Drugs and Cosmatic Act,1940 and its rules 1945

Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs Classes of drugs and cosmetics prohibited from import
,Import under license or permit. Offences and penalties.
Manufacture of drugs Prohibition of manufacture and sale of certain drugs
Conditions for grant of license and conditions of license for manufacture of
drugs, Manufacture of drugs for test, examination and analysis
,manufacture of new drug, loan license and repacking license.

1. Drugs and Cosmetics Act
1940 &Rules1945
Guided By -
Mr.Chandraprakash Dwivedi
M.Pharma (Pharmaceutics)
ACP Durg ,C .G
Submitted by –
Tameshwar Kamariya
B.pharmacy(5
th
sem)
Apollo college of Pharmacy,
Durg

2. Topic to beDiscuss……..
Objectives, Definitions, Legal definitions of schedules to the Act andRules
Import of drugsClassesofdrugs and cosmetics prohibited fromimport
,Import under license or permit. Offences and penalties.
Manufacture of drugs Prohibition of manufacture and sale of certaindrugs
Conditions for grant of license and conditions of license for manufacture of
drugs,Manufactureofdrugsfortest,examinationandanalysis
,manufacture of new drug, loan license and repackinglicense.

3. ShortHistory
British misrule-Providing poor healthcare system
to Indiancitizens
Use of filthy drugs in themarket
Observationsmadeby-DrugsEnquiry
CommitteeandIndian MedicalAssociation
Reports in-Indian Medical Gazette during 1920-
30
1940 –Drugs and CosmeticsAct
1945 –Rules under theAct
Extended to whole ofIndia……

4. LIST OF AMENDING ACTS ANDADAPTATION
ORDERS
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 Drugs and cosmetics (Amendment) Act,2008
9.The Drugs and cosmetics (Amendment) Act,2017
10.The Drugs and cosmetics (Amendment) Act,2018
-Duration oflicence
-Inspection for grant of license and verification ofcompliance
-Inspection for verification ofcompliance
11.The Drugs and cosmetics (Amendment) Act, 2019
https://www.scconline.com/blog/post/2019/01/11/drugs-and-cosmetics-
second-amendment-rules-2019-notified/

5. Objectives
Toregulatetheimport,manufacture,distribution
and sale of drugs & cosmetics throughlicensing.
Manufacture,distributionandsaleofdrugsand
cosmetics by qualified personsonly.
To prevent substandard indrugs.
ToregulatethemanufactureandsaleofAyurvedic,
SiddhaandUnanidrugs.
ToestablishDrugsTechnicalAdvisoryBoard(DTAB)
andDrugsConsultativeCommittees(DCC)for
Allopathicandallieddrugsandcosmetics.

6. Definitions
•Drugs:Allmedicinesforinternalorexternaluseofhuman
beingsoranimalsandallsubstancesintendedtobeusedfororin
thediagnosis,treatment,mitigationorpreventionofanydisease
ordisorderinhumanbeingsoranimals,includingpreparations
appliedonhumanbodyforthepurposeofrepellinginsectslike
mosquitoes.
•Cosmetic:Anyarticleintendedtoberubbed,poured,sprinkledor
sprayedon,orintroducedinto,orotherwiseappliedto,thehumanbody
oranypartthereofforcleansing,beautifying,promotingattractiveness,
oralteringtheappearanceandincludesanyarticleintendedforuseasa
componentofcosmetic.

7. Misbrandeddrugs
(A)Ifitissocoloured,coated,powderedorpolishedthat
damageisconcealedorifitismadetoappearofbetteror
greatertherapeuticvaluethanitreallyis;or
(B)Ifitisnotlabelledintheprescribedmanner.
Adulterateddrug:
(A)Ifitconsists,inwholeorinpart,ofanyfilthy,putridor
decomposedsubstance;or
(B)Ifithasbeenprepared,packedorstoredunderinsanitary
conditionswherebyitmayhavebeencontaminatedwithfilthor
wherebyitmayhavebeenrenderedinjurioustohealth;or
(C)Ifitscontaineriscomposedinwholeorinpart,ofany
poisonousordeleterioussubstancewhichmayrenderthe
contentsinjurioustohealth.

8. Spuriousdrugs:
(A)ifitisimportedunderanamewhichbelongstoanother
drug;or
(B)ifitisanimitationof,orasubstitutefor,anotherdrugor
resemblesanotherdruginamannerlikelytodeceiveorbears
uponitoruponitslabelorcontainerthenameofanotherdrug
Manufacture:
Inrelationtoanydrugorcosmetic,itincludesanyprocessor
partofaprocessformaking,altering,ornamenting,
finishing,packing,labelling,breakinguporotherwise
treatingoradoptinganydrugorcosmeticwithaviewto
itssaleordistribution.

9. Administration of the act andrules
A)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 instates
3)Government Analysts
C)Executives:
1)Licensing authorities
2)Controlling authorities
3)Drug Inspectors

10. A)Advisory
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 ResearchInstitute,
Izatnagar
(vi)President of Medical Council ofIndia
(vii)President of the Pharmacy Council ofIndia
(viii)Director of Central Drug Research Institute,Lucknow

11. Nominated:
1)Two persons by the CentralGovernment.
2)One person by the Central Government from thepharmaceutical
industry
3)TwopersonsholdingtheappointmentofGovernmentAnalyst
under thisAct.
Elected:
1)One person, to be elected by the Executive Committeeof
the Pharmacy Council ofIndia
2)One person, to be elected by the Executive Committeeof
the Medical Council ofIndia
3)OnepharmacologisttobeelectedbytheGoverning
Body of the Indian Council of MedicalResearch
4)One person to be elected by the Central Council ofthe
Indian MedicalAssociation
5)One person to be electedbytheCouncilofthe
Indian Pharmaceutical Association

12. Functions:
To advise the Central Governmentand
the State Governments on technical
matters.
To carry out the other functionsassigned
to it by thisAct.

13. Drugs Consultative Committee(DCC)
•Itisalsoanadvisorybodyconstituted
by centralgovernment.
•Constitution:
•TworepresentativesoftheCentral
Government
•OnerepresentativeofeachState
Government

14. Functions:
•ToadvisetheCentralGovernment,theState
GovernmentsandtheDrugsTechnical
AdvisoryBoardonanyothermattertending
tosecureuniformitythroughoutIndiainthe
administrationofthisAct.
•TheDrugsConsultativeCommitteeshallmeet
whenrequired
•Haspowertoregulateitsownprocedure.

15. Central DrugLaboratory(CDL)
•EstablishedinCalcutta,underthecontrolofadirector
appointed by the CentralGovernment.
Functions:
•Analysis or test of samples of drugs/cosmetics sent by the
custom collectors or courts.
•Analytical Q.C. of the importedsamples.
•Collection, storage and distribution of internalstandards.
•Preparation of reference standards and theirmaintenance.
•Maintenance of microbialcultures.
•Any other duties entrusted by CentralGovernment.
•Acting as an appellate authority in matter ofdisputes.

16. Drug control laboratories instate
•In Gujarat, three laboratories established which collect,analysed
and report the various sample of the drugs andfood.
1)Baroda: Established in1959.
2)Bhuj: Established in1979.
3)Rajkot: Established in1983
The laboratory has the followingdivision:-
•Pharmaceutical ChemistryDivision
•ImmunologyDivision
•PharmacologyDivision
•PharmacognosyDivision
•FoodDivision
•AyurvedicDivision

17. Function:
Testing of drugsample
Analysis of foodsample
Analysis of excisesample
LINK:

18. Governmentanalyst
•Theseofficersareappointedbythecentralorstate
governmentandperformtheduties.
•Qualificationofgovernmentanalysist
•1Personshavingqualificationforappointmentas
governmentasgovernmentalAnalysisforallopathic
drugs;
•2havingadegreeinmedicine,ayurved,sidhaor
unanisystemandnotlessthanthreeyearpost
graduateexperienceintheanalysisofdrugsina
laboratoryundercontrolofagovernmentanalyst.

19. Duties:
•1)TheGovernmentAnalystshallcausetobe
analysedortestedsuchsamplesordrugsand
cosmeticsasmaybesenttohimbyInspectors.
•2)AGovernmentAnalystshallfromtimeto
timeforwardreportstotheGovernment
givingtheresultofanalyticalworkand
researchwithaviewtotheirpublication.

20. Licensingauthority
•Qualification:
(i)GraduateinPharmacyonPharmaceutical
ChemistryorinMedicinewithspecializationin
clinicalpharmacologyormicrobiologyfroma
UniversityestablishedinIndiabylaw;and
(ii)Experienceinthemanufactureortestingof
drugsaminimumperiodoffiveyears

21. 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)Toprocure andsendfortestoranalysis,if
necessary, importedpackages.
(4)To investigate anycomplaint.
(5)Tomaintainarecordofallinspectionsmadeand
actiontakenbyhimintheperformanceofhisduties,
(6)Tomakesuchenquiriesandinspectionsasmaybe
necessarytodetectthesaleofdrugsincontravention
totheAct;

22. Controllingauthority
Qualification:
•GraduateinPharmacyorPharmaceutical
ChemistryorinMedicinewithspecializationin
clinical
•PharmacologyormicrobiologyfromaUniversity
establishedinIndiabylawand
•Experienceinthemanufactureortestingofdrugs
orenforcementoftheprovisionsoftheActfora
minimumperiodoffiveyears:

23. DrugInspector
Qualification
1Personshavingqualificationforappointmentas
governmentasgovernmentalAnalysisfor
allopathicdrugs;or
2Havingadegreeinayurveda,siddhaorunani
systemandnotlessthanthreeyearpostgraduate
experienceintheanalysisofdrugsinalaboratory
undercontrolof
(a)Agovernmentanalyst,or
(b)Achemicalexaminer,or
(c)Headofaninstitutionspeciallyapprovedforthis
purpose.

24. Power:
A)Inspect:
(i)Anypremiseswhereinanydrugorcosmeticisbeing
manufactured.
(ii)Anypremiseswhereinanydrugorcosmeticisbeing
sold,orstockedorexhibitedorofferedforsale,or
distributed;
(B)Takesamplesofanydrugorcosmetic:
(i)Whichisbeingmanufacturedorbeingsoldorisstocked
orexhibitedorofferedforsale,orisbeingdistributed;
(ii)Fromanypersonwhoisinthecourseofconveying,
deliveringorpreparingtodeliversuchdrugorcosmeticto
apurchaseroraconsignee.

26. IMPORT ofdrugs
Classes of drugs prohibited toimport
•Import of drug underlicense
1)Specified in Schedule-C/C1
2)Specified inSchedule-X
3)Imported forTest/Analysis
4)Imported for personaluse
5)Any newdrugs
•Drugs exempted from provisions ofimport
•Offences andPenalties

27. Classes of drugs prohibited to
import
Misbrandeddrugs
Drugs of substandardquality
Drugs claiming to cure diseases specified inSch-J
Adulterateddrugs
Spuriousdrugs
Drugswhosemanufacture,sale/distributionare
prohibitedinoriginalcountry,exceptforthe
purposeoftest,examinationandanalysis.
Patent/Proprietarymedicineswhosetrue
formulaisnotdisclosed.

28. Import of the biologicaldrugs(C/C1)
Conditions to befulfillled:
•Licenseemusthaveadequatefacilityforthe
storage.
•Licensee must maintain a record of thesale.
•Licenseemustallowaninspectortoinspect
premisesandtochecktherecords.
•Licenseemustfurnishthesampletotheauthority.
•Licenseemustnotselldrugsfromwhichsampleis
withdrawnandheisadvisednottosale,andrecall
thebatchfromthemarket.

29. Import of the Schedule-X drugs
(Narcotic & Psychotropicdrugs)
Conditionstobefulfilled:
•Licenseemusthaveadequatestoragefacility.
•Applicantmustbereputableintheoccupation,
tradeorbusiness.
•Thelicensegrantedevenbeforeshouldnotbe
suspendedorcancelled.
•Thelicenseehasnotbeenconvictedanyoffence
undertheDrugsandCosmeticsActorNarcotic
andPsychotropicSubstancesAct.

30. Drugs Imported for
examination, test oranalysis
Conditionstobefulfilled:
•Licenseisnecessaryunderform-11
•Mustuseimporteddrugsonlyfor
saidpurposeandattheplace
specifiedinthelicense.
•Mustkeeptherecordwithrespect
toquantities,nameofthe
manufactureranddateofimport.
•Mustallowaninspectortoinspect
thepremisesandcheckthe
records.

31. Drugs imported for personaluse
Conditionstobefulfilled:
•Upto100averagedosesmaybeimported
withoutanypermit,provideditispartof
passenger’sluggage.
•Morethan100dosesimportedwithlicense.
Applyonformno.-12-A,12-B
•Drugsmustbebonafidepersonaluse.
•Drugsmustbedeclaredtothecustom
collectorsifsodirected.

32. Import of drugs withoutlicense
•Substancesnotusedformedicinalpurpose
•Substanceswhicharebothdrugsandfoods
suchas:Condensed/PowderedMilk,Malt
Lactose,Farex/Cereal,Oats,Predigestedfoods,
Ginger,Pepper,Cumin,Cinnamon

33. Penalties related toImport

34. Cosmetics prohibited toimport
•Misbrandedcosmetics
•Spuriouscosmetics
•Cosmetic containing harmfulingredients
•Cosmeticsnotofstandardqualitywhich
containsmorethan-2ppmArsenic,20ppm
lead,100ppmheavymetals

35. MANUFACTURE
Prohibition ofmanufacture
•Manufacture ofother
than in Sch-C/C1
•Manufacture of thosein
Sch-C/C1
•Manufacture ofSch-X
drugs
•Loanlicense
•Repackaginglicense
•Offences &Penalties

36. Prohibition ofmanufacture
•Drugnotofstandardqualityormisbranded,
adulterated orspurious.
•PatentorProprietarymedicineordrugsin
Sch-J
•Risky to human beings oranimals
•Drugs without therapeuticvalue
•Preparation containingcyclamates

37. Manufacture of drugs other than inSchedule-
C/C1
Conditions:
•Premises should comply with schedule ‘M’
•Adequatefacilityfortesting,separatefrom
manufacturing
•Adequate storagefacility
•Records maintained for at least 2 years fromdate
ofExp.
•Should provide sample toauthority
•Furnish data ofstability
•Maintain the inspectionbook
•Maintain reference samples from eachbatch

38. Manuf. of drugs those inSchedule-
C/C1(Biological)
Conditions:
•Drugs must be issued in previously sterilized sealed glass
or suitablecontainer
•Containers should comply withSch-F
•Someclassestestedforaerobic&anaerobic
microorganism. eg. Sera ,Insulin, Pituitaryhormones.
•Serum tested for abnormaltoxicity
•Parenteral in doses of 10 ml or more should be testedfor
freedom fromPyrogens
•Separate lab. for culture & manipulation of sporebearing
Pathogens
•Test for sterility should be carriedout.

39. Manufacture Of Sch-Xdrugs
Conditions:
•Accounts of all transactions regarding manuf. Should be
maintained in serially.(Preserved for 5years)
•Have to sent invoice of sale to licensing authority every3
months
•Store drugs in direct custody of responsibleperson.
•Preparation must be labelled withX-Rx
•Marketed in packing notexceeding
•100 unit dose–Tablets/Capsules
•300 ml-Oralliquid
•5 ml -Injection

40. Manufacture ofcosmetics
Prohibited for the following classes ofdrug:
•Misbranded or spurious cosmetics andof
substandardquality
•Cosmetics containing hexachloropheneor
mercurycompounds
•Cosmetics containing color which containmore
than-
•2 ppm ofarsenic
•20 ppm oflead
•100 ppm of heavymetals
•Eye preparations containing coal-tarcolor

41. Penalties related toManufacture

42. LoanLicense
Definition:
•Aperson(applicant)whodoesnothavehisown
arrangements(factory)formanufacturebutwho
wishtomanufacturingfacilitiesownedby
anotherlicenseesuchlicensesarecalledLoan
licenses.
•Loanlicensesareissuedfor:
1)DrugsotherthanspecifiedinC/C1&X.
2)DrugsspecifiedinSchedule-C/C1

43. Repackaginglicense
Definition:
•Processofbreakingupanydrugfromabulk
containerintosmallpackagesandlabelling
withaviewtotheirsaleanddistribution.
•Repackagingofdrugsisgrantedofdrugsother
thanSchdule-C/C1andX.

44. SALE
Classes of drugs prohibited to besold
•Wholesale of biological(C/C1)
•Wholesaleofotherthanthosespecifiedin
C/C1 andX

45. Class of drug prohibited tosale
•Misbranded, spurious, adulterated and drugs
not of standardquality
•Patent/Proprietary drugs with undisclosed
formula
•Sch-Jdrugs
•Expireddrugs.
•Drugs used for consumption by government
schemes such as, Armedforce.
•Physician’ssamples

46. Wholesale of biological(C/C1)
•Adequatepremises,withgreaterthan10M2
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

47. whole sale from otherthan
specified in C/C1 andX
•Alltheconditionsasdiscussedinfor
biological.
•Compoundingismadebyorunderthedirect
andpersonalsupervisionofaqualified
person.

48. Labelling &Packaging
•Allthegeneralandspecificlabellingand
packagingspecifiedtoallclassesof
drugsandcosmeticsshouldbeasper
theprovisionsmadeundertheact.
Link:
•https://www.slideshare.net/SaloniAmbasana/labeling-and-
packaging-of-drugs-as-per-drugs-and-cosmetic-act
•https://www.slideshare.net/BiNduXtrEiy/labelling-of-drugs-
cosmetics-nd-biotech
•http://www.mcrhrdi.gov.in/drugs/week2/Labels%20&%20labelling2
.pdf

51. IMPORTANTLINKS
•http://ijpsr.com/bft-article/regulatory-process-for-import-and-export-of-
drugs-in-india/?view=fulltext
•http://apps.who.int/medicinedocs/documents/s17098e/s17098e.pdf
•https://www.healthcarelawinsights.com/2019/01/recent-developments-
in-state-pharmacy-law-regulation-looking-back-at-2018-and-what-to-
expect-in-2019/
•http://epilepsyns.com/buying-medicines-online-advantages-and-
disadvantages/
•https://blog.soliant.com/pharmacy/local-pharmacy-vs-online-pharmacy/