Drugs and cosmetics act, 1940 and rules

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1. Drugs and Cosmetics Act, 1940 and Rules Ravish Yadav

2. Sub-topics Objective, Definitions Schedules to the Act, Rules Schedule M and Y in detail Administrative Bodies DTAB, DCC CDL Drug Inspectors, Government Analyst Provisions governing Manufacturing of drugs Sale of drugs Import of drugs A/S/U drugs Homoeopathic drugs Labelling and Packaging of drugs

3. Definitions Drug: includes (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 to human body for the purpose of repelling insects like mosquitoes

4. Drug definition (cont.…..) (ii) Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals (iii) All substances intended for use as components of a drug including empty gelatin capsules (iv) Such devices intended for use in diagnosis, treatment, mitigation or prevention of disease or disorders in human beings or animals

5. Definition 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 in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha or Unani systems of medicine, specified in First Schedule

6. Definition: Patent or Proprietary Medicine In relation to A/S/U, formulations containing only such ingredients mentioned in the formulae described in the authoritative books of A/S/U systems of medicine specified in the First Schedule and does not include a formulation included in the authoritative books.

7. Patent or Proprietary Medicine In relation to other systems, 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 IP or any other Pharmacopoeia authorized by the Central Govt after consultation with the DTAB.

8. Definition Cosmetic It means any article intended to be rubbed, poured, sprinkled or sprayed on or introduced into or applied to any part of the human body, for cleansing, beautifying, promoting attractiveness or altering the appearance and includes any article intended for use as a component of cosmetic

9. Definition New Drug- (Rule-122E) i) A new substance of chemical, biological or biotechnological origin in bulk or prepared dosage form used for prevention, diagnosis or treatment of disease in man or animals, which except during local clinical trials has not been used in the country to any significant extent and which, except during local clinical trials, has not been recognized in the country as effective and safe for the proposed claims.

10. New Drug cont.… ii) A drug already approved by the licensing authority for certain claims, which is now proposed to be marketed with modified or new claims namely indications, dosage, dosage form (including sustained release dosage form) and route of administration

11. New Drug cont.… iii) A fixed dose combination of two or more drugs, individually approved earlier for certain claims which are now proposed to be combined for the first time in a ratio or if the ratio of ingredients in an already marketed combination is proposed to be changed with certain claims viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration

12. Manufacture Definition In relation to any drug or cosmetic 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 drugs, or the packing of any drug or cosmetic, in the ordinary course of retail business

13. Misbranded Drug A drug shall deemed to be misbranded : a. If it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear better or of greater therapeutic value than it really is, or b. If it is not labelled in the prescribed manner, or c. If its label or container or anything accompanying the drugs bears any statement, design or device which makes false claim for the drug or which is false or misleading in any particular way

14. Definition Adulterated Drugs - a drug is deemed to be adulterated- If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or 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 injurious to health; or 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

15. Adulterated drugs cont.… If it bears or contains, for purposes of coloring only, a colour other than one which is prescribed; or If it contains any harmful or toxic substance which may render it injurious to health; or If any substance has been mixed therewith so as to reduce its quality or strength

16. Definition Spurious Drugs : A drug is deemed to be spurious- If it is imported under a name which belongs to another drug; or If it is an imitation of or is 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 conspicuously marked so as to reveal it true character and its lack of identity with such other drugs; or

17. Spurious drugs cont.… If the label of container bears the name of an individual or company purporting to be manufacturer of the drug, which individual or company is fictitious or does not exist; or If it has been substituted wholly or in part by another drug or substance; or If it purports to be the product of a manufacturer of whom it is not truly a product

18. Schedules to the Act Two schedules (Listing) to the Act First Schedule: List of Ayurvedic, Siddha and Unani Books Second Schedule: Standards to be complied with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distributed

19. Schedule Contents A List of Forms for making applications for issuing licenses, granting licenses, sending memorandum B Fees for test or analysis by the Central Drugs Laboratory or Government Analyst C Biological and special products C(1) Other Special products (the import, manufacture and sale of schedule C and C(1) drugs governed by special provisions) D Class of exempted drugs, which are exempted from a certain provisions applicable to import of drugs D(1) D(II) Information and Undertaking to be submitted by the manufacturer with the Application form for Registration Certificate Information to be submitted by the manufacturer with application form for registration of a bulk drug/formulation/special product import into India

20. Schedule Contents E List of poisonous substances (Omitted 22-6-1982) E(1) List of poisonous substances in Ayurvedic, Siddha and Unani systems of medicine F Part XII B- Requirement for functioning and operation of blood bank and/or preparation of blood components F(I) Part I: Provisions applicable to production of bacterial and viral vaccines Part II: Provisions applicable to the production of all sera from living animals Part III: Provisions applicable to manufacture and standardization of diagnostic agents (bacterial origin)

21. Schedule Contents F(II) Standards for surgical dressings F(III) Standards for umbilical tapes FF Standards for ophthalmic preparations G List of substances that are required to be used under medical supervision and which are to be labeled accordingly H List of prescription drugs- to be sold on prescription of Registered Medical Practitioner only I Omitted J List of diseases and ailments which a drug may not purport to prevent or cure

22. Schedule Contents K List of drugs exempted from certain provisions applicable to manufacture of drugs and sale of drugs L Omitted M Part 1 Part 1A Part 1B Good Manufacturing Practices and Requirements of factory premises, plant, equipment etc for the manufacture of drugs GMP for premises and Materials Specific requirements for manufacture of sterile products, parenteral preparations (small volume injectables and LVPs) and sterile ophthalmic preparations Specific requirements for manufacture of oral solid dosage forms (tablets and capsules)

23. Schedule Contents M Part 1C Part 1D Part 1E Part 1F Part II Specific requirements for manufacture of oral liquids (syrups, elixirs, emulsions, suspensions) Specific requirements for manufacture of topical (external) products like creams, ointments, pastes, emulsions, lotions, solutions etc) Specific requirements for manufacture of metered dose inhalers Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients (bulk drugs) Requirements of plant and equipment M-I M-II M-III Requirements of factory premises for manufacture of homoeopathic medicines Requirement of factory premises for the manufacture of cosmetics Requirements of factory premises for manufacture of medical devices

24. Schedule Contents N List of minimum equipment for efficient running of a pharmacy O Part I Part II Standards for disinfectant fluids Provisions applicable to black fluids and white fluids Provisions applicable to other fluids P P1 Life periods of drugs Pack sizes of drugs Q Part I Part II List of dyes, colours and pigments permitted in cosmetics and soaps List of colours permitted in soaps R R1 Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives Standards for medical devices like Sterile Disposable Perfusion sets, Sterile Disposable Hypodermic Syringes and Sterile Disposable Hypodermic Needles S Standards for Cosmetics

25. Schedule Contents T GMP for Ayurvedic, Siddha and Unani medicines U U (I) Particulars to be shown in manufacturing, raw material and analytical records of drugs Particulars to be shown in manufacturing, raw material and analytical records of cosmetics V Standards for patent or proprietary medicines W List of drugs which are to be marketed under generic names only (deleted as per GOI notification dt 8.2.2000) X List of drugs whose import, manufacture and sale, labeling and packaging are governed by special provisions Y Requirements and guidelines on clinical trials for import and manufacture of new drugs

26. Pharmacy Chemist and Druggist Drug Store

27. Classify as drug, A/U/s medicine, patent or proprietary medicine, cosmetic, food and justify Water for Injection, IP IV infusion set Absorbent cotton Cardamom Antiseptic cream Cold cream Cresol with soap solution, IP Vicks VapoRub ®

28. Case Studies Gudakhu- tobacco preparation rubbed on teeth mfd by a person in Orissa without license. Is a license required under D & C Act? Sub-standard quality- is it an offence? Ranbaxy Laboratories v State of MP: Ampicillin Injection samples- label indicated that 2ml Water for Injection is supplied in this pack. Pack did not contain vial for water for injection. Any Offence?? Olive Oil of medical quality- label claim. Specifications not meeting BP standards. What is the offence?

29. Administrative bodies Advisory DTAB DCC Analytical CDL State Drug Control Laboratories Government Analyst Executive Licensing Authorities Drug Inspectors Customs Collectors

30. DTAB: Drugs Technical Advisory Board Constituted by the Central Government To advise Central and State Government on technical matters arising our of the administration of this Act Consists of 18 members- 8 are ex-officio, 5 nominated and 5 elected Nominated and elected hold office for 3 years Sub committees may be formed Outside persons may be invited temporarily

31. DTAB Constitution Ex-officio The Director General of Health Services (DGHS) who is the Chairman of DTAB Drugs Controller of India Director, Central Drugs Laboratory, Kolkata Director, Central Research Institute, Kasauli Director, Indian Veterinary Research Institute, Izatnagar President, Pharmacy Council of India President, Medical Council of India Director, Central Drug Research Institute, Lucknow

32. Drugs Consultative Committee Advisory Committee constituted by Central Government Advises Central, State Govts. And DTAB Ensure uniformity throughout India in the administration of this Act. Constitution Two representatives of Central Government nominated by Central Govt. One representative of each State Government nominated by the concerned Govt.

33. Central Drugs Laboratory Central Drugs Laboratory in Kolkata under the control of Director Functions 1. To analyze or test samples of drugs or cosmetics sent to it by Customs collectors or any authorized officers or Courts 2. To carry out such duties as may be entrusted to it by the Central Government after consultation with the DTAB.

34. DCC CDL Government Analysts Duties Procedure Drug Inspectors: Powers and Duties Licensing Authorities

35. CRI, Kasauli: Biologicals such as toxins, sera, vaccines, ligatures Veterinary Research Inst, Mukteshwar: Antisera, toxins etc for veterinary use Central Pharmacopeial Laboratory, Ghaziabad: Condoms

36. OPV: Pasteur Institute of India, Haffkine Institute IUD and Fallopian tube rings: CDTL, Thane Blood grouping reagents, HIV Diagnostic kits: National Institute of Biologicals, NOIDA

37. Protocol for dispatch of sample Dispatch of samples for test or analysis: Samples for test or analysis: sent by registered post in a sealed packed, enclosed with a memorandum in Form 1, in an outer cover addressed to the Director The packet as well as the outer cover shall be marked with a distinguishing number A copy of the memorandum in Form 1 and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director

38. Recording of condition of seal : On receipt of the sample packet, an authorized person will open and record the condition of the seal on the packet Report of result of test or analysis : After test or analysis, the result together with full protocols of the tests applied shall be sent Fees : The fees for test and analysis shall be those specified in Schedule B

39. Government Analyst State Government, by notifying in the Official Gazette, appoints Government analysts for analysis and testing of samples of drugs and cosmetics in the Drug Control Laboratories Central Government may also appoint Government Analyst for specified categories of drugs or cosmetics

40. Government Analyst A person appointed as GA should have no financial interest in the import, manufacture or sale of drugs or cosmetics GA for Ayurvedic, Siddha and Unani drugs is appointed by State and Central Government under Section 33-F of the Act

41. Protocol to be followed by GA On receipt of sample from Inspector, the GA should compare the seals on the packet with the specimen seal received separately On completion of analysis, the report in triplicate with full protocols of the tests of analysis applied should be sent to the Inspector

42. Duties of Government Analyst To analyze or test samples of drugs and cosmetics sent to him by Drug Inspectors or other persons and to furnish the reports of the results of such analysis or test To forward to the Government the reports of analytical and research work with a view to their publication at the discretion of the Government

43. Drug Inspectors Central or State Govt. appoints Inspectors by notification in the Official Gazette A person to be appointed as Drug Inspector should have no financial interest in manufacture, import or sale of drugs or cosmetics A Drug Inspector is a Public Servant under sec 21 of Indian Penal Code

44. Powers of Inspectors Inspect : Any premises wherein any drug or cosmetic is being manufactured. May also inspect the means employed for standardizing and testing the drug or cosmetic Any premises wherein any drug or cosmetic is being sold or stocked or exhibited or offered for sale or distributed

45. Powers of Inspectors Take samples of any drug or cosmetic which is being manufactured or sold or is stocked or offered for sale or exhibited or distributed From any person conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee

46. Powers of Inspectors Search any person in connection with the offence under this Act at all reasonable times Enter and Search at all reasonable times any premises in which he has reason to believe that an offence is being committed Stop and Search any vehicle or other conveyance which he has reason to believe is being used to carry any drug or cosmetic in respect of which offence has been or is being committed

47. Powers of Inspectors Give order in writing to the person in possession of drug or cosmetic in respect of which offence has been committed, not to dispose stock of such drug or cosmetic for a specified period not exceeding twenty days and may seize the stock of such drug or cosmetic or any substance or article employed for commission of offence

48. Powers of Inspectors Examine any record, register, document or any other material object with any person or in any place mentioned above and seize the same if it is likely to furnish the evidence of an offence Exercise any other powers as may be necessary, for carrying out the purpose of this act and the rules made there under

49. Duties of Drug Inspector 1. Duties in relation to the Sale of Drugs and Cosmetics 2. Duties in relation to the manufacture of drugs and cosmetics

50. Duties in relation to sale of drugs and cosmetics (Rule-51) To inspect at least once a year all establishments licensed for sale of drugs in the area assigned to him and to satisfy himself whether the conditions are observed or not To obtain and sent samples of imported drugs and cosmetics for test or analysis, which are being sold or stocked in contravention of the provisions of the Act

51. Duties in relation to sale of drugs and cosmetics (Rule-51) To investigate any complaint in writing made to him To institute prosecution in case of breach of the Act and Rules To maintain records relating to all inspections and actions taken by him and to submit copies of such records to the controlling authority

52. Duties in relation to sale of drugs and cosmetics (Rule-51) To make inquiries and inspections regarding the sale of drugs in contravention of the Act To detain imported packages, if he suspects them to contain drugs, the import of which is prohibited

53. Duties in relation to manufacture of drugs and cosmetics (Rule-51) Subject to instructions of the controlling authority, following shall be the duty of an Inspector To inspect at least once a year, all premises licensed for manufacture of drugs within the area allotted to him and to find out whether conditions of the license and the provisions under the Act and Rules are being observed

54. Duties in relation to manufacture of drugs and cosmetics (Rule-51) To inspect premises licensed for manufacture of drugs specified in Schedule C and C(1) and to observe process of manufacture, means employed for standardization and testing, storage conditions, qualifications of technical staff employed and all other details of location, construction, administration of establishment which may likely to affect purity or potency of the product

55. Duties in relation to manufacture of drugs and cosmetics (Rule-51) To send after each inspection, a detailed report of inspection to the controlling authority indicating the conditions of the license and provisions of the Act and Rules there under which are being observed and any provisions which are not being observed. To take the samples of drugs manufactured on the premises and send them for test of analysis

56. Duties in relation to manufacture of drugs and cosmetics (Rule-51) To check all records and registers required to be maintained under the Rules To institute prosecution in respect of any breaches under the Act and Rules there under

57. Procedure for Inspection For taking any samples for analysis and dispatch to GA The Inspector shall intimate the purpose to a person from whom he take sample in writing in a prescribed form (Form-17) Tender fair price and obtain acknowledgement for the same. If price is refused or where the Inspector seizes the stock, he should issue a receipt for the same in the prescribed form

58. Divide the sample in the presence of concerned person in four parts unless he willfully absents himself If sample is taken from manufacturing premises, it should be divided into three parts

59. Restore one portion or container with a person from whom sample is taken, send one portion to the GA for analysis with memorandum in Form 18. Reserve one portion/container to be produced before the court if need arises Send remaining portion to a warrantor, if any

60. For Seizure of Stocks If any offence is suspected to have been committed in contravention to the Act, stock of such drugs, records, registers and documents which are believed to be evidence of the commission of an offence can be seized This should be informed to a Judicial Magistrate and take his order for custody of the same

61. Penalty for obstructing Inspector: Willful obstruction of Inspector in the exercise of his powers conferred upon him or refusal to produce any record, register or document shall be punishable with imprisonment up to 3 years or with fine or with both.

62. Report of the GA GA sends the report in triplicate in prescribed form The Inspector then delivers one copy to the person from whom sample was taken, another copy to warrantor if any and third is reserved for use in prosecution, if any. The report signed by the GA is considered conclusive unless it is challenged within 28 days after receipt of the report by the person from whom sample is taken. If challenged, the sample of such drug or cosmetic is sent to CDL by court and the report signed by the Director, CDL is considered final.

63. Licensing Authorities License for import of drugs issued by Central Government State Governments appoint licensing authorities to issue license for manufacture, sale and distribution of drugs or cosmetics The authorities have the power to either refuse or issue license, depending on whether the applicant fulfils the conditions prescribed under the Act

64. Licensing Authorities The authorities can also suspend or cancel licenses if licensees fail to comply with any of the conditions The decision can be appealed against before the State or Central Government as the case may be.

65. Central License Approving Authority (CLAA) The Central Govt. may appoint CLAA to issue license after notification in the official gazette, for grant or renewal of license. Following categories of drugs presently notified Large Volume Parenteral, Sera and Vaccines Operation of Blood Bank/Processing of whole human blood for components and Manufacture of blood products

66. Delegation of powers by the CLAA : The CLAA may with the approval of central government by notification delegate his powers of signing licenses and any other power under the rule to any person under his control having same qualifications as prescribed for controlling authority

67. Controlling Authority: The Central or State Govt. may appoint controlling authority having prescribed qualifications All Inspectors appointed by the Central Govt shall be under the control of an officer appointed in this behalf by the Central Govt. All Inspectors appointed by the State Govt shall be under the control of an officer appointed in this behalf by the State Govt

68. Customs Collectors The Customs Collector or any other person authorized on his behalf may detain any imported package which he suspects to contain any drug or cosmetics, import of which is prohibited, reports such detention to Drug Controller, India and if required forwards sample of such drug or cosmetic to CDL

69. Import of drugs: provisions Classes of drugs that are banned from import Classes of drugs that can be imported under license or permit Classes of drugs that can be imported without license Conditions of license Methods of registration, license application

70. Provisions governing Import of Drugs- Flow chart

71. Conditions to be satisfied

72. Manufacture of drugs- provisions governing Types of licenses Manufacturing Loan and license manufacturing Repacking license Conditions for grant of license Conditions to be complied after grant of license Additional conditions for Sch X drugs Accounts of drugs used for manufacture, production, manufactured drug

73. Provisions governing Sale of Drugs

74. Conditions for Licence

75. Labelling of drugs R x Benzoyl metronidazole Oral Suspension I. P. FLAGYL ® Suspension 60 ml Each 5ml contains: Benzoyl metronidazole I.P. equivalent to Metronidazole 200mg Excipients q. s. in a flavored syrupy base Colour: Tartrazine Protect from light and moisture Dose: as prescribed by the physician SHAKE WELL BEFORE USE Medicine: Keep out of reach of children SCHEDULE H DRUG Warning: To be sold by retail on prescription of a Registered Medical Practitioner only Warning: Metronidazole has been shown to be carcinogenic in mice and rats. Therefore, unnecessary use should be avoided. Mfg Lic No: Max retail price: Batch No: Mfg Date: Exp Date:

76. Special labelling requirements Schedule G: The words “Caution: It is dangerous to take this preparation except under medical supervision ” Schedule H: The words “Warning: To be sold by retail on prescription of a Registered Medical Practitioner only” Schedule X: Symbol XR x Drug under NDPS Act, 1985: NR x

77. Special labelling requirements Ointments, Liniments, Liquids for external application: FOR EXTERNAL USE ONLY Ophthalmic preparations: Use within one month after opening the container Name and concentration of preservative Warning: If irritation persists of increases, discontinue use and consult physician NOT FOR INJECTION Do not touch the dispensing tip to any surface since this may contaminate the solution

78. Special labelling requirements Labelling of drugs meant for export Vaccines: Conditions of storage If dried form, method of reconstitution Use of reconstituted product within specified time Instructions for use Precautions to be taken during use

79. Packing of drugs As per provisions given in Schedule P-1 Tablets/Capsules: < 10- integral number, > 10: multiples of 5 Liquid orals: 30ml (pediatric) 60ml/100ml/200/450ml Pediatric oral drops: 5ml/10ml/15ml Eye/Nasal/Ear drops: 3ml/5ml/10ml Ointment: 3gm/5gm/10gm Does not apply to imported finished products, physician’s samples, hospital supplies etc

80. Schedule X drugs: packing Tablets/Capsules: Not more than 100 unit doses for retail sale Liquid orals: Not more than 300ml Injections: not more than 5ml

81. Provisions governing Sale of drugs (other than homoeopathic) Types of licenses Retail sale Other than Sch C, C1 and X Sch C and C1 drugs Sch X drugs Wholesale Distribution from motor vehicle Restricted license Conditions to be followed Compounding and dispensing of drugs ‘Pharmacy’, ‘Drug Store’, ‘Chemists and Druggists’

82. Special conditions Veterinary use drugs Schedule X drugs Special register to be maintained Disposal of drugs in case of cancellation of license

83. Manufacture of a/s/u drugs License is required for manufacture Conditions for grant/renewal of license : Comply with Schedule T Competent technical staff: qualified in respective discipline Conditions for license : Maintenance of proper records Allow Inspection Maintain Inspection book

84. Provisions: ayurvedic/siddha/unani drugs Ayurvedic (including Siddha) and Unani DTAB Government Analyst Inspectors

85. Sale of A/S/U drugs: No license required Prohibition of Manufacture/Sale of: Adulterated/Spurious/Misbranded Patent or proprietary medicine without true list of ingredients Any product manufactured in contravention of any provisions of the Act or Rules Offences and Penalties

86. Labelling and packing of A/S/U drugs Label should contain following particulars: True list of ingredients Caution in case of poisonous substance (as listed in Sch E1) Name of the drug as per literature in First Schedule Other details Pack size: Not more than 15 ml for high alcohol content preparations.

87. Patent or proprietary medicine- In relation to any other system of 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 time being or any other Pharmacopoeia authorized in this behalf by the Central Government after consultation with the DTAB.

88. Provisions applicable to homoeopathic medicines Import: No license required. Only for new homoeopathic medicine. Manufacture: License is required Schedule M(I) compliance Competent technical staff Sale: License required; No records required be maintained (up to 60ml)

89. Labelling: “Homoeopathic medicine” Name of the medicine Potency in decimal/centesimal/millisimal Name of each ingredient % of alcohol Batch or Lot Number Manufacturing License Proprietary name, if so.