IT MAKE EASY TO STUDY ALL SCHEDULE OF RGPV PHARMACY SUBJECT UNIT 2 SCHDULES IN DETAIL....

1. DRUGSCHEDULES
Mr. Shashank Chaurasiya
Asst. Professor
Bansal College of Pharmacy
College of pharmacy, Bhopal

2. DrugsandCosmeticsAct, 1940
■ The Drugs andCosmetics Bill waspassedby the Central LegislativeAssembly
and it received the assentof theGovernorGeneralon 10thApril, 1940and thus
becamethe DrugsandCosmeticsAct, 1940(23of 1940).
■ The quality of the drugs imported, manufactured andsold in the country are
regulated underthe provisionsof DrugsandCosmeticsAct, 1940and Rules
made thereunder.
■ The primary objective of the act isto ensurethat the drugs & cosmeticssold in
India are safe, effective and conform to state quality standards and to make
availableStandardQuality drug/ cosmetic to consumer.

3. Contd….
 TheAct visualizesthe regulatory control over the drugs importedin to the country by the
Central Government while the manufacture, sale and distribution of drugs is primarily
regulated by the State DrugControlAuthorities appointedby the StateGovernments.
 The manufacture and sale of the drugsis regulated through asystem of licensingand
inspection by the LicensingAuthorities.
 The Central Drugs Standard Control Organization (CDSCO), headed by the Drugs
ControllerGeneral(India) is concerned with the regulatory control over the quality of drugs
& cosmetics.

4. Roleof DrugsandCosmeticsAct, 1940
■ Toprevent substandardin drugs, maintaining high standardsof medical care.
■ Toregulate the import, manufacture, distribution and saleof drugs& cosmetics
through licensing.
■ Toregulate the manufacture andsale ofAyurvedic,Siddha andUnani drugs.
■ Toestablish DrugsTechnicalAdvisory Board(DTAB)andDrugsConsultative
Committees(DCC)forAllopathic and allied drugs& cosmetics.

5. LISTOFAMENDINGACTSAND
ADAPTATIONORDERS
1. The Repealing andAmendingAct, 1949(40 of 1949).
2. TheAdoption of LawsOrder, 1950
3. The part BStates (Laws)Act, 1951(3of 1951).
4. The Drugs (Amendment)Act, 1955(11of 1955).
5. The Drugs (Amendment)Act, 1960(35of 1960).
6. The Drugs (Amendment)Act, 1962(21of 1962).
7. The Drugs andCosmetics (Amendment)Act, 1964
8. The Drugs andCosmetics (Amendment)Act, 1972
9. The Drugs andCosmetics (Amendment)Act, 1982
10. The Drugs andCosmetics (Amendment)Act, 1986
11. The Drugs andCosmetics (Amendment)Act, 1995
12. The Drugs and Cosmetics (Amendment)Act,2003
13. The Drugs and Cosmetics (Amendment)Act,2008
14. The Drugs andCosmetics (Amendment)Act,2013
15. The Drugs andCosmetics (Amendment)Act,2015
16. The Drugs andCosmetics (Amendment)Act,2016

6. Definitions in D&CAct, 1940
Drug:-
 All medicines for internal or external useof human beings or animals and
 All substancesintended to be usedfor or in the diagnosis,treatment,
mitigation or prevention of anydiseaseor disorder in human beingsor
animals
 Preparationsappliedon human body for the purposeof repelling insectslike
mosquitoes.
Cosmetic:-
 Any article intended to be rubbed, poured, sprinkled or sprayedon,or
introduced into, or otherwise applied to, the human body or any part
 for cleansing,beautifying, promoting attractiveness, or altering the
appearance
 Includesanyarticle intended for useasacomponent of cosmetic.

7. Schedules inD&C Act
■ First schedule –Namesof books under Ayurvedic,Siddha andUnanisystems.
– A.—Ayurvedic system books like ArogyaKalpadruma,Arka Prakasha,etc. and
Siddhasystemsbookslike VaidyaThirattu,TherayarMaha Karisal,etc.
– B.—Unani system books like KarabadinQadri,KarabadinKabir,etc.
■ Second schedule –Various Standards to be Complied with by ImportedDrugs and by
DrugsManufactured for Sale,Sold,StockedOr Exhibited for Saleor Distributed.

8. DrugsandCosmeticsRules,1945
■ TheDrugs andCosmetics Rules, 1945is anAct of the Parliamentof India which
containsprovisionsfor classificationof drugs undergiven schedulesand there are
guidelines for the storage, sale,display andprescriptionof eachschedule.

9. Schedule A
Givesthe specimens of prescribed forms necessary for obtaining licenses,permits, certificates,
intimations and soon.
■ FORM 2A- Certificate of test oranalysis from the Pharmacopoeial Laboratory for Indian
Medicine or GovernmentAnalyst
■ FORMS 3-7-(Omitted)
■ FORM 8 -Application for licenceto importdrugs (excludingthose specified inScheduleX)to
the DrugsandCosmetics Rules,1945
■ FORM 8A - Application for licenceto importdrugs specified inScheduleX to the Drugsand
Cosmetics Rules,1945
■ FORM 9 - Formof undertaking to accompany anapplication for an importlicence
■ FORM 46- Permission /Approval for manufacture of new drug formulation
■ There are in total upto 50forms.

11. Schedule B
ThisSchedule includes fees for test or analysis by the Central Drug
Laboratory or the GovernmentAnalyst.
1. Feesfor test and assayof Drugsrequiring useof animals
– Eg:- Adrenocorticotrophic hormone assay- 1000Rs
2. Microbiological tests andassays
– Eg:-Microbiological assayof vitamins - 300Rs
3.Identification tests
– Eg:- Electrophoresis -Polyacrylamide Gel- 300Rs
4. Physical tests-Optical rotation, Specificgravity,
Viscosity, Solubility, pH, Refractive index, Solubility,
Absorbancy, Disintegration and dissolutiontest.

12. Contd….
• Feesfor SeraandVaccine,Cosmetics , Homoeopathicmedicines,etc.
arealsoincluded in ScheduleB.
• Schedule B(1)
Feesfor the test or analysis by the Pharmacopoeial Laboratory for Indian
Medicine (PLIM) or the Governmentanalyst
Eg:- Determination of lethal does LD 50to 10on mice –2500Rupees

13. Schedule C
 ScheduleC:-
Includesbiological and specialproducts suchasSera,Vaccines,
Antigens,Toxin, Antitoxin, Insulin, Bacteriophages, solution of serum
proteins intended for injection, etc.
 ScheduleC1:-
IncludesOther Special products suchasDigitalis Preparations,fish
liver oil, ergot preparations,Liver extract, vitamins, hormones,etc.
■ Labelled with the words-- ‘Caution: It isdangerousto take this
preparation exceptunder medicalsupervision’.
■ Prohibition of import of these products after expiry of potency.

14. Schedule D
Provides extent and conditions of exemption regarding import of drugs.
Eg:-
1.Classof drugs which are substances not intended for medicinal use
 Exemptedaccording to provisions of ChapterIII of thisAct and Rules,thereunder subject to
the condition:-
 If the substance is imported in bulk, the importer should certify that the substance
is imported fornon-medicinal uses,and
 If imported otherwise than in bulk, each container should bear alabel indicating
that the substance is not intended for medicinal use or is intended for some
purposes other than medicinal use.
E.g.Skimmed milk, powdered milk fortified with vitamins, Lactose, cereal products, oats, ginger,
pepper,cummins, etc. comeunder this classofdrugs.

15. Contd….
2. Drugsand cosmeticsimported for manufacture and export:-
– Exemptedunderthe provisionsof ChapterIII of theAct and rules,provided:-
■ they are covered under animport licence,import registration andimport
through notified port of entry.
■ Subject to the conditions that these drugs and cosmeticsshallnot be
diverted for salein the country.

16. Schedule D I
■ Contains Information andundertakingrequired to be submitted by the manufacturer
or his authorized agent with theApplication Form for aRegistrationCertificate.
■ The details requiredare:
1. Particulars of the manufacturerand manufacturingpremises
2. Particulars of the manufactured drugsto beregisteredunderRegistration
Certificate
3. Undertakingto declarethat manufacturershouldcomply with all the
conditions imposedonthe RegistrationCertificate.

17. Schedule DII
■ Here, the information is required to be submitted by the manufacturer for registration of a
bulk drug/formulation/special product for its import into India.
■ The details requiredare:
– Generallike name, regulatory status of drug, etc.
– Chemicaland pharmaceutical information of drugs.
– Biological and biopharmaceuticalinformation
– Pharmacological and toxicological information of Drugs.
– Clinical documentation
– Labelling and packing information of drug
– Specified information requiredfor special products.

18. Schedule E
ScheduleE- Omitted asperGOINotification No.G.S.R.462(E) dt 22-6-1982.
ScheduleE (I):- List of poisonous substances under theAyurvedic (includingSiddha)
andUnani Systems of Medicine :
Ayurvedic System:-
■ Drugs ofVegetable origin :- Bhang, Dhatura, Jaiphala, etc
■ Drugs of Animal origin:- SnakePoison
■ Drugs of Mineral origin :- Hartala (arsenic), Parada (mercury), etc.
■ Thecontainer of a medicine for internal useshould belabelled conspicuously with the
words ‘Caution: Tobetaken under medical supervision’both in English and Hindi
language.

19. Schedule F
 It includesrequirements for the Functioning and operation of ablood
bankand / or for preparationof blood components.
 General:- Blood bank location, infrastructure requirements,Staff and
equipments required,etc.
 Minimum requirement for grant of licenseto procureblood
componentsfrom whole human blood.

20. Contd….
 F(I) :- Give details of the standards of bacterial vaccines, antisera
and diagnostic antigens made from any microorganism
pathogenic to man or other animals.
■ F(II):- Standards for SurgicalDressings that include bandage
cloth, absorbent gauze, rolledbandage,etc
■ F(III):- Standards ForUmbilicalTapeslike umbilical polyester tape,
cotton tape,etc.

21. Schedule FF
It lays down Standards for Ophthalmic preparations.
■ Part-A. Ophthalmic Solutions andsuspensions.
1. sterile whendispensed
2. contain suitable substances to prevent the growth of micro-organisms
3. free from foreign matter & in bottles made of either neutral glassor sodaglass
LabelContains:-
o The statement ‘Use the solution within one month after opening the container’.
o The words ‘NOT FOR INJECTION’.
o WARNING:-“ Do not touch the dropper tip or other dispensing tip to any surface since
this may contaminatesolutions”.
■ Part B:Ophthalmic Ointments
1. sterile when dispensed
2. free from foreignmatter
3. Label contains:- “Warning :- If irritation persists or increases discontinue the
use and consultphysicians”

22. Schedule G
Medicines listed asscheduleGmedicines carryon the label acaution
■ Caution –“it is dangerous to take this preparationexcept under
medical supervision”
■ TheCautionis conspicuously printed andsurrounded by aline within
which there should be no other words.
 It is necessaryto makeproper bill of sale.
 Recordsof purchaseand saleof these medicines must be
maintainedfor aperiod of 2years.
■ Eg:Aminopterin, L-Asparaginase,Bleomycin,Busulphan,
Chlorambucil, Chlorthiazide, Glibenclamide, Hydantoin,
Hydroxyurea, Insulin, Metformin,etc.

23. Schedule H
• This Schedule includes PRESCRIPTION DRUGS i.e. Drugs and
Medicines which must be sold by retail only when a prescription
by RMP isproduced.
• Thetime and date of prescriptionmust be noted.
• Thedrug label must display the texts "Rx" and"ScheduleHdrug.
Warning:Tobesold byretailonthe prescriptionof aRegistered
Medical practitioner only"prominently.
• Drugs specified in Schedule H, and comes within {Narcotic Drugs
and Psychotropic SubstancesAct, 1985}labelled with the symbol
“NRx” & ScheduleHdrugWarningprominently.
• Contains alist of 536drugs.
• Eg:-Abxicimab,Acyclovir, Diclofenac, Baclofen,Carbidopa,
Terazosin,etc.

24. Schedule H1
■ Schedule H1:- Introduced under the Drugs and Cosmetics (4th
amendment ) rules 2013,by MOHFWon 30Aug, 2013vide GSR
588(E)to regulate saleof antibiotics.
■ Tohave separate regulation to check unauthorized sale of
antibiotics, thus monitoring useand abuse of these antibiotics.
■ Here, the drug hasto be labelled with symbol “Rx”in redand
conspicuously displayed on left corner of the label with the
following words in box with red border
 Warning-
1. It isdangerousto take this preparation except in
accordancewith the medicaladvice.
2. Not to besold by retail without the prescription of a
RMP.
■ Eg:-Alprazolam,Gemifloxacin, Isoniazid,Cefixime, Levofloxacin,
Cefpodoxime,Clofazimine, Zolpidem, etc

25. Schedule I
 Particularsasto proportion of poison in certain cases.
 OmittedbyGOINotification No.G.S.R462(E)dt 22.6.1982
Schedule J
 Contains alist of various diseasesand conditions which adrug may not
purport to prevent or cureor makeclaimsto prevent or cure.
 No drug maylegally claim to treat these diseases.
 Eg:-AIDS,Blindness,Deafness,Encephalitis,Diabetes, Leukemia,
Paralysis,etc.

26. Schedule K
 The drugs specified in Schedule K shall be exempted from the
provisions of Chapter IV of the Act and the Rules to the extent and
subjectto the conditions specified in that Schedule.
 Classof Drugs which is not sold for medicinal useshould be
labelled conspicuouslywith the words “NOT FOR MEDICINAL
USE”.
 However, these drugsshould not containany substance
specifiedin SchedulesG,HorXof D&CAct andRules.
 The Mashelkar Recommendation Committee on Drug Regulatory
Systemsuggested to expand the scopeof Schedule K toinclude
OTC drugs.

27. OTCDrugs
 The phrase ‘OTC’hasno legal recognition in India, all the drugs not included in the list of
‘prescription-only drugs’are considered to be non-prescription drugs (orOTCdrugs).
 Hence ‘OTCDrugs’means drugs legally allowed to be sold ‘OverTheCounter’ by
pharmacists, i.e. without the prescription of aRegistered Medical Practitioner.
 Prescription-only drugs are those medicines that are listed in Schedules HandXandGof
the Drug andCosmetics Rules.
 Currently, non drug-licensed stores (e.g. non-pharmacists) can sell afew medicines
classified as‘Household Remedies’listed in Schedule K.

28. Contd….
 The Schedule Kinclude:-
 QuinineSulphate and other antimalarial drugs
 Drugssupplied by RMP to his own patient
 Drugs supplied by hospital or supported by government or local body
 Substances which are used both asarticles of food aswell asdrugs
 Household remedies.
 The medicinesthat continue to be under 'household remedy' category:-
 Paracetamol tablets,Analgesic Balms,Antacid Preparations,Calcium preparations with or
without Vitamin D,GripeWater for useof infants, Inhalers (containing drugs for treatment
of cold and nasal congestion), Syrups lozenges, pills and tablets for cough, cold or sore
throat.

29. Schedule L
Schedule L:-Omitted
Schedule L(I) :-
Good Laboratory Practices and requirements of premises and equipments,
Chemicals & Reagents,etc.

30. Schedule M
ThisSchedule includesGood Manufacturing Practicesand requirements of premises, plant
and equipment for manufactureof pharmaceutical products.
■ Part 1:-Good Manufacturing Practicesfor premisesand materials
– 1A- Specific requirements for manufacture of sterile products, parenteral
preparations (small volume injectables and large volume parenterals) and sterile
ophthalmic preparations
– 1B- oral solid dosage forms (tablets andcapsules)
– 1C- oral liquids (syrups, elixirs, emulsions andsuspensions)
– 1D- topical products (creams, ointments, pastes, emulsions, lotions,etc.)
– 1E- metered-dose-inhalers(mdi)
– 1F- specific requirements of premises, plant and materials for manufacture of
active pharmaceutial ingredients (bulk drugs)
■ Part 2 :- Requirements of Plant and equipments

31. Good Manufacturing Practices(GMP)
 Generalrequirements:-
 Locationand surroundings-Freefrom opensewage,publiclavatory, dust,smoke,
excessivesoot,obnoxiousodour,chemicalorbiological emission
 Buildingsand premises-Designssuitable for manufacturing operationand maintain
hygiene.
 Watersystem-Validatedsystemfor water treatment to makeit usableandfree
from microbialgrowth.
 Disposalof wastes-Disposalshall beaccordingto Environment PollutionControl
Board and asperprovision.
■ Warehousingarea-Designsallow sufficient andorderly warehousingof various
categoriesof materials and products.
■ Productionarea-Area shallbe designedto allow the production preferably in uniflow
with logical sequenceof operation and avoiding the risk of crosscontamination.

32. Contd….
■ Quality control area-Lab independent of production areawith separateand adequate
spacefor eachtype of testing.
■ Manufacturingoperation-All operationsshallbe carried out under supervisionof
technicalstaff approvedby LicensingAuthority.
■ Documentation and record- It shall specify the title, nature and purposeand laid out in
orderly fashion.

33. Contd….
Schedule M- I:- Prescribes in detail requirements of factory
premises for the manufacture of Homeopathic drugs.
Schedule M- II:- Prescribes requirements of factory
premises for manufacture of cosmetics.
Schedule M- III:- Prescribes requirements of factory
premises for manufacture of medical devices.

34. Schedule N
o List of minimum equipment for the efficient running of a
pharmacy
o Gives directions toPharmacies regarding:-
a) Entrance ofPharmacy
b) Premises
c) Furniture &Apparatus
d) GeneralProvisions.
o Entrance shall bearan inscription“Pharmacy” in front

35. Schedule O
Dealswith the provisionsapplicableto disinfectant fluids.
• Part1:-Provisionsapplicable to blackand white fluids
• Part2:- Provisionsapplicable to Other Disinfectants.
(A)Black fluids-Homogeneousdarkbrown solution of coal tar acidor similaracids.
(B)Whitefluids-Finelydispersedhomogeneous emulsionof coal tar acidorsimilaracids.

36. Schedule P
 It deals with lifeperiod of drug and the conditions of the storage of drugs.
 Period in months (unlessotherwise specified) between date of manufacture and date
of expiry.
 Theschedule includesantibiotics,vitamins, insulin preparation,normal human
plasma,seratoxins,toxoids , other toxins , anti-toxins,miscellaneous drugs.
Drug Life Period(months) Storage
Adramycin 30 In aCoolplace
Ampicillin 36 In aCoolplace
Ampicillin Sodium 36 In aCoolplace
AmpicillinTrihydrate 30 In aCoolplace

37. Schedule P1
 Schedule P1–specifies the pack size of certain drugs.
 It gives the namesof drugs, along with the dosageform andthe pack size.
 No other pack sizethan the one listed is allowed to be marketed.
Drug Dosage form PackSize
Aspirin (LowDose) Tablets 14Tabs
Cholecalciferol Granules 1gmSachet
Famotidine Tablets 14Tabs
GlycerylTrinitrate Spansules 25Spansules

38. Schedule Q
 Givesthe list of dyes,colors and pigments permitted to be used
in cosmetics andsoaps.
 No drug should containacolours other than specified specifiedby
the Bureauof IndianStandardsbelow :
(1)Natural Colours:-Carotene, Chlorophyll, RedOxide ofIron,
YellowOxideof Iron,Titanium Di-oxide,BlackOxideof iron
(2)ArtificialColours:-Caramel
(3)CoalTarColours

39. Schedule R
 Standards for condoms made of rubber latex intended for single useand other
mechanical contraceptives.
 Eg.Condom, Cu-T,etc
 Label contain:-
– The date ofmanufacture.
– The date up to which the contraceptive is expected to retain its properties.
Schedule R1
 Standards for medicaldevices.
 The following medical device shall conform to the IndianStandards specification
laid down from time to time by the Bureau of Indian Standards: -
1. Sterile Disposable Perfusion setsfor single useonly
2. Sterile Disposable Hypodermic Syringes for singleuseonly
3. Sterile Disposable Hypodermic Needles for single useonly

40. Schedule S
 Prescribes Standard forCosmetics
 The following cosmeticsin finished form should conform to the specifications laid
down from time to time by the Bureau of Indian Standards (BIS).
1. Skin Powders
2. Tooth Powder
3. Toothpaste
4. ShavingCreams
5. HairCreams
6. Shampoo
7. Nail Polish

41. Schedule T
 Laysdown the Good Manufacturing Practices forAyurvedic,Siddha
and UnaniMedicines
 PARTI:- GOODMANUFACTURINGPRACTICES
 PART II:- List of recommended machinery,equipmentand minimum
manufacturing premises required for the manufacture of various
categoriesof ayurvedic,siddhasystem of medicines.

42. Schedule U & U1
 Givesthe particulars to be shownin manufacturingrecords.
 Givesthe particularsto be recorded of rawmaterials.
 Givesthe particularsto be recorded in analyticalrecords.
 Therecordsor registersshallberetainedfor aperiodof 5yearsforDrugs & 3yearsfor
Cosmeticsfrom the dateof manufacture
Schedule V
• Give details of standards for patent and proprietary
medicines.

43. Schedule W
 Inserted asperG.O.I.Notificiation No.GSR27(E)dt 17.1.1981and
deleted asperG.O.I.Notification No.GSR94(E) dt 8.2.2000.
 Givesthe nameof the drugswhich shall be marketed under
generic namesonly.
 Its label containthe Namesand quantities of active ingredients.
 Thisincludes only five drugs that shall be marketed under generic
namesonly:
1. Analgin
2. Aspirin and itssalt
3. Chlorpromazine and itssalt
4. Ferroussulfate
5. Piperazine and itssalts

44. Schedule X
 Contains list of narcotic drugs and psychotropic substance.
 Have awarning mentioned on alabel ‘ScheduleXdrug’ -Warning : to be sold
on retail on prescription of a RMPonly.
 The label will also have asymbol ‘NRx’ in red & conspicuously displayed on the
top leftcorner.
 After dispending the drug the pharmacist must Stamp & retain the prescription
for 2years.
 Maintain & record purchase& saleof the drug and preserveit for aperiod of 2
years from the date of transactions.
 All the regulations of Schedule Happly.The drugs must be kept under lock and
key.
 Examples of few drugs under schedule X:- Phencyclidine, Secobarbital,
Amobarbital,Amphetamines,Glutethimide, Methylphenidate, etc.

45. Schedule Y
ThisSchedule includesrequirements andguidelines for permission
to import and / or manufacture of new drugs for sale or to
undertake clinicaltrials
It include:
 Application forpermission
 Clinical trial:-
 Approval fortrial
 Responsibilities of sponsor,investigator, Ethics
Committee
 PhasesI, II, III,IV
 Studies in specialpopulation likeGeriatric, Paediatric
and Pregnant/ Nursingwomen
 Post MarketingSurveillance

46. Data required to besubmitted with application for permission
to market aNew Drug
1.Introduction
2. Chemical And PharmaceuticalInformation
3.Animal Pharmacology
4.AnimalToxicology
5.Human/Clinical Pharmacology (PhaseI).
6. Exploratory ClinicalTrials (PhaseII).
7.Confirmatory ClinicalTrials (PhaseIII)
8. SpecialStudies
9.RegulatoryStatus InOtherCountries.
10.Prescription Information.

47. ClinicalTrials
 Nature of trials. -Theclinical trials required to be carried out in the country before a
new drug is approved for marketing depend on the status of the drug in other
countries.
 Drug alreadyapproved/marketed---PhaseIII trials required.
 Drug not approved/marketed--- trials started one phaseearlier to the phaseof
trials in other countries.
 New drug substancesdiscoveredin other countries---phaseI trials are not usually
allowed to be initiated in India unlessPhaseI from other countries are available.
 New drug substancesdiscovered in India, clinicaltrials carried out in India right
from phaseI.

48. Schedule Y1
■ Amended under Rule122-DAB
■ ThisSchedule includesRegistrationof ClinicalResearchOrganization (CRO)for
conducting clinicaltrials.
■ It also dealswith compensationin caseof Injury / Death duringTrial.

49. RecentAmendments
 In the Drugs and Cosmetics Rules, 1945, in Rule 3A, in sub-rule (8), in clause (b), after
item (5)andthe entries relating thereto, the following shall be inserted, namely:-
(6)Enzyme and Hormones suchas- Streptokinase, HCG,etc.
(7)Bacterial vaccine such as- (BCG)vaccine
(8)Viral vaccines such as- LiveAttenuated Measles& RubellaVaccine,Cell culture Rabies
vaccine
 Serial No. "537. Etizolam" is added in Schedule H, after serial number 536wef from
30.3.2017.
 In the Drugs and Cosmetics Rules, 1945,Rule 135Aand 145Dsubstituted with new
Regulationfor cosmetics containing Mercury.

50. Summary
 The Drug & CosmeticsAct andRules controls how medicines and chemicals
are made available to the public.
 They ensure that good quality medicines and cosmetics are made available to
consumers from themanufacturers.
 The growing impact of regulations on the economy hasled the administration
to searchfor new waysof reforming and amending the regulatory processto
make it more feasible.
 Theseregulatory processes thus play akey role in protecting public health and
safety.