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DRUGS AND COSMETICS RULES, 1945

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R.1 Short title, extent and commencement
R.2 Definitions
R.3 Functions
R.3(a) .
R.4 Despatch of samples for test or analysis
R.5 Recording of condition of seals
R.6 Report of result of test or analysis
R.7 Fees
R.8 Signature of certificates
R.9 .
R.10 .
R.11 .
R.12 .
R.13 .
R.14 .
R.15 .
R.16 .
R.17 .
R.18 .
R.19 .
R.20 .
R.21 .
R.22 .
R.23 Import licences
R.24 Form and manner of application for import licence
R.24(a) Form and manner of application for Registration Certificate
R.25 Licences for import of drugs manufactured by one manufacturer
R.25(a) Conditions to be satisfied before a licence in Form 10 or Form 10A is granted
R.25(b) Registration Certificate for import of drugs manufactured by one manufacturer
R.26 Conditions of import licence
R.27 Grant of import licence
R.27(a) Grant of Registration Certificates
R.28 Duration of import licence
R.28(a) Duration of Registration Certificate
R.29 Suspension and cancellation of import licence
R.29(a) Suspension and cancellation of Registration Certificate
R.30 Prohibition of import after expiry of potency
R.30(a) .
R.30(a)(a) Import of New Homoeopathic medicines
R.30(b) Prohibition of import of certain drugs
R.31 Standard for certain imported drugs
R.32 Packing and labelling of imported drugs
R.32(a) Packing and labelling of Homoeopathic medicine
R.33 Import of drugs for examination, test or analysis
R.33(a) Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients
R.34 Application for licence for examination, test or analysis
R.34(a) Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients
R.35 Cancellation of licence for examination, test or analysis
R.35(a) Cancellation of licence for import of small quantities of new drugs
R.36 Import of drugs for personal use
R.37 Packing of patent or proprietary medicines
R.38 Statement to accompany imported drugs
R.39 Documents to be supplied to the Customs Collector
R.40 Procedure for the import of drugs
R.41 .
R.42 .
R.43 .
R.43(a) .
R.43(b) .
R.44 Qualifications of Government Analyst
R.45 Duties of Government Analysts
R.46 Procedure on receipt of sample
R.47 Report of result of test or analysis
R.48 Fees
R.49 Qualifications of Inspectors
R.49(a) Qualification of a Licensing Authority
R.50 Controlling Authority
R.50(a) Qualification of a Controlling Authority
R.51 Duties of Inspectors of premises licensed for sale
R.52 Duties of inspectors specially authorised to inspect the manufacture of 1[drugs or cosmetics]
R.53 Prohibition of disclosure of information
R.54 Form of order not to dispose of stock
R.54(a) Prohibition of sale
R.55 Form of receipts for seized drugs, cosmetic, record, register, documents or any other material objects
R.55(a) Manner of certifying copies of seized documents
R.56 Form of intimation of purpose of taking samples
R.56(a) Form of receipt for samples of drugs where fair price tendered is refused
R.57 Procedure for despatch of sample to Government Analyst
R.58 Confiscation of drugs, implements, machinery, etc
R.58(a) Procedure for disposal of confiscated drugs
R.59 .
R.60 .
R.61 Forms of licences to sell drugs
R.62 Sale at more than one place
R.62(a) Restricted licences in Forms 20A and 21A
R.62(b) Conditions to be satisfied before a licence in Form 20A or Form 21A is granted
R.62(c) Application for licence to sell drugs by wholesale or to distribute the same from a motor vehicle
R.62(d) Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicle
R.63 Duration of licence
R.63(a) Certificate of renewal of a sale licence
R.63(b) Certificate of renewal of licence
R.64 Conditions to be satisfied before a licence in 2[Form 20, 20B, 20F, 20G, 21 or 21B] is granted 3[or renewed]
R.65 Condition of licences
R.65(a) Additional information to be furnished by an applicant for licence or a licensee to the licensing authority
R.66 Cancellation and suspension of licences
R.66(a) Procedure for disposal of drugs in the event of cancellation of licence
R.67 .
R.67(a) .
R.67(b) .
R.67(c) Form of licences to sell drugs
R.67(d) Sale at more than one place
R.67(e) Duration of licences
R.67(e)(e) Certificate of renewal
R.67(f) Conditions to be satisfied before a licence in Form 20C or Form 20D is granted
R.67(g) Additional information to be furnished by an applicant for licence or a licensee to the licensing authority
R.67(h) Cancellation and suspension of licences
R.68 Manufacture on more than one set of premises
R.68(a) Grant or Renewal of Licences by the Central Licence Approving Authority
R.68(b) Delegation of Powers by the Central Licence Approving Authority
R.69 Application for licence to manufacture drugs other than those specified in Schedules C and C (1) to the Drugs and Cosmetics Rules
R.69(a) Loan licences
R.69(b) .
R.70 Form of licence to repack or manufacture drugs other than those specified in Schedules C and C(1)
R.70(a) Form of loan licence to manufacture for sale 2[or for distribution] of drugs other than those 3[specified in Schedules C, C(1) and X]
R.71 Conditions for the grant or renewal of a licence in Form 25 2[or Form 25F.]
R.71(a) Conditions for the grant or renewal of a licence in Form 25B
R.71(b) Conditions for the grant or renewal of a licence in Form 25A
R.72 Duration of licence
R.73 Certificate of renewal
R.73(a) A certificate of renewal of loan licence
R.73(a)(a) Duration of loan licence
R.73(b) Certificate of renewal of licence in Form 25B
R.74 Conditions of licence in 2[Form 25 and Form 25F]
R.74(a) Conditions for licence in Form 25B
R.74(b) Conditions of licence in Form 25A
R.75 Forms of application for licence to manufacture for sale or distribution of drugs specified in Schedules C and C (1) 2[excluding those specified in Part XB and Schedule X]
R.75(a) Loan licences
R.75(b) .
R.76 Form of licences to manufacture drugs specified in Schedules C and C(1), excluding those specified in 2[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
R.76(a) Form of loan licence to manufacture for sale 2[or for distribution of] 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
R.77 Duration of licence
R.78 Conditions of licence
R.78(a) Conditions of licence in Form 28A
R.79 Inspection before grant or renewal of licence
R.80 Report by Inspector
R.81 Procedure of licensing authority
R.82 Further application after rejection
R.83 Renewal
R.83(a) Certificate of renewal of a loan licence
R.83(a)(a) Duration of loan licence
R.84 .
R.84(a) Provisions for appeal to the State Government or Central Government by party whose licence has not been granted or renewed
R.84(a)(a) Additional information to be furnished by an applicant for licence or a licensee to the licensing authority
R.84(b) Prohibition for the manufacture for sale of cyclamates and preparations containing cyclamates
R.85 Cancellation and suspension of licences
R.85(a) Manufacture on more than one set of premises
R.85(b) Application for licence to manufacture Homoeopathic medicines
R.85(c) Application to manufacture ‘New Homoeopathic medicines’
R.85(d) Form of licence to manufacture Homoeopathic medicines
R.85(e) Conditions for the grant or renewal of a licence in Form 25C
R.85(e)(a) Inspection before grant or renewal of licence
R.85(e)(b) Report by Inspector
R.85(e)© Grant or refusal of licence
R.85(e)(d) Further application after rejection
R.85(e)(e) Appeal to the State Government
R.85(f) Duration of licence
R.85(g) Certificate of renewal
R.85(h) Conditions of licence
R.85(h)(h) Additional information to be furnished by an applicant for licence or a licensee to the licensing authority
R.85(i) Cancellation and suspension of licences
R.86 Conditions relating to manufacture for examination, test or analysis
R.87 Labelling
R.88 Labelling of drugs supplied to other persons
R.89 Licence
R.90 Form of application
R.91 Duration of licence
R.92 Conditions of Licence
R.93 Cancellation of licences
R.94 Exemption of certain drugs from certain provisions of this Part
R.95 Prohibition of sale or distribution unless labelled
R.96 Manner of Labelling
R.97 Labelling of medicines
R.98 .
R.99 .
R.100 .
R.101 .
R.102 Non-Sterile Surgical Ligature and Suture
R.103 .
R.104 Use of letters I.P., etc
R.104(a) Prohibition against altering inscriptions on containers, labels or wrappers of drug
R.105 Packing of drugs
R.105(a) Packing of drugs specified in Schedule X
R.106 Diseases which a drug may not purport to prevent or cure
R.106(a) Manner of labelling of Homoeopathic medicines
R.106(b) Prohibition of quantity and percentage
R.107 Name of substance
R.108 Container
R.109 Labelling
R.109(a) Labelling of Medical Devices
R.110 Prohibition of sale of substance after prescribed date
R.110(a) .
R.111 Standards
R.112 Tests for strength and quality
R.113 .
R.114 .
R.115 Application of tests for sterility
R.116 .
R.117 .
R.118 .
R.119 .
R.120 .
R.121 Test for freedom from abnormal toxicity
R.121(a) Test for pyrogens
R.122 Substances specified in Schedule C(1)
R.122(a) Application for permission to import new drug
R.122(b) Application for approval to manufacture new drug 1[***]
R.122(c) .
R.122(d) Permission to import or manufacture fixed dose combination
R.122(d)(a) Application for permission to conduct clinical trials for New Drug/ Investigational New Drug
R.122(d)(a)(b) Compensation in case of injury or death during clinical trial.--
R.122(d)(a)© Permission to conduct clinical trial.--
R.122(d)(b) Suspension or cancellation of Permission/Approval
R.122(d)© Appeal
R.122(e) Definition of new drug
R.122(e)(a) Definitions
R.122(f) 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
R.122(g) 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
R.122(h) Duration of licence
R.122(i) Inspection before grant or renewal of licence for operation of Blood Bank, processing of whole human blood for components and manufacture of blood products
R.122(j) Report by Inspector
R.122(k) Further application after rejection
R.122(l) Delegation of powers by the Central Licence Approving Authority
R.122(m) Provision for appeal to the State Government by a party whose licence has not been granted or renewed
R.122(n) Additional information to be furnished by an 1[applicant] for licence or by a licensee to the licensing authority
R.122(o) Cancellation and suspension of licences
R.122(p) Conditions of licence
R.123 .
R.124 Standards of drugs
R.124(a) Standards for veterinary drugs
R.124(b) Standards for patent or proprietary medicines
R.124(c) Standards for Surgical Dressings
R.124(d) Standards for Sterilised Umbilical tapes
R.125 Standards for substances (other than food) intended to affect the structure or any function of human body—Contraceptives
R.125(a) Standards for Medical Devices
R.126 Standards for substances intended to be used for the destruction of vermin or insects which cause disease in human beings or animals—Disinfectants
R.126(a) Standards for ophthalmic preparations 2[including Homoeopathic ophthalmic preparations]
R.127 12127. List of colours permitted to be used in drugs--
R.128 .
R.129 Statement to accompany imported cosmetics
R.130 Documents to be supplied to the Collector of Customs
R.131 Procedure for the import of cosmetics
R.132 Exemption of cosmetics
R.133 Import through points of entry
R.134 Cosmetic to contain dyes, colours and pigments
R.134(a) Prohibition of import of cosmetic containing hexachlorophene
R.135 Import of cosmetic containing Lead or Arsenic compounds prohibited
R.135(a) Import of cosmetics containing Mercury compounds prohibited
R.136 Import of cosmetics for personal use
R.137 Manufacture on more than one set of premises
R.138 Application for licence to manufacture cosmetics 1[for sale or for distribution]
R.138(a) Application for loan licence to manufacture cosmetics
R.139 Condition for the grant or renewal of a licence in Form 32
R.139(a) Form of licence to manufacture cosmetics for sale 2[or for distribution]
R.139(a)(a) Inspection before grant or renewal of licence
R.139(a)(b) Report by Inspector
R.139(a)© Grant or refusal of licence
R.139(a)(d) Further application after rejection
R.139(a)(e) Appeal to the State Government
R.139(b) Form of loan licence to manufacture cosmetics for sale 1[or for distribution]
R.140 Duration of licence
R.141 Certificate of renewal
R.141(a)(a) Duration of a loan licence
R.141(a) Certificate of renewal of loan licence
R.142 Conditions of licence
R.142(a) Additional information to be furnished by an applicant for licence or a licensee to the licensing authority
R.142(b) Conditions of licence in Form 32A
R.143 Cancellation and suspension of licence
R.144 Prohibition of manufacture of cosmetics containing colours other than those prescribed
R.144(a) Prohibition of manufacture of cosmetic containing Hexachlorophene
R.145 Use of Lead and Arsenic compounds for the purpose of colouring cosmetics prohibited
R.145(a)(a) Form of receipt of samples of cosmetics where fair price tendered is refused
R.145(a) Form of intimation for purposes of taking samples of cosmetics
R.145(b) Form of receipt for seized cosmetics
R.145(b)(a) Manner of certifying copies of seized documents
R.145(c) Form of order not to dispose of stocks of cosmetics
R.145(d) Prohibition of manufacture of cosmetic containing Mercury compounds
R.146 Prohibition of sale or distribution
R.147 Exemption of Cosmetics not manufactured for consumption or sale in India from the provisions of this Part
R.148 Manner of labelling
R.148(a) Prohibition against altering inscriptions on containers, labels or wrappers of cosmetic
R.149 1[Labelling of hair dyes containing dyes, colours and pigments
R.149(a) Special provisions relating to toothpaste containing fluoride
R.150 Report of result of test or analysis of cosmetics
R.150(a) Standards for cosmetics
R.150(b) Application for grant of approval for testing drugs/cosmetics
R.150(c) 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
R.150(d) Duration of approval
R.150(e) Conditions of approval
R.150(f) Inspection before grant of approval
R.150(g) Report of Inspection
R.150(h) Procedure of approving authority
R.150(i) Further application after rejection
R.150(j) Renewal
R.150(k) Withdrawal and suspension of approvals
R.151 Manufacture on more than one set of premises
R.152 Licensing authorities
R.153 Application for licence to manufacture Ayurvedic (including Siddha) or Unani drugs
R.153(a) Loan Licence
R.154 Form of licence to manufacture Ayurvedic (including Siddha) or Unani drugs
R.154(a) Form of loan licence to manufacture for sale Ayurvedic (including Siddha) or Unani drugs
R.155 Certificate of renewal
R.155(a) Certificate of renewal of a loan licence
R.155(b) Certificate of award of Good Manufacturing Practices Ayurveda, Siddha and Unani Drugs
R.156 Duration of licence
R.156(a) Duration of loan licence
R.157 Conditions for the grant or renewal of a licence in Form 25D
R.158 Conditions of licence
R.158(a) Conditions of loan licence
R.159 Cancellation and suspension of licences
R.160 Identification of raw materials
R.160(a) Application for grant of approval for testing Ayurvedic, Siddha and Unani drugs
R.160(b) 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
R.160(c) Duration of approval
R.160(d) Conditions of approval
R.160(e) Inspection before grant of approval
R.160(f) Report of inspection
R.160(g) Procedure of approving authority
R.160(h) Application after rejection
R.160(i) Renewal
R.160(j) Withdrawal and suspension of approvals
R.161 1[Labelling, packing and limit of alcohol]
R.161(a) Exemption in labelling and packing provisions for export of Ayurvedic (including Siddha) and Unani Drugs
R.162 Duties of inspectors specially authorised to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs
R.162(a) Qualifications for State Drug Licensing Authority for licensing of Ayurveda, Siddha and Unani drugs
R.163 Procedure for despatch of sample to Government Analyst and its receipt by the Government Analyst
R.163(a) A Functions
R.163(b) .
R.163(c) Despatch of samples for test or analysis
R.163(d) Recording of condition of seals
R.163(e) Report of result of test or analysis
R.163(f) Fees
R.163(g) Signature on certificates
R.164 Method of test or analysis to be employed in relation to Ayurvedic (including Siddha) or Unani drugs
R.165 Qualifications of Government Analyst
R.166 Duties of Government Analyst
R.167 Qualifications of Inspector
R.168 Standards to be complied with in manufacture for sale or for distribution of Ayurvedic, Siddha and Unani Drugs
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