Drugs and Cosmetics Act, 1940 and its Rules 1945 - PowerPoint Presentation

1. Drugs and Cosmetics Act, 1940 and its Rules 1945Course Content:- (Unit-I & II)Dr. Prakash Chandra GuptaAssistant ProfessorUniversity Institute of PharmacyC.S.J.M. University, Kanpur

2. IntroductionThe Drug & Cosmetic Act was passed in 1940 and Rules 1945 with the objective of :Regulating Import, manufacture, distribution and sale of drug & cosmetics The act provide for the manufacture, distribution and sale of drugs and cosmetics by qualified and trained persons onlyThe act regulates the import of drugs in India, so that no substandard or spurious drug will enter into India.

3. .The act prohibits the manufacture of substandard or spurious drug in the India. The act also provide for the control over the manufacture, sale & distribution of Ayurvedic, Siddha, Unani & Homeopathic drugsTo establish Drugs Technical Advisory Board(DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs and cosmetics. Regular inspection of licensed premises by drug inspectors.

4. .Act provide special provisions to regulate the preparation, standardization & storage of biological & special products. To prescribe the manner of labeling & packing of the various classes of drugs & cosmetics.

5. Chapters of the actCHAPTER I: INTRODUCTORY CHAPTER II: THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUG LABORATORY, THE DRUGS CONSULTATIVE COMMITTEE CHAPTER III: IMPORT OF DRUGS AND COSMETICS CHAPTER IV: MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS CHAPTER IV-A: PROVISIONS RELATING TO AYURVEDIC, SIDDHAAND UNANI DRUGSCHAPTER V: MISCELLANEOUS

6. LIST OF AMENDING ACTS AND ADAPTATION ORDERSThe Drugs (Amendment) Act, 1955 The Drugs (Amendment) Act, 1960 The Drugs (Amendment) Act, 1962 The Drugs and Cosmetics (Amendment) Act, 1964 The Drugs and Cosmetics (Amendment) Act, 1972 The Drugs and Cosmetics (Amendment) Act, 1982 The Drugs and Cosmetics (Amendment) Act, 1995 The Drugs and cosmetics (Amendment) Act, 2008 The Drugs and cosmetics (Amendment) Act, 2017 The Drugs and cosmetics (Amendment) Act, 2018 Duration of license Inspection for grant of license and verification of compliance Inspection for verification of compliance The Drugs and cosmetics (Amendment) Act, 2019

7. DEFINITIONS Drugs: 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 on human body for the purpose of repelling insects like mosquitoes.

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

9. .Misbranded drugs: if it is so colored, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or if it is not labeled in the prescribed manner; or if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

10. .Adulterated drug : A drug shall be deemed to be adulteratedif 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 rendered 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;

11. .Spurious drugs: A drug shall be deemed to be spuriousIf it is imported under a name which belongs to another drug; or If it is an imitation of, or 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 its true character and its lack of identity with such other drug; or

12. .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. Misbranded cosmetic: A cosmetic shall be deemed to be misbrandedIf it contains a colour which is not prescribed; or If it is not labeled in a prescribed manner; or If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

13. .Spurious cosmetic: A cosmetic shall be deemed to be spurious ifIf it is imported under the name which belongs to another cosmetic; orIf it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly or conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or

14. .If the label or the container bears the name of an individual or company purporting to be the manufacturer of the cosmetic, which individual or company is fictitious or does not exist; or If it purports to be the product of a manufacturer of whom it is not truly a product.

15. .Patent or proprietary medicine: Means In relation to Ayurvedic, Siddha or Unani systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as listed in the First Schedule;

16. .In relation to any other systems 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 the time being or any other Pharmacopoeia authorized in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board

17. .Manufacture: Manufacture 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 drug, or the packing of any drug or cosmetic, in the ordinary course of retail business.

18. .Homeopathic medicines: Includeany drug which is recorded in Homeopathic proving or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative homeopathic literature of India and abroad and which is prepared according to the techniques of Homeopathic Pharmacy and covers combination of ingredients of such homeopathic medicines but does not include a medicine which is administered by parenteral route.

19. Schedules to the Act & Rules First Schedule: List of Ayurvedic, Siddha & Unani books Ayurvedic books Charak SamhitaSushrut Samhita, Vaidya Chintamani Ayurveda Chintamani Siddha Books Siddha vaidya Thiratu, Nagmuni Bhogar (700) Unani books Karabadin Quadri Karabadin Kabir Karabadin Azam

20. .Second Schedule: Standards to be complied with by imported drugs & by drugs manufactured for sale, sold, stocked or exhibited for sale or distributeSchedules to the Rule A: List of forms for making applications for issuing licences, granting licences, sending memorandum B: Fees for test or analysis by the Central Drugs Laboratory C: List Of biological and special products (Injectable) applicable to special provisions.

21. .C1: List of other special products whose import, sale, distribution and manufacture are governed by special provisionsD: Classes of exempted drugs which are exempted from certain provisions applicable to import of drugsE(1): List of poisinous substances under the Ayurvedic, Siddha, and Unani poisonsF: Provisions applicable to blood bank (Requirements and licencing process)

22. .F (I) : Provisions applicable to other biological and special products such as vaccines, antigens, diagnostic antigens, tuberculin, etc. regarding their production, testing, storage, packing, etc. F (II) :Standards for Surgical dressings and bandage cloth. F (III): Standard for umbilical tapes. FF: Standards for ophthalmic preparations.G: List of substances required to be used under medical supervision and labelled accordingly.H: List of substances (prescription) that should be sold by retail only on prescriptions of R.M.P

23. .J: List of diseases and ailments that drug should not claim to cureK: List of drugs that are exempted from certain provisions regarding manufactureM: Good manufacturing requirement of factory premises, plants and equipments M1: Requirements of factory premises for manufacture of homeopathic medicines M2: Requirements of factory premises for manufacture of cosmetics M3: Requirements of factory premises for manufacture of medical devices

24. .N: List of equipment to run a pharmacy O: standards for disinfectant fluidsP: Life period(expiry) of drugsP 1: Pack size of certain drugs. Q: List of coaltar colours permitted to be used in drug and cosmeticsR: Standards for mechanical contraceptives R1: Standards for medical devices S: Standards for cosmetics T: Requirements (GMP) of factory premises for ayurvedic, siddha, unani drugs

25. .U: Manufacturing and analytical records of drugs U1: Manufacturing and analytical records of cosmeticsV: Standards for patent or proprietary medicines W: List of drugs marketed under generic namesX: List of narcotic drugs and psychotropic substances Y: Requirement and guidelines on clinical trials for import and manufacture of new drugs

26. Administration of the act and rulesA) Advisory :Drugs Technical Advisory Board-DTAB Drugs Consultative Committee-D.C.C. B) Analytical : 1)Central Drugs Laboratory - CDL 2)Drug Control Laboratory in states 3)Government Analysts C) Executives : 1)Licensing authorities 2)Controlling authorities 3)Drug Inspectors

27. Administration of the act and rulesDTAB is constitute by Central government. It consist of 18 members, of whom 8 are ex-officio members, 5 nominated and 5 elected members. Ex-Officio Members: 1. Director General of Health Services (Chairman) 2. Drugs Controller of India 3. Director of the Central Drugs Laboratory, Calcutta 4. Director of the Central Research Institute, Kasauli5. Director of Indian Veterinary Research Institute, Izatnagar

28. .6. President, Pharmacy Council of India7. President, Medical Council of India8. Director of Central Drug Research Institute, LucknowNominated Members: Two persons nominated by the Central Government from among persons who are in charge of drugs control in the States One person nominated by the Central Government from the pharmaceutical industryTwo persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government

29. .Elected Members: 1. One person, to be elected by the Executive Committee of the Pharmacy Council of India, from among teachers in Pharmacy or Pharmaceutical chemistry or Pharmacognosy on the staff of an Indian university or an affiliated college2. One person, to be elected by the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics on the staff of an Indian University or an affiliated college3. One pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research

30. .4. One person to be elected by the Central Council of the Indian Medical Association5. One person to be elected by the Council of the Indian Pharmaceutical AssociationFunctions: To advise the Central Government and the State Governments on technical matters arising out of the administration of this Act. Modification & Amendments in the Act with consultation of Board.To carry out the other functions assigned to it by this Act. The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination and re-election

31. Drugs Consultative Committee(DCC) It is also an advisory body constituted by central government. Constitution: Two representatives of the Central Government One representative of each State Government Drugs Consultative Committee(DCC) DCC advise the Central Government and State Governments and the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout India in the administration of this Act.The Drugs Consultative Committee shall meet when required Has power to regulate its own procedure.

32. Central Drug Laboratory (CDL)Establishment of Central Drug Laboratory under the control of a director appointed by the Central Government. Functions: Analysis of samples of drugs and cosmetics sent by the custom collectors or courts.Analytical Q.C. of the imported samples. Collection, storage and distribution of internal standardsPreparation of reference standards and their maintenanceMaintenance of microbial cultures. Advise the central drug control administration in respect of quality & toxicity.

33. Government Analyst State Government may appoint such persons, having prescribed qualification as Government Analysts for the purpose of analysis/testing of samples of drugs and cosmetics. The central government may also appoint such person as a Government Analysts. Person who is directly or indirectly engaged in any trade connected with manufacture or sale of drugs & cosmetics can not be appoint as Government Analyst

34. . QUALIFICATION: person should be:- Graduate in medicine or science or pharmacy or Pharmaceutical chemistry and have 5 year post graduate experience in testing of drug in a laboratoryA postgraduate degree in medicine or science or pharmacy OR pharmaceutical chemistry and with at least 3 years experience in testing of drugs in laboratoryHolding associateship Diploma of the Institution of Chemists with Analysis of drugs & pharmaceuticals with at least 3 year experience in testing.

35. .Duties of Government Analyst: To cause analysis or testing of samples of drugs or cosmetics sent to him by Drug Inspectors or other persons under the provisions of the Act and furnish reports as per rules. Forward from time to time reports giving the results of analysis work and research with a view to their publication at the discretion of the Government.Procedure On receipt of samples from an Inspector the Government Analyst should record the condition or the seal and compare the seals with impression of the seal received separatelyAfter completion of the analysis the report in triplicate with full protocols applied should be sent to the inspector.

36. Licensing AuthoritiesFor import: The central government appoints licensing authorities to issue or renewal of licences for the import of drugs. For manufacture and sale: The state governments appoint licensing authorities for respective territories to issues licence for the sale of drugs and for the manufacture and sale of drugs and for manufacture of cosmetic. The Drug Controller of India has been notified as the Central License Approving Authority

37. .Qualification A graduate in Pharmacy or Pharmaceutical Chemistry or Medicine with specialization in clinical Pharmacology or Microbiology from a recognized universityAt least 5 year experience in the manufacture or testing of drugs or enforcement of the provision of the Act.

38. Controlling AuthorityDrug Inspectors at central and state level are under the control of controlling authority.Qualifications : He is a graduate in Pharmacy / Pharmaceutical chemistry / Medicine with specialization in Clinical pharmacology or Microbiology from a University established in India He has experience in manufacturing or testing of drugs or enforcement of the provisions of the Act for a minimum period of 5 yrs.

39. Drug Inspector Central and State Government are empowered to appoint a qualified persons as Drug Inspectors to inspect premises licensed for manufacture of drugs & cosmetics & sale of drugs. Drug Inspectors should have no any financial interest in the import, manufacture or sale of drugs and cosmetics. Drug Inspectors are deemed to be public servant.Drug Inspectors are required to keep all information's confidential & not to disclose.

40. .Qualifications of Drug Inspectors A graduate in Pharmacy or Pharmaceutical Sciences or Medicine with specialization in Clinical Pharmacology or Microbiology from a recognized University.Provided that for the purpose of Inspection of Manufacture of substances specified in Schedule C, a person appointed as a Drug Inspector should haveNot less than 18 months experience in the manufacture of at least one of the substances specified in Schedule C; orNot less than 18 months experience in testing of at least one of the substances specified in Schedule C in a approved laboratory; or

41. .Not less than 3 years experience in the inspection of firms manufacturing any of the substances specified in Schedule C during the tenure of their services as the Drug Inspectors

42. .Powers of Inspectors:Inspect:Inspection of any premises wherein any drug or cosmetic is being manufactured and he 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 distributedTake samples of any drug or cosmetic: He may take sample which is being manufactured or being sold or is stocked or offered for sale or exhibited or being distributed

43. .ii. Take sample from any person conveying, delivering or preparing to deliver any drug or cosmetic to a purchaser or a consigneeWith necessary assistance, search any person who has secret about his person, any drug or cosmetics in respect of which an offence relating to manufacture, sale, distribution under has been or is being committed at all reasonable times Enter and search at all reasonable times, any place or premises in which he has reason to believe that an offence is being committed or has been committed

44. .v. Stop and search any vehicle or conveyance which he has reason to believe, used for carrying any drug or cosmetic in respect of which offence has been or is being committedvi. Examine any record, register, document, or any other material object found while exercising above powers and seize the same if he has reason to believe that it is an evidence of commission of an offence under the Act viii. Exercise any other powers as may be necessary, for carrying out the purpose of this Act and the Rules made there under.

45. .Duties of Drug Inspectors: Classified under 2 headsA) Inspection of premises, licensed for the sale of drugs.B) Inspection of premises licensed for the manufacture of drugs & cosmetics Inspection of sale premises Inspect not less than twice a year all shops within the area assigned to himHe satisfy himself that the conditions of licenses are being fulfilled or not.Procure and send the samples for analysis, if necessary.

46. .Investigate any written complaints Maintain a record of all inspection made and action taken by himEnter and search where an offence is believed to be committed. Exercise other duties as may be necessaryInspection of manufacturing premises To inspect not less than once a year all shops licensed for manufacture of drug within the area assigned to him.If establishment licensed to manufacture of biological products specified in schedule C & C1, inspect the plant and the process of manufacturing, standardizing and testing of drugs and method of storage, technical qualification of the staff.

47. .Procedure of Drug Inspectors :Taking any samples of drug and dispatching them to laboratory: i. Whenever Drug Inspector take sample of drug or cosmetics, he may require a written acknowledge for the same.ii. He should pay its fair price and if price is not accepted he should issue a receipt for the same in prescribed formiii. Where an Inspector takes a sample of a drug or cosmetic for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he willfully absents himself.

48. .iv. He should divide the sample into four portions and each portion should be sealed and suitably mark.v. The sample from whom taken should be permit o add his own seal and mark to all or any of the portions so sealed and marked. vi. When the sample is taken from manufacturing premises, it should be necessary to divide the sample into three portions only. vii. Where the sample is made up in containers of small volume or is likely to deteriorate or be otherwise damaged by exposure, the Inspector shall take three or four such containers after suitably marking the same and, where necessary, seal them.

49. .viii. The Inspector shall restore one portion of a sample to the person from whom he takes it, and second portion is sent to the Government Analyst for test or analysis, third is reserved for the court, if required and fourth is sent to warrantor, if any.Seizure of stocks: Whenever an inspector suspects contravention of the Act, he may seize any stock of such drug or records, registers, documents which are believed to be evidence of commission of offence, he should as soon as may be, inform a Judicial Magistrate and take his order for custody.

50. Import of drugs and cosmeticsClasses of drugs prohibited to import.Import of drug under license Specified in Schedule C/C1 Specified in Schedule X Imported for Test/Analysis Imported for personal use Import of Homeopathic & Cosmetics Drugs Drugs exempted from provisions of import Offences and Penalties

51. Classes of Drugs Prohibited to ImportAny drug which is not of standard quality. Any misbranded, spurious or adulterated drug Any misbranded or spurious cosmetic Any drugs not labeled / packed in prescribed manner.Any drug or cosmetics which require import license and if imported without such license. Patent/Proprietary medicines whose true formula is not disclosed.

52. .Any cosmetics containing any such ingredient which may render it unsafe or harmful for use. Any drug which claim to cure or prevent any disease or ailment described in schedule J. Any drug or cosmetic the import of which is prohibited by rules.Drugs of biological products (C/C1) after the date of expiry

53. . Import of drug & cosmetics permitted under license only Drugs specified in schedule C & C1Drugs specified in schedule X Drugs for examination, test or analysis Drugs for personal use Any new drug

54. Import of drug under license/permitLicense is required for import of drug An application should be made to licensing authority to obtain import license License is valid up to 31st December. Licensee should inform to the licensing authority, if any changes.

55. Import of schedule C and C1 drugsConditions to be fulfilled :Licensee must have adequate facility for the storage.Licensee must maintain a record of the sale, showing the particulars of the names of drugs and of the persons to whom they have been sold. Licensee must allow an inspector to inspect premises and to check the records. Licensee must furnish the sample to the authority.Licensee must not sell the drugs from any batch from which samples have been supplied to the licensing authority, except under the advise of the licensing authority. Licensee must comply with undertaking given in Form 9The import license may be cancelled or suspended, if conditions are not satisfied.

56. Import of schedule X drugs The license for the import of schedule X drug is granted subject to the following condition. Licensee must have adequate facilities for the storage of imported drugs, so that the properties of drugs are preserved. Licensing authority may also refuse to grant the license if the license granted to the applicant previously was suspended or cancelled. Or in case if the applicant failed to comply with any provision of the Act IHowever if the applicant is not satisfied with the decision may appeal to central government within 30 days.

57. Import of small quantities of drug for examination, test or analysisSmall quantities of drugs, the import of which is prohibited under the act may be imported for the purpose of examination, test or analysis, subject to the following conditions. Imported only under a license in form-11 The licensee must use imported drug exclusively for the purpose for which they are imported & specified in the license. Licensee must maintain the records of imported drugs, showing particulars of their quantities, names of manufacturer and date of import. Licensee must allow the inspector to inspect the premises where imported drugs are kept & to check the record and to take the samples for test or analysis. Licensee must comply with other conditions as prescribed.

58. Import of drugs for personal useThe drug whose import is otherwise prohibited may be imported in small quantity for personal use without any license subject to the following conditions.The drug shall form the passenger’s bonafide baggage and must be exclusively for personal use of the passenger. The drug shall be declared to the customs authority, if so direct The quantity of any single drug so imported must not exceed 100 doses. The licensing authority may in an exceptional case, sanction the import of large quantity.

59. .Drug is not forming a part of bonafide personal luggage of the passenger may be allowed on an application made to Licensing authority in Form 12-A. If Licensing authority is satisfy that: The drug is for bonafide personal use. The quantity to be imported is reasonable and is covered by prescription of RMP.A permit is granted in respect of the said drug in Form 12-B

60. Import of new drugNo new drugs are allowed to imported without the sanction of the licensing authority. The importer of new drug when applying for permission, shall produce all documentary evidence and other evidences relating to its standards of quality & purity, strength, and such other information including the clinical trials; to the licensing authority.

61. Drugs exempted from provisions regulating imports of drug Substances not intended for medical use. (condition: label should bear that not for medicinal use.) Following substance which are used both as article of foods and drugs. (Condition: Exempted from all provisions of chapter III)Condensed/powdered milk, malt lactose farex /cereal oats, may be imported without any permit or license.Virol, Bovril, Chicken essence & other similar predigested food. Cinnamon, pepper, zinger & other condiment & spices.

62. Offences & Penalty related to import of drugOffence: Import of adulterated or spurious drug or any cosmetic unsafe for use or drug which involves risk to human beings or animals or drug not having therapeutic values Penalty: Punishable with imprisonment up to 3 years or with fine up to 5,000 or both on first conviction . And punishable with imprisonment up to 5 years or with fine up to 10,000 or both on subsequent conviction Offence: Import of any drug or cosmetic, other than referred above the import of which is prohibited. under section 10Penalty: 6 months imprisonment or fine up to Rs. 500 or both on first conviction. And 1 year imprisonment or Rs. 1000 fine for subsequent offence.

63. .Offence: Import of any drug or cosmetic prohibited under section 10.Penalty: Imprisonment upto 3 years or fine up to Rs. 5000 or both.

64. Manufacture of Drugs Manufacture in relation to any drug or cosmetics includes any process or part of process for making, altering, ornamenting, finishing, packing, labeling, breaking up or otherwise treating or adopting any drug or cosmetic for sale or distribution but does not include compounding or dispensing of any drug or the packing of any drug or cosmetic in the ordinary course of retail business. Types of manufacturing licenses provided under D&C Act and RulesLicense for manufacture of schedule C & C1 drugsLicense for manufacture of schedule X drugs License for manufacture of drugs other than those specified in schedule C & C1, X.

65. .License for manufacture of drugs meant for examination, test or analysis. Loan license Repacking license

66. Prohibition of manufacture and sale of certain drugsDrug not of standard quality or misbranded, adulterated or spurious. Patent or Proprietary medicine whose formula is not disclosed on the labelAny drug which claim to prevent or cure any diseases specified in schedule J Any cosmetic containing any ingredient which may render it unsafe or harmful to use.Drugs without therapeutic value Any drug or cosmetic in contravention of this Act or Rules .

67. Manufacture of drugs specified in schedule C&C1License is obtained from licensing authority on application in prescribed Form 27 with prescribed fees If the conditions is fulfilled, then license is issued in a prescribed Form 28.A person licensed to manufacture schedule C and C1 drugs, is required to observe the following general conditions :Licensed premises must conform to the requirements of GMP specified in schedule M. The licensee must provide adequate arrangement for testing the strength and quality of drugs.

68. .The manufacture of drugs must be carried out under active direction and personal supervision of technically qualified staff who should be either:Graduate in pharmacy or pharmaceutical chemistry with at least 18 months experience in the manufacture of drugs orA graduate in medicine with at least 3 years experience in the manufacture and testing of drugs orGraduate in science with chemistry or microbiology as the principal subject or graduate in chemical engineering with at least 3 years experience in the manufacture & testing of drugs or Any other equivalent foreign qualification. Licensee must have adequate facilities for the storage of imported drugs, so that the properties of drugs are preserved.

69. .Licensee must maintain the manufacturing and analytical records of the drugs (records should be preserved for at lest 2 years after the expiry of date for drugs with expiry and 5 years from the date of manufacture for other drugs.) Licensee must allow the inspector to inspect the premises where imported drugs are kept and to check the record and to take the samples for test or analysis.Licensee must inform to the licensing authority about any changes in the technical staff or any material changes in the plant or premises since the date of last inspection. Licensee on request, shall supply the samples of drugs from all the batches to the licensing authority for test or analysis.

70. .The following special provision related to biological or other special product must comply. All schedule C drugs must be issued in a previously sterilized glass containers sealed so as to prevent entry of bacteria.Drugs must comply with the standards of strength, quality & purity as specified in schedule F. Biological products such as sera, vaccine, antigen, antitoxin, insulin etc. should be tested for the absence of living & anaerobic microorganism. The test for sterility must be carried out.

71. Manufacture of Schedule-X drugsA License is obtained from licensing authority on an application in prescribed Form 27B with prescribed fees. If the conditions fulfilled ,then license is issued in a prescribed Form 28B. In addition to general conditions as mentioned before the licensee should observe the following conditions.Accounts of all transactions relating to the manufacture should be maintained in a serially bound and paged register.

72. .Drugs should be stored in bulk and if needed for manufacture outside storage place they should be kept in a separate place in the custody of responsible person. Licensee must submit a report to the licensing authority every three months regarding manufacture & sale of drugs. No schedule X drugs should be supplied by way of physician sample.

73. Manufacture of drugs other than those specified in schedule C, C1 & XA License is obtained from licensing authority on application in prescribed Form 24 for the manufacture of drugs other than those specified in schedule C, C1 and X and for manufacture of schedule X drugs in Form 24F. If the conditions is fulfilled, then respective license are issued in a prescribed Form 25 and 25F.In addition to general conditions as mentioned before the licensee should observe the following conditions. The licensee should maintain an inspection book in which the inspector may record their inferences.

74. .If the licensee desires to undertake the manufacture of any additional categories of drugs he should pay a fee of Rs. 10 for each such additional category. Licensee must comply with such additional requirements of which he has been given at least 4 months notice by the licensing authority.

75. Manufacture of drugs for examination, test or analysisLicense is necessary for the manufacture of any drug in small quantity for the purpose of examination, test or analysis. If a person proposing to manufacture does not hold license- To manufacture drugs other than those specified in Schedule C, C1 & X, orTo manufacture drugs specified in Schedule C, C1 in respect to such drugs; he should obtain license in Form 29

76. .If drug is not recognized as safe for use, license in Form 29 is only granted after producing no objection certificate from licensing authority appointed by Central Government. License remains valid for a period of one year time. Drugs should be kept in containers bearing labels indicating the purpose for which it has been manufactured.If the drugs are to be supplied to any other manufacturer, it should bear label stating name and address of manufacturer, scientific name of substance and purpose for which it has been manufactured.

77. .The following conditions must be observed by the licensee. Licensee must use manufactured drug exclusively for the purpose for which they are manufactured. Licensee must maintain the records of the manufactured drugs, showing particular of their quantities and names of the persons to whom they have been supplied. Licensee must allow the inspector to inspect the premises where drugs are kept and also allow to take the samples for test or analysis. Licensee must comply with such additional requirements of which he has been given at least 1 month notice by the licensing authority.

78. Manufacture of New DrugsA new drug is defined as a drug the composition of which is such that it is not generally recognized among experts as safe for use under conditions recommended; or suggested on the label thereof.Provisions applicable for the manufacture of new drugs whether classifiable under schedule C & C1 or otherwise.No new drug can be manufactured unless prior approval of the licensing authority has been taken.

79. .Applicant should produce all documentary and other evidence relating to the standards of quality, purity, strength and such other information as may be required including the results of therapeutic trials carried out on the new drug. While applying for a license to manufacture a new drug, or its preparations an applicant should produce along with his application evidence that the drug has already been approved.

80. Loan licensesA person who does not have his own arrangements(factory) for manufacture but who intends to avail the manufacturing facilities owned by another licensee. Such licenses are called Loan licenses. Loan licenses are issued for the manufacture of drugs other than specified in C, C1 & XA License is obtained from licensing authority on an application made in prescribed Form 24-A and the license is issued in a prescribed Form 25- A.Before granting a loan license the licensing authority inspect the premises and also enquire into qualification of technical staff, equipment and space for manufacture of drugs.

81. .The loan license shall be deemed to be cancelled or suspended, if the license owned by licensee whose manufacturing facilities have been availed by the licensee is cancelled or suspended. Licensee must test each batch of raw material and finished product. Licensee should maintain manufacturing and analytical records of drugs. Licensee must allow the inspector to inspect the premises where drugs are kept and to check the record and to take the samples for test or analysis.

82. Repacking licenseMeans the process of breaking up any drug from a bulk container into small packages and the labeling of such package with a view to its sale and distribution.Repackaging license of drugs is granted for drugs other than Schedule C, C1 and X License is obtained from licensing authority on an application made in prescribed Form 24B and license is issued in a Form 25B subject to satisfy the following condition: Factory premises must comply to the requirements of GMP specified in schedule M. Licensee should have adequate arrangements for the testing of drugs.

83. .The repacking must be carried out under hygienic conditions and personal supervision of competent person. A person who holds Diploma in Pharmacy or is a registered pharmacist or A person has passed the intermediate examination with chemistry as principal subject orA person has passed matriculation examination and have not less than 4 years of experience in manufacturing, dispensing or repacking of drugs. Licensee must have adequate facilities for the storage of drugs, so that the properties of drugs are preserved.

84. .Licensee must allow the inspector to inspect the premises where drugs are repacked and allow to take the samples for test or analysis.Licensee must inform to the licensing authority about any changes in the competent staff.License should be displayed on the licensed premises.Licensee must maintain the records for the repacking of drugs.Apart from other particulars, the repacked drug should bear the name and address of the licensee and his license no. preceded by words “Rpg. Lic. No.” on its label.

85. Sale of Drugs Sale may be defined as the process of passage of articles from the manufacturer to the consumer.There are two general types of sale: Whole sale of drugsDrugs other than those specified in Schedule C, C1 and XOther than Schedule C, C1 drugs from Motor VehicleSchedule X drugsDrugs specified in Schedule C and C1 but not included in Schedule X drugsDrugs specified in Schedule C and C1 from Motor Vehicle

86. .Retail sale of drugsGeneral licenses Restricted licenses

87. Wholesale of drugs other than those specified in Schedule C, C1 and XThe License is issued in Form 20B.Following conditions are to be satisfied by the licensee: The license should be displaced in a prominent part of premises opened to the public. The licensee must have adequate premises which should not be less than 10 sq. meters, equipped with facilities for the proper storage of drugs.Drug should be purchased only from a duly licensed dealer or manufacturer.

88. .Drugs should not be sold to any person who do not hold the license for the retail sale or distribution of drugs of these class. Licensee should maintain records related to all purchase and sale of drugs The licensee should comply with all the provisions as per the Act.

89. Wholesale of drugs other than Schedule C, and C1 drugs from Motor VehicleThe License is issued in Form 20BB.Following conditions are to be satisfied by the licensee: The license should be displaced in a prominent part of the vehicle. Drug should be purchased only from a duly licensed dealer or manufacturer.Drug should be sold only to those persons who are licensed to retail them.

90. .The licensee should comply with all the provisions as per the Act.The licensee should inform the licensing authority in writing in the event of any changes in the ownership of the vehicle.

91. Wholesale of Schedule X The license is issued in Form 20GFollowing conditions are to be satisfied by the licensee: The license should be displaced in a prominent part of premises opened to the public. The licensee must have adequate premises which should not be less than 10 sq. meters, equipped with facilities for the proper storage of drugs.Drug should be purchased only from a duly licensed dealer or manufacturer.The licensee should comply with all the provisions as per the Act.

92. .The licensee should forward to the licensing authority copies of the invoices of sale made to the retail dealers.Drug should be sold only to those persons who are licensed to sell or distribute drugs specified in schedule X.However it does not apply to the sale of drugs to:- Hospital, medical, educational or research institute Government authorities

93. Wholesale of drugs specified in Schedule C and C1 but not included in Schedule XThe license is issued in Form 21BFollowing conditions are to be satisfied by the licensee: The license should be displaced in a prominent part of premises opened to the public. The licensee should observe precautions prescribed for stocking or sale of drugsFor the sale of each additional category of drugs the permission should be obtained from the licensing authority

94. .Drug should be purchased only from a duly licensed dealer or manufacturer.The licensee should comply with all the provisions as per the Act.Drug should be sold only to those persons who are licensed to sell or distribute themHowever it does not apply to the sale of drugs to:- Hospital, medical, educational or research institute Government authorities A manufacturer of hydrogenated vegetable oils, beverages and other non medicinal products.

95. Wholesale of drugs specified in Schedule C and C1 from motor vehicleThe license is issued in Form 21BBFollowing conditions are to be satisfied by the licensee: The license should be displaced in a prominent part of premises opened to the public. The licensee should observe the precautions prescribed for the storage of drugsFor the sale of each additional category of drugs the permission should be obtained from the licensing authority

96. .Drug should be purchased only from a duly licensed dealer or manufacturer.Wholesale for resale can be made to a person holding the requisite license to sell or distribute the drugsHowever it does not apply to the sale of drugs to:- Hospital, medical, educational or research institute Government authorities A manufacturer of hydrogenated vegetable oils, beverages and other non medicinal products.The licensee should inform the licensing authority in writing in the event of any changes in the ownership of the vehicle.

97. Classes of drugs prohibited for wholesaleMisbranded, spurious and adulterated drugs and drugs not of standard quality Any patent or proprietary medicine Any drug which claims to cure or prevent any disease or ailments as described in schedule J.Any drug manufactured or imported in contravention to the act. Drugs whose expiry date has expired. Physician samples.

98. Retail saleFor retail sale two types of license are issuedGeneral license: Granted to a person who have premises for business and who have engage the services of qualified person to supervise the sale of drug and do the compounding and dispensing. Retail sale license for drugs other than those specified in schedule C, C1 and X are issued in Form 20, Retail sale license for drugs specified in schedule C, C1 and excluding schedule X are issued in Form 21Retail sale license for drugs specified in schedule X are issued in Form 20F2. Restricted license: Granted to those dealer who do not engage the services of qualified person.

99. . Condition for retail sale license.The license should be displayed at prominent place. The licensee should comply with all the provisions as per the Act.If any changes in qualified staff report to the licensing authority.The licensee must have an adequate premises equipped with facility for storage. Requirement prescribed to run pharmacy as per schedule N. Licensee must allow an inspector to inspect the premises, register and records. Precaution should be taken for the storage of schedule C and C1 drug.Drug should be purchased from license manufacturer.

100. Restricted licenseRestricted licenses for sale of drugs other than those specified in schedule C, C1 and X are issued in Form 20A. Restricted licenses for sale of drugs specified in schedule C, C1 and excluding schedule X are issued in Form 21ARestricted licenses are granted to :Dealers or person in respect of drugs whose sale does not require the supervision of qualified person Vendors who purchase drugs from a licensed dealer for distribution in sparsely populated areas where other channels of distribution of drugs are not available

101. .Conditions for restricted license The license should be prominently displayed in the premise.The licensee can in deal only in such drugs which can be sold without supervision of a qualified person. If licensee is vendor he should buy drugs only from fixed dealer which is specified in his license. Licensee should take all precautions for preserving the properties of the drugs. The drugs should be sold in their original containers. Drugs should be purchased only from a duly licensed dealer or manufacturer.

102. OffencesPenalties for first convictionPenalties for subsequent convictionAnyone who sells any adulterated or spurious drugs or drugs which likely to cause deathImprisonment for a minimum of 5 Years extend upto life time imprisonment and fine of not less than Rs.10,000 Imprisonment upto 10 Years or fine upto Rs. 20,000 or bothSeles of any adulterated or spurious drugs or drugs which is not likely to cause death.Imprisonment for 1 -3 Years and fine of not less than Rs. 5,000Imprisonment for 2 -4 Years and fine of not less than Rs. 10,000Sale of drug in contravention of any other provision1-2 years imprisonment and fine 2-4 years imprisonment and fine not less than Rs. 5,000 Offences and penalties for manufacture and sale of drugs

103. OffencesPenalties for first convictionPenalties for subsequent convictionNot disclosing the name of manufacturer or the place where the manufactured drug are keptImprisonment upto 3 Years or fine upto Rs.1,000 or bothFailure to keep records of manufacture or sale of drugsImprisonment upto 3 Years or fine upto Rs.1,000 or bothUse of govt. analyst report for advertising any drug Fine upto Rs. 500Imprisonment upto 10 Years or fine or both

104. Labeling of drugsThe containers of all the drugs should be labeled as per the provisions of Drug and Cosmetics Rules 1945.Following general particulars should be appear in a conspicuous position on the innermost container in which the drug is packed and every other covering in which that container is packed: Name of drug (official name, trade name) Net content in terms of weight, measure, volume, number of units of contents, number of units of activity, as the case may be.

105. .The content of active ingredients− For oral liquid preparations in terms of the content per single dose, being indicated in 5 ml or multiple thereof. (Where the dose is below 5 ml, the contents of active ingredients may be expressed in terms of 1 ml or fraction thereof) For liquid parenteral preparations ready for administration in terms of 1 ml or percentage by volume or per dose in the case of single dose container (If the preparation is contained in an ampoule the composition is shown on the label or wrapper affixed to any package in which such ampoule is issued for sale)

106. .For drugs in solid form intended for parenteral administration, in terms of units or weight per milligram or gram; For tablets, capsules, pills etc. in terms of the content in each unit, as the case may be. For other preparations, in terms of percentage by weight or volume or in terms of unit per gram or ml, as the case may be. Name and address of the manufacturer Manufacturing license number (Mfg. Lic. No.) under which the drug has been manufacturedA distinctive batch number, lot number (preceded by words “Batch No.”, “B. No.:, “Lot No.”)Manufacturing and expiry date

107. .Precautionary information related to care in handling, usage etc. Information related to storage. General information such as:Shake well before use (Suspension, Emulsion, lotion) For external use only ( if external preparation)Not to be sold ( if physician sample) For animal use only ( for veterinary products)

108. Special labelling requirementsClass of drugNature of MedicineParticulars which should appear on labelSchedule C In original form 1) Proper name of the substance in addition to any patent or proprietary name 2) License No. 3) Batch or Lot No. 4) Potency in units 5) Name & address of manufacturer 6) Date of manufacture 7) Date of expiry 8) Precaution necessary for preserving the properties of drugSchedule GMedicines made up ready for internal useThe words “Caution: it is dangerous to take this preparation except under medical supervision” – conspicuously printed and surrounded by a line within which there shall be no other words; Schedule GAny drug (External use)No caution required

109. Class of drugNature of MedicineParticulars which should appear on labelSchedule HFor internal use and not comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985)1) Symbol Rx displayed on left top corner of the label 2) Schedule H drugs-Warning: to be sold by retail on the prescription of a R.M.P. onlySchedule HFor internal use and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 1) Symbol NRx displayed on left top corner of the label 2) Schedule H drugs- Warning: to be sold by retail on the prescription of a R.M.P. onlySchedule XFor internal useSymbol NRx in red ink displayed on left top corner of the label 2) Schedule X drugs- Warning: to be sold by retail on the prescription of a R.M.P. only

110. Class of drugNature of MedicineParticulars which should appear on labelSchedule PAny drug1) Date of manufacturing 2) Date of expiry of the potencySchedule WSingle ingredientProper name (no trade name)Patent and proprietary-----1) Quantities of the active ingredient 2) Name and address of manufacturer Ophthalmic ointments-----1) special instructions regarding storage, wherever applicable2) Warning: If irritation persist or increase discontinue the use and consult the physicianMechanical contraceptive-----1) Particulars specified in schedule R 2) Date of manufacture 3) Storage condition

111. Packing of drugsThe pack sizes of drugs meant for retail sale shall be as prescribed in Schedule P1 to the rules and for other drugs. The pack sizes for Tablets/Capsules shall be– Where the number of Tablets (coated or uncoated)/Capsules (hard or soft gelatin) is less than 10 :- Packing shall be made by the integral number.Where the number of Tablets (coated or uncoated)/Capsules (hard or soft gelatin) is more than 10: Pack size of Tablets/Capsules shall contain multiples of 5. The pack sizes for liquid Oral preparations shall be: 30 ml (pediatric only)/60 ml/100 ml/200 ml/450 ml.

112. .The pack sizes for Pediatric Oral Drops shall be: 5 ml/10 ml /15 ml. The pack sizes for Eye/Ear/Nasal drops shall be: 3 ml/5 ml /10 ml. The pack size for Eye Ointment shall be: 3 gm/5 gm/10 gmProvided that the provisions of the pack sizes covered under this rule shall not apply to: – The imported formulations in finished form. Preparations intended for Veterinary use. Preparations intended for Export. Vitamins/Tonics/Cough preparations/Antacids/Laxatives in liquid oral forms, Unit dose forms

113. .Pack sizes of dosage forms meant for retail sale to Hospitals, Registered Medical Practitioners, Nursing homes. Physician’s Samples. Pack sizes of large volume intravenous fluids: The drugs specified in Schedule X shall be marketed in packings not exceeding- 100 unit doses in the case of tablets/capsules 300 ml in the case of oral liquid preparations 5 ml in the case of injections Provided that nothing in this rule shall apply to packing meant for use of a hospital or a dispensary subject to the conditions that–

114. .Such supplies are made by the manufacturers or distributors direct to the hospital/dispensaries; and Hospital packs shall not be supplied to a retail dealer or to a Registered Medical Practitioner.

115. ReferencesJain N. K. A Text Book of Forensic Pharmacy. Vallabh Prakashan.Mithal B.M. A Textbook of Forensic Pharmacy, Vallabh Prakashan.

116. Thank You