1. 1Under the esteemed guidance ofRaja Reddy SirAndSunithaMadam(Dept Of Pharmaceutics)By:G. Jyothsna256212886012M.Pharm 1styr (Pharmaceutics)Malla Reddy College Of Pharmacy

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 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 India3 4. Objectives To regulate the import, manufacture, distribution and sale of drugs &cosmetics through licensing. Manufacture, distribution and sale of drugs and cosmetics by qualifiedpersons only. To prevent substandard in drugs, presumably for maintaining highstandards of medical treatment. To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs. To establish Drugs Technical Advisory Board(DTAB) and Drugs ConsultativeCommittees(DCC) for Allopathic and allied drugs and cosmetics.4 5. The salient features of the Drugs & Cosmetics Act, 1940are as follows:a) Maximum penalty life imprisonment and fine of Rs. 10 lakhs or 3 timesthe value of the confiscated goods, whichever is more.b) Some of the offences cognizable and non-bailable;c) Besides officers from the Drug Controllers Office, other gazette officersalso authorized to launch prosecution under the Act;d) Specially designated courts for trial of offences covered under the Act;e) Provision for compounding of minor offences.5 6. DefinitionsDrugs :All medicines for internal or external use of human beings oranimals and all substances intended to be used for or in thediagnosis, treatment, mitigation or prevention of any disease ordisorder in human beings or animals.6 7. Cosmetic :Any article intended to be rubbed, poured, sprinkled orsprayed on, or otherwise applied to, the human body or any partthereof for cleansing, beautifying, promoting attractiveness, oraltering the appearance, and includes any article intended foruse as a component of cosmetic.7 8. Misbranded drugs :a) if it is so coloured, coated, powdered or polished that damage is concealedb) if it is not labelled in the prescribed manner; orc) if its label or container or anything accompanying the drug bears anystatement, design or device which makes any false claim for the drug orwhich is false or misleading in any particular.8 9. Adulterated drug :(a) if it consists, in whole or in part, of any filthy, putrid or decomposedsubstance; or(b) if it has been prepared, packed or stored under insanitary conditionswhereby it may have been contaminated with filth or whereby it may havebeen rendered injurious to health; or(c) if its container is composed in whole or in part, of any poisonous ordeleterious substance which may render the contents injurious to health;or9 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 resemblesanother drug in a manner likely to deceive or bears upon it or upon itslabel or container the name of another drug.(c) if it has been substituted wholly or in part by another drug orsubstance.10 11. Manufacture :In relation to any drug or cosmetic, it includes any processor part of a process for making, altering, ornamenting, finishing,packing, labelling, breaking up or otherwise treating or adoptingany drug or cosmetic with a view to its sale or distribution butdoes not include the compounding or dispensing of any drug.11 12. Patent or Proprietary medicine :A drug which is a remedy or prescriptionpresented in a form ready for internal or externaladministration of human beings or animals and which isnot included in the edition of the Indian Pharmacopoeia forthe time being or any other Pharmacopoeia authorized inthis behalf by the Central Government.12 13. Administration of the act and rulesA) Advisory :1)Drugs Technical Advisory Board-DTAB2)Drugs Consultative Committee-D.C.C.B) Analytical :1)Central Drugs Laboratory - CDL2)Drug Control Laboratory in states3)Government AnalystsC) Executives :1)Licensing authorities2)Controlling authorities3)Drug Inspectors13 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)Director of Indian Veterinary Research Institute, Izatnagar(vi) President of Medical Council of India(vii) President of the Pharmacy Council of India(viii)Director of Central Drug Research Institute, Lucknow14 15. Nominated:1) Two persons by the Central Government from among persons whoare in charge of drugs control in the States2) One person by the Central Government from the pharmaceuticalindustry3) Two persons holding the appointment of Government Analyst underthis Act, to be nominated by the Central Government15 16. Elected:1)one person, to be elected by the Executive Committee of the Pharmacy Council ofIndia, from among teachers in pharmacy or pharmaceutical chemistry orpharmacognosy on the staff of an Indian university or a college affiliatedthereto;2)one person, to be elected by the Executive Committee of the Medical Council ofIndia, from among teachers in medicine or therapeutics on the staff of an Indianuniversity or a college affiliated thereto;3)one pharmacologist to be elected by the Governing Body of the Indian Council ofMedical Research;4)one person to be elected by the Central Council of the Indian MedicalAssociation;5)one person to be elected by the Council of the Indian Pharmaceutical Association; 16 17. Functions:To advise the Central Government and the State Governments ontechnical matters arising out of the administration of this Act.To carry out the other functions assigned to it by this Act.(The nominated and elected members of the Board shall hold office for threeyears, but shall be eligible for re-nomination and re-election)17 18. Drugs Consultative Committee(DCC) It is also an advisory body constituted by central government. Constitution:Two representatives of the Central GovernmentOne representative of each State Government18 19. Functions: To advise the Central Government, the State Governments and theDrugs Technical Advisory Board on any other matter tending tosecure uniformity throughout India in the administration of this Act. The Drugs Consultative Committee shall meet when required Has power to regulate its own procedure.19 20. Central Drug Laboratory(CDL) Established in Calcutta, under the control of a director appointed by theCentral GovernmentFunctions: Analysis or test of samples of drugs/cosmetics sent by the custom collectorsor courts. Analytical Q.C. of the imported samples. Collection, storage and distribution of internal standards. Preparation of reference standards and their maintenance. Maintenance of microbial cultures. Any other duties entrusted by Central Government. Acting as an appellate authority in matter of disputes. 20 21. IMPORT of drugs Classes of drugs prohibited to import Import of drug under license1)Specified in Schedule-X2)Any new drugs Drugs exempted from provisions of import Offences and Penalties21 22. Classes Of Drugs Prohibited To Import Misbranded drugs Drugs of substandard quality Drugs claiming to cure diseases specified in Sch-J Adulterated drugs Spurious drugs Drugs whose manufacture, sale/distribution are prohibited inoriginal country, except for the purpose of test, examination andanalysis. Patent/Proprietary medicines whose true formula is not disclosed.22 23. Import of the biological drugs(C/C1)Conditions to be fulfillled: Licensee must have adequate facility for the storage. Licensee must maintain a record of the sale, showing the particulars of the namesof 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.23 24. Import of the Schedule-X drugs(Narcotic & Psychotropic drugs)Conditions to be fulfilled: Licensee must have adequate storage facility. Applicant must be reputable in the occupation, trade or business. The license granted ever before should not be suspended or cancelled.24 25. Drugs Imported for examination, test oranalysisConditions to be fulfilled: License is necessary under form-11 Must use imported drugs only for said purpose and at the placespecified in the license. Must keep the record with respect to quantities, name of themanufacturer and date of import. Must allow an inspector to inspect the premises and check the records.25 26. Penalties related to ImportOFFENCES PENALTIESImport of spurious OR adulterateddrug OR drug which involves risk tohuman beings or animals OR drugnot having therapeutic valuesa) 3 years imprisonment and 5000Rs. fine on first convictionb) 5 years imprisonment OR 1000 Rs.fine OR both for subsequentconvictionContravention of the provision a) 6 months imprisonment OR 500Rs. fine OR both for firstconvictionb) 1 year imprisonment OR 1000 Rs.fine for subsequent offence26 27. Import of cosmeticsCosmetics 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 heavymetals27 28. MANUFACTURE28 29. Prohibition of manufacture Drug not of standard quality or misbranded, adulterated or spurious. Patent or Proprietary medicine Drugs which claims to cure diseases specified in Sch-J Drugs which Risky to human beings or animals Drugs without therapeutic value29 30. 30Types of manufacturing licencesAllopathic DrugsOther than Sch.-C/C1 & XSch.- C/C1But not -XSch.-X Sch.-C/C1 & X Drugs for thepurpose ofexamination testor analysisOwn Premises Own PremisesOwn Premises Loan LicenceRepackinglicence 31. Manuf. of drugs other than in Sch-C/C1Conditions: Premises should comply with schedule M Adequate facility for testing, separate from manufacturing Adequate storage facility Records of mfg. & testing-maintained for at least 2 years from date of Exp. Licence should provide sample to authority Furnish data of stability Maintain the inspection book Maintain reference samples from each batch Accounts of production recorded & maintained for 5 years or 1 year afterExpiry.31 32. Manufacture Of Sch-X drugsConditions: Have to sent invoice of sale to licensing authority every 3 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 - Injection32 33. Manuf. of drugs those in Schedule-C/C1(Biological)Conditions: Drugs must be issued in previously sterilized sealed glass or suitablecontainer Containers should comply with req. of Sch-F/F1 Drug must comply with std. (quality, purity, strength) specified in sch.-F Parenteral in doses of 10 ml or more should be tested for freedom fromPyrogens Separate lab. for culture & manipulation of spore bearing Pathogens Test for sterility should be carried out.33 34. Loan LicenseDefinition:A person(applicant) who does not have his own arrangements(factory) formanufacture but who wish to avail the manufacturing facilities owned byanother licensee. Such licenses are called Loan licenses.Procedure:Licence is obtained from licensing authority (FDA) on application inprescribed forms (24-A , 27-A) with prescribed fees (Rs. 6000, 1500).34 35. 35FORM 27-A(See Rule 75-A)Application for grant or renewal of a loan license to manufacture for sale 8a(or for distribution of) drugsspecified in Schedules C and C(1)8b(excluding those specified in 8c(Part XB and) Sch. X)1.I/We *.. of.hereby apply for the grant/renewal of loanlicense to manufacture on the premises situated atC/o the under mentioned drugs, beingdrugs specified in Schedules C and C(1) 8b(excluding those specified in 8c(Part XB and) Sch .X) to theDrugs and Cosmetics Rules, 1945.Names of drugs (each substance to be separately specified).1. The names, qualifications and experience of the expert staff actually connected with the manufacture andtesting of the specified products in the manufacturing premises.a)Name(s) of expert staff responsible for manufacture..b)Name(s) of expert staff responsible for testing1. I/We enclose:-a)A true copy of a letter from me/us to the manufacturing concern whose manufacturing capacity isintended to be utilized by me/us.b) A true copy of a letter from the manufacturing concern that they agree to lend the services of their 36. Repackaging licenseDefinition:Process of breaking up any drug from a bulk container into smallpackages and labeling with a view to their sale and distribution.Repackaging of drugs is granted of drugs other than Schedule-C/C1 and X.Procedure:Licence is obtained from licensing authority (FDA) on applicationin prescribed forms (24-B) with prescribed fees (Rs. 500, 200).36 37. Penalties related to Manufacture37OFFENCES PENALTIESManufacture of any spurious drugs a) 1-3 years imprisonment and Rs.5000fineb) 2-6 years imprisonment & Rs.10000fine on subsequent convictionManufacture of adulterated drugs a) 1 year imprisonment & Rs.2000 fineb) 2 years imprisonment & Rs.2000fine for subsequent convictionManuf. of drugs in contravention of theprovisionsa) Imprisonment up to 3 months &Rs.500 fineb) Imprisonment up to 6 months &Rs.1000 fine on subsequentconviction 38. SALE38 39. 39TYPES OF SALES LICENCESAllopathic DrugsWhole Sale Retail Sale Sales FromMotor Vehicle( Vender)General Licence RestrictedLicenceDrugs otherthan sch.-C/C1 & XDrugs inSch.- C/C1Drugs inSch.- XForSch.- C/C1 40. Classes of drugs prohibited to besold Misbranded, spurious, adulterated and drugs not of standard quality Patent/Proprietary drugs with undisclosed formula Sch-J drugs Expired drugs.40 41. S.No. Category Type SaleApplicationFormLicence FormFees forGrant/RenewalRenewalCertificate FormNo.Fee+ Penalty afterexpiry but within sixmonthsFees forduplicatecopy of Org.Lic.4/2/2012 411Drugs other thanthose specified inSchedule C&C (1)&XWhole Sale 19 20-B Rs.1500 21 -CRs.1500+Rs.500 p.m.or part there ofRs.150Retail Sale 19 20 Rs.1500 21 -CRs.1500+Rs.500 p.m.or part there ofRs.150Restricted(Gen.Store) 19-A 20-A R-61 (1) Rs.500 R-59 (2) 21 -CRs.500+Rs.250 p.m. orpart thereof R-59 (4)Rs.150 R- 59(3)2Drugs specified inSchedule C&C (1)but excluding thosespecified in ScheduleXWhole Sale 19 21B Rs.1500 21 -CRs.1500+Rs.500 p.m.or part there ofRs.150Retail Sale 19 21 Rs.1500 21 -CRs.1500+Rs.500 p.m.or part there ofRs.150Restricted(Gen.Store) 19-A 21-A R-61 (1) Rs.500 R-59 (2) 21 -CRs.500+Rs.250 p.m. orpart thereof R-59 (4)Rs.150 R- 59(3)3Drugs specified inSchedule XWhole Sale 19-C 20-G Rs.500 21-CRs.500+Rs.250 p.m. orpart there ofRs.150Retail Sale 19-C 20-F R-61(1) Rs.500 R-59(2) 21-CRs.500+Rs.250 p.m. orpart there of R-59(4)Rs.150 R- 59(3)4Sale of Drugs frommotor vehicles (1)Drugs other thanthose specified inSchedule C&C (1)Whole Sale 19-AA 20-BB Rs.500 21-CCRs.500+Rs.250 p.m. orpart there ofRs.150(2) Drugs specified inSchedule C&C (1)Whole Sale 19-AA 21-BB R-62-D Rs.500 21-CCRs.500+Rs.250 p.m. orpart there ofRs.1505HomoeopathicMedicinesWhole Sale 19-B 20-D Rs.250 20-ERs.250+Rs.50p.m. orpart there ofRs. 50Retail Sale 19-B20-CR-67-CRs. 250R-67-A(2)20-ERs.250+Rs.50p.m. orpart there of R-67-A(2)Rs. 50R-67-A(2)*GSR No. 421dated24/08/2001Forms 42. 42FORM 19-C{See Rule 59(2)}Application for grant or renewal of a {licence to sell, stock, exhibit or offer for sale, ordistribute} drugs specified in Schedule X1. I/We .. of ..hereby apply for a licence to sell byWholesale/retail drugs specified in Schedule-X to the Drugs and Cosmetics Rules,1945. We operate a pharmacy on the premises, situated at.2. The sale and dispensing of drugs will be made under the personal supervision of thequalified persons mentioned below:-Name.(Qualification)Name.(Qualification)1. Name of drugs to be sold .2. Particulars of storage accommodation.3. A fee of rupees.. has been credited to Government account underthe head of account.Date.Signature 43. Wholesale Of Biological (C/C1) Adequate premises, with greater than 10 M2 area, with proper storagefacility Drugs sold only to retailer having license Premises should be in charge of competent person who is Reg. Pharmacist. Records of purchase & sale Records preserved for 3 years from date of sale License should displayed on premises43 44. Wholesale Of Other Than ThoseSpecified In C/C1 And X All the conditions as discussed in for biological. Compounding is made by or under the direct and personal supervision of aqualified person.44 45. Retail sale For retail sale, two types of licenses are issued:i) General licensesii) Restricted licensesRestricted license:Granted to those dealers who do not engage the services of aqualified person and only deal with such classes of drugs whose sales canbe effected without qualified person and vendors who do not have fixedpremises.45 46. 46FORM 19-A{(See Rule 59(2)}Application for the grant or renewal of a restricted licence to sell, stock or exhibit {or offer}for sale or distribute drugs by retail by dealers Who do not engage the service of a qualifiedperson.1.I/We .. of..hereby apply for a licence to sell by retail (i){Drugs other thanthose specified in Schedule C, C(1) and X on the premises situated at.or (ii) Drugs specified in {Schedule C(1) on the premisessituated drugs specified in {Schedule C(1) as vendor in the at..are..2. Sales shall be restricted to such drugs as can be sold without the supervision of aqualified person under the Drugs and Cosmetics Rules.3. Names or classes of drugs proposed to be sold..4. Particulars of the storage accommodation for the storage of {Schedule C(1) drugs on thepremises referred to above.5. The drugs for sale will be purchased from the following dealers and such other dealers asmay be endorsed on the licence by the licensing authority from time to time.6. A fee of rupees __________ has been credited to Government under the head of accountDate..Signature. 47. Labeling&Packaging All the general and specific labeling and packaging specified to allclasses of drugs and cosmetics should be as per the provisions madeunder the act.47 48. Schedules to the act First schedule Names of books under Ayurvedic and Siddhasystems Second schedule Standard to be complied with by importeddrugs and by drugs manufactured for sale, sold, stocked orexhibited for sale or distribution48 49. Schedules to the rules49TYPE CONTENTA Performa for forms no. 1 to 50( Application, issue, renewal, etc.)B Rates of fee for test or analysis by CDL or Govt. analystsC List of Biological and special products (Injectable) applicable to special provisions.Ex. Sera, Vaccines, Penicillin..etcC1 List of Biological and special products (nonparenteral) applicable to specialprovisions.Ex. Digitalis, Hormones , ErgotD List of drugs that are exempted from provisions of importE1 List of poisonous substances under the Ayurvedic , Siddha and Unani systemsF Provisions applicable to blood bank 50. Schedules to the rulesTYPE CONTENTF1 Special provision applicable to biological and special products, eg.Bacterial and viral vaccines, sera from living animals, bacterial origindiagnostic agentsF2 Standards for surgical dressingsF3 Standards for umbilical tapesFF Standards for ophthalmic preparationsG List of substances required to be used under medical supervision and50labelled accordingly Ex. Metformin, Anti Histaminic, etcH List of substances (prescription) that should be sold by retail only onprescriptions of R.M.P. Ex. Atenolol, Lorazepam, Dapson etc 51. Schedules to the rules51TYPE CONTENTJ List of diseases and ailments that drug should not claim to cureEx. Cancer, AIDS, Cataract, DiabetesetcK List of drugs that are exempted from certain provisions regarding manufactureM Requirements 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 devicesN List of equipment to run a PharmacyO Standards for disinfectant fluids Ex Phenol, H2O2, alcohol. 52. Schedules to the rulesTYPE CONTENTP Life period(expiry) of drugs Ex. Insuline Inj. 24 monthsQ Coal tar colors permitted to be used in cosmetics Ex. Caramel, TiO2, Toney red..R Standards for mechanical contraceptivesR1 Standards for medical devicesS Standards for cosmeticsT Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unani drugsU Manufacturing and analytical records of drugs52 53. Schedules to the rulesTYPE CONTENTU1 Manufacturing 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 substancesEX. Opium, Morphine, BarbitalY Requirement and guidelines on clinical trials for import and manufacture ofnew drugs53 54. References Available on www.cdsco.nic.in Pharmaceutical Jurisprudence by Dr.S.P. Agarwal;Rajesh Khanna; Pg: 40-109. Forensic Pharmacy by C.K. Kokate and S.B. Gokhle;Published by Pharma Book Syndicate; Pg: 47-121.54 55. 55