacture of oral
solid forms (Capsule and Teblets)
Part 1C: Describes the Specific Requirements for Manufacture of Oral
Liquids (Syrups, Elixirs, Emulsions and Suspensions)
Part 1D: Describes the Specific requirements for Manufacture of
Topical Products i.e. External Preparations (Cream, Ointments, Pastes,
Emulsions, Lotions, Solutions, Dusting Powders and Identical
Products)
Part 1E: Describes the Specific requirements for manufacture of
Metered Dose Inhalers (MDI)
Part 1F: Describes the Specific requirements of premises, plant and
material for manufacture of Active Pharmaceutical Ingredients (Bulk
Drugs)
Part 2: Describes the Requirements of Plant and Equipment
Schedule M-1:
Schedule M-1 describes the Good Manufacturing Practice
requirements of factory premises for manufacture of Homoeopathic
preparations:
Schedule M-2:
Schedule M-2 describes the requirements of factory premises for
manufacture of cosmetics
Schedule M-3:

32. Schedule M-3 describes the requirements of factory premises for
manufacture of medical devices
Schedule N:
Schedule N Describes the Equipment for efficient running of a
Pharmacy:
1. Entrance. – The front of a pharmacy shall bear an inscription
“Pharmacy” in front.
2. Premises. –
 The premises of a pharmacy shall be separated from rooms for
private use. The premises shall be well built, dry, well lit and
ventilated and, of sufficient dimensions to allow the goods in stock,
especially medicaments and poisons to be kept in a clearly visible
and appropriate manner. The areas of the section to be used as
dispensing department shall be not less than 6 square meters for
one pharmacist working therein with additional 2 square meters for
each additional pharmacist. The height of the premises shall be at
least 2.5 meters.
 The floor of the pharmacy shall be smooth and washable. The walls
shall be plastered or tiled or oil painted so as to maintain smooth,
durable and washable surface devoid of holes, cracks and crevices.
 A pharmacy shall be provided with ample supply of good quality
water.
 The dispensing department shall be separated by a barrier to
prevent the admission of the public.
3. Furniture and apparatus. –
 The furniture and apparatus of a pharmacy shall be adopted to the
uses for which they are intended and correspond to the size and
requirements of the establishment.
 Drugs, chemicals, and medicaments shall be kept in a room
appropriate to their properties and in such special containers as will
prevent any deterioration of the contents or of contents of

33. containers kept near them. Drawers, glasses and other containers
used for keeping medicaments shall be of suitable size and capable
of being closed tightly to prevent the entry of dust.
 Every container shall bear a label of appropriate size, easily
readable with names of medicaments as given in the
Pharmacopoeias.
 A pharmacy shall be provided with a dispensing bench, the top of
which shall be covered with washable and impervious material like
stainless steel, laminated or plastic, etc.
 A pharmacy shall be provided with a cupboard with lock and key for
the storage of poisons and shall be clearly marked with the work
‘POISON’ in red letters on a white background.
 Containers of all concentrated solution shall bear special label or
marked with the words “To be diluted”.
 A Pharmacy shall be provided with the following minimum
apparatus and books necessary for making of official preparations
and prescriptions:-
Apparatus: –
 Balance, dispensing, sensitivity 30 mg.
 Balance, counter, capacity 3 Kgm., sensitivity 1 gm.
 Beakers, lipped, assorted sizes.
 Bottles, prescription, ungraduated assorted sizes.
 Corks assorted sizes and tapers.
 Cork, extracter.
 Evaporating dishes, porcelain.
 Filter paper.
 Funnels, glass.
 Litmas paper, blue and red.
 Measure glasses cylindrical 10 ml, 25 ml, 100 ml and 500 ml.
 Mortars and pestles, glass.
 Mortars and pestles, wedgwood.
 Ointment pots with bakelite or suitable caps.
 Ointment slab, porcelain

34.  Pipette graduated, 2 ml, 5 ml and 10 ml.
 Ring, stand (retort) iron, complete with rings.
 Rubber stamps and pad
 Scissors
 Spatulas, rubber or vulcanite
 Spatulas, stainless steel.
 Spirit lamp
 Glass stirring rods.
 Thermometer, 0oC to 200oC.
 Tripod stand.
 Watch glasses.
 Water bath.
 Water distillation still in case Eye drops and Eye lotions are
prepared.
 Weights, Metric, 1 mg. to 100 gm.
 Wire Gauze.
 Pill finisher, boxwood.
 Pill Machine.
 Pill Boxes.
 Suppository mould.
Books :
 The Indian Pharmacopoeia (Current Edition).
 National Formulary of Indian (Current Edition).
 The Drugs and Cosmetics Act, 1940.
 The Drugs and Cosmetics Rules, 1945.
 The Pharmacy Act, 1948.
 The Dangerous Drugs Act, 1930.4.
General provisions. –
 A pharmacy shall be conducted under the continuous personal
supervision of a Registered Pharmacist whose name shall be
displayed conspicuously in the premises.
 The Pharmacist shall always put on clean white overalls.

35.  The premises and fittings of the pharmacy shall be properly kept
and everything shall be in good order and clean.
 All records and registers shall be maintained in accordance with
the laws in force.
 Any container taken from the poison cupboard shall be replaced
therein immediately after use and the cupboard locked. The keys
of the poison cupboard shall be kept in the personal custody of
the responsible person.
 Medicaments when supplied shall have labels conforming to the
provisions of laws in force.
Note: – The above requirements are subject to modifications at the
discretion of the licensing authority, if he is of opinion that having
regard to the nature of drugs dispensed, compounded or prepared by
the licensee. It is necessary to relax the above requirements or to
impose additional requirements in the circumstances of a particular
case. The decision of the licensing authority in that regard shall be
final.
Schedule P:
Schedule P describes the life period of drugs in months (unless
otherwise specified) between date of manufacture and date of expiry
which the labelled potency period of the drug shall not exceed under
the conditions of storage specified in column no. 4 of schedule P.
Column No. 1 defines the serial number of drug listed.
Column No. 2 defines the name of drug listed.
Column No. 3 defines the period in months of expiry date of drug listed
Column No. 4 defines the conditions for Storage of drug listed
 The term “cool place” means place having a temperature between
10C and 25C.
 The term “cold place” means a place having a temperature not
exceeding 8C.

36.  Capsules should be kept in a well-closed container at temperature
not exceeding 30 C.
 Wherever condition of storage is not specified in Column 4, it may
be stored under normal room temperature.
Schedule P1:
Schedule P1 describes the Pack size of drugs. Schedule P1 contains
Name of drug, their dosage form and pack size of listed drugs.
Schedule T:
Schedule T describes the Good Manufacturing Practice for Ayurvedic,
Siddha and Unani Medicines.
Part 1-
Part 1 Describes the Good Manufacturing Practice of Ayurvedic,
Sidha and Unani Medicines.
The Good Manufacturing Practices (GMP) are prescribed as follows in
Part I and Part II to ensure that:
 Raw materials used in the manufacture of drugs are authentic, of
prescribed quality and are free from contamination.
 The manufacturing process is as has been prescribed to maintain
the standards.
 Adequate quality control measures are adopted.
 The manufactured drug which is released for sale is of acceptable
quality.
 To achieve the objectives listed above, each licensee shall evolve
methodology and procedures for following the prescribed process
of manufacture of drugs which should be documented as a manual
and kept for reference and inspection. However, under IMCC Act
1970 registered Vaidyas, Siddhas and Hakeems who prepare
medicines on their own to dispense to their patients and not selling
such drugs in the market are exempted from the purview of G.M.P.
Good Manufacturing Practice for Ayurvedic, Sidha and Unani
Products:

37. A Manufacturing Premises should have adequate space for all daily
activity like:
 Receiving and Storage of Herbs, Packaging material & other raw
material
 Production and Manufacturing Activity Area
 Quality Control Section
 Finished Goods Store
 Office and Administration
 Rejected Products/Drugs Store
Minimum area required for setting up Ayurveda, Sidha and Unani
Medicine manufacturing unit is 1200 square feet covered with
separate cabins and partitions for each activity. If unani
medicines/ayurvedic medicine are manufactured along with
ayurvedic medicine/unani medicine additional 400 square feet area is
required.
General Requirements:
1. Location and Surroundings: The factory building for Ayurveda, Sidha
and Unani Medicine manufacturing shall be situated and constructed
to avoid contamination from open sewerage, drain, disagreeable or
obnoxious odour, dust and smoke etc.
2. Buildings: A building for manufacturing unit for Ayurvedic, Sidha
and Unani Medicines shall permit work under hygienic conditions. It
should be free from any insects/rodents. Light and ventilation facility
should be adequate. Walls and floor should be free from cracks and
damp. Premises should also conformity with provisions of factory act.
It shall be located so as to be:
 Building should compatible of other manufacturing operations
carried out in same premises.
 Space should be adequate for Placement of equipment and
materials to avoid mix-up/contamination risk of different drugs and
components.

38.  Designed, constructed and maintained to prevent entry of insects
and rodents. Interior surface (walls, floors and ceilings) shall be
smooth and free from cracks and permit easy cleaning and
disinfection. The walls of the room in which the manufacturing
operations are carried out shall be impervious to and be capable of
being kept clean. The flooring shall be smooth and even and shall
be such as not to permit retention or accumulation of dust or waste
products.
 Building should have a proper drainage system. Sanitary fitting and
electric fixtures shall be proper and safe.
 Burner/Bhatti section could be covered with tin roof and proper
ventilation but care should be done to prevent flies and dust.
 Proper fire safety measures and proper exists should be there.
 Drying space for raw material, in process medicines should be
separate and measures should be done to prevent it from
flies/insects/dust etc.
3. Water Supply: Water needed for manufacturing should be pure and
of potable quality. Adequate provision of water for wasting the
premises shall be made.
4. Disposable of Waste: Proper waste management care should be
done.
5. Container’s Cleaning: Washing, cleaning and drying section of
containers such as bottles, vials and jars should have adequate
arrangement and should be separated from manufacturing
operations.
6. Stores: Store should have adequate space for independently and
separately store raw material, packaging material and finished
products. Read in detail Storage of Ayurvedic, Sidha and Unani
Products under Goods Manufacturing Practice.
7. Working Space: Manufacturing area should be adequate for orderly
placement of equipment, machinery and material used during

39. manufacturing operations and quality control to facilitate easy and
safe working and to minimize or eliminate any risk of mix-up between
different drugs, raw materials and to prevent the cross contamination
during manufacturing, storage and handling operations.
8. Health Clothing, Sanitation and Hygiene of Workers: All workers
should be healthy and should be free from any contagious diseases.
Proper uniform should be provided to workers according to nature of
work and the climates. It should be clean. A uniform may include cloth
or synthetic covering for hands, feet and head wherever required.
Adequate facilities for personnel use should be provided like clean
towel, soap etc. Lavatories for men and women should be separate
and should away from processing and manufacturing area. Changing
room facility should also be provided for changing their clothes and to
keep their personal belongings.
9. Medical Services: Adequate facility for first aids should be provided
by manufacturer. Medical examination of workers at the time of
employment and periodical check-up should be conducted at least
once in a year and proper record should be maintained.
10. Machinery and Equipment: To carryout manufacturing process,
adequate machinery and equipment require. These machinery could
be manually operated or semi-automatic or fully automatic based
upon your need and investment. Read in detail about machinery and
equipment in Part II of Schedule T.
11. Batch Manufacturing Record: Each batch record should be
maintained irrespective of product manufactured (classical
preparations or patent or proprietary medicines). Manufacturing
records are required to provide an account of the list of raw materials
and their quantities obtained from the store, tests conducted during
the various stages of manufacture like taste, colour, physical
characteristics and chemical tests as may be necessary or indicated in
the approved books of Ayurveda, Siddha and Unani mentioned in the

40. First Schedule of the Drugs and Cosmetics Act. These tests may include
any in-house or pharmacopoeial test adopted by the manufacturer in
the raw material or in the process material and in the finished product.
Manufacturing Batch record should be signed by production chemist
and analytical chemist. Stock should be transferred to finished goods
store along with record of testing with date and quantity of drug. Only
after the manufactured drugs have been verified and accepted quality
shall be allowed to be cleared for sale. It should be essential to
maintain the record of date, manpower, machine and equipments
used and to keep in process record of various shodhana, bhavana,
burning and fire and specific grindings in terms of internal use.
12. Distribution Record: Distribution record (Dispatch register) should
be maintained to facilitate process of prompt and complete recall of
the batch. Distribution record should be maintained till expiry of
batch. For drugs who don’t have expiry date like Bhasma, Rasa, Asava-
arishtha etc, record should maintain upto five years of the exhausting
of stock.
13. Record of Market Complaints: A complain register should maintain
to record all reports of market complaints received regarding the
products sold in the market. . The manufacturer shall enter all data
received on such market complaints, investigations carried out by the
manufacturers regarding the complaint as well as any corrective
action initiated to prevent recurrence of such market complaints shall
also be recorded. Once in a period of six months the manufacturer
shall submit the record of such complaints to the licensing authority.
The Register shall also be available for inspection during any
inspection of the premises.
Reports of any adverse reaction resulting from the use of Ayurvedic,
Siddha and Unani drugs shall also be maintained in a separate register
by each manufacturer. The manufacturer shall investigate any of the
adverse reaction to find if the same is due to any defect in the product,

41. and whether such reactions are already reported in the literature or it
is a new observation.
14. Quality Control: A manufacturer can set-up own quality control
section or testing could be done through government approved
testing laboratory read in detail about Ayurvedic, Sidha and Unani
manufacturing unit quality control Section
Part 2
Part 2 describes a list of recommend machinery, equipment and
minimum manufacturing premises required for the manufacture of
various categories of Ayurvedic, Siddha system of medicines. read in
detail about machinery, equipment and minimum manufacturing
premises here
Schedule U:
Schedule U describes the particulars to be shown in manufacturing
record.
Following details are included in Schedule U:
1. Particulars to be shown in Manufacturing Records:
 Substances other than Parenteral Preparation in General
 Parenteral Preparations
2. Records of Raw Materials
3. Particulars to be recorded in the Analytical Records
 Tablet and Capsules
 Parenteral Preparations
 For other Drugs
 Raw Materials
 Container, Packing Material Etc.
Schedule U(I):
Schedule U(I) describes the particulars to be shown in the
manufacturing record for cosmetics

42. Schedule V:
Schedule V describes the standards for patent or proprietary
medicines
Patent or proprietary medicines containing vitamins for prophylactic,
therapeutic or paediatric use shall contain the vitamins in quantities
not less than and not more than those specified in single or in two
divided daily doses.
Schedule X:
Schedule X describes the habit forming and narcotics drugs list.
Dispensing:
The person dispensing a prescription containing a drug specified in
Schedule H and Schedule H1 and Schedule X shall comply with the
following requirements in addition to other requirement of these
rules.
 The prescription must not be dispensed more than once unless the
prescriber has stated thereon that it may be dispensed more than
once
 If the prescription contains a direction that it may be dispensed a
stated number of times or at stated intervals it must not be
dispensed otherwise than in accordance with the directions;
 At the time of dispensing there must be noted on the prescription
above the signature of the prescriber the name and address of the
seller and the date on which the prescription is dispensed.
 No person dispensing a prescription containing substances
specified in Schedule H and Schedule H1 or X, may supply any other
preparation, whether containing the same substance or not, in lieu
thereof.
Conditions:
 Substances specified in Schedule H and Schedule H1 or Schedule X
shall not be sold by retail except on and in accordance with the
prescription of a Registered Medical Practitioner and in the case of

43. substances specified in Schedule X, the prescriptions shall be in
duplicate, one copy of which shall be retained by the licensee for a
period of two years.
 The supply of drugs specified in Schedule H and Schedule H1 or
Schedule X to Registered Medical Practitioners, Hospitals,
Dispensaries and Nursing Homes shall be made only against the
signed order in writing which shall be preserved by the licensee for
a period of two years
List of Schedule X Drugs:
Schedule X describes the list of drugs that covered in schedule
 Amobarbital
 Amphetamine
 Methylphenidate
 Barbital
 Methylphenobarbital
 Cyclobarbital
 Pentobarbital
 Dexamphetamine
 Phencyclidine
 Ethclorvynol
 Phenometrazine
 Glutethimide
 Meprobamate
 Secobarbital
 Methamphetamine
Schedule Y:
Schedule Y describes requirements and guidelines for permission to
import and/or manufacture of new drugs for sale or to undertake
clinical trials.
Schedule F:

44. Part I to Part XII-A– Omitted
Part XII B:
Part XII-B describes the requirements for the functioning and
operation of a Blood Bank and/or for preparation of Blood
components.
I. Blood Banks/Blood Components
A. General
B. Accommodation for a Blood Bank
C. Personnel
D. Maintenance
E. Equipment
F. Supplies and Reagents
G. Good Manufacturing Practices (GMPs)/ Standard Operating
Procedures (SOPs)
H. Criteria For Blood Donation
I. General Equipments and Instruments
J. Special Reagents
K. Testing of whole blood
L. Records
M. Labels
II. Blood Donation Camps
A Premises, personnel etc.
B Personnel for Out-door Blood Donation Camp
C Equipments
III. Processing of Blood components from whole blood by a Blood
bank:
A. Accommodation
B. Equipment
C. Personnel

45. D. Testing Facilities
E. Categories of Blood Components
 Concentrated Human Red Blood Corpuscles
 Platelets Concentrates
 Granulocyte Convcentrate
 Fresh Frozen Plasma
 Cryoprecipitate
F. Plasmapheresis, Plateletpheresis, Leucapheresis, Using a cell
Separator
Part XII C:
I. Requirements for manufacture of Blood Products
A. General Requirements
B. Collection and Storage of Plasma for Fractionation
C. Personnel
D. Production Control
E. Viral Inactivation Process
F. Quality Control
G. Testing of Blood Products
H. Storage of finished products
I. Labelling
J. Records
K. Master Formula Record
II. Requirements for Manufacture of Blood products from Bulk
Finished products
Part XIII
General
Schedule F(I):
Part I: Vaccines

46. A. Provisions applicable to the production of bacterial vaccines
1. Definition
2. Staff of Establishment
3. Proper Name
4. Records
5. Combined Vaccines
6. Preparation
7. General Standards
8. Labelling
9. Storage
10. Date of manufacture
B. Provisions applicable to the production of viral vaccines
1. Definition
2. Staff of Establishment
3. Proper Name
4. Records
5. Tests
6. Storage
7. Condition of housing of animals
8. Labelling
9. Date of Manufacture
Part II : Antisera
Provisions applicable to the production of all Sera from Living Animals
1. Definition
2. Staff of Establishment
3. Proper Name
4. Records
5. Cultures
6. Quantity
8. Unhealthy or Infected Animals
9. Conditions and Housing of animals Part III:Diagnostic Antigens

47. Provisions Applicable to the Manufacture and Standardisation of
Diagnostic Agents (Bacterial Origin)
1 Definition
2 Staff of establishment-
3 Proper Name
4. Record
5. Preparation
6. General Standard:
7. Labelling
8. Storage
9. Date of manufacture
Part IV:
General
Schedule F-II
Standards for surgical dressings
Schedule F-III
Standards for Umbilical Tapes
A. Standards for Sterilised Umbilical Polyster Tape.
B. Standards for Sterilised Umbilical Cotton Tape–
Schedule FF
Standards for ophthalmic preparations.
Part-A: Ophthalmic Solutions and suspensions.
Part B: Ophthalmic Ointments
SALE OF DRUGS
The Sale Drug license in India is acquired by wholesalers and retailers
who are engaging in the distribution of drugs in India. There are three
different types of Drug License in India as follows:
a. Wholesale Drug License in India-

48. The wholesale Drug License in India is issued by CDSCO (Central Drugs
Standard Control Organization) to those wholesalers who are doing
business in pharmaceuticals. The person who wants to obtain this
License must have some degree or diploma in pharmacy from a
recognized university and a minimum of one-year experience in drug
dealing.
b. Retail Drug License-
Retail Drug License in India is issued by Licensing Authorities to
retailers who are doing business in pharmaceuticals, stand-alone
pharmacists, etc. The applicant should be registered pharmacist under
the State Pharmacy Council.
C. Restricted License for General Store in India-
This License is issued under Forms 20A and 21A to dealers or persons,
to sell drugs without the supervision of any qualified person.
LABELING AND PACKAGING OF DRUGS
Labelling of medicines (Drugs and Cosmetics Act ,1940 and
Rules, 1945)
(1) The container of a medicine for internal use shall—
(a) if it contains a substance specified in Schedule G, be labelled with
the words ―Caution: it is dangerous to take this preparation except
under medical supervision – conspicuously printed and surrounded by
a line within which there shall be no other words.
(b) if it contains a substance specified in Schedule H, be labelled with
the symbol Rx and conspicuously displayed on the left top corner of
the label and be also labelled with the following words:
Schedule H drug- Warning: To be sold by retail on the prescription of
a Registered Medical Practitioner only‘,
(c) if it contains a substance specified in Schedule H, and comes within
the purview of the 2[Narcotic Drugs and Psychotropic Substances Act,

49. 1985 (61 of 1985)] be labelled with the symbol NRx which shall be in
red and conspicuously displayed on the left top corner of the label,
and be also labelled with the following words:
Schedule H drug -Warning: To be sold by retail on the prescription of
a Registered Medical Practitioner only‘.
(d) If it contains a substance specified in Schedule X, be labelled with
the symbol XRx which shall be in red conspicuously displayed on the
left top corner of the label and be also labelled with the following
words : –
Schedule X drug -Warning: To be sold by retail on the prescription of
a Registered Medical Practitioner only‘.
(e) if it contains a drug substance specified in Schedule H1, the drug
formulation shall be labeled with the symbol Rx which shall be in red
conspicuously displayed on the left top corner of the label, and shall
also be labelled with the following words in a box with a red border:
“SCHEDULE H1 DRUG- WARNING.
- it is dangerous to take this preparation except in accordance with
the medical advice
- not to be sold by retail without the prescription of a Registered
Medical Practitioner
(2) The container of an embrocation, liniment, lotion, ointment,
antiseptic cream,] liquid antiseptic or other liquid medicine for
external application shall be labelled with the words:
―FOR EXTERNAL USE ONLY
3) The container of a medicine made up ready only for treatment of
an animal shall be labelled conspicuously with the words Not for
human use; for animal treatment only‘ and shall bear a symbol
depicting the head of a domestic animal.

50. The container of a medicine for treatment of food producing animals
shall be labeled with the withdrawal period of the drug for the species
on which it is intended to be used:
Provided that if the specific withdrawal period has not been validated,
the withdrawal period shall not be less than seven days for eggs or
milk, twenty eight days for meat from poultry and mammals including
fat and offal, five hundred degree days for fish meat.
Explanation:- For the purpose of this Rule, the withdrawal period is
the period of interval between the last administration of a veterinary
medicine to animals under the normal conditions of use and the
production of food stuff from such animals to ensure that food stuffs
do not contain residues in quantities in excess of the maximum
residue limits laid down.
The container of a medicine prepared for treatment of human
ailments shall if the medicine contains industrial methylated spirit,
indicate this fact on the label and be labelled with the words :
For External Use only
Substances specified in Schedule X in bulk form shall bear a label
wherein the symbol as specified in sub-Rule
(1) shall be given conspicuously in red letters.
Non-Sterile Surgical Ligature and Suture.- Every container of, and
wrapper enclosing surgical ligature or suture other than a ligature or
suture offered or intended to be offered for sale as sterile, shall bear
a label on which are printed or written in a conspicuous manner in
indelible red ink the words
―Non-sterile surgical ligature (suture) – not to be used for operations
upon the human body unless efficiently sterilized.
(2) The name and address of the manufacturer shall be printed on the
label of the container of a patent or proprietary medicine.
The true formula or list of the ingredients shall be printed or written
in indelible ink on the outer label of every package containing patent
or proprietary medicine.

51. Use of letter I.P. etc.–The letters I.P‘. and recognized abbreviations of
pharmacopoeias and official compendia of drug standards prescribed
under these Rules shall be entered on the label of the drug only for
the purpose of indicating that the drug is in accordance with standards
set out in the Indian Pharmacopoeia or in any such pharmacopoeia or
official compendium of drug standards recognized under the Rules.
Prohibition against altering inscriptions on containers, labels or
wrappers of drug. –No person shall alter, obliterate or deface any
inscription or mark made or recorded by the manufacturer on the
container, label or wrapper of any drug:
Provided that nothing in this rule shall apply to any alteration, any
inscription or mark made on the container, label or wrapper of any
drug at the instance or direction or with the permission of the
Licensing Authority.
Packing of drugs (Drugs and Cosmetics Act ,1940 and
Rules, 1945)
(1) The pack sizes of drugs meant for retail sale shall be as prescribed
in Schedule P1 to these rules.
(2) The pack sizes of drugs not covered by Schedule P-1 shall be as
given below: –
Unless specified otherwise in Schedule P-1,
(i) The pack sizes for Tablets/Capsules shall be–
Where the number of Tablets (coated or uncoated)/Capsules (hard or
soft gelatin) is less than 10, such packing shall be made by the integral
number.
For numbers above 10, the pack size of Tablets/Capsules shall contain
multiples of 5.
(ii) The pack sizes for liquid Oral preparations shall be 30 ml (paediatric
only)/60 ml/100 ml/200 ml/450 ml.
(iii) The pack sizes for Paediatric Oral Drops shall be 5 ml/10 ml/15 ml.
(iv) The pack sizes for Eye/Ear/Nasal
drops shall be 3 ml/5 ml/10 ml.
(v) The pack size for Eye Ointment shall be 3 gm/5 gm/ 10 gm:

52. Provided that the provisions of the pack sizes covered under this rule
shall not apply to: –
1. Pack sizes or dosage forms not covered by the foregoing provisions
of this rule.
2. The imported formulations in finished form.
3. Preparations intended for Veterinary use.
4 Preparations intended for Export.
5. Vitamins/Tonics/Cough Preparations/Antacids/Laxatives in Liquid
Oral forms, Unit dose (including applicaps).
6. Pack sizes of dosage forms meant for retail sale to Hospitals,
Registered Medical Practitioners, Nursing Homes.
7. Physician‘s Samples.
8. Pack sizes of large volume Intravenous Fluids:
Provided further that] pack sizes of any of the new drug as and when
approved by the Licensing Authority appointed under Rule 21 and if
not covered under this rule, shall be examined for the purpose of
approval with specific justification by the said Licensing Authority:
Provided also that] Oxytocin injection meant for sale shall be in single
unit blister pack only:
Provided also that Diclofenac injection for human use shall be in single
unit dose pack only.
Packings of drugs specified in Schedule X.- The drugs specified in
Schedule X shall be marketed in packings not exceeding-
(i) 100 unit doses in the case of tablets/capsules.
(ii) 300 ml in the case of oral liquid preparations; and
(iii) 5 ml in the case of injections:
Provided that nothing in this rule shall apply to packing meant for use
of a hospital or a dispensary subject to the conditions that–
(i) such supplies are made by the manufacturers or distributors direct
to the hospital/dispensaries and
(ii) hospital packs shall not be supplied to a retail dealer or to a
Registered Medical Practitioner.
Diseases which a drug may not purport to prevent or cure.—
(1) No drug may purport or claim to prevent or cure or may convey to
the intending user thereof any idea that

53. it may prevent or cure one or more of the diseases or ailments
specified in Schedule J.
(2) No drug may purport or claim to procure or assist to procure, or
may convey to the intending user thereof any idea that it may procure
or assist to procure, miscarriage in women.
List of colours permitted to be used in drugs.−
(1) No drug shall contain a colour other than specified below :-
(1) Natural Colours
 Annatto
 Carotene
 Chlorophyll
 Cochineal
 Curcumin
 Red Oxide of iron
 Yellow Oxide of iron
 2 [Titanium Oxide]
 3[Black Oxide of iron]
 6[Titanium dioxide coated mica pearlescent pigments]
(2) Artificial Colours
 Caramel
 4[Riboflavin]
(3) Coal Tar Colours

54. (4) LAKES
The aluminum or calcium salts (lakes) of any of the water-soluble
colours listed above:
[Provided that disinfectants may also contain colours specified under
Schedule Q, which are non-staining.]
(2) The label on the container of a drug containing a permitted colour
shall indicate the common name of the colour.]

55. Central Drugs laboratory under D &C Act
The Central Drugs Laboratory, Kolkata is the nation statutory
laboratory of the Government of India for Quality control of Drugs and
Cosmetics and is established under the Indian Drugs & Cosmetic Act,
1940. It is the oldest quality control laboratory of the Drugs Controls
Authorities in India. It functions under the administrative control of
the Director General of Health Services in the Ministry of the Health
and Family Welfare.
The functions of the Laboratory include:
 Statutory function:
 Analytical quality control of majority of the imported drugs
available in Indian market.
 Analytical quality control of drug and cosmetic manufactures
with in the country on behalf of the Center and State Drug
Controller Administrations.
 Acting as an appellate authority in matters of disputers related
of quality of drugs
 Other functions:
 Collection, storage and distribution of International Standard
International Reference preparations of drug and
Pharmaceutical substances.
 Preparation of National Reference Standards and maintenance
of such standards. Maintenance of microbial cultures useful in
drug analysis distribution of standards and cultures to state
quality control laboratories and other Institutions.
 Training of drug Analysts deputed by State Control Laboratories
and other Institutions.
 Training of World Health Organisation Fellows from abroad on
Modern Methods of Drug Analysis.
 To advise the Central Drug Control Administration in respect of
quality and toxicity of drugs awaiting License.
 To work out analytical specifications for preparation of
Monographs of Drugs for the Indian Pharmacopoeia and the
Homoeopathic Pharmacopoeia of India.

56.  To undertake analytical research on standardisation and
methodology of Drugs and Cosmetic.
 Analysis of Cosmetics received as survey samples from Central
Drug Standard Control organization.
 Quick analysis of life saving drugs on ALL- India basis received
under National Survey of Quality of Essential Drug Programme
from Zonal Officers of Central Drug Standard Control
Organisation.
 In addition to the above functions the Central Drug Laboratory also
actively collaborates with the World Health Organisation in the
preparation of International Standards and Specifications for
International Pharmacopoeia. It also undertakes collaborative
study on behalf on the Indian Pharmacopoeia Committee. The
senior officers of the laboratory have been appointed as
Government Analysts on behalf of most of the states of the Union
for analysis of drug samples.
Government analyst
A person who is appointed a Government Analyst under section 33 F
of the Act shall be a person possessing the qualifications prescribed in
rule 44 or a degree in Ayurveda, Siddha or Unani System, as the case
may be, conferred by a University, a State Government or Statutory
Faculties, Councils and Boards of Indian Systems of Medicine
recognized by the Central or State Government, as the case may be,
for this purpose and has had not less than three years' post graduate
experience in the analysis of drugs in a laboratory under the control
of
(i) a Government Analyst appointed under the Act, or
(ii) a Chemical Examiner to Government, or
(iii) the Head of an institution specially approved for the purpose by
the appointing authority.
Duties of Government Analyst-
(1) The Government Analyst shall analyze or test or cause to be
analyzed or tested such samples of Ayurvedic (including Siddha) or

57. Unani drugs as may be sent to him by Inspectors or any other persons
or authority authorised by the Central Government or State
Government under the provisions of Chapter IV A of the Act and shall
furnish reports of the results of test or analysis in accordance with
these rules.
(2) A Government Analyst appointed under section 33F shall from
time to time forward to the Government reports giving the result of
analytical work and research with a view to their publications at the
discretion of the Government.
The Drugs Technical Advisory Board.—
(1) The Central Government shall, as soon as may be, constitute a
Board (to be called the Drugs Technical Advisory Board) to advise the
Central Government and the State Governments on technical matters
arising out of the administration of this Act and to carry out the other
functions assigned to it by this Act.
(2) The Board shall consist of the following members, namely:—
(i) the Director General of Health Services, ex officio, who shall be
Chairman;
(ii) the Drugs Controller, India, ex officio;
(iii) the Director of the Central Drugs Laboratory, Calcutta, ex officio;
(iv) the Director of the Central Research Institute, Kasauli, ex officio;
(v) the Director of Indian Veterinary Research Institute, Izatnagar, ex
officio;
(vi) the President of Medical Council of India, ex officio;
(vii) the President of the Pharmacy Council of India, ex officio;
(viii) the Director of Central Drug Research Institute, Lucknow, ex
officio;
(ix) two persons to be nominated by the Central Government from
among persons who are in charge of drugs control in the States;
(x) one person, to be elected by the Executive Committee of the
Pharmacy Council of India, from among teachers in pharmacy or
pharmaceutical chemistry or pharmacognosy on the staff of an Indian
university or a college affiliated thereto;

58. (xi) one person, to be elected by the Executive Committee of the
Medical Council of India, from among teachers in medicine or
therapeutics on the staff of an Indian university or a college affiliated
thereto;
(xii) one person to be nominated by the Central Government from the
pharmaceutical industry;
(xiii) one pharmacologist to be elected by the Governing Body of the
Indian Council of Medical Research;
(xiv) one person to be elected by the Central Council of the Indian
Medical Association;
(xv) one person to be elected by the Council of the Indian
Pharmaceutical Association;
(xvi) two persons holding the appointment of Government Analyst
under this Act, to be nominated by the Central Government.]
(3) The nominated and elected members of the Board shall hold office
for three years, but shall be eligible for re- nomination and re-election:
[Provided that the person nominated or elected, as the case may be,
under clause (ix) or clause (x) or clause (xi) or clause (xvi) of sub-
section (2) shall hold office for so long as he holds the appointment of
the office by virtue of which he was nominated or elected to the
Board.]
(4) The Board may, subject to the previous approval of the Central
Government, make bye-laws fixing a quorum and regulating its own
procedure and the conduct of all business to be transacted by it.
(5) The Board may constitute sub-committees and may appoint to
such sub-committees for such periods, not exceeding three years, as
it may decide, or temporarily for the consideration of particular
matters, persons who are not members of the Board.
(6) The functions of the Board may be exercised notwithstanding any
vacancy therein.
(7) The Central Government shall appoint a person to be Secretary of
the Board and shall provide the Board with such clerical and other staff
as the Central Government considers necessary.

59. The Drugs Consultative Committee.—
(1) The Central Government may constitute an advisory committee to
be called ―
the Drugs Consultative Committee‖ to advise the Central Government,
the State Governments and the Drugs Technical Advisory Board on any
other matter tending to secure uniformity throughout [India] in the
administration of this Act.
(2) The Drugs Consultative Committee shall consist of two
representatives of the Central Government to be nominated by that
Government and one representative of each State Government to be
nominated by the State Government concerned.
(3) The Drugs Consultative Committee shall meet when required to do
so by the Central Government and shall have power to regulate its
own procedure.
[7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani
drugs.—nothing contained in sections 5 and 7 shall apply to
[Ayurvedic, Siddha or Unani] drugs.]
Licensing Authority.—
No person shall be qualified to be a Licensing Authority under the Act
unless:-
(i) he is a graduate in Pharmacy or Pharmaceutical Chemistry or in
Medicine with specialization in clinical pharmacology or microbiology
from a University established in India by law; and
(ii) he has experience in the manufacture or testing of drugs or
enforcement of the provisions of the Act for a minimum period of five
years: [ Provided that the requirements as to the academic
qualification shall not apply to those inspectors and the Government
Analysts who were holding those positions on the 12th day of
April,1989.]

60. Controlling authority.
(1) All Inspectors appointed by the Central Government shall be under
the control of an officer appointed in this behalf by the Central
Government.
(2) All Inspectors appointed by the State Government shall be under
the control of an officer appointed in this behalf by the State
Government.
(3) For the purposes of these rules an officer appointed by the Central
Government under sub-rule (1), or as the case may be, an officer
appointed by the State Government under sub-rule (2), shall be a
controlling authority.]
Drug Inspector
The Drug Inspectors are appointed both by State Government and
Central Government for specific areas or for specific category of
activity. There could be a set of inspectors exclusively for the
manufacturing of drug formulations. Drug Inspector works under the
Drug Controlling Authority under State Government or Central
Government as the case may be. An inspector has been charged with
the responsibility of ensuring strict implementation of Drugs and
Cosmetics Act in the area of his/her. jurisdiction.
(i) Qualification for Drug Inspector
 The person should not have direct or indirect financial interest in
any of the activities concerned with import, manufacturing, sale or
distribution of drugs.
 A graduate in pharmacy or pharmaceutical sciences or medicine
with specialization in clinical pharmacology or microbiology from a
University established in India, is eligible for the post of Inspector.
 For the purpose of Schedules C and C (1) drugs, (i) a drug inspector
with atleast 18 months of experience in manufacturing of atleast
one substance specified in Schedules C and C (1) or (ii) a drug
inspector with atleast 3 years experience in inspecting the firms
manufacturing Schedules C and C (1) drugs or (iii) a drug inspector

61. with minimum of 18 months experience in testing of atleast one
ofthe substances in schedules C and C (1) in a laboratory approved
for the purpose.
 The requirement of these qualifications shall not, however, apply
to those persons appointed as Inspector on or before 18th October,
1993.
 Every Inspector shall be deemed to be a public servant under
Section 21 of the Indian Penal code.
(ii) Duties of Inspectors of Premises Licensed for Sale
Subject to instructions of Controlling Authority, it shall be the duty of
an Inspector authorised to inspect premises licensed for the sale of
drugs.
(i) to inspect, not less than once a year, all establishment for sale.
(ii) to satisfy himself that conditions of licences are being
observed.
(iii) to procure and send the drug for test or analysis if he has
reason to suspect that drug is sold or stocked in contravention
with provisions of the Act or Rules.
(iv) to investigate complaint in writing.
(v) to maintain a record of inspections.
(vi) to make necessary enquiries.
(vii) to institute prosecutions in respect of breaches of the Act
and Rules.
(viii) when authorized by the State Government, to detain
imported packages which he has reason to believe contain
drugs, the import of which is prohibited.