Drugs and Cosmetics Rules, 1945


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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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