Drugs & cosmetics act schedules to be prescribed

drugs and cosmetics act

1. DRUG SCHEDULES
Ms. PRIYA TIWARI
Assistant Professor
Faculty of Pharmaceutical Sciences
Rama University
Kanpur

2. •TherapeuticgoodsintheUnitedStatesare
regulatedbytheU.S.FoodandDrug
Administration(FDA),whichmakessome
drugsavailableoverthecounteratretail
outletsandothersbyprescriptiononly.
Eachofthecontrolledsubstancesisidentified
underoneoffiveControlledSubstances
Schedules.
■ScheduleI
■ScheduleII
■ScheduleIII
■ScheduleIV
■ScheduleV

3. •ScheduleI Drugs–
•Highpotentialforabuse.
•NoacceptedmedicaluseintheU.S.orlacks
acceptedsafetyforuseintreatmentintheU.S.
•–Maybeusedforresearchpurposesby
properly registeredindividuals.
•Examples:heroin,methylene
dioxymethamphetamine,lysergic acid
diethylamide, mescaline,and all saltsand
isomersthereof

4. ScheduleII Drugs
Highpotential for abuse.
Has a currentlyaccepted medical use in the
U.S.
Abuse of substancemay leadto severe
psychological or physical dependence.
Examples:morphine, oxycodone, fentanyl,
meperidine,dextroamphetamine, cocaine,
amobarbital

5. •ScheduleIII Drugs
•Abuse potentiallessthansubstancesin
scheduleIor schedule
•Has a currentlyaccepted medical use in the
U.S.
•Abuse of substancemayleadto moderate to
low physical dependenceor high psychological
dependence.
•Examples:anabolicsteroids, nalorphine,
ketamine,certainscheduleII substancesin
suppositories, mixtures, orlimited amounts per
dosage unit

6. ScheduleIV Drugs–
Abuse potentiallessthansubstancesin
scheduleIII.
Has a currentlyaccepted medical use in the
U.S.
Abuse of substancemay leadto limited
physical or psychological dependencerelative
to substancesin scheduleIII.
Examples:alprazolam, phenobarbital,
meprobamate, modafinil

7. INDIANSCHEDULES:
•ScheduleA
•Givesthe specimens ofprescribed formsnecessaryforobtaining
licenses, permits, certificates,intimationsand soon.
•FORM2A-Certificateoftest or analysisfromthePharmacopoeial
Laboratoryfor IndianMedicineorGovernmentAnalyst
•FORMS3-7-(Omitted)
•FORM8 -Applicationforlicence toimportdrugs–biological and
other special products(excludingthose specified in Schedule X) to
the Drugsand Cosmetics Rules,1945
•FORM9 -Formofundertakingto accompanyan applicationfor
an importlicense
•FORM46-Permission/ Approvalformanufactureof newdrug
formulation
•■There are in total upto50 forms.

8. Schedule B
•This Schedule includes fees for testor analysis by the
Central Drug Laboratory or the GovernmentAnalyst.
1. Fees fortest and assayof Drugs requiringuseof
animals–Eg:-Adrenocorticotrophichormoneassay-
1000 Rs
2. Microbiologicaltests and assays –Eg:-Microbiological
assayof vitamins-300 Rs
Schedule B(1)
Fees forthe test or analysis by thePharmacopoeial
Laboratory forIndianMedicine(PLIM) or the
Governmentanalyst
Eg:-Determinationof lethaldoesLD 50 to 10 on mice–
2500 Rupee

9. •ScheduleC:-
•Includes biologicaland special productssuchas
Sera,Vaccines,Antigens,Toxin, Antitoxin, Insulin,
Bacteriophages,solution of serumproteins
intended for injection,etc.
•ScheduleC1:-
•Includes OtherSpecialproductssuchas Digitalis
Preparations,fish liver oil,ergot preparations,
Liverextract,vitamins, hormones, etc.
■Labelled withthe words--„Caution:It is dangerous
to takethis preparation except undermedical
supervision‟.
■Prohibitionof import of these productsafterexpiry
of potency

10. Schedule D
•Provides extentandconditions of exemption regarding
import of drugs.
Eg:-Class of drugswhichare substancesnot intendedfor
medicinal use
•If thesubstanceis importedin bulk,theimporter should
certifythatthesubstanceis imported fornon-medicinal
uses, and
•If imported otherwisethanin bulk,each containershould
bear a label indicatingthatthesubstanceis not intendedfor
medicinaluse or isintendedforsome purposesotherthan
medicinaluse.
•E.g. Skimmed milk, powderedmilk fortifiedwith vitamins,
Lactose, cereal products,oats,ginger, pepper,cummins, etc.
come under this class ofdrugs.
•SheduleDI-permission formanufacture and DII-
permission forimport.

11. •Schedule E
Omitted as per GOI Notification
•Schedule E (I):-
List of poisonous substancesunderthe Ayurvedic
(including Siddha)and Unani Systemsof
Medicine : AyurvedicSystem:-
■Drugs of Vegetableorigin:-Bhang, Dhatura,
Jaiphala,etc
■Drugs of Animalorigin :-Snake Poison
■Drugs of Mineralorigin :-Hartala (arsenic),
Parada (mercury), etc.

12. Schedule F
It includesrequirementsfor the Functioning
and operationof a blood bank and / or for
preparation ofblood components.
General:-Blood banklocation, infrastructure
requirements,Staffand equipmentsrequired,
etc.
Minimum requirementfor grantof licenseto
procure blood components from whole human
blood.

13. F (I) :-Give details of thestandardsof bacterial
vaccines,antiseraand diagnostic antigens.
F (II):-Standards for Surgical Dressingsthat
includebandage cloth,absorbentgauze,rolled
bandage,etc.
F (III):-Standards For Umbilical Tapes like
umbilicalpolyester tape, cotton tape, etc.

14. •Schedule FF
It lays down Standardsfor Ophthalmicpreparations.
OphthalmicSolutionsand suspensions.
1. sterile when dispensed
2. containsuitable substancesto prevent thegrowthof
micro-organisms
3. freefromforeign matter& in bottles made of either
neutral glass or sodaglass.
4.LabelContains:-„Usethesolutionwithinonemonth
after openingthecontainer‟.
The words „NOT FOR INJECTION‟.
WARNING:-“ Do nottouch thedropper tip or other
dispensing tip toanysurfacesince thismay
contaminatesolutions”.

15. •Schedule G
•Medicines listedas schedule Gmedicines carry on the
label a caution
•Caution–“it is dangerousto take thispreparation
except under medical supervision”
•The Cautionis conspicuouslyprintedand surrounded
by a linewithinwhich there should beno otherwords.
•It is necessaryto makeproper bill of sale.
•Recordsofpurchase and sale of these medicines must
be maintainedfor a period of 2 years.
•Eg: Aminopterin,L-Asparaginase,Bleomycin,
Busulphan, Chlorambucil,Chlorthiazide,
Glibenclamide,Hydantoin,Hydroxyurea,Insulin,
Metformin,etc.

16. •Schedule H
•This Schedule includes PRESCRIPTION DRUGSi.e.
Drugs and Medicines which must be sold by retail only
when a prescription by RMPis produced.
•The timeanddate of prescription must be noted.
•The druglabel must display thetexts "Rx" and
"Schedule H drug.
•Warning: Tobe sold by retail on the prescription of a
Registered Medical practitioneronly" prominently.
•Drugs specified in Schedule H, and comeswithin
{NarcoticDrugs and PsychotropicSubstancesAct,
1985} labelled with the symbol “NRx” & ScheduleH
drug Warningprominently.
•Eg:-Abxicimab,Acyclovir, Diclofenac, Baclofen,
Carbidopa, Terazosin, etc.

17. •Schedule H1
•Introducedunder theDrugs and Cosmetics(4th
amendment) rules 2013, to regulatesale of antibiotics.
•To have separate regulationto check unauthorizedsale
of antibiotics,thus monitoringuse and abuseof these
antibiotics.
•Here, thedrug has to be labelled withsymbol “Rx”in
red and conspicuously displayed on leftcorner of the
label with the followingwordsin box with red border
•Warning1. Itisdangerousto take thispreparation
except in accordancewiththe medical advice.
•2 Notto be sold by retail withoutthe prescription of a
RMP.
•Eg:-Gemifloxacin,Cefixime, Levofloxacin,
Cefpodoxime, Clofazimine,Zolpidem,etc

18. •ScheduleI
•Particularsas to proportionof poisonin certain
cases.
•Omittedby GOI Notification.
ScheduleJ
•Containsa list of variousdiseasesand conditions
which adrugmay notpurportto prevent orcure
or makeclaims to prevent or cure.
•No drugmaylegally claim to treatthese diseases.
Eg:-AIDS, Blindness,Deafness,Encephalitis,
Diabetes, Leukemia,Paralysis,etc.

19. Schedule-K
•Drugsexempted from certain provisionsrelating to the
manufactureandsale ofdrugs
•Currently,non drug-licensedstores (e.g. non-
pharmacists)cansell afewmedicines classified as
„Household Remedies‟ listed in ScheduleK.
•Eg-Paracetamoltablets,Analgesic Balms,Antacid
Preparations,Calcium preparationswith or
without VitaminD, Gripe Water for useof infants,
Inhalers (containing drugsfor treatmentof cold
and nasalcongestion),Syrupslozenges, pillsand
tabletsforcough, cold or sorethroat.

20. •ScheduleL :-
•Omitted ScheduleL
•Good LaboratoryPracticesand requirementsof
premises andequipments,Chemicals& Reagents,
etc.
ScheduleM
This ScheduleincludesGoodManufacturingPractices
and requirementsof premises, plant and
equipmentfor manufactureof pharmaceutical
products.
■Part1 :-Good ManufacturingPracticesfor premises
and materials.
.Part2 :-Requirementsof Plant and equipments

21. M-I:-Prescribesindetail requirementsof
factory premises for the manufactureof
Homeopathic drugs.
M-II:-Prescribesrequirementsof factory
premises for manufactureof cosmetics.
M-III:-Prescribesrequirementsof factory
premises for manufactureof medical devices.

22. •Schedule N
List of minimumequipment for theefficient runningof a
pharmacy
Gives directionsto Pharmacies regarding:-
a)Entranceof Pharmacy
b)b) Premises
c)c) Furniture& Apparatus
d)d) General Provisions.
Schedule O
Deals with the provisions applicable to disinfectant fluids.
• Part1:-Provisions applicable toblack and white fluids
Part 2:-Provisionsapplicable to OtherDisinfectants.

23. Schedule P
•Itdeals with lifeperiod of drugand the
conditions of the storage of drugs.
•Period inmonths (unlessotherwisespecified)
betweendate ofmanufactureand dateof
expiry
•ampicillin-stable for 36month and store in
cool place
•Schedule P1
•specifiesthe pack size of certain drugs
•Aspirin (Low Dose) Tablets14 Tabs perpack.

24. •Schedule Q
•Gives thelist ofdyes,colors and pigments
permitted to be used incosmetics and soaps.
•No drugshould containa colors other than
specified bythe Bureauof IndianStandards
below :
(1) NaturalColors:-Carotene,Chlorophyll, Red
Oxide ofIron,Yellow Oxideof Iron,Titanium
Di-oxide, BlackOxideof iron
(2) ArtificialColors:-Caramel
(3) CoalTar Colors

25. •Schedule R
•Standards formechanicalcontraceptives.
•Eg. Cu-T,etc
•Label contain:-–The date of manufacture.
•–The dateup to which thecontraceptiveis expected to
retain its properties.
Schedule R1
•Standards formedicaldevices.
The following medical device shallconform to theIndian
Standards specification laid down fromtimeto time by the
BureauofIndianStandards:-
1. Sterile Disposable Perfusion sets for single useonly
2. Sterile Disposable Hypodermic Syringes forsingle use only
3. Sterile DisposableHypodermic Needles forsingle useonly

26. Schedule S
PrescribesStandardfor Cosmetics
Thefollowingcosmeticsinfinishedform
shouldconformtothespecificationslaiddown
fromtimetotimebytheBureauofIndian
Standards (BIS).
SkinPowders,ToothPowder,Toothpaste
,Shaving Creams,HairCreams.

27. Schedule T
Laysdownthe GoodManufacturingPractices
for Ayurvedic, Siddhaand UnaniMedicines
PART I:-Good manufacturingpractices.
PART II:-List of recommendedmachinery,
equipmentand minimum manufacturing
premises requiredfor the manufactureof
various categoriesof ayurvedic,siddha system
of medicines.

28. ScheduleU & U1
•Givestheparticularstobeshownin
manufacturingrecords.
•Givestheparticularstoberecordedofraw
materials.
•Givestheparticularstoberecordedinanalytical
records.
•Therecordsorregistersshallberetainedfora
periodof5yearsforDrugs&3yearsforCosmetics
from the date ofmanufacture
ScheduleV
•Givedetailsofstandardsforpatentand
proprietary medicines.

29. Schedule W
Insertedas per G.O.I in1981 and deleted IN
2000.
Gives thenameof the drugs whichshallbe
marketed undergenericnames only.
Its label contain the Names and quantitiesof
active ingredients.

30. •Schedule X
•Containslist of narcoticdrugsand psychotropic substance.
•Have a warning mentionedon a label „ScheduleX drug‟-
Warning : tobe sold on retail on prescriptionofa RMP only.
•The label will also have a symbol „NRx‟inred&
conspicuouslydisplayedon thetop left corner.
•Afterdispending thedrugthepharmacist must Stamp&
retain theprescriptionfor2 years.
•Maintain& recordpurchase& sale of thedrugand
preserveitfora periodof 2 years fromthedate of
transactions.
•Alltheregulations of Schedule H apply.The drugsmust be
kept underlock and key.
•Examples offew drugsunder schedule X :-Phencyclidine,
Secobarbital, Amobarbital, Amphetamines,Glutethimide,
Methylphenidate,etc.

31. Schedule Y
•ThisScheduleincludesrequirementsandguidelines
forpermissiontoimportand/ormanufactureofnew
drugs for sale ortoundertakeclinicaltrialsItinclude:
•Application for permission
•Clinicaltrial:-
Approvalfor trial
Responsibilitiesofsponsor,investigator,Ethics
Committee
Phases I,II,III,IV
StudiesinspecialpopulationlikeGeriatric,Pediatric
and Pregnant/Nursing women
Post MarketingSurveillance