(Updated in 2025) [As Amended by G.S.R. 28(E)., dt. 13/01/2025 Amendments - in Rule 158B, Schedule TB G.S.R. 669(E)., dt. 29/10/2024 Amendments in Part XVI, XVIA, XVIII, XIX, Rule 2(dd), Rule 2(eb), Rule 2(ed), Rule 2(hh), Rule 2(hi), Rule 30AA, Rule 67A(2), Rule 67A(4), Rule 67C, Rule 67E, Rule 67EE, Rule 67G(6), Rule 85B, Rule 85B(3), Rule 85B(4), Rule 85B(5), Rule 85BA, Rule 85BB, Rule 85D, Rule 85EA, Rule 85EB, Rule 85EC, Rule 85ED, Rule 85F, Rule 85FA, Rule 85G, Rule 85H, Rule 106A, Rule 153, Rule 153A(1), Rule 156C(1), Rule 157(2), Rule 161B(2), Rule 162A, Rule 168, Schedule A - FORM 20C, FORM 20D, FORM 20E, FORM 24C, FORM 24C1, FORM 24-C-2, FORM 25C, FORM 25-C-1, FORM 26C-1 G.S.R. 360(E)., dt. 02/07/2024 Amendments in - Rule 170, SCHEDULE A, FORM 26 E4 and FORM 26 E5 G.S.R. 293(E)., dt. 28/03/2024 Amendments in - Rule 43A G.S.R. 216(E)., dt. 18/03/2024 Amendments in - Rule 105(2), Schedule P1 G.S.R. 95(E)., dt. 05/02/2024 Amendment in - Schedule H1 Notification No. G.S.R. 341(E)

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S.¹[Rule 73 Certificate of renewal.--

S.Rule 73-A A certificate of renewal of loan licence.--

S.¹[Rule 73-AA Duration of loan licence.--

S.¹[Rule 73-AB Inspection for grant of licence and verification of compliance.--

S.¹[Rule 73-B Certificate of renewal of licence in Form 25-B.--

S.¹[Rule 74 Conditions of licence in2[Form 25 and Form 25-F].--

S.¹[Rule 74-A Conditions for licence in Form 25-B.--

S.¹[Rule 74-B Conditions of licence in Form 25-A.--

S.¹[Rule 75 Forms of application for licence to manufacture for sale or distribution of drugs specified in Schedules C, C(1) and X2[excluding those specified in Part X-B and Schedule X].--

S.¹[Rule 75-A Loan Licences.--

S.¹[Rule 75-B Applications to manufacture 'new drugs' classifiable under Schedules C and C(1).--

S.¹[Rule 76 Forms of licences to manufacture drugs specified in Schedules C and C(1), excluding those specified in2[Part X-B and] Schedule X, or drugs specified in Schedules C, C(1) and X and the conditions for the grant3[x x x x] of such licences.--

S.¹[Rule 76-A 2[Forms of loan licences to manufacture for sale or for distribution drugs specified in Schedule C and C-1 excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs, and conditions for the grant3[x x x x] of such licences.--

S.¹[Rule 77 Duration of licence.--

S.Rule 78 Conditions of licence.--

S.¹[Rule 78-A Conditions of licence in2[Form 28-A or Form 28-DA].--

S.¹[Rule 79 Inspection before grant2[x x x x] of licence.--

S.¹[Rule 80 Report by Inspector.--

S.Rule 81 Procedure of Licensing Authority.--

S.¹[Rule 82 Further application after rejection.--

S.¹[Rule 83 Duration of loan licence.--

S.Rule 83-A Certificate of renewal of a loan licence.--

S.Rule 83-AA Duration of loan licence.--

S.Rule 84

S.¹[²[Rule 84-A Provisions for appeal to the State Government or Central Government by party whose licence has not been granted3[x x x x].--

S.¹[Rule 84-AA Additional information to be furnished by an applicant for licence or a licensee to the licensing authority.--

S.¹[Rule 84-AB Information to be uploaded by the licensee on online portal SUGAM.--

S.¹[Rule 84-B Prohibition for the manufacture for sale of cyclamates and preparations containing cyclamates.--

S.¹[Rule 84-C Inspection for verification of compliance.--

S.¹[Rule 84-D Agreement for marketing.--

S.¹[Rule 84-E Responsibility of marketer of the drugs.--

S.¹[Rule 85 Cancellation and suspension of licences.--

S.Rule 85A Manufacture on more than one set of premises.--

S.Rule 85B Application for licence to manufacture Homoeopathic medicines.--

S.¹[Rule 85BA Application for loan licence to manufacture Homoeopathic Medicines.--

S.Rule 85BB Application for Certificate of Good Manufacturing Practices for Homoeopathic medicines manufacturing unit.--

S.Rule 85C Application to manufacture 'New Homoeopathic medicines'.--

S.¹[Rule 85D Form of licence to manufacture Homeopathic medicines.--

S.Rule 85-E Conditions for the grant6[x x x x] of a licence in Form 25-C.--

S.¹[²[Rule 85-EA Inspection for grant of license and verification of compliance.--

S.²[Rule 85-EB Report by Inspector.--

S.Rule 85-EC Procedure of Licensing Authority.--

S.¹[²[Rule 85ED Further application after rejection.--

S.Rule 85EE Appeal to the State Government.--

S.Rule 85F Duration of licence.--

S.¹[Rule 85FA Duration of Certificate of Good Manufacturing Practices for Homoeopathic medicines manufacturing units.--

S.1Rule 85-G

S.Rule 85-H Conditions of licence.--

S.¹[Rule 85-HH Additional information to be furnished by an applicant for licence or a licensee to the licensing authority.--

S.Rule 85-I Cancellation and suspension of licences.--

S.Rule 86 Conditions relating to manufacture for examination, test or analysis.--

S.Rule 87 Labelling.--

S.Rule 88 Labelling of drugs supplied to other persons.--

S.Rule 89 Licence.--

S.Rule 90 Form of application.--

S.Rule 91 Duration of licence.--

S.Rule 92 Conditions of licence.--

S.Rule 93 Cancellation of licences.--

S.Rule 94 Exemption of certain drugs from certain provisions of this Part.--

S.Rule 95 Prohibition of sale or distribution unless labelled.--

S.¹[Rule 96 Manner of Labelling.--

S.Rule 97 Labelling of medicines.--

S.¹[Rule 97-A Modified application of Rules 96 and 97 for certain period.--

S.¹[Rule 98

S.¹[Rule 99

S.¹[Rule 100

S.¹[Rule 101

S.¹[Rule 102 Non-Sterile Surgical Ligature and Suture.--

S.Rule 103

S.¹[Rule 104 Use of letters I.P., etc.--

S.¹[Rule 104-A Prohibition against altering inscriptions on containers, labels or wrappers of drug.--

S.¹[Rule 105 Packing of drugs.--

S.¹[Rule 105-A Packing of drugs specified in Schedule X.--

S.¹[Rule 106 Diseases which a drug may not purport to prevent or cure.--

S.Rule 106-A Manner of labelling of Homoeopathic medicines.--

S.¹[Rule 106-B Prohibition of quantity and percentage.--

S.¹[Rule 107 Name of substance.--

S.¹[Rule 108 Container.--

S.¹[Rule 109 Labelling.--

S.¹[Rule 109-A Labelling of medical devices.--

S.¹[Rule 109-B Exemption of certain labelling requirements for medical devices for export from India.--

S.¹[Rule 109-C Shelf life of the medical devices.--

S.Rule 110 Prohibition of sale of substance after prescribed date.--

S.Rule 110-A

S.Rule 111 Standards.--

S.Rule 112 Tests for strength and quality.--

S.Rule 113 Tests for sterility.--

S.Rule 114 Tests for presence of living aerobic or anaerobic bacteria.--

S.Rule 115 Application of tests for sterility.--

S.Rule 116 Amount of samples.--

S.Rule 117 Method of preparing and using media.--

S.Rule 118 Method of testing.--

S.Rule 119

S.Rule 120

S.¹[Rule 121 Test for freedom from abnormal toxicity.--

S.¹[Rule 121-A Test for pyrogens.--

S.Rule 122 Substances specified in Schedule C(1).--

S.Rule 122-A Application for permission to import new drug.--

S.Rule 122-B Application for approval to manufacture new drug1[x x x x].--

S.Rule 122-C

S.¹[Rule 122-D Permission to import or manufacture fixed dose combination.--

S.Rule 122-DA Application for permission to conduct clinical trials for New Drug/Investigational New Drug.--

S.¹[Rule 122-DAA Non-application of certain rules for new drugs and investigational new drugs for human use.--

S.¹[Rule 122-DAB Compensation in case of injury or death during clinical trial.--

S.¹[Rule 122-DAC Permission to conduct clinical trial.--

S.Rule 122-DB Suspension or cancellation of Permission/Approval.--

S.Rule 122-DC Appeal.--

S.¹[Rule 122-DD Registration of Ethics Committee.--

S.Rule 122-E Definition of new drug.--

S.Rule 43

S.¹[Rule 43-A

S.¹[Rule 43-B

S.²[Rule 44 Qualifications of Government Analyst.--

S.Rule 45 Duties of Government Analysts.--

S.Rule 46 Procedure on receipt of sample.--

S.Rule 47 Report of result of test or analysis.--

S.Rule 48 Fee.--

S.¹[Rule 49 Qualifications of Inspectors.--

S.¹[Rule 49-A Qualification of a Licensing Authority.--

S.¹[Rule 50 Controlling Authority.--

S.¹[Rule 50-A Qualification of a Controlling Authority.--

S.Rule 51 Duties of Inspectors of premises licensed for sale.--

S.Rule 52 Duties of Inspectors specially authorised to inspect the manufacture of drugs1[x x x x]. --

S.Rule 53 Prohibition of disclosure of information.--

S.Rule 54 Form of order not to dispose of stock.--

S.¹[Rule 54-A Prohibition of sale.--

S.¹[Rule 55 Form of receipts for seized drug,2[x x x x], record, register, documents or any other material objects.--

S.¹[Rule 55-A Manner of certifying copies of seized documents.--

S.Rule 56 Form of intimation of purpose of taking samples.--

S.¹[Rule 56-A Form of receipt for samples of drugs where fair price tendered is refused.--

S.Rule 57 Procedure for despatch of sample to Government Analyst.--

S.¹[Rule 58 Confiscation of drugs, implements, machinery, etc.--

S.¹[Rule 58-A Procedure for disposal of confiscated drugs.--

S.Rule 59

S.Rule 60

S.¹[Rule 61 Forms of licences to sell drugs.--

S.Rule 62 Sale at more than one place.--

S.¹[Rule 62-A Restricted licences in Forms 20-A and 21-A.--

S.¹[Rule 62-B Conditions to be satisfied before a licence in Form 20-A or Form 21-A is granted.--

S.¹[Rule 62-C Application for licence to sell drugs by wholesale or to distribute the same from a motor vehicle.--

S.Rule 62-D Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicle.--

S.¹[Rule 63 Duration of licence.--

S.¹[Rule 63-A Certificate of renewal of a sale licence.--

S.¹[Rule 63-B Certificate of renewal of licence.--

S.¹[Rule 64 Conditions to be satisfied before a licence in2[Forms 20, 20-B, 20-F, 20-G, 21 or 21- B] is granted3[x x x x].--

S.Rule 65 Condition of licences.--

S.¹[Rule 65-A Additional information to be furnished by an applicant for licence or a licensee to the licensing authority.--

S.¹[Rule 65-B Inspection for verification of compliance.--

S.Rule 66 Cancellation and suspension of licences.--

S.¹[Rule 66-A Procedure for disposal of drugs in the event of cancellation of licence.--

S.Rule 67

S.Rule 67-A

S.Rule 67-B

S.¹[Rule 67C Forms of licences to sell drugs.--

S.Rule 67-D Sale at more than one place.--

S.¹[Rule 67E Duration of licences.--

S.¹[Rule 67-EE

S.Rule 67-F Conditions to be satisfied before a licence in Form 20-C or Form 20-D is granted.--

S.Rule 67-G Conditions of licence.--

S.¹[Rule 67-GG Additional information to be furnished by an applicant for licence or a licensee to the licensing authority.--

S.Rule 67-H Cancellation and suspension of licences.--

S.Rule 68 Manufacture on more than one set of premises.--

S.¹[Rule 68-A Grant2[x x x x] of Licences by the Central Licence Approving Authority.--

S.¹[Rule 68-B Delegation of powers by the Central Licence Approving Authority.--

S.¹[Rule 69 Application for licence to manufacture drugs other than those specified in Schedules C and C(1) to the Drugs and Cosmetics Rules.--

S.¹[Rule 69-A Loan licences.--

S.¹[Rule 69-B Applications to manufacture 'new drugs' other than the drugs classifiable under Schedules C and C(1) products.--

S.¹[Rule 70 Form of licence to repack or manufacture drugs other than those specified in Schedules C and C(1).--

S.¹[Rule 70-A Form of loan licence to manufacture for sale2[or for distribution] of drugs other than those3[specified in Schedules C, C(l) and X].--

S.¹[Rule 71 Conditions for the grant2[x x x x] of a licence in Form 253[or Form 25-F].--

S.¹[Rule 71-A Conditions for the grant2[x x x x] of a licence in Form 25-B.--

S.¹[Rule 71-B Conditions for the grant2[x x x x] of a licence in Form 25-A.--

S.¹[Rule 72 Duration of licence.--

S.Rule 1 Short title, extent and commencement.--

S.Rule 2 Definitions.--

S.Rule 3 Functions.--

S.Rule 3-A

S.Rule 4 Despatch of samples for test or analysis.--

S.Rule 5 Recording of condition of seals.--

S.Rule 6 Report of result of test or analysis.--

S.Rule 7 Fees.--

S.Rule 8 Signature of certificates.--

S.1 (Rules 9 to 20)

S.Rule 21

S.Rule 22

S.¹[Rule 23 Import licences.--

S.¹[Rule 24 Form and manner of application for import licence.--

S.¹[Rule 24-A Form and manner of application for Registration Certificate.--

S.Rule 25 Licences for import of drugs manufactured by one manufacturer.--

S.¹[Rule 25-A Conditions to be satisfied before a licence in Form 10 or Form 10-A is granted.--

S.¹[Rule 25-B Registration Certificate for import of drugs manufactured by one manufacturer.--

S.Rule 26 Conditions of import licence.--

S.Rule 27 Grant of import licence.--

S.¹[Rule 27-A Grant of Registration Certificate.--

S.¹[Rule 28 Duration of import licence.--

S.¹[Rule 28-A Duration of Registration Certificate.--

S.Rule 29 Suspension and cancellation of import licence.--

S.¹[Rule 29-A Suspension and cancellation of Registration Certificate.--

S.Rule 30 Prohibition of import after expiry of potency.--

S.¹[Rule 30-A

S.¹[Rule 30-AA Import of New Homoeopathic medicines.--

S.¹[Rule 30-B Prohibition of import of certain drugs.--

S.¹[Rule 31 Standard for certain imported drugs.--

S.¹[Rule 32 Packing and labelling of imported drugs.--

S.¹[Rule 32-A Packing and labelling of Homoeopathic medicine.--

S.Rule 33 Import of drugs for examination, test or analysis.--

S.¹[Rule 33-A Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients.--

S.Rule 34 Application for licence for examination, test or analysis.--

S.¹[Rule 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.--

S.Rule 35 Cancellation of licence for examination, test or analysis.--

S.¹[Rule 35-A Cancellation of licence for import of small quantities of new drugs.--

S.Rule 36 Imports of drugs for personal use.--

S.¹[Rule 36-A Import of drugs by charitable hospital free of cost.--

S.¹[Rule 37 Packing of patent or proprietary medicines.--

S.Rule 38 Statement to accompany imported drugs.--

S.Rule 39 Documents to be supplied to the Customs Collector.--

S.¹[Rule 40 Procedure for the import of drugs.--

S.Rule 41

S.Rule 42

S.⁴[Rule 122-EA Definitions.--

S.Rule 122-F Form of application for licence for operation of1[Blood Centre]/processing of whole human blood for components/manufacture of blood products for sale or distribution2[, collection, processing, testing, storage, banking and release of umbilical cord blood stem cells].--

S.Rule 122-G 1[(1)] Form of licence for the operation of a2[Blood Centre]/processing of whole human blood for components and3[/manufacture of blood products/collection, processing, testing, storage, banking and release of umbilical cord blood stem cells] and the conditions for the grant or renewal of such licence.--

S.Rule 122-H Duration of licence.--

S.Rule 122-I Inspection before grant or renewal of licence for operation of1[Blood Centre], processing of whole human blood for components and manufacture of blood products.--

S.Rule 122-J Report by Inspector.--

S.Rule 122-K Further application after rejection.--

S.Rule 122-L Delegation of powers by the Central Licence Approving Authority.--

S.Rule 122-M Provision for appeal to the State Government by a party whose licence has not been granted or renewed.--

S.Rule 122-N Additional information to be furnished by an1[applicant] for licence or by a licensee to the Licensing Authority.--

S.Rule 122-O Cancellation and suspension of licences.--

S.Rule 122-P Conditions of licence.--

S.Rule 123

S.¹[Rule 124 Standards of drugs.--

S.¹[Rule 124-A Standards for veterinary drugs.--

S.¹[Rule 124-B Standards for patent or proprietary medicines.--

S.¹[Rule 124-C Standards for Surgical Dressings.--

S.¹[Rule 124-D Standards for Sterilised Umbilical tapes.--

S.¹[Rule 125 Standards for substances (other than food) intended to affect the structure or any function of human body-contraceptives.--

S.¹[Rule 125-A Standards for Medical Devices.--

S.¹[Rule 126 Standards for substances intended to be used for the destruction of vermin or insects which cause disease in human beings or animals.--]

S.¹[Rule 126-A Standards for ophthalmic preparations2[including Homeopathic ophthalmic preparations]

S.¹[Rule 127 List of colours permitted to be used in drugs.--

S.Rule 128

S.Rule 129 Registration of cosmetic products imported into the country.--

S.Rule 129-A Form and manner of application for Registration Certificate.--

S.Rule 129-B Registration Certificate for the import of cosmetics manufactured by one manufacturer.--

S.Rule 129-C Grant of Registration Certificate.--

S.Rule 129-D Duration of Registration Certificate.--

S.Rule 129-E Suspension and cancellation of Registration Certificate.--

S.Rule 129-F Prohibition of import of certain cosmetic.--

S.Rule 129-G Standard for imported cosmetics.--

S.Rule 129-H Labelling and Packing of Cosmetics.--

S.Rule 130 Documents to be supplied to the Collector of Customs.--

S.Rule 131 Procedure for the import of cosmetics.--

S.Rule 132 Exemption of cosmetics.--

S.Rule 133 Import through points of entry.--

S.Rule 134 Cosmetic to contain Dyes, Colours and Pigments.--

S.Rule 134-A Prohibition of import of cosmetics containing hexachlorophene.--

S.Rule 135 Import of cosmetics containing lead or arsenic compound prohibited.--

S.Rule 135-A Regulation of import of cosmetics containing mercury.--

S.Rule 135-B Prohibition of import of cosmetics tested on animals.--

S.Rule 136 Import of cosmetics for personal use.--

S.Rule 137 Manufacture on more than one set of premises.--

S.Rule 138 Application for licence to manufacture cosmetics for sale or for distribution.--

S.Rule 138-A Application for loan licence to manufacture cosmetics.--

S.Rule 139 Condition for the grant of a licence in Form 32.--

S.Rule 139-A Form of licence to manufacture cosmetics for sale or for distribution.--

S.Rule 139-AA Inspection before grant [x x x x] of licence.--

S.Rule 139-AB Report by Inspector.--

S.Rule 139-AC Grant or refusal of licence.--

S.Rule 139-AD Further application after rejection.--

S.Rule 139-AE Appeal to the State Government.--

S.Rule 139-B Form of loan licence to manufacture cosmetics for sale or for distribution.--

S.Rule 140 Duration of licence.--

S.Rule 141 Certificate of renewal.--

S.Rule 141-A Certificate of renewal of loan licence.--

S.Rule 141-AA Duration of a loan licence.--

S.Rule 142 Conditions of licence.--

S.Rule 142-A Additional information to be furnished by an applicant for licence or a licensee to the licensing authority.--

S.Rule 142-B Conditions of licence in Form 32-A

S.Rule 143 Cancellation and suspension of licence.--

S.Rule 143-A Inspection for grant of licence and verification of compliance.--

S.Rule 144 Prohibition of manufacture of cosmetics containing colours other than those prescribed.--

S.Rule 144-A Prohibition of manufacture of cosmetic containing hexa-chlorophene.--

S.Rule 145 Use of Lead and Arsenic compounds for the purpose of colouring cosmetics prohibited.--

S.Rule 145-A Form of intimation for purposes of taking samples of cosmetics.--

S.Rule 145-AA Form of receipt of samples of cosmetics where fair price tendered is refused.--

S.Rule 145-B Form of receipt for seized cosmetics.--

S.Rule 145-BA Manner of certifying copies of seized documents.--

S.Rule 145-C Form of order not to dispose of stocks of cosmetics.--

S.Rule 145-D Regulation of use of mercury compounds in cosmetics.--

S.Rule 146 Prohibition of sale or distribution.--

S.Rule 147 Exemption of cosmetics not manufactured for consumption or sale in India from the provisions of this Part.--

S.Rule 148 Manner of labelling.--

S.Rule 148-A Prohibition against altering inscriptions on containers, labels or wrappers of cosmetics.--

S.Rule 148-B Prohibition against false or misleading claims.--

S.Rule 148-C Prohibition of testing of cosmetics on animals.--

S.Rule 149 Labelling of Hair Dyes containing Dyes, Colours and Pigments.--

S.Rule 149-A

S.Rule 150 Report of result of test or analysis of cosmetics.--

S.Rule 150-A Standards for cosmetics.--

S.Rule 150-B Application for grant of approval for testingdrugs/4[x x x x].--

S.Rule 150-C Form in which approval to be granted for carrying out tests ondrugs/1[x x x x] on behalf of licensees for manufacture ofdrugs/2[x x x x]3[or for an individual or organisation or procurement agency] and conditions for grant4[x x x x] of such approval.--

S.¹[Rule 150-D Duration of approval.--

S.Rule 150-E Conditions of approval.--

S.Rule 150-F Inspection before grant of approval.--

S.Rule 150-G Report of Inspection.--

S.Rule 150-H Procedure of approving authority.--

S.Rule 150-I Further application after rejection.--

S.Rule 150-J Renewal.--

S.Rule 150-K Withdrawal and suspension of approvals.--

S.Rule 151 Manufacture on more than one set of premises.--

S.Rule 152 Licensing authorities.--

S.¹[Rule 153 Application for licence to manufacture Ayurvedic, Siddha or Unani drugs.--

S.¹[Rule 153-A Application for loan licence to manufacture Ayurvedic, Siddha or Unani drugs.--

S.Rule 153-B Application for Certificate of Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs manufacturing unit.--

S.¹[Rule 154 Form of licence to manufacture Ayurvedic, Siddha or Unani drugs.--

S.¹[Rule 154-A Form of loan licence to manufacture for sale of Ayurvedic, Siddha or Unani drugs.--

S.Rule 155 Certificate of renewal.--

S.Rule 155-A Certificate of renewal of a loan licence.--

S.¹[Rule 155-B Certificate of award of G.M.P. of5[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs].--

S.¹[Rule 156 Duration of licence.--

S.¹[Rule 156-A Duration of loan licence.--

S.¹[Rule 156-B Duration of Certificate of Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs manufacturing units.--

S.¹[Rule 156-C Inspection for grant of licence and verification of compliance.--

S.¹[Rule 156-D Report by Inspector.--

S.¹[Rule 156-E Procedure of Licensing Authority.--

S.¹[Rule 156-F Further application after rejection.--

S.Rule 157 Conditions for the grant1[x x x x] of a licence in Form 25-D.--

S.¹[Rule 157-A Maintaining of records of raw material used by licensed manufacturing unit of3[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] in the preceding financial year.--

S.Rule 158 Conditions of licence.--

S.¹[Rule 158-A Conditions of loan licence.--

S.¹[Rule 158-B Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drugs.--

S.¹[Rule 158-C Form of Free Sale Certificate and Non-Conviction Certificate.--

S.Rule 159 Cancellation and suspension of licences.--

S.Rule 160 Identification of raw materials.--

S.Rule 160-A Application for grant of approval for testing2[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs].--

S.Rule 160-B Form in which approval to be granted for carrying out tests on3[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] on behalf of licensees for manufacture of3[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] and conditions for grant or renewal of such approval.--

S.¹[Rule 160-C Duration of approval.--

S.¹[Rule 160-D Conditions of approval.--

S.¹[Rule 160-E Inspection before grant of approval.--

S.¹[Rule 160-F Report of inspection.--

S.¹[Rule 160-G Procedure of approving authority.--

S.¹[Rule 160-H Application after rejection.--

S.¹[Rule 160-I Renewal.--

S.¹[Rule 160-J Withdrawal and suspension of approvals.--

S.¹[Rule 160-K Information to be uploaded by the licencee on online portal.--

S.Rule 161 1[Labelling, packing and limit of alcohol].--

S.¹[Rule 161-A Exemption in labelling and packing provisions for export of Ayurvedic (including Siddha) and Unani drugs.--

S.¹[Rule 161-B Shelf life or date of expiry of medicines.--

S.Rule 162 Duties of Inspectors specially authorised to inspect the manufacture of1[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs].--

S.¹[Rule 162-A Qualifications for State Drug Licensing Authority for licensing of3[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs].--

S.Rule 163 Procedure for despatch of sample to Government Analyst and its receipt by the Government Analyst.--

S.¹[Pharmacopoeia Commission for Indian Medicine and Homoeopathy and Central Drugs Laboratory of Indian Medicine and Homoeopathy to function as Central Drugs Laboratory for the purpose of testing or analysis of Ayurveda, Siddha, Unani and Homoeopathy Drugs

S.¹[Rule 163-B

S.Rule 163-BB

S.Rule 163-C Despatch of samples for test or analysis.--

S.Rule 163-D Recording of condition of seals.--

S.Rule 163-E Report of result of test or analysis.--

S.Rule 163-F Fees.--

S.Rule 163-G Signature on certificates.--

S.¹[Rule 164 Method of test or analysis to be employed in relation to Ayurvedic, Siddha, Unani or Homoeopathy drugs.--

S.Rule 165 Qualifications of Government Analyst.--

S.Rule 166 Duties of Government Analyst.--

S.¹[Rule 167 Qualifications of Inspector.--

S.Rule 168 Standards to be complied with in manufacture for sale or for distribution of2[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs].--

S.¹[Rule 169 Permitted Excipients.--

S.¹[Rule 170

S.SCHEDULE A

S.SCHEDULE B

S.SCHEDULE B-1

S.SCHEDULE C

S.SCHEDULE D

S.ANNEXURES

S.¹[SCHEDULE D-III

S.¹[SCHEDULE E LIST OF POISONOUS SUBSTANCES

S.SCHEDULE E(1)

S.SCHEDULE -F

S.SCHEDULE-F(I)

S.SCHEDULE F(II)

S.SCHEDULE F(III)

S.SCHEDULE FF

S.SCHEDULE G

S.SCHEDULE H

S.SCHEDULE H1

S.SCHEDULE H2

S.¹[SCHEDULE I PARTICULARS AS TO PROPORTION OF POISON IN CERTAIN CASES

S.SCHEDULE J

S.SCHEDULE K

S.¹[SCHEDULE L

S.SCHEDULE L-I

S.SCHEDULE M

S.SCHEDULE M-I

S.¹[SCHEDULE M-II

S.SCHEDULE M-III

S.SCHEDULE N

S.SCHEDULE O

S.SCHEDULE P

S.SCHEDULE P I

S.¹[SCHEDULE Q

S.SCHEDULE R

S.SCHEDULE R 1

S.¹[SCHEDULE S

S.SCHEDULE T

S.SCHEDULE T-A

S.SCHEDULE T-B

S.SCHEDULE U

S.¹[SCHEDULE U(I)

S.SCHEDULE V

S.¹[SCHEDULE W

S.SCHEDULE X

S.SCHEDULE Y

S.Drugs (Amendment) Rules, 2024 All Amendments incorporated at appropriate place

S.Drugs (Second Amendment) Rules, 2024 All Amendments incorporated at appropriate place

S.Drugs (Third Amendment) Rules, 2024. All Amendments incorporated at appropriate place

S.Drugs (Fourth Amendment) Rules, 2024 All Amendments incorporated at appropriate place

S.Drugs (Fifth Amendment) Rules, 2024 All Amendments incorporated at appropriate place

S.Drugs (First Amendment) Rules, 2025 All Amendments incorporated at appropriate place