Pharmaceutical Jurisprudence.pdf

A bridge between the producer and consumer,
-Identification of the product, its contents, dosage form
-name and address of producers.

1. PHARMACEUTICAL
JURISPRUDENCEASSIGNMENT
SUBMITTEDTO-Dr.ZeeshanMa'am
SUBMITTEDBY-PrachiPandey,RahulPal

2. PHARMA
LABELS

3. Whatislabel?
Label meansadisplayofwritten,printedorgraphicmatteruponimmediate
containerorthewrapperofadrugpackage

4. Labelis
-abridgebetweentheproducerandconsumer,
-Identificationoftheproduct,itscontents,dosageform
-nameandaddressofproducer
–tocontact,ifneeded
-cautions&warnings
-directionsforuse,
-batch number,dateofmanufacture,dateofexpiry
-storageconditions,
-maximumretailprice,
-andinsuresagainstcounterfeiting/spuriousproducts,

5. Contentsofalabel
If,targetedforexport–
•Regulationsoftheimportingcountryshallbeadheredto
andshallcontainthefollowingminimumdetails:
-nameofthedrug,
-batch/lotnumber,
-dateofexpiry,ifany,
-manufacturinglicensenumber,
-name&addressofthemanufacturer/(codenumber)*
*(ifnotclassifiedunderSch-F/F1,X,Bloodproducts)

6. Contentsofalabel
•Thenameofthedrug
(propername,conspicuously,andbrandname,ifany)
-inclusion of the letters, I.P, NFI,B.P,USP,INN, or
descriptiveofthetruenatureororigin(genericname)
•TheNetContents,
•Thecontentsofactiveingredients,
•Thename&addressofthemanufacturer,
•BatchNumber/B.No./Batch/LotNo./Lot,
•Manufacturinglicencenumber-M.L./Mfg.Lic.No.
•Dateofmanufacture&thedateofexpiryofpotency,

7. Contentsofalabel.(contd.,)
“Importlicence”number,ifofsch-c/c1&imported,
•“Physician'ssample–Nottobesold”,
•PercentageofAlcohol,ifnotless than3%,
•Red vertical line -of not less than 1mm thickness,
(falling under schedule G,H,X, narcotic analgesics,
hypnotics, sedatives, tranquilizers, corticosteroids,
hormones, hypoglycemics, antimicrobials, antiepileptics,
anticancerdrugs)
(Exceptions –Vet. drugs, external use, ophthalmic preparations, ear
drops,sterilesutures,surgicaldressings,preparationsforparenteral
use)
•Mechanicalcontraceptives+ScheduleR.

8. Contentsofalabel.(contd.,)-Medicines
ScheduleGdrug–
“Caution:itisdangeroustotakethispreparation
exceptundermedicalsupervision”
-conspicuouslyprinted,-surroundedbyaline,-no
otherwords.
(exceptiontopical/externalpreparations.)
ScheduleHdrug-
-Rx on the left top corner conspicuously
ScheduleHdrug–warning:tobesoldbyretailon
the prescription of a Registered Medical
Practitioneronly

9. Contentsofalabel.(contd.,)
Medicines.
-ScheduleHdrug–fallingunderNDPSAct,1985
-NRx,inredcolour,onthelefttopcorner,conspicuously
Schedule H drug –warning: to be sold by retail on the
prescriptionofaRegisteredMedicalPractitioneronly
-ScheduleHdrug–specifiedinScheduleX
XRx,inredcolour,onthelefttopcorner,conspicuously
-ScheduleXdrug–warning:tobesoldbyretailonthe
prescriptionofaRegisteredMedicalPractitioneronly.
*ifitisabulkpacking-onlyXRxinredcolour,displayed
conspicuously

10. Contentsofalabel.(contd.,)
Medicines.
Liniment, lotion etc., -”For external use only.”
Containsindustrialmethylatedspirit(forhumanuse),
-declarethefact&-”Forexternaluseonly.”
Ifforveterinaryuse–“Notforhumanuse;
foranimaltreatmentonly”
Namesoftheapprovedcoloursadded,ifany.
Nonsterilesurgicalligatures&sutures–
“nonsterilesurgicalligature(suture)–nottobeused
foroperationsuponthehumanbodyunlessefficiently
sterilised.

12. Contentsofalabel.(cosmetics)
If,targetedforexport–
•Regulationsoftheimportingcountryshallbeadheredto
•Shallcontainname&addressofthemanufacturer(code
number-ifrequestedbytheconsignee)
•IftargetedforsaleorconsumptioninIndia
-shallbemanufacturedbyalicensedmanufacturer,
-shallbelabeledasprescribed,
-shallnotcontainmisleading/falseclaims

13. Contentsofalabel.(cosmetics)
•Shallbelabeledoninnerandouterlabel
-nameofthecosmetic,
-nameandaddressofthemanufacturer(ifthe
containerissosmallthenameandprincipalplaceof
business)
-Usebefore…..,
-Netcontents(Onouterlabel),
-Adequatedirectionsforuse,warning,cautionorspecial
directions, names and quantities of hazardous /
poisonousmaterialsadded--(wherehazardexists)

14. Contentsofalabel.(cosmetics)contd.,
•Batchnumber,precededby“B”,
•Manufacturinglicensenumber–
precededby“M”,
•Litofingredientsofmorethanorequalto1%,inthe
orderofaddition,indescendingorder(exemptionto
lessthan60ml/30g),precededbythewords
“INGREDIENTS”
•Schedule-S,r.w.BSIspecifications,ifany
(directionsissuedbylicensingauthority)

15. Contentsofalabel.(cosmetics)contd.,
•Toothpastecontainingfluoride
-contentoffluorideinppm(shallnotbemore
than1000ppm)
-dateofexpiryontubeandcartoon.
Note:-Medicatedtoothpastesaredrugs.
•Hairdyescontainingdyes,colours,pigments–
shallbearacaution(R-149)

16. Contentsofalabel.(cosmetics)contd.,
Hairdyescontainingdyes,colours
“Caution—This product contains ingredients which may cause skin irritation in
certain cases and so a preliminary test according to the accompanying direction
shouldfirstbemade.Thisproductshouldnotbeusedfordyeingtheeye-lashesor
eye-browsassuchausemaycauseblindness”.
•EachpackageshallalsocontaininstructionsinEnglishandlocallanguagesonthe
followinglinesforcarryingoutthetest:
“Thispreparationmaycauseseriousinflammationoftheskininsomecasesandsoa
preliminary test should always be carried out to determine whether or not special
sensitivity exists. To make the test, cleanse a small area of skin behind the ear or
upontheinnersurfaceoftheforearm,usingeithersoapandwateroralcohol.Apply
asmallquantityofthehairdyeaspreparedforusetotheareaandallowittodry.
After twenty-four hours, wash the area gently with soap and water. If no irritation or
inflammation is apparent, it may be assumed that no hypersensitivity to the dye
exists. The test should, however, be carried out before each and every application.
Thispreparationshouldonnoaccountbeusedfordyeingeye-browsoreye-lashesas
severeinflammationoftheeyeorevenblindnessmayresult”

18. misleading:
•Factorsthatmakeclaimsmisleading:
–Lackofadequatebasisforcomparativeclaims
–Relianceoninadequatestudies
–Manipulationofdata,statisticalanalysis
–Lackofsufficientemphasisonadverseeffect
information
–PromotionofusesbeyondapprovedND