Regulation of ASU drugs.ppt by Dr.U.Srinivasa

Useful for B.Pharm students

1. Regulation of manufacture of ASU drugs-
Schedule Z of drugs and Cosmetics Act
for ASU drugs
Dr.U.Srinivasa, D.Pharm, M. Pharm., M.Phil., Ph.D.
Professor and Head, (Dept. of Pharmacognosy)
Srinivas college of pharmacy, Mangalore.
Email. [email protected]

2. Sections for manufacture and sale of drugs
•Section33(EEC) –
Prohibition of manufacture and sale of certain ASU drugs
•Section33(EED) –
Power of central government to prohibit manufacture, etc.,
of ASU drugs in public interest.
•Section33(F) -Government analysts
•Section33(G)-Inspectors
•Section33(H) -Application of provision of section
22,23,24,25.
•Section33(I) –
Penalty for manufacture, sale, et,. Of ASU drugs in
contravention of this chapter.

3. •Section33(J) -Penalties for subsequent offences
•Section33(K) -Confiscation
•Section33(I)-
Application of provisions to government departments
•Section33(M) -Cognizance of offences
•Section33(N) –
Power of central government to make rules
•Section33(O) -Power to amend first schedule

4. Schedule Z of drugs and Cosmetics Act for ASU
drugs
TheSection33(EEB)oftheDrugsandCosmeticsAct
describestheregulationsforthemanufactureandsale
ofASUdrugs.
TheActhassetsomestandardsrelatedtothe
Hygienicconditions,factorypremises,prohibitionof
manufactureandsaleofcertaindrugsandpenaltiesfor
contraventionofthisact.
Thefollowingrequirementsaretakenintoaccount

5. A. Requirements of Factory premises and
hygienic conditions
1.AspertheAct,itismandatorytomaintainproper
hygienicconditionsinthefactorypremisesalongwith
thefollowingrequirements.
2.FactoryorindustryinvolvedinthemanufactureofASU
drugsshouldnotbesituatedadjacenttoopensewage,
drain,publiclaboratoryoranyotherfactorywhich
producesobnoxiousodour,largequantitiesofwaste,
dustorsmoke.
3.Thepremisesofmanufacturingunitshallbeclean,
hygienicandfreefrominsects,rodentsandother
contamination.
•NOTE: All the sections fall under the schedule-Z of the
Drugs & Cosmetics Act.

6. 4.Thewallsandfloorofmanufacturingroomsshould
besmooth,easilycleanablewithwaterandshould
notaccumulatedustorwasteproducts.
5.Thewaterusedinthemanufactureshallbepureand
drinkingquality.Itshouldbefreefrompathogenic
organisms.
6.Adequatefacilityshouldbeprovidedtoprocessthe
containersandclosuresforwashing,cleaning,drying,
etc.anditshouldbeseparatedfromthe
manufacturingunit.

7. 7.Suitablearrangementshallbeprovidedfordisposing
waterandothermaterialsinamannerthatitdoes
notaffectthehealthofpeopleinthesurrounding
area.
8.Personnelworkinginthefactoryshouldbefreefrom
contagiousdiseases.
10.Appropriatedressshouldbeprovidedtothe
workersbasedonthenatureoftheirwork.

8. 11. Adequate facilities for personal cleanliness such as
soap, towel and antiseptics should be provided.
12. Facilities for drinking water, separate wash rooms and
change rooms should be provided for men and women.

9. B. Prohibition of manufacture and sale of certain ASU
drugs
•TheActprescribessomecriteriatoprohibitthe
manufactureandsaleofcertainASUdrugswhichare
notmanufacturedorsoldinaccordanceoftherules.
•ThefollowingcategoriesofASUdrugscanbeprohibited
from
•Manufactureandsale.
•Anymisbranded,adulteratedorspuriousASUdrugs.
•Anyproprietaryorpatentedmedicinewhichdoesnot
displaythelistofallingredientsonthelabelofthe
container.

10. B. Prohibition of manufacture and sale of certain ASU
drugs
Theselling,stockinganddistributionofanyASUdrug
whichhasnotbeenmanufacturedincontraventionof
theprovisionsofthisAct.
Themanufacture,saleanddistributionofanyASU
drugsforwhichlicensehasnotbeenissuedbythe
prescribedauthority.
Theaboverulesdonotapplytovaidyasandhakims
whopreparedASUdrugsfortheuseoftheirown
patients.
TheaboverulesdonotapplytoASUdrugswhichare
manufacturedinsmallquantitiesforthepurposeof
examination,testoranalysis.

11. C. Power of central government to prohibit the
manufacture, sale & distribution of ASU drugs in Public
interest
Thesection33(EED)ofthedrugsandcosmeticsAct
prescribescertainpowerofthecentralgovernment
basedonwhichthegovernmentcanprohibitthe
manufacture,saleanddistributionofASUdrugswhich
involveanyrisktohumansoranimalsorsuchdrug
doesnothavetherapeuticvalueasclaimedbythe
manufactureroranymisbrandedandspuriousdrugs.
Henceinsuchcircumstance,thegovernmentmay
prohibitthemanufacture,sale&distributionofdrugsin
publicinterest.

12. D. Penalty for the manufacture, sale and distribution of
prohibited ASU drugs
Asprescribedunderthesection33-1oftheDrugsand
cosmeticsAct,anypersonhimself,onhisbehalfis
engagedinthemanufacture,saleanddistributionof
prohibitedASUdrugs,penaltyhasbeenfixedasper
thefollowingguidelines.
AnyASUdrugwhichisdeemedtobeadulteratedor
manufacturedwithoutavalidlicenceshallbe
punishableuptooneyearimprisonmentandwithfine
upto2thousandrupees.

13. D. Penalty for the manufacture, sale and distribution of
prohibited ASU drugs
•AnyASUdrugwhichisdeemedtobespuriousshallbe
punishablewithImprisonmentupto1to3yearsand
withfineupto5thousandrupees.
•AnyASUdrugwhichcontravenesanyotherprovisionof
theActshallbepunishablewithimprisonmentupto3
monthsandwithfineupto500rupees

14. E. Manufacture on more than one set of premises
If ASU drugs are manufactured on more than one set
of premises, a separate application shall be made and
a separate license shall be obtained for each
premises.