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Drugs and Cosmetics Rules, 1945
w w w .
L
a w y e r
S
e r v i c e s . i n
Section
Section Title
INTRODUCTION
1 . Short title, extent and commencement
2 . Definitions
3 . Functions
4 . Despatch of samples for test or analysis
5 . Recording of condition of seals
6 . Report of result of test or analysis
7 . Fees
8 . Signature of certificates
-n/a-
10
11
12
13
14
15
16
17
18
19
20
21 . In this Part
22
23 . 1 Import licences
24 . 1 Form and manner of application for import licence
24A . 1 Form and manner of application for Registration Certificate
25 . Licences for import of drugs manufactured by one manufacturer
25A . 1 Condition to be satisfied before a licence in Form 10 or Form 10-A is granted
25B . 1 Registration Certificate for import of drugs manufactured by one manufacturer
26 . Conditions of import licence
27 . Grant of import licence
27A . 1 Grant of Registration Certificate
28 . 1 Duration of import licence
28A . 1 Duration of Registration Certificate
29 . 1 Suspension and cancellation of import licence
29A . 1 Suspension and cancellation of Registration Certificate
30 . Prohibition of import after expiry of potency
30AA . Import of new Homoeopathic medicine
30B . 1 Prohibition of import of certain drugs
31 . 1 Standard for certain imported drugs
32. [2] Packing and labelling of imported drugs
32A [4] Packing and Labelling of Homoeopathic medicine
33 . Import of drugs for examination, test or analysis
33A . 1 Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients
Small quantities of new drug, as defined in Rule 122-E, the import of which is otherwise prohibited under section 10 of the Act, may be imported for treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such disease requiring therapies for unmet medical needs, by a Medical Officer of a Government Hospital or an Autonomous Medical Institution providing tertiary care, duly certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous Medical Institution, subject to the following conditions, namely:-
34A . 1 Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients
35 . Cancellation of licence for examination, test or analysis
35A . 1 Cancellation of licence for import of small quantities of new drugs
36 . Import of drugs for personal use
37 . 1 Packing of patent or proprietary medicine
38 . Statement to accompany imported drugs
39 . Documents to be supplied to the Customs Collector
40 . 1 Procedure for the import of drugs
41
42
43
44 . 1 Qualifications of Government Analyst
45 . Duties of Government Analysts
46 . Procedure on receipt of sample
47 . Report of result of test or analysis
48 . Fees
49 . 1 Qualifications of Inspectors
49A . 1 Qualification of a Licensing Authority
50 . 1 Controlling authority
50A . 1 Qualification of a Controlling Authority
51 . Duties of Inspectors of premises licensed for sale
52 . Duties of Inspectors specially authorized to inspect the manufacture of 1 [drugs or cosmetics
53 . Prohibition of disclosure of information
54 . Form of order not to dispose of stock .-
54A . 1 Prohibition of sale
55 . 1 Forms of receipts for seized drug, cosmetic, record register, document or any other material object
55A . 1 Manner of certifying copies of seized documents
56 . Form of intimation of purpose of taking samples
6A . 1 Form or receipt for samples of drugs where fair price tendered is refused
57 . Procedure for despatch of sample to Government Analyst
58 . 1 Confiscation of drugs, implements, machinery etc
58A . 1 Procedure for disposal of confiscated drugs
59
60
61 . 1 Forms of licences to sell drugs
62 . Sale at more than one place
62A . 1 Restricted licences in Forms 20-A and 21-A
62B . 1 Conditions to be satisfied before a licence in Form 20-A or Form 21-A is granted
62C . 1 Application for licence to sell drugs by wholesale or to distribute the same from a motor vehicle
62D . 1 Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicle
63 . 1 Duration of licence
63A . 1 Certificate of renewal of a sale licence
63B . 1 Certificate of renewal of licence
64 . 1 Conditions to be satisfied before a licence in Form 2 [20, 20-B, 20-F,20-G, 21 or 21-B] is granted
65 . Condition of licences
65A . 1 Additional information to be furnished by an applicant for liscence or a licensee to the Licensing Authority
66 . Cancellation and suspension of licences
66A . 1 Procedure for disposal of drugs in the event of cancellation of licence
67A . .-
67B
67C . Forms of licences to sell drugs
67D . Sale at more than one place
67E . Duration of licences
67EE . 1 Certificate of renewal
67F . Condition to be satisfied before a licence in Form 20-C or Form 20-D is granted
67G . Conditions of licence
67GG . 1 Additional information to be furnished by an applicant for licence or a licensee to the Licensing Authority
67H . Cancellation and suspension of licences
Manufacture on more than one set of premises
68A . 1 Grant or Renewal of Licences by the Central Licence Approving Authority
68B . Delegation of Powers by the Central Licence Approving Authority
69 . 1 Application for licence to manufacture drugs other than those specified in Schedules C and C(1) to the Drugs and Cosmetics Rules
69A . 1 Loan Licences
70 . 1 Form of licence to repack or manufacture drugs other than those specified in Schedules C and C(1)
71 . 1 Conditions for the grant or renewal of a licence in Form 25 2 [or Form 25-F
71A . 1 Conditions for the grant or renewal of a licence in Form 25B
71B . 1 Conditions for the grant of renewal of a licence in Form 25-A
72 . 1 Duration of licence
73 . 1 Certificate of renewal
73A . 1 A certificate of renewal of loan licence
73AA . 1 Duration of loan licence
73B . 1 Certificate of renewal of licence in Form 25-B
74 . 1 Conditions of licence in Form 25
74A. Conditions for licence in Form 25-B. A licence in Fom 25-B shall be subject to the conditions stated therein and to the following conditions
74B . 1 Conditions of licence in Form 25-A
75 . 1 Form of application for licence to manufacture for sale or distribution of drugs specified in Schedules C and C(1) and X 2 [excluding those specified in Part XB and Schedule X]
75A . 1 Loan licences
76 . 1 [ 2 Forms of licence to manufacture drugs specified in Schedules C and C(1), 3 [excluding those specified in Part XB and Schedule X], or drugs specified in Schedules C, C(1) and X and the conditions for the grant or renewal of such licences
76A . 1 Form of loan 2 [licence to manufacture for sale or for distribution] drugs specified in Schedules C and C(1) 3 [excluding the drugs specified in Schedule X] and conditions for the grant or renewal of such licence
77 . 1 Duration of licence
78 . 1 Conditions of licence
79 . 1 Inspection before grant or renewal of licence
80 . 1 Report by Inspector
81 . Procedure of Licensing Authority
82 . 1 Further application after rejection
83 . Renewal
83A . 1 Certificate of renewal of a loan licence
83AA . 1 Duration of loan licence
84
84A . 1 Provision for appeal to the State Government or Central Government by party whose licence has not been granted or renewed
84AA . Additional information to be furnished by an applicant for licence or a licensee to the licensing authority
84B . 1 Prohibition for the manufacture for sale of cyclamates and preparations containing cyclamates
85 . 1 Cancellation and suspension of licences
85A . Manufacture on more than one set of premises
85B . Application for licence to manufacture Homoeopathic medicines
85C . Application to manufacture 'New Homoeopathic medicines'
85D . 1 Form of licence to manufacture Homoeopathic medicines
85E . Conditions for the grant or renewal of a licence in Form 25C .-
85EA . 1 Inspection before grant or renewal of licence
85EB . Report by Inspector
85EC . Grant or refusal of licence
85ED . Further application after rejection
85EE . Appeal to the State Government
85F . Duration of licence
85G . Certificate of renewal
85H . Conditions of licence
85HH . 1 Additional information to be furnished by an applicant for the licence or a licensee to the Licensing Authority
85I . Cancellation and suspension of licences
86 . Conditions relating to manufacture for examination, test or analysis
87 . Labelling
88 . Labelling of drugs supplied to other persons
89 . Licence
90 . Form of application
91 . Duration of licence
92 . Conditions of licence
93 . Cancellation of licences
94 . Exemption of certain drugs from certain provisions of this Part
95 . Prohibition of sale or distribution unless labelled
96 . 1 Manner of Labelling
97 . Labelling of medicines
98
99
100
101
102 . 1 Non-Sterile Surgical Ligature and Suture
103
104 . 1 Use of letter I.P. etc
104A . 1 Prohibition against altering inscriptions on containers, labels or wrappers of drug
105 . 1 Packing of drugs
105A . 1 Packings of drugs specified in Schedule X
106 . 1 Diseases which a drug may not purport to prevent or cure
106A . Manner of labelling of Homoeopathic medicines
106B . 1 Prohibition of quantity and percentage
107 . 1 Name of substance
108 . Container
109 . 1 Labelling
109A . 1 Labelling of Medical Devices
110 . Prohibition of sale of substance after prescribed date
111 . 1 Standards
112 . 1 Tests for strength and quality
113
114
115 . Application of tests for sterility
116
117
118
199
120
121 1 Test for freedom from abnormal toxicity
121A
122 . Substances specified in Schedule C(1)
122A . Application for permission to import new drug
122B . Application for approval to manufacture new drug other than the drugs classifiable under Schedules C and C(1)
122C
122D . 1 Permission to import or manufacture fixed dose combination
122DA . Application for permission to conduct clinical trials for New Drug/Investigational New Drug
122DAA . 1 Definition of Clinical trial
122DB . Suspension or cancellation of Permission/Approval
122DC . Appeal
122E . Definition of new drug
122EA . 1 Definitions
122F . Form of application for licence for operation of Blood Bank/processing of whole human blood for components/manufacture of blood products for sale or distribution
122G . Form 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
122H . Duration of licence
122I . Inspection before grant or renewal of licence for operation of Blood Bank, processing of whole human blood for components and manufacture of blood products
122J . Report by Inspector
122K . Further application after rejection
122L . Delegation of powers by the Central Licence Approving Authority
122M . Provision for appeal to the State Government by a party whose licence has not been granted or renewed
122N . Additional information to be furnished by an applicant for licence or by a licensee to the Licensing Authority
122O . Cancellation and suspension of licences
122P . Conditions of licence
123
124
124A . 1 Standards for veterinary drugs
124B . 1 Standards for patent or proprietary medicines
124C . 1 Standards for Surgical Dressings
124D . 1 Standards for Sterilised Umbilical tapes
125 . 1 Standards for substances (other than food) intended to affect the structure or any function of human body-contraceptives
125A . 1 Standards for Medical Devices
126
126A . 1 Standards for ophthalmic preparations 2 [including Homoeopathic ophthalmic preparations]
127 . 1 List of colours permitted to be used in drugs
128
129 . Statement to accompany imported cosmetics
130 . Documents to be supplied to the Collector of Customs
131 . Procedure for the import of cosmetics
132 . Exemption of cosmetics
133 . Import through points of entry
134 . 1 Cosmetic to contain Dyes, Colours and Pigments
135 . Import of cosmetic containing Lead or Arsenic compound prohibited
136 . Import of cosmetic for personal use
137 . Manufacture on more than one set of premises
138 . Application for licence to manufacture cosmetics
138A . 1 Application for loan licence to manufacture cosmetics
139 . Conditions for the grant or renewal of a licence in Form 32
139A . 1 Form of 2 [licence to manufacture cosmetics for sale or for distribution]
139AA . 1 Inspection before grant or renewal of licence
139AB . Report by Inspector
139AC . Grant or refusal of licence
139AD . Further application after rejection
139AE . Appeal to the State Government
139B . 1 Form of loan 2 [licence to manufacture cosmetics for sale or for distribution]
140 . Duration of licence
141 . Certificate of renewal
141AA . 1 Duration of a loan licence
142 . Conditions of licence
142A . 1 Additional information to be furnished by an applicant for licence or a licensee to the Licensing Authority
142B . 1 Conditions of licence in Form 32-A
143 . Cancellation and suspension of licence
144 . 1 Prohibition of manufacture of cosmetics containing colours other than those prescribed
144A . 1 Prohibition of manufacture of cosmetics containing Hexachlorophene
145 . Use of Lead and Arsenic compounds for the purpose of colouring cosmetics prohibited
145A . 1 Form of intimation for purpose of taking samples of cosmetics
145AA . 1 Form of receipt of samples of cosmetics where fair price tendered is refused
145B . Form of receipt for seized cosmetics
145BA . 1 Manner of certifying copies of seized documents
145C . 1 Form of order not to dispose of stocks of cosmetics
145D . 1 Prohibition of manufacture of cosmetics containing mercury compounds
146 . Prohibition of sale or distribution
147 . 1 Exemption of cosmetics not manufactured for consumption or sale in India from the provisions of this Part
148 . Manner of labelling
148A . 1 Prohibition against altering inscriptions on containers, labels or wrappers of cosmetics
149 . 1 [Labelling of Hair dyes containing Dyes, Colours and Pigments
149A. [2] Special provisions relating to toothpaste containing fluoride
150 . Report of result of test or analysis of cosmetics
150A . Standard for cosmetics
150B . Application for grant of testing drugs/cosmetics
150C . Form in which approval to be granted for carrying out tests on drugs / cosmetics on behalf of licensees for manufacture of drugs/cosmetics and conditions for grant or renewal of such approval
150D . Duration of approval
150E . Conditions of approval
150F . Inspection before grant of approval
150G . Report of Inspection
150H . Procedure of approving authority
150I . Further application after rejection
150J. Renewa.l
150K. Withdrawal and suspension of approvals
151 . Manufacture on more than one set of premises
152 . Licensing Authorities
153 . Application for licence to manufacture Ayurvedic (including Siddha) or Unani drugs
153A . 1 Loan Licence
154 . Form of licence to manufacture Ayurvedic (including Siddha) or Unani drugs
154A . 1 Form of loan licence to manufacture for sale of Ayurvedic (including Siddha) or Unani drugs
155 . Certificate of renewal
155A . 1 Certificate of renewal of a loan licence
155B . 1 Certificate of award of G.M.P. of Ayurveda, Siddha and Unani Drugs
156 . Duration of licence
156A . 1 Duration of loan licence
157 . Conditions for the grant or renewal of a licence in Form 25-D
158 . Conditions of licence
158A . 1 Condition of loan licence
159 . Cancellation and suspension of licences
160 . Identification of raw materials
160A . Application for grant of approval for testing Ayurvedic, Siddha and Unani drugs
160B . Form in which approval to be granted for carrying out tests on Ayurvedic, Siddha and Unani drugs on behalf of licensees for manufacture of Ayurvedic, Siddha and Unani drugs and conditions for grant or renewal of such approval
160C . Duration of approval
160D . Conditions of approval
160E . Inspection before grant of approval
160F . Report of inspection
160G . Procedure of approving authority
160H . Application after rejection
160I . Renewal
160J . Withdrawal and suspension of approvals
161 . 1 [Labelling, packing and limit of alcohol.]
161A . 1 Exemption in labeling and packing, provisions for export of Ayurvedic (including Siddha) and Unani drugs
162 . Duties of Inspectors specially authorised to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs
162A . 1 Qualifications of the State Drug Licensing Authority for Licensing of Ayurvdeda , Siddha and Unani drugs
163 . Procedure for despatch of sample to Government Analyst and its receipt by the Government Analyst
164 . Method of test or analysis to be employed in relation to Ayurvedic (including Siddha) or Unani drugs
165 . Qualifications of Government Analyst
166 . Duties of Government Analyst
167 . 1 Qualifications of Inspector
168 . Standards to be complied with in manufacture for sale or for distribution of Ayurvedic, Siddha and Unani Drugs .-
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