Drugs & Cosmetics Act 1940 and Rules 1945

Drugs and Cosmetics Act 1940and Rules 1945 Prepared by :Rakshit V. ThumarM.Pharm Q.A. SEM-II

Guided by:Ms. Urvisha V. BangoriyaAssistant professorQuality Assurance DepartmentS. J. Takkar Pharmacy collegeRajkot

1SJTPCContentsHistory and ObjectivesDefinitionsAdministration of the act and rulesProvisions related to ImportProvisions related to ManufactureProvisions related to SaleLabeling and PackagingSchedules to the act and rulesRecent amendment act, 2008List of forms

2SJTPCHistoryBritish 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 Act1945 Rules under the Act

Extended to whole of India3SJTPCLIST OF AMENDING ACTS AND ADAPTATION ORDERS

1. 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, 20084SJTPCObjectivesTo regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing.Manufacture, distribution and sale of drugs and cosmetics by qualified persons only. To prevent substandard in drugs.To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.To establish Drugs Technical Advisory Board(DTAB) and Drugs Consultative Committees(DCC) for Allopathic and allied drugs and cosmetics.5SJTPCDefinitionsDrugs :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.

6SJTPCCosmetic :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.

7SJTPCMisbranded 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.

8SJTPCAdulterated 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.9SJTPCSpurious 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 drug10SJTPCManufacture : In relation to any drug or cosmetic, it 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.11SJTPCPatent 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.12SJTPCAdministration 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 Inspectors13SJTPCDrugs 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, Lucknow 14SJTPCNominated:Two persons by the Central Government.One person by the Central Government from the pharmaceutical industry Two persons holding the appointment of Government Analyst under this Act,

15SJTPCElected:1)one person, to be elected by the Executive Committee of the Pharmacy Council of India,

2)one person, to be elected by the Executive Committee of the Medical Council of India,

3)one pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;

4)one person to be elected by the Central Council of the Indian Medical Association;

5)one person to be elected by the Council of the Indian Pharmaceutical Association; 16SJTPCFunctions:To advise the Central Government and the State Governments on technical matters.To carry out the other functions assigned to it by this Act.

17SJTPCDrugs 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 Government18SJTPCFunctions:To advise the Central Government, the 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. 19SJTPCCentral Drug Laboratory(CDL)Established in Calcutta, under the control of a director appointed by the Central Government.

Functions:Analysis or test of samples of drugs/cosmetics sent by the custom collectors or 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.20SJTPCDrug control laboratories in stateIn gujarat three laboratories established which collect, analysed and report the various sample of the drugs and food.Baroda: Established in 1959.Bhuj: Established in 1979.Rajkot: Established in 1983The laboratory has the following devision:-Pharmaceutical Chemistry DivisionImmunology DivisionPharmacology DivisionPharmacognocy DivisionFood DivisionAyurvedic Division

SJTPC21Function:Testing of drug sampleAnalysis of food sampleAnalysis of exicse sampleSJTPC22Government analystThese officers are appointed by the central or state government and perform the duties.Qualification of government analysist1 Persons having qualification for appointment as government as govermental Analysis for allopathic drugs ; 2 having a degree in medicine, ayurved, sidha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of a government analyst.

SJTPC23Duties:1) The Government Analyst shall cause to be analysed or tested such samples or drugs and cosmetics as may be sent to him by Inspectors.2)A Government Analyst shall from time to time forward reports to the Government giving the result of analytical work and research with a view to their publication.

SJTPC24Licencing authorityQualification: (i) Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and(ii)Experience in the manufacture or testing of drugs a minimum period of five years, Provided that the requirements as to the academic qualification shall not apply to those inspectors .SJTPC25Duties:(1) to inspect all establishments licensed for the sale of drugs within the area assigned to him;(2) to satisfy himself that the conditions of the licences are being observed;(3) to procure and send for test or analysis, if necessary, imported packages.(4) to investigate any complaint.

SJTPC26(5) to maintain a record of all inspections made and action taken by him in the performance of his duties, (6) to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to the Act;

SJTPC27Controlling authorityQualification: graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical Pharmacology or microbiology from a University established in India by law andexperience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:SJTPC28Drug InspectorQualification1 Persons having qualification for appointment as government as govermental Analysis for allopathic drugs ; or2 having a degree in ayurved, sidha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of (a) a government analyst, or (b) a chemical examinar, or (c) head of an institution specially approved for this purpose.

SJTPC29Power:a) Inspect, --(i) any premises where in any drug or cosmetic is being manufactured.(ii) any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed ;(b) Take samples of any drug or cosmetic,--(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed;(ii) from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee.

SJTPC3031SJTPC IMPORT

32SJTPCIMPORT of drugsClasses of drugs prohibited to importImport of drug under license1)Specified in Schedule-C/C12)Specified in Schedule-X3)Imported for Test/Analysis4)Imported for personal use5)Any new drugsDrugs exempted from provisions of importOffences and Penalties

33SJTPCClasses of drugs prohibited to importMisbranded drugsDrugs of substandard qualityDrugs claiming to cure diseases specified in Sch-JAdulterated drugsSpurious drugsDrugs whose manufacture, sale/distribution are prohibited in original country, except for the purpose of test, examination and analysis.Patent/Proprietary medicines whose true formula is not disclosed.34SJTPCF exp34Import 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.

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 drugs from which sample is withdrawn and he is advised not to sale, and recall the batch from the market.35SJTPCImport 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 even before should not be suspended or cancelled.

The licensee has not been convicted any offence under the Drugs and Cosmetics Act or Narcotic and Psychotropic Substances Act.36SJTPCDrugs Imported for examination, test or analysisConditions 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.

37SJTPCDrugs 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 custom collectors if so directed.38SJTPCImport of drugs without licenseSubstances not used for medicinal puposeDrugs in Sch-C1 required for manufacturing and not for medicinal use.Substances which are both drugs and foods such as:Condensed/Powdered MilkMaltLactoseFarex/CerealOatsPredigested foodsGinger, Pepper, Cumin, Cinnamon39SJTPCPenalties related to ImportOFFENCESPENALTIESImport of spurious OR adulterated drug OR drug which involves risk to human beings or animals OR drug not having therapeutic values3 years imprisonment and 5000 Rs. fine on first conviction5 years imprisonment OR 1000 Rs. fine OR both for subsequent convictionContravention of the provision6 months imprisonment OR 500 Rs. fine OR both for first conviction1 year imprisonment OR 1000 Rs. fine for subsequent offence

40SJTPCCosmetics prohibited to importMisbranded cosmeticsSpurious cosmeticsCosmetic containing harmful ingredientsCosmetics not of standard qualitywhich contains more than-2 ppm Arsenic, 20 ppm lead, 100 ppm heavy metals

41SJTPCMANUFACTURE

42SJTPCManufactureProhibition of manufactureManufacture of other than in Sch-C/C1Manufacture of those in Sch-C/C1Manufacture of Sch-X drugsLoan licenseRepackaging licenseOffences & Penalties

43SJTPCProhibition of manufactureDrug 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 cyclamates

44SJTPCManuf. of drugs other than in Sch-C/C1Conditions:Premises should comply with schedule MAdequate facility for testing, separate from manufacturingAdequate storage facilityRecords maintained for at least 2 years from date of Exp.Should provide sample to authorityFurnish data of stabilityMaintain the inspection bookMaintain reference samples from each batch45SJTPCManuf. of drugs those in Schedule-C/C1(Biological)Conditions:Drugs must be issued in previously sterilized sealed glass or suitable containerContainers should comply with Sch-FSome classes tested for aerobic & anaerobic micro-organism.eg. Sera ,Insulin, Pituitary hormones.Serum tested for abnormal toxicityParentral in doses of 10 ml or more should be tested for freedom from PyrogensSeparate lab. for culture & manipulation of spore bearing PathogensTest for sterility should be carried out.46SJTPCManufacture Of Sch-X drugsConditions:Accounts of all transactions regarding manuf. should be maintained in serially.(Preserved for 5 years)Have to sent invoice of sale to licensing authority every 3 monthsStore drugs in direct custody of responsible person.Preparation must be labeled with XRxMarketed in packings not exceeding100 unit dose Tablets/Capsules300 ml- Oral liquid5 ml - Injection

47SJTPCLoan LicenseDefinition: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/C148SJTPCRepackaging licenseDefinition: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.49SJTPCPenalties related to ManufactureOFFENCESPENALTIESManufacture of any spurious drugs1-3 years imprisonment and Rs.5000 fine2-6 years imprisonment & Rs.10000 fine on subsequent convictionManufacture of adulterated drugs1 year imprisonment & Rs.2000 fine2 years imprisonment & Rs.2000 fine for subsequent convictionManuf. of drugs in contravention of the provisionsImprisonment up to 3 months & Rs.500 fineImprisonment up to 6 months & Rs.1000 fine on subsequent conviction

50SJTPCManufacture of cosmeticsProhibited for the following classes of drug:Misbranded or spurious cosmetics and of substandard qualityCosmetics containing hexachlorophene or mercury compoundsCosmetics containing color which contain more than-- 2 ppm of arsenic- 20 ppm of lead- 100 ppm of heavy metalsEye preparations containing coal-tar color51SJTPCSALE

52SJTPCSale of DrugsClasses of drugs prohibited to be soldWholesale of biological (C/C1)Wholesale of other than those specified in C/C1 and X53SJTPCClass of drug prohibited to saleMisbranded, spurious, adulterated and drugs not of standard qualityPatent/Proprietary drugs with undisclosed formulaSch-J drugsExpired drugs.Drugs used for consumption by government schemes such as, Armed force.Physicians samples54SJTPCWholesale of biological (C/C1)

Adequate premises, with greater than 10 M2 area, with proper storage facilityDrugs sold only to retailer having licensePremises should be in charge of competent person who is Reg. Pharmacist.Records of purchase & saleRecords preserved for 3 years from date of saleLicense should displayed on premises55SJTPC

whole sale from other than specified in c/c1 and xAll the conditions as discussed in for biological.Compounding is made by or under the direct and personal supervision of a qualified person.56SJTPCLabeling & 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.

57SJTPCFor allopathyLabel

SJTPC58For ayurvedic, siddha, unani homoepathy and cosmeticsLABEL

SJTPC59Schedules to the actFirst 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 distribution60SJTPCSchedules to the rulesTYPECONTENTAPerforma for forms( Application, issue, renewal, etc.)BRates of fee for test or analysis by CDL or Govt. analystsCList of Biological and special products (Injectable) applicable to special provisions.C1List of Biological and special products (nonparenteral) applicable to special provisions.

DList of drugs that are exempted from provisions of importE1List of poisonous substances under the Ayurvedic , Siddha and Unani systems FProvisions applicable to blood bank61SJTPCSchedules to the rulesTYPECONTENTF1Special provision applicable to biological and special products, eg. Bacterial and viral vaccines, sera from living animals, bacterial origin diagnostic agentsF2Standards for surgical dressingsF3Standards for umbilical tapesFFStandards for ophthalmic preparationsGList of substances required to be used under medical supervision and labelled accordinglyHList of substances (prescription) that should be sold by retail only on prescriptions of R.M.P.62SJTPCSchedules to the rulesTYPECONTENTJList 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 equipmentsM1Requirements of factory premises for manufacture of Homeopathic medicinesM2Requirements of factory premises for manufacture of cosmeticsM3Requirements of factory premises for manufacture of medical devicesNList of equipment to run a PharmacyOStandards for disinfectant fluids63SJTPCTYPECONTENTPLife period(expiry) of drugsQCoal tar colors permitted to be used in cosmeticsRStandards for mechanical contraceptivesR1Standards for medical devicesSStandards for cosmetics

TRequirements (GMP) of factory premises for Ayurvedic, Siddha, Unani drugsUManufacturing and analytical records of drugs64SJTPCSchedules to the rulesTYPECONTENTU1Manufacturing and analytical records of cosmeticsVStandards for patent or proprietary medicinesWList of drugs marketed under generic names- OmittedXList of narcotic drugs and psychotropic substancesYRequirement and guidelines on clinical trials for import and manufacture of new drugs 65SJTPCDrugs and Cosmetics (Amendment) Act, 2008Salient features of the Act:-

Substantial enhancement in punishment

Life imprisonment for offenders involved in manufacture, sale and distribution of spurious and adulterated drug likely to cause grievous hurt

Minimum punishment of seven years which may extend to life imprisonment

Provision for compensation to affected person66SJTPCDifferent types of formsForms.SJTPC67QUESTIONSDescribe the functions of Central Drug Laboratory. Sale of drugs according to Drugs and Cosmetic Act.Describe the administration of Drug and cosmetics actManufacture of drugs according to Drugs and Cosmetics Act.SJTPC68Referenceswww.cdsco.nic.inPharmaceutical Jurisprudence, Jani GK, Atul prakashan; Fifth edition(2005-06); 28.Forensic Pharmacy, Kokate CK and Gokhle SB, Pharma Book Syndicate; 152Laboratories http://www.gujhealth.gov.in/fdc-laboratory.htm

69SJTPCThank you.70SJTPC