Drugs and cosmetics act 1940 and rules 1945

Drugs and cosmetics act 1940 and rules 1945 ppt

1. 1
Submitted By-
Baikunth Barik
B.Pharma 5
th
sem
ACP

2. Contents
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History andObjectives
Definitions
Administration of the act andrules
Provisions related toImport
Provisions related toManufacture
Provisions related toSale
Labeling andPackaging
Schedulestotheactandrules
Recent amendment act,2008
List offorms

3. History
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British misrule-Providing poor healthcare systemto
Indiancitizens
Observations made by-Drugs Enquiry
Committee, Indian MedicalAssociation
Reports in-IndianMedicalGazetteduring1920-30
1940 –Drugs and CosmeticsAct
1945 –Rules under theAct
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Extended to whole ofIndia……

4. LISTOFAMENDING ACTSAND
ADAPTATIONORDERS
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1.The Drugs (Amendment) Act,1955
2.The Drugs (Amendment) Act,1960
3.The Drugs (Amendment) Act,1962
4.The Drugs and Cosmetics (Amendment) Act,1964
5.The Drugs and Cosmetics (Amendment) Act,1972
6.The Drugs and Cosmetics (Amendment) Act,1982
7.The Drugs and Cosmetics (Amendment) Act,1995
8.The Drugsandcosmetics(Amendment) Act,2008

5. Objectives
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To regulate the import, manufacture, distribution
and sale of drugs & cosmetics throughlicensing.
drugsandManufacture,distributionandsaleof
cosmetics by qualified personsonly.
To prevent substandard indrugs.
Toregulatethemanufactureand
Ayurvedic, SiddhaandUnanidrugs.
saleof
AdvisoryToestablish
Board(DTAB)
Drugs Technical
and Drugs Consultative
Committees(DCC)forAllopathicandallieddrugs
andcosmetics.

6. Definitions
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Drugs:
Allmedicinesforinternalorexternaluseof
human
intended
beings
to
oranimals
beused
andallsubstances
fororinthe
diagnosis,treatment,mitigationorpreventionof
anydiseaseordisorderinhumanbeingsoranimals,
includingpreparationsappliedonhumanbodyfor
thepurposeofrepellinginsectslikemosquitoes.

7. Cosmetic:
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intended toAny article
rubbed,poured,sprinkledor
otherwise
sprayed
appliedintroducedinto,or
oranypartthereof
be
on,or
to,the
forhumanbody
cleansing, beautifying, promoting
attractiveness,oralteringtheappearance,and
includesanyarticleintendedforuseasa
componentofcosmetic.
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8. Misbrandeddrugs:
(a)ifitissocoloured,coated,powderedor
polishedthatdamageisconcealedorifitis
madetoappearofbetterorgreater
therapeuticvaluethanitreallyis;or
(b)ifitisnotlabelledintheprescribed
manner.
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ACP

9. Adulterated drug:
(a)ifitconsists,inwholeorinpart,ofany
filthy, putrid or decomposed substance;or
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(b)ifithasbeenprepared,packedorstoredunder
insanitaryconditionswherebyitmayhavebeen
contaminatedwithfilthorwherebyitmayhave
beenrenderedinjurioustohealth;or
(c)ifitscontaineriscomposedinwholeorin
part,ofanypoisonousordeleterious
substancewhichmayrenderthecontents
9injuriousto Health.

10. Spurious drugs:
anamewhich(a)ifitisimportedunder
belongs to another drug;or
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(b)ifitisanimitationof,orasubstitutefor,
anotherdrugorresemblesanotherdrugina
mannerlikelytodeceiveorbearsuponitor
uponitslabelorcontainerthenameof
anotherdrug

11. Manufacture:
toanydrugorcosmetic,itInrelation
includesanyprocessorpartofaprocessfor
making,altering,ornamenting,finishing,pac
king,labelling,breakinguporotherwise
treatingoradoptinganydrugorcosmeticwitha
viewtoitssaleordistributionbutdoesnot
includethecompoundingordispensingofany
drug,orthepackingofanydrugorcosmetic,in
theordinarycourseofretailbusiness.
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12. Patent or Proprietary medicine:
Adrugwhich
prescriptionpresentedin
isaremedyor
aformreadyfor
internalorexternaladministrationofhuman
beingsoranimalsandwhichisnotincluded
intheeditionoftheIndianPharmacopoeia
forthetimebeingoranyotherPharmacopoeia
authorizedinthisbehalfbytheCentral
Government.
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13. Administration of the act and
rules
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A)Advisory:
1)Drugs Technical AdvisoryBoard-DTAB
2)Drugs ConsultativeCommittee-D.C.C.
B)Analytical:
1)Central Drugs Laboratory -CDL
2)Drug Control Laboratory instates
3)GovernmentAnalysts
C)Executives:
1)Licensingauthorities
2)Controllingauthorities
3)DrugInspectors

14. Drugs Technical AdvisoryBoard(DTAB)
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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
Research
Institute,
(v)Director of Indian Veterinary
Institute,Izatnagar
(vi)President of Medical Council ofIndia
(vii)President of the Pharmacy Council ofIndia
(viii)DirectorofCentralDrugResearch
Lucknow

15. Nominated:
1)Two persons by the CentralGovernment.
2)One person by the Central Governmentfrom
the pharmaceuticalindustry
3)Twopersonsholdingtheappointmentof
Government Analyst under thisAct,
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16. Elected:
1)one person, to be elected by the Executive Committee of
the Pharmacy Council ofIndia,
2)one person, to be elected by the Executive Committee of
the Medical Council ofIndia,
3)one pharmacologist to be elected by the GoverningBody
of the Indian Council of MedicalResearch;
4)one person to be electedby the CentralCouncilofthe
Indian MedicalAssociation;
5)onepersontobeelectedbytheCounciloftheIndian
PharmaceuticalAssociation;
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17. Functions:
ToadvisetheCentralGovernmentandthe
State Governments on technicalmatters.
Tocarryouttheotherfunctionsassignedtoitby
thisAct.
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18. Drugs ConsultativeCommittee(DCC)
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Itisalsoanadvisorybodyconstitutedbycentral
government.
oftheCentral
ofeachState
Constitution:
Tworepresentatives
Government
Onerepresentative
Government

19. Functions:
 ToadvisetheCentralGovernment,theState
GovernmentsandtheDrugsTechnicalAdvisory
Boardonanyothermattertendingtosecure
uniformitythroughoutIndiainthe
administrationofthisAct.
TheDrugsConsultativeCommitteeshallmeet
whenrequired
Has power to regulate its ownprocedure.
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20. Central DrugLaboratory(CDL)
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EstablishedinCalcutta,underthecontrolofadirector
appointed by the CentralGovernment.
Functions:
Analysis or test of samples of drugs/cosmetics sent by
the custom collectors orcourts.
Analytical Q.C. of the importedsamples.
Collection,storageanddistributionofinternal
standards.
Preparationofreferencestandardsandtheir
maintenance.
Maintenance of microbialcultures.
Any other duties entrusted by CentralGovernment.
Actingasanappellateauthorityinmatterof disputes.

21. Drug control laboratories instate
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In gujarat three laboratories establishedwhich
collect,analysedandreportthevarioussampleofthedrugs
andfood.
1)Baroda: Established in1959.
2)Bhuj: Established in1979.
3)Rajkot: Established in1983
The laboratory has the followingdevision:-
Pharmaceutical ChemistryDivision
ImmunologyDivision
PharmacologyDivision
PharmacognocyDivision
FoodDivision
AyurvedicDivision

22. Function:
Testingof drugsample
Analysis of foodsample
Analysis of exicsesample
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23. Governmentanalyst
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Theseofficersareappointedbythecentralorstate
governmentandperformtheduties.
Qualificationofgovernmentanalysist
1Personshavingqualificationforappointmentas
governmentasgovermentalAnalysisforallopathic
drugs;
2having 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 undercontrolofa governmentanalyst.

24. Duties:
1) The Government Analyst shall cause tobe
analysed or tested such samples or drugs
and cosmetics as may be sent to him by
Inspectors.
2)A Government Analyst shall from timeto
time forward reports to the Government
giving the result of analytical work and
researchwithaviewtotheirpublication.
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25. Licencingauthority
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Qualification:
(i)Graduate in Pharmacy on Pharmaceutical
Chemistry or in Medicine with specializationin
clinical pharmacology or microbiology from a
University established in India by law;and
(ii)Experienceinthemanufactureortestingofdrugs
a minimum period of five years, Provided that the
requirementsastotheacademicqualificationshall
not apply to those inspectors.

26. Duties:
(1)to inspect all establishments licensed
for the sale of drugs within the area
assigned tohim;
(2)to satisfy himself that the conditions
of the licences are beingobserved;
(3)to procure and send for test or
analysis, if necessary, imported
packages.
(4)to investigate anycomplaint.
ACP

27. (5)to maintain a record of all inspections made and
action taken by himintheperformance of his
duties,
(6)to make such enquiries and inspections as may be
necessary to detect the sale of drugs in
contravention to theAct;
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28. Controllingauthority
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Qualification:
graduate in Pharmacy or PharmaceuticalChemistry
or in Medicine with specialization in clinical
Pharmacology or microbiology from a University
established in India by lawand
experienceinthemanufactureortestingofdrugsor
enforcement of the provisions of the Act for a
minimum period of fiveyears:

29. DrugInspector
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Qualification
1Personshavingqualificationforappointmentas
governmentasgovermentalAnalysisforallopathic
drugs;or
2having a degree in ayurved, sidha or unani system
and not less than three year post graduate experience
intheanalysisofdrugsinalaboratoryundercontrolof
(a)a government analyst, or (b) a chemical
examinar, or (c) head of an institutionspecially
approved for thispurpose.

30. Power:
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a)Inspect,--
(i)anypremiseswhereinanydrugorcosmeticis
beingmanufactured.
(ii)anypremiseswhereinanydrugorcosmeticis
beingsold,orstockedorexhibitedorofferedfor
sale,ordistributed;
(b)Takesamplesofanydrugorcosmetic,--
(i)which is being manufactured or being sold or is
stockedorexhibitedorofferedforsale,orisbeing
distributed;
(ii)from any person who is in the course of
conveying, delivering orpreparing to deliver such
drugorcosmetictoapurchaseroraconsignee.

31. Provision
ofAct
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Import
Manufacturi
ng
Sales Labeling
&
Packaging

32. IMPORT
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33. IMPORT ofdrugs
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Classes of drugs prohibited toimport
Import of drug underlicense
1)Specified in Schedule-C/C
1
2)Specified in Schedule-X
3)Imported forTest/Analysis
4)Imported for personal use
5)Any newdrugs
Drugs exempted from provisions ofimport
Offences andPenalties

34. Classes of drugs prohibited to
import
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Misbrandeddrugs
Drugs of substandardquality
Drugs claiming to cure diseasesspecifiedinSch-J
Adulterateddrugs
Spuriousdrugs
Drugswhosemanufacture,sale/distributionare
prohibitedinoriginalcountry,exceptforthepurpose
oftest,examinationandanalysis.
Patent/Proprietarymedicineswhosetrueformulais
notdisclosed.

35. Importofthebiological
drugs(C/C
1)
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Conditions to befulfillled:
Licenseemusthaveadequatefacilityforthestorage.
Licensee must maintain arecord of the sale.
Licensee must allow an inspector to inspectpremises
and to check therecords.
Licenseemustfurnishthesampletotheauthority.
Licenseemustnotselldrugsfromwhichsampleis
withdrawnandheisadvisednottosale,andrecallthe
batchfromthemarket.

36. Import of the Schedule-X drugs (Narcotic
& Psychotropicdrugs)
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Conditions to befulfilled:
Licensee must have adequate storagefacility.
Applicantmustbereputableintheoccupation,
tradeorbusiness.
Thelicensegrantedevenbeforeshouldnotbe
suspendedorcancelled.
Thelicenseehasnotbeenconvictedany
offenceundertheDrugsandCosmeticsActor
NarcoticandPsychotropicSubstancesAct.

37. Drugs Imported for
examination,testora
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nalysis
Conditions to befulfilled:
License is necessary underform-11
Mustuseimporteddrugsonlyforsaidpurpose
andattheplacespecifiedinthelicense.
Mustkeeptherecordwithrespecttoquantities,
nameofthemanufactureranddateofimport.
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Mustallowaninspector toinspectthepremises
andcheckt
Sh
JTe
PCrecords.

38. Drugs imported for personaluse
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38
Conditionstobefulfilled:
Upto100averagedosesmaybeimported
withoutanypermit,provideditispartof
passenger’sluggage.
Morethan100dosesimportedwithlicense.
Applyonformno.-12-A,12-B
custom
Drugs must be bonafide personaluse.
Drugsmustbedeclaredtothe
collectors if sodirected.

39. Import of drugs withoutlicense
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39
Substances not used for medicinalpupose
Drugs in Sch-C
1 required for manufacturing and not for
medicinaluse.
Substanceswhicharebothdrugsandfoodssuchas:
Condensed/PowderedMilk
Malt
Lactose
Farex/Cereal
Oats
Predigestedfoods
Ginger, Pepper, Cumin,Cinnamon

40. Penalties related toImport
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OFFENCES PENALTIES
Importof spuriousOR
adulterateddrugORdrugwhich
involvesrisktohumanbeingsor
animalsORdrugnothaving
therapeuticvalues
a)3yearsimprisonmentand
5000Rs.fineonfirst
conviction
b)5yearsimprisonmentOR
1000Rs.fineORbothfor
subsequentconviction
Contravention of theprovisiona)6monthsimprisonmentOR
500Rs.fineORbothforfirst
conviction
b)1yearimprisonmentOR1000
Rs.fineforsubsequent
offence
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41. Cosmetics prohibited toimport
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Misbrandedcosmetics
Spuriouscosmetics
Cosmetic containing harmfulingredients
Cosmetics not of standardquality
which contains morethan-2ppmArsenic, 20ppm
lead, 100 ppm heavymetals

42. MANUFACTURE
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43. Manufacture
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43
Prohibition ofmanufacture
Manufacture of other than inSch-C/C
1
Manufacture of those inSch-C/C
1
Manufacture of Sch-Xdrugs
Loanlicense
Repackaginglicense
Offences &Penalties

44. Prohibition ofmanufacture
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4
4
Drugnotofstandardqualityormisbranded,
adulterated orspurious.
Patent or Proprietarymedicine
Drugs inSch-J
Risky to human beings oranimals
Drugs without therapeuticvalue
Preparation containingcyclamates

45. Manuf. of drugs other than in Sch-
C/C
1
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45
Conditions:
Premises should comply with schedule‘M’
Adequatefacilityfortesting,separatefrom
manufacturing
Adequate storagefacility
Recordsmaintainedfor atleast2years from date of
Exp.
Should provide sample toauthority
Furnish data ofstability
Maintain the inspectionbook
Maintain reference samples from eachbatch

46. Manuf. of drugs those in
Schedule-C/C
1(Biological)
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46
Conditions:
Drugsmustbeissuedinpreviouslysterilizedsealed
glass or suitablecontainer
Containers should comply withSch-F
Someclassestestedforaerobic&anaerobicmicro-
organism.eg. Sera ,Insulin, Pituitaryhormones.
Serum tested for abnormaltoxicity
Parentral in doses of 10 ml or more should be tested for
freedom fromPyrogens
ofsporeSeparatelab.forculture&manipulation
bearingPathogens
Test for sterility should be carriedout.

47. Manufacture Of Sch-Xdrugs
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47
Conditions:
Accounts of all transactions regarding manuf. should
be maintained in serially.(Preserved for 5years)
Have to sent invoice of sale to licensing authorityevery
3months
Storedrugsindirectcustodyofresponsibleperson.
Preparation must be labeled withXRx
Marketed in packings notexceeding
100 unit dose–Tablets/Capsules
300 ml-Oralliquid
5 ml -Injection

48. LoanLicense
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48
Definition:
Aperson(applicant)whodoesnothavehis
ownarrangements(factory)formanufacturebut
whowishtomanufacturingfacilitiesownedby
anotherlicensee.SuchlicensesarecalledLoan
licenses.
Loan licenses are issuedfor:
1)Drugs other than specified in C/C
1 &X.
2)Drugs specified inSchedule-C/C
1

49. Repackaginglicense
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49
Definition:
Processofbreakingupanydrugfromabulk
containerintosmallpackagesandlabelingwitha
viewtotheirsaleanddistribution.
Repackaging of drugs is granted of drugs other than
Schdule-C/C
1 andX.

50. Penalties relatedto
Manufacture
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OFFENCES PENALTIES
Manufacture of any spuriousdrugsa)1-3yearsimprisonmentand
Rs.5000fine
b)2-6yearsimprisonment&
Rs.10000fineonsubsequent
conviction
Manufacture of adulterateddrugsa)1yearimprisonment&Rs.2000
fine
b)2yearsimprisonment&
Rs.2000fineforsubsequent
conviction
Manuf. of drugs in contravention of
theprovisions
a)Imprisonmentupto3months&
Rs.500fine
b)Imprisonmentupto6months
&Rs.1000fineonsubsequent
conviction
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51. Manufacture ofcosmetics
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51
Prohibited for the following classes ofdrug:
Misbranded or spurious cosmetics and ofsubstandard
quality
Cosmeticscontaininghexachloropheneormercury
compounds
Cosmeticscontainingcolorwhichcontainmorethan-
-2 ppm ofarsenic
-20 ppm oflead
-100 ppm of heavymetals
Eye preparations containing coal-tarcolor

52. SALE
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52

53. Sale ofDrugs
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53
Classes of drugs prohibited to besold
Wholesale of biological(C/C
1)
Wholesaleofother thanthosespecifiedin C/C
1
andX

54. Class of drug prohibited tosale
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54
Misbranded,spurious,adulteratedanddrugsnot
of standardquality
Patent/Proprietary drugs with undisclosedformula
Sch-Jdrugs
Expireddrugs.
bygovernmentDrugsusedforconsumption
schemes such as, Armedforce.
Physician’ssamples

55. Wholesale of biological(C/C
1)
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55
Adequatepremises,withgreaterthan10M
2
area, with proper storagefacility
Drugs sold only to retailer havinglicense
Premisesshouldbeinchargeofcompetent
person who is Reg.Pharmacist.
Records of purchase &sale
Records preserved for 3 years from date ofsale
License should displayed onpremises

56. whole sale from otherthan
specified in c/c1 andx
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56
Alltheconditionsasdiscussedinforbiological.
Compoundingis made by or under the direct and
personal supervision of a qualifiedperson.

57. Labeling &Packaging
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Allthe
labeling
generalandspecific
and packaging
specifiedtoallclassesofdrugs
andcosmeticsshouldbeasper
theprovisionsmadeunderthe
act.
57

58. Forallopathy
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58
Label

59. For ayurvedic, siddha, unani
homoepathy andcosmetics
59
LABEL

60. Schedules to theact
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60
underFirstschedule–Namesofbooks
Ayurvedic and Siddhasystems
Secondschedule–Standardtobecomplied
withbyimporteddrugsandbydrugs
manufacturedforsale,sold,stockedorexhibited
forsaleordistribution

61. Schedules to therules
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61
TYPE CONTENT
“A”Performa for forms( Application, issue, renewal,etc.)
“B”RatesoffeefortestoranalysisbyCDLorGovt.analysts
“C”List of Biological and special products (Injectable)
applicable
to specialprovisions.
“C
1”ListofBiologicalandspecialproducts
(nonparenteral)
applicable to specialprovisions.
“D” Listofdrugsthatareexemptedfromprovisionsofimport
“E
1”List of poisonous substances under the Ayurvedic , Siddha
and Unanisystems
“F”Provisions applicable to bloodbank

62. Schedules to therules
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62
TYPE CONTENT
“F
1”Specialprovisionapplicabletobiologicalandspecialproducts,eg.
Bacterialandviralvaccines,serafromlivinganimals,bacterial
origindiagnosticagents
“F
2”Standards for surgicaldressings
“F
3”Standards for umbilicaltapes
“FF”Standards for ophthalmicpreparations
“G”Listofsubstancesrequiredtobeusedundermedical
supervision and labelledaccordingly
“H”List of substances (prescription) that should be sold by retail only
on prescriptions ofR.M.P.

63. Schedules to therules
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TYPE CONTENT
“J”Listofdiseasesandailmentsthatdrugshouldnotclaimtocure
“K”List of drugs that are exempted from certain provisionsregarding
manufacture
“M” Requirements of manufacturing premises, GMP requirements of factory
premises, plants andequipments
“M
1”Requirements of factory premises for manufacture ofHomeopathic
medicines
“M
2”Requirements of factory premises for manufacture ofcosmetics
“M
3”Requirements of factory premises for manufacture of medicaldevices
“N” Listof equipment to run a Pharmacy
“O” Standards for disinfectantfluids
SJTPC 63

64. TYPE CONTENT
“P” Life period(expiry) ofdrugs
“Q” Coal tar colors permitted to be used incosmetics
“R” Standards for mechanicalcontraceptives
“R
1” Standards for medicaldevices
“S” Standards forcosmetics
“T” Requirements (GMP) of factory premises forAyurvedic, Siddha,
Unanidrugs
“U” Manufacturing and analytical records ofdrugs
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65. Schedules to therules
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65
TYPE CONTENT
“U
1”Manufacturing and analytical records ofcosmetics
“V”Standardsforpatentorproprietarymedicines
“W” List of drugs marketed under genericnames-
Omitted
“X” List of narcotic drugs and psychotropicsubstances
“Y” Requirement and guidelines on clinical trials for import and
manufacture of newdrugs

66. Drugs and Cosmetics (Amendment)
Act,2008
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66
Salient features of theAct:-
Substantial enhancement inpunishment
Lifeimprisonmentforoffendersinvolvedin
manufacture,saleanddistributionofspurious
andadulterateddruglikelytocausegrievous
hurt
Minimumpunishmentofsevenyearswhich
mayextendtolifeimprisonment
Provision for compensation to affectedperson

67. Different types offorms
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67
Forms.

68. QUESTIONS
Describe the functions of Central Drug
Laboratory.
Saleofdrugsaccording toDrugsand Cosmetic
Act.
DescribetheadministrationofDrugand
cosmeticsact
Manufactureofdrugsaccordingto
Drugsand CosmeticsAct.
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68

69. References
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69
www.cdsco.nic.in
“Pharmaceutical Jurisprudence”, JaniGK,Atul
prakashan; Fifth edition(2005-06);28.
“ForensicPharmacy”,Kokate CK andGokhle
SB, Pharma Book Syndicate;152
“Laboratories”http://www.gujhealth.gov.in/fdc-
laboratory.htm

70. ACP
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