1. Prepared by :Rakshit V. Thumar M.Pharm Q.A. SEM-IIGuided by: Ms. Urvisha V. BangoriyaAssistant professorQuality Assurance Department S. J. Takkar Pharmacy collegeRajkot SJTPC 1

2. Contents History and Objectives Definitions Administration of the act and rules Provisions related to Import Provisions related to Manufacture Provisions related to Sale Labeling and Packaging Schedules to the act and rules Recent amendment act, 2008 List of forms SJTPC2 3. History British misrule-Providing poor healthcare system to Indian citizens Observations made by-Drugs Enquiry Committee, Indian Medical Association Reports in- Indian Medical Gazette during 1920-30 1940 Drugs and Cosmetics Act 1945 Rules under the ActExtended to whole of IndiaSJTPC3 4. LIST OF AMENDING ACTS ANDADAPTATION ORDERS1. The Drugs (Amendment) Act, 19552. The Drugs (Amendment) Act, 19603. The Drugs (Amendment) Act, 19624. The Drugs and Cosmetics (Amendment) Act, 19645. The Drugs and Cosmetics (Amendment) Act, 19726. The Drugs and Cosmetics (Amendment) Act, 19827. The Drugs and Cosmetics (Amendment) Act, 19958. The Drugs and cosmetics (Amendment) Act, 2008 SJTPC4 5. Objectives To regulate the import, manufacture, distributionand sale of drugs & cosmetics through licensing. Manufacture, distribution and sale of drugs andcosmetics by qualified persons only. To prevent substandard in drugs. To regulate the manufacture and sale ofAyurvedic, Siddha and Unani drugs. ToestablishDrugsTechnicalAdvisoryBoard(DTAB)and Drugs ConsultativeCommittees(DCC) for Allopathic and allied drugsand cosmetics. SJTPC5 6. DefinitionsDrugs : 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.SJTPC6 7. Cosmetic :Anyarticle intended tobe 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. SJTPC 7 8. Misbranded drugs :(a) if it is so coloured, 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 (b) if it is not labelled in the prescribed manner.SJTPC 8 9. Adulterated drug : (a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or (b) 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 (c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.SJTPC9 10. Spurious drugs : (a) if it is imported under a name which belongs to another drug; or (b) 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 SJTPC10 11. Manufacture :In relation to any drug or cosmetic, it includes any process or part of a process for making, altering, ornamenting, finishing, pac king, 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.SJTPC11 12. Patent or Proprietary 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. SJTPC 12 13. Administration of the act and rulesA) Advisory : 1)Drugs Technical Advisory Board-DTAB 2)Drugs Consultative Committee-D.C.C.B) Analytical : 1)Central Drugs Laboratory - CDL 2)Drug Control Laboratory in states 3)Government AnalystsC) Executives : 1)Licensing authorities 2)Controlling authorities 3)Drug InspectorsSJTPC13 14. Drugs Technical Advisory Board(DTAB) Ex-Officio:(i) Director General of Health Services (Chairman)(ii) Drugs Controller, India(iii)Director of the Central Drugs Laboratory, Calcutta(iv) Director of the Central Research Institute, Kasauli(v)DirectorofIndianVeterinaryResearch Institute, Izatnagar(vi) President of Medical Council of India(vii) President of the Pharmacy Council of India(viii)Director of Central Drug Research Institute,Lucknow SJTPC14 15. Nominated:1) Two persons by the Central Government.2) One person by the Central Government from the pharmaceutical industry3) Two persons holding the appointment ofGovernment Analyst under this Act,SJTPC 15 16. Elected:1)one person, to be elected by the Executive Committee ofthe Pharmacy Council of India,2)one person, to be elected by the Executive Committee ofthe Medical Council of India,3)one pharmacologist to be elected by the Governing Bodyof the Indian Council of Medical Research;4)one person to be elected by the Central Council of theIndian Medical Association;5)one person to be elected by the Council of the IndianPharmaceutical Association; SJTPC16 17. Functions:To advise the Central Government and the State Governments on technical matters.To carry out the other functions assigned to it by this Act.SJTPC17 18. Drugs Consultative Committee(DCC) It is also an advisory body constituted by central government. Constitution:Tworepresentativesof the Central GovernmentOne representativeofeach State GovernmentSJTPC 18 19. Functions: To advise the Central Government, the StateGovernments and the Drugs Technical AdvisoryBoard on any other matter tending to secureuniformity throughout India in theadministration of this Act. The Drugs Consultative Committee shall meetwhen required Has power to regulate its own procedure.SJTPC19 20. Central Drug Laboratory(CDL) Established in Calcutta, under the control of a directorappointed by the Central Government.Functions: Analysis or test of samples of drugs/cosmetics sent bythe custom collectors or courts. Analytical Q.C. of the imported samples. Collection, storage and distribution of internalstandards. Preparation of reference standards and theirmaintenance. Maintenance of microbial cultures. Any other duties entrusted by Central Government. Acting as an appellate authority in matter of disputes.SJTPC 20 21. Drug control laboratories in stateIn gujarat three laboratories established whichcollect, analysed and report the various sample of the drugsand food.1) Baroda: Established in 1959.2) Bhuj: Established in 1979.3) Rajkot: Established in 1983The laboratory has the following devision:- Pharmaceutical Chemistry Division Immunology Division Pharmacology Division Pharmacognocy Division Food Division Ayurvedic DivisionSJTPC21 22. Function: Testing of drug sample Analysis of food sample Analysis of exicse sample SJTPC22 23. Government analyst These officers are appointed by the central or stategovernment and perform the duties.Qualification of government analysist1Persons having qualification for appointment asgovernment as govermental Analysis for allopathicdrugs ;2having a degree in medicine, ayurved, sidha orunani system and not less than three year postgraduate experience in the analysis of drugs in alaboratory under control of a government analyst. SJTPC 23 24. Duties: 1) The Government Analyst shall cause to beanalysed or tested such samples or drugsand cosmetics as may be sent to him byInspectors. 2)A Government Analyst shall from time totime forward reports to the Governmentgiving the result of analytical work andresearch with a view to their publication. SJTPC24 25. Licencing authorityQualification:(i) Graduate in Pharmacy on PharmaceuticalChemistry or in Medicine with specialization inclinical pharmacology or microbiology from aUniversity established in India by law; and(ii)Experience in the manufacture or testing of drugsa minimum period of five years, Provided that therequirements as to the academic qualification shallnot apply to those inspectors .SJTPC25 26. Duties:(1) to inspect all establishments licensedfor the sale of drugs within the areaassigned to him;(2) to satisfy himself that the conditionsof the licences are being observed;(3) to procure and send for test oranalysis, if necessary, importedpackages.(4) to investigate any complaint. SJTPC 26 27. (5) to maintain a record of all inspections made andaction taken by him in the performance of hisduties,(6) to make such enquiries and inspections as may benecessary to detect the sale of drugs incontravention to the Act; SJTPC 27 28. Controlling authorityQualification: graduate in Pharmacy or Pharmaceutical Chemistryor in Medicine with specialization in clinicalPharmacology or microbiology from a Universityestablished in India by law and experience in the manufacture or testing of drugs orenforcement of the provisions of the Act for aminimum period of five years:SJTPC28 29. Drug InspectorQualification1Persons having qualification for appointment asgovernment as govermental Analysis for allopathicdrugs ; or2 having a degree in ayurved, sidha or unani systemand not less than three year post graduate experiencein the analysis of drugs in a laboratory under control of(a) a government analyst, or (b) a chemicalexaminar, or (c) head of an institution speciallyapproved for this purpose. SJTPC29 30. Power:a) Inspect, --(i) any premises where in any drug or cosmetic isbeing manufactured.(ii) any premises where in any drug or cosmetic isbeing sold, or stocked or exhibited or offered forsale, or distributed ;(b) Take samples of any drug or cosmetic,--(i) which is being manufactured or being sold or isstocked or exhibited or offered for sale, or is beingdistributed;(ii) from any person who is in the course ofconveying, delivering or preparing to deliver suchdrug or cosmetic to a purchaser or a consignee.SJTPC 30 31. Provisionof Act ManufacturiLabelingImport Salesng & Packaging SJTPC 31 32. IMPORTSJTPC32 33. IMPORT of drugs Classes of drugs prohibited to import Import of drug under license1)Specified in Schedule-C/C12)Specified in Schedule-X3)Imported for Test/Analysis4)Imported for personal use5)Any new drugs Drugs exempted from provisions of import Offences and PenaltiesSJTPC33 34. Classes of drugs prohibited toimport Misbranded drugs Drugs of substandard quality Drugs claiming to cure diseases specified in Sch-J Adulterated drugs Spurious drugs Drugswhose manufacture, sale/distribution areprohibited in original country, except for the purposeof test, examination and analysis. Patent/Proprietary medicines whose true formula isnot disclosed.SJTPC34 35. Import of the biologicaldrugs(C/C1)Conditions to be fulfillled: Licensee must have adequate facility for the storage. Licensee must maintain a record of the sale. Licensee must allow an inspector to inspect premisesand to check the records. Licensee must furnish the sample to the authority. Licensee must not sell drugs from which sample iswithdrawn and he is advised not to sale, and recall thebatch from the market.SJTPC 35 36. Import of the Schedule-X drugs(Narcotic & Psychotropic drugs)Conditions to be fulfilled: Licensee must have adequate storage facility. Applicant must be reputablein theoccupation, trade or business. The license granted even before should not besuspended or cancelled. The licensee has not been convicted anyoffence under the Drugs and Cosmetics Act orNarcotic and Psychotropic Substances Act.SJTPC 36 37. Drugs Imported forexamination, test or analysis Conditions to be fulfilled: License is necessary under form-11 Must use imported drugs only for said purpose and at the place specified in the license. Must keep the record with respect to quantities, name of the manufacturer and date of import. Must allow an inspector to inspect the premises and check the records.SJTPC 37 38. Drugs imported for personal useConditions to be fulfilled: Up to 100 average doses may be imported without any permit, provided it is part of passengers luggage. More than 100 doses imported with license. Apply on form no.-12-A,12-B Drugs must be bonafide personal use. Drugs must be declared to the customcollectors if so directed.SJTPC 38 39. Import of drugs without license Substances not used for medicinal pupose Drugs in Sch-C1 required for manufacturing and not formedicinal use. Substances which are both drugs and foods such as:Condensed/Powdered MilkMaltLactoseFarex/CerealOats Predigested foods Ginger, Pepper, Cumin, Cinnamon SJTPC 39 40. Penalties related to ImportOFFENCES PENALTIESImportofspuriousOR a) 3 years imprisonment andadulterated drug OR drug which5000 Rs. fine on firstinvolves risk to human beings orconvictionanimals OR drug not having b) 5 years imprisonment ORtherapeutic values1000 Rs. fine OR both forsubsequent convictionContravention of the provision a) 6 months imprisonment OR500 Rs. fine OR both for firstconviction b) 1 year imprisonment OR 1000Rs. fine for subsequentoffenceSJTPC40 41. Cosmetics prohibited to import Misbranded cosmetics Spurious cosmetics Cosmetic containing harmful ingredients Cosmetics not of standard quality which contains more than-2 ppm Arsenic, 20 ppm lead, 100 ppm heavy metals SJTPC 41 42. MANUFACTURESJTPC42 43. Manufacture Prohibition of manufacture Manufacture of other than in Sch-C/C1 Manufacture of those in Sch-C/C1 Manufacture of Sch-X drugs Loan license Repackaging license Offences & PenaltiesSJTPC 43 44. Prohibition of manufacture Drug not of standard quality or misbranded,adulterated or spurious. Patent or Proprietary medicine Drugs in Sch-J Risky to human beings or animals Drugs without therapeutic value Preparation containing cyclamatesSJTPC44 45. Manuf. of drugs other than in Sch-C/C1 Conditions: Premises should comply with schedule M Adequatefacility for testing, separate from manufacturing Adequate storage facility Records maintained for at least 2 years from date of Exp. Should provide sample to authority Furnish data of stability Maintain the inspection book Maintain reference samples from each batch SJTPC45 46. Manuf. of drugs those in Schedule-C/C1(Biological)Conditions: Drugs must be issued in previously sterilized sealedglass or suitable container Containers should comply with Sch-F Some classes tested for aerobic & anaerobic micro-organism.eg. Sera ,Insulin, Pituitary hormones. Serum tested for abnormal toxicity Parentral in doses of 10 ml or more should be tested forfreedom from Pyrogens Separate lab. for culture & manipulation of sporebearing Pathogens Test for sterility should be carried out. SJTPC 46 47. Manufacture Of Sch-X drugsConditions: Accounts of all transactions regarding manuf. shouldbe maintained in serially.(Preserved for 5 years) Have to sent invoice of sale to licensing authority every3 months Store drugs in direct custody of responsible person. Preparation must be labeled with XRx Marketed in packings not exceeding 100 unit dose Tablets/Capsules 300 ml- Oral liquid 5 ml - Injection SJTPC47 48. Loan License Definition:A person(applicant) who does not have his own arrangements(factory) for manufacture but who wish to manufacturing facilities owned by another licensee. Such licenses are called Loan licenses.Loan licenses are issued for: 1) Drugs other than specified in C/C1 & X. 2) Drugs specified in Schedule-C/C1SJTPC 48 49. Repackaging license Definition: Process of breaking up any drug from a bulk container into small packages and labeling with a view to their sale and distribution. Repackaging of drugs is granted of drugs other than Schdule-C/C1 and X. SJTPC 49 50. Penalties related toManufacture OFFENCES PENALTIESManufacture of any spurious drugs a) 1-3 years imprisonment and Rs.5000 fineb) 2-6 years imprisonment & Rs.10000 fine on subsequent convictionManufacture of adulterated drugsa) 1 year imprisonment & Rs.2000 fineb) 2 years imprisonment & Rs.2000 fine for subsequent convictionManuf. of drugs in contravention of a) Imprisonment up to 3 months &the provisions Rs.500 fineb) Imprisonment up to 6 months & Rs.1000 fine on subsequent convictionSJTPC50 51. Manufacture of cosmeticsProhibited for the following classes of drug: Misbranded or spurious cosmetics and of substandardquality Cosmetics containing hexachlorophene or mercurycompounds Cosmetics containing color which contain more than- - 2 ppm of arsenic - 20 ppm of lead - 100 ppm of heavy metals Eye preparations containing coal-tar colorSJTPC 51 52. SALESJTPC52 53. Sale of Drugs Classes of drugs prohibited to be sold Wholesale of biological (C/C1) Wholesale of other than those specified in C/C1 and X SJTPC 53 54. Class of drug prohibited to sale Misbranded, spurious, adulterated and drugs notof standard quality Patent/Proprietary drugs with undisclosed formula Sch-J drugs Expired drugs. Drugs used for consumption by governmentschemes such as, Armed force. Physicians samples SJTPC54 55. Wholesale of biological (C/C1) Adequate premises, with greater than 10 M2area, with proper storage facility Drugs sold only to retailer having license Premises should be in charge of competentperson who is Reg. Pharmacist. Records of purchase & sale Records preserved for 3 years from date of sale License should displayed on premisesSJTPC 55 56. whole sale from other than specified in c/c1 and x All the conditions as discussed in for biological. Compounding is made by or under the direct andpersonal supervision of a qualified person.SJTPC56 57. Labeling & PackagingAll the general and specific labeling and packaging specified to all classes of drugs and cosmetics should be as per the provisions made under the act. SJTPC57 58. For allopathy LabelSJTPC 58 59. For ayurvedic, siddha, unanihomoepathy and cosmeticsLABELSJTPC59 60. Schedules to the act First schedule Names of books under Ayurvedic and Siddha systems Second schedule Standard to be complied with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distributionSJTPC60 61. Schedules to the rulesTYPECONTENTA Performa for forms( Application, issue, renewal, etc.)B Rates of fee for test or analysis by CDL or Govt. analystsC List of Biological and special products (Injectable) applicableto special provisions.C1List of Biological and special products (nonparenteral)applicable to special provisions.D List of drugs that are exempted from provisions of importE1List of poisonous substances under the Ayurvedic , Siddha andUnani systemsF Provisions applicable to blood bankSJTPC61 62. Schedules to the rulesTYPE CONTENTF1 Special provision applicable to biological and special products, eg. Bacterial and viral vaccines, sera from living animals, bacterial origin diagnostic agentsF2 Standards for surgical dressingsF3 Standards for umbilical tapesFF Standards for ophthalmic preparationsGList of substances required to be usedunder medical supervision and labelled accordinglyHList of substances (prescription) that should be sold by retail only on prescriptions of R.M.P.SJTPC 62 63. Schedules to the rulesTYPECONTENT J List of diseases and ailments that drug should not claim to cureKList of drugs that are exempted from certain provisions regarding manufactureMRequirements of manufacturing premises, GMP requirements of factory premises, plants and equipmentsM1 Requirements of factory premises for manufacture of Homeopathic medicinesM2 Requirements of factory premises for manufacture of cosmeticsM3 Requirements of factory premises for manufacture of medical devicesNList of equipment to run a PharmacyOStandards for disinfectant fluidsSJTPC63 64. TYPECONTENTPLife period(expiry) of drugsQCoal tar colors permitted to be used in cosmeticsRStandards for mechanical contraceptivesR1 Standards for medical devicesSStandards for cosmeticsTRequirements (GMP) of factory premises for Ayurvedic, Siddha, Unani drugsUManufacturing and analytical records of drugsSJTPC64 65. Schedules to the rulesTYPECONTENTU1Manufacturing and analytical records of cosmeticsV Standards for patent or proprietary medicinesW List of drugs marketed under generic names-OmittedX List of narcotic drugs and psychotropic substancesY Requirement and guidelines on clinical trials for import andmanufacture of new drugs SJTPC65 66. Drugs and Cosmetics (Amendment)Act, 2008Salient features of the Act:- Substantial enhancement in punishment Life imprisonment for offenders involved inmanufacture, sale and distribution of spuriousand adulterated drug likely to cause grievoushurt Minimum punishment of seven years whichmay extend to life imprisonment Provision for compensation to affected personSJTPC 66 67. Different types of forms Forms. SJTPC67 68. QUESTIONS Describe the functions of Central Drug Laboratory. Sale of drugs according to Drugs and Cosmetic Act. Describe the administration of Drug and cosmetics act Manufacture of drugs according to Drugs and Cosmetics Act.SJTPC68 69. References www.cdsco.nic.in Pharmaceutical Jurisprudence, Jani GK, Atulprakashan; Fifth edition(2005-06); 28. Forensic Pharmacy, Kokate CK and GokhleSB, Pharma Book Syndicate; 152 Laboratories http://www.gujhealth.gov.in/fdc-laboratory.htm SJTPC69 70. SJTPC 70