university of the punj ab

UNIVERSI TY OF THE PUNJ ABFi naI Prol A/2015

Examination: Doctor of Pharmacv i Roll No. ,.................... :..........................

TIME ALLOWED: 3 hrs.Subject:

P

Forensic Pharmacy

4

Ｑ．Ｍｌ

０６

０２

０２

０５

０２

０３

０８

08

０４

０５

ｂ

　●

4a

b

6a

b

c

7

５

５

０

０

Explain the procedure ofsampling by an lnspector? 10

What are thi functions ofProvincial Quality Control Board (PQCB) and 07

‐０

０３

０５

０７

０８

NOTE: Attempt any FIVE questions, All questions carry equal marks'

Question

Give brief answers

i. Define Drug as per DRAP 2012.

ii. Conditions ofdrug sale license related to schedule G drugs

iii. Pharmacy Services

iv. Misbranded Drug

v. Altemate medicine

vi. Manufacturing Cost

What aie the requirements ofPlant and Equipment (Schedule B-I for

manufacturing of tablets?

Explain provision ofthe Drugs Act 1976 related to the advertisement ofdrugs? What type of drugs can be advertised under this Act?

What are the labelling requirements for suspensions?

What is the formula for fixation of Maximum Retail Price of a drug to be

manufactured locally?

Describe procedure of renewal ofregistration ofa veterinary drug.

What are the conditions of drug manufacturing license (by way offormdlation) under Drugs Act 1976?

Discuss following under Pharmacy.dct 1967

(a) Preparation and maintenance ofregisters

(b) Procedure for regishation' (c) certificate ofregistmtion

(e) Election of Vic.e-Pres ident..

(0 Fumishing of information

Discuss the following under Factory Act:

i. Seasonal factory

ii. Restriction on the working houn ofa child

District Quality Control Board (DQCB)?

What are the conditions ofdrug sale license?

What is Provincial Appellate Authority and its function?

Describe the following under Drug Act 1976

i. Cognizanceofoffences

ii. Pleas

iii. Offences and Penalties

Marks

08

07

04 each

100

(Pharm.D.)

メア

Subj eCt :PAPER:

UNIVERSI TY OF TⅡE PUNJ AB̈● ● ● ¨ ・

°"・ ・

● ● ¨ ・¨ ●

: 。・ ●

Fi nal PrO■ A/2016: 。 191' 91∵ : ∵ : ∵ : ∵ : ∵ : ∵ : 1l F

TI PI E ALLOWED: 3 hrs.

rム

ヽ

4Forensic PharmacY MAX.

Question

Give brief answers of the following

i. Define adulterated drug

ii. Quatification of Covt' AnalYst

iii. Seasonal factory

iv. Landed cost

v. Validation

Discuss cood lvianufacturing Practices (aMP) related to design of building and

services for License to manu-facture by way of formulation (schedule B-ll)

Is the advertisemerrt of every drug legal? Provide a list of drug/categories that

can be advertised.

a) Define the following terms as per DRAP Act20l2'

i) PlrarmacY services

ii) Biologicals

iii) Alternative tnedicine

b)DescribethepowerandfunctionsofDrugRegularityAuthorityofPakistan(DRAP).

a) bescribe the following under Drug (labeling and packing) Rules 1986

i) ExemPtion

ii) l,atrelling ot'drtrgs for expcxt

b) Describe prohibitions and penalties

assets, aiding/abetrnent in narcotic

Substances Act 1997.

What types of health and safety measures should be provided to workers under

Marks

4 each

10

10

a)

b)

related to owning premises, possession of

offences given under Control of Narcotic

5+3+2

10

5+_5

10

10

5+5

10

■ザ1, |

″

きた

↓　り

ａ＞

Factory Act?

What L the composition and functions of Central Pharmacy Council?-

tto* ,runy types of drug sale license are? How you will apply for the new

license of your PlrarmacY?

What are condiiions of drug sale license related with

i) ScheduleB&Ddrugsii) schedule E drug

Desciibe the following as under Drug Act 1976

i. Composition of Drug Registration Board'

It Offences and Plnaltil

０

０

b)

一一̈一̈

一一̈̈̈一

mrny FIVE questions. Au questions cnrry equor marks.

Q. No1

UNIVERSI TY OF THE PUNJ ABProf.

Forensic PharmacY

4

Fi nal 2"d NZ0l6P

aa aaaaa aa aa aaaaaaa

"t "t ta

a'a" a

3 Rou No. ........ :lr a o al taa a aaa

""tt" o' l'

TI Pl E ALLOWED: 3 hrs.Subject:

PAPER:MARKS: 100

Question

Give brief answers of the following under the Drugs Act 1976

i. Spurious drug

ii. Types of drug manufacturing licenses

iii. Qualification of Federal Inspector

iv. IMS data

v. Quarantine

a) Discuss bood Manufacturing Practices (AMP) related to location and l0

surrounding and size of builJing for License to manufacture by way of

Marks

4 each

ｂ

ａ３

of drug l0

5+3+2

5+5

5+5

10

a)

b)

a)

b)

a)

b)

Regularity Authority of Pakistan l0

(DRAP)? l*otbescribe the following under Drug (labeling and packing) Rules 1986

i) Labetling of medical devices.

iil Labelling of drugs for Government supply'

Describe prohibiiions and penalties related to possession, import/export

and trafficking of narcotic drugs given under control of Narcotic

Substances Act 1997.

Discuss the following under Factory Act:

i) lnspecting staff and their powers'

ii) SafetY of workers.

Discuss following under Pharmacy Act 1967

Al Preparation ind maintenancaof registers utrder section 24 5+5

iii; eroceaure for registration under section 26

Enlist various types of drug sale license' How you will apply for the new l0

license of Your PharmacY?

What are ionditions of drug sale license related with

i) Registered MedicaiPractitioner (RMP) 5+5

ii) Schedule E drugs

Describe the fotlowing under Drug Act 1976

i) Conditions under which a drug is registered'

ii) Reports of Govt' AnalYst

l0l0

NOTE: Attempt any FIYE questions. All questions carry equal murks'

Q.Not

i) Drug

ii) Medical devices

iii) TheraPeutic goods

b) What is the comPosition of Drug

formulation (Schedule B-ll)

Is the advertisement of every drug legal? Provide a list

categories that cannot be advertised.

Defrne the following terms as per DRAP Act2012'

ヽ

UNIVERSI TY OF THE PUNJ ABFinal Prof: Annual - 2017

Examination: Doctor of Pharmacv

SuЦ eCt : Forensi c PharmacyPAPER: 4

: Rol l No. ". " . . . " . ・・・̈ …… :

TIME ALLOWED: 3 hrs.MAX. MARKS: 100

NOTE: Attempt any FIW questions. All questions carry equatl morks.

Ql

Q2 a}

b)

Q3 a)

b}

Q4 a)

b)

Q5 a)

b)

Q6 a)

b)

Q7 a)

Give brief answers of following terms.i. Counterfeit drugs

ii. Form 5 & 7 for alternative drugs

iii. Name the cognizable offencesiv. Controlled delivery under Narcotic Act.v. Formula of price fixation for imported drugs.

Describe the requirements of plant and equipment forsterile dosage forms as given in Schedule B-l under DrugsAct 1976.

Give labeling requirements for external preparations underdrugs labelling and packaging rules 19g6.What type of drugs can be advertised under Drugs Act7976 and rules framed thereunder? Describe theconditions to be fulfilled for advertisement of drugs,Write down the Powers of lnspector under Drugs Act 1976.Give procedure of registration of a drug for localmanufacturing.

Give types of drug manufacturing Licenses, Briefly describethe condition of drug manufacturing License.Describe the procedure of peCB in a case of over pricing ofdrugs referred by provincial inspector of drugs.Mr."X" wants to start a business of sale of drugs. Discussthe conditions according to punjab Drugs Rules 2007 whichare required to be fulfilled to get the License.

Discuss the following under Factory Act 1934:i) Certificate of fitness ( Section 52)ii) Restriction on the working hours of a child worker(Section 54)

Discuss the prohibition of practice withor.rt registrationunder section 31 in pharmacy Act 1967?Define the following terms as per DRAp Act 2012.

i) Healttr and OTC products

ii) Medicaldevices

iii) Qualification of chief executive officer (CEO)

Describe the procedure for change of qualified person of aPha rrnacy.

4 Marks

each

L0 marks

10 Marks

10 marks

10 Marks

10 Marks

10 Marks

L0 Marks

10 Marks

5 marks

each

10 Marks

(4+4+21

Marks

b) 10 Marks

Subj ect :PAPER:

UNIVERSI TY OF THE PUNJ ABfinal Prof: 2nd Annual - 2017

Examination: Doctor of Pharmacv (Pharm.D.)

Forensic Pharmacy

4

●・・・・・・・・・ ● ● ● ● ● ● ● ● ● ● ● ● ● ● ヽ

1191翠 ?l =: ==∵ : 1・ : ∵ : t t iTIⅣl E ALLOWED: 3 hrs.PIAX, MARKS: 100

Ql

Q2 a)

Q3

Q4

Q5

Q6

Q7

NOTE: Attempt any FIW questions. All questions carry equol marks.

Give brief answers of following terms

i. Adulterated drug

ii. Health and OTC Products

iii, opium under Narcotic Act

iv. Formula of price fixation for local drugs

v. Quality a udit

Describe the requirements of Premises as given in

Schedule B under Drugs Act 1975.

b) Name the types of drugs/remedies that cannot be

advertised under Drugs Act 19,76. Describe the conditions

to be fulfilled for advertisement of drugs.

Describe the followings under Drugs Act 1976.

i) Offences and Pena lties

ii) Drug courts

a) Give composition of Central Licensing Board (CLB)'

b) Enlist various types of application of registration of drugs'

How renewal of registratlon can be obtained for biological

drugs.

a) Describe the procedure of PQCB in a case of expired drugs

referred by provincial inspector of drugs.

b) Describe Prohibitions and Penalties under Control of

Narcotic Substances Act 1997.

a) Describe the following under Factory Act 1934

i) Precautionary measures taken in case of fire

ii) Facilities provided to workers

b) Describe the following under Pharmacy Act 1967.

i) Election of Vice-President under Section 11

ii) Furnishing of information under Section 20

a) Write a list of instructions for a Pharmacist working in

Pharmacy with reference to controlled drugs.

b) What is the composition of Drug Regularity Authority of

Pakistan (DRAP)?

4 Marks

each

10 Marks

10 Marks

10 marks

each

10 Marks

10 Marks

10 Marks

10 Marks

5 Marks

each

5 Marks

each

10 marks

10 Marks

へｔ

UNIVERSI TY OF TⅡ E PUNJ AB` ヽ``、 Rol l No。 """"・ "・ "● ●

Final Prof: Annual - 2018 ".Examination: Doctor of Pharmacv (Pharm.D.) ".. \ \

Subject: Forensic Pharmacy

."PAPER: 4 Part-I (Compulsory)

、 フg

TIME ALLOWED: 30 min. ".MAX. MARKS:20 '.. \

ヽノ．

after exnirv of time limit mentioned above.

Q.1 select and mark the most appropriate answer of each of following questions.

l. Adulterated drugs means a drug that contains

A. Decomposed substance

B. Contarninated with dirt.C. Deleterious sr-rbstance

D. All of the given options are correct

2. tmitation product means a product that is

A. Homeopathic

B. AllopathicC. Contanrinated rvith dust

D. Resembles lvith some drr.rg in its outer packing.

3. ln case of inconsistency between DRAp Act 2012 and Drugs Act r976.provision of which Act will prevail

A. Drugs Act 1976

B. DRAP AdZADCl. Facrory Act 1934

D. All of above

4. on which Forrn; Federal lnspector olDrugs requiring a person nor t() disposeof the stocks in lris possession.

A. Form I

B. Form 2

C. Form 4

D. Forrn 5

5. Under clause I'olsub-section I orsection lg under.Drugs Act 1976 lnspecrorof'Drtrgs can

A. Seal the rnedical store.

B. l'ake santples

C. Seize the dnrg

D. Call for personal appearance.

6. A medical store can sell, store, exhibit tbr sale, & distribute drugs other thanthose specitied in

A. Schedule B

B. Schedule F

C. Schedule D

D. Schedule C

7. Daily working hrs lor adult worker in non-seasonal lhctr.rry shall he ninehrs and in seasonal factory he may work lor

A. I lhrs

B. l0 lrrs

C. ll hrs

[). l2 hrs

8. Notice of atr exanrination lbl legistration as phalrnacist unrJer Pharrnacy Act1967 shall be published tbr a continuous period ofnot less than

A. One year

B. Two weeks

C. One month

D. One rveek

PTO

1l

9. The certificate of fitness forpractitioner shall be valid for

A. One monthB. Two monthC. Three nrontlr

D. Four month

ernployment in a factory by authorizeda period of

I 0. DrLrg Regulatory AuLhority ol. pakistan ( DRAp) is aA. provirrcial OrgarrizationB, District Oigan iz.ation

C. Federal OrganizationD. All olabove

I l. Enlistrnenr certiflcate for herbal drug issued onA. Form 4

lJ. I:orrn 5

C. Form 6D. Fonn 7

12. Which one is NOT a cognizable offence?A. sale of expired drugB. Sale of spurioLrs drugC. Sale of un_registereci clrLrgD. manulhcturing oldrugs without I-icense.

13. A person sentenced by the Drug Court may prefer an appeal to a bench otA. Suprcrne CourtB. IJigh CoLrn

C. Session CoLrrtD. Civil Court

14. Which statelnent is correct,lA. Constitution is frarned under ActB. Rules are fi.arned under ActC. Act is frarned under Rules.D. None ofabove.

15. Application of drug registration tbr imported clrug is given onA. Forrn 5-AB. Form 5-BC. Fonn 5-DD. Fornr 5_8.

16. Fedc'al Drug lnspecto'can forwnrd cases of'cclntr.aventr.n or D*rgs Act toA. Registration Boarci

ts. Central Licensing Board.C. Any other authority specified for the purpose.D. Allof above.

17. Duration ol-validity of registration certitlcate of clrug isA. one year

B. 1'hree years

C. Five years

D. Ten years.

18. Minimurn age lirnit for appoinrrnent as CEO of DIiAp isA. 40 years

B. 45 years.

Cl. 50 !'ctrrsD. 5-5 -Ye615.

19. Prices of drugs flxed under. which section ol'Drugs Act 1976A. section 8

B. Section l0C. Section l2D. Section l4

20. Drug Appellate Board listen the appeals against decisions ofA. Proviucial Quality control Boar.dB. Registration and Licensing Board.C. Pharmacy CouncilD. Allof above.

′

TINTVERSITY OF' THE PUNJABFinal prof: Annual _ 20lg

.a a aa a a aa a a a a a a aaaaa a a a aaaaal

! RoltNo. ..................... :ao aaaaaaoa aaaatlola l ll alo

TIME ALLOWED:2 Hrs. & 30 min.MAX. MARKS:80

lubject: Forensic pharmacyPAPER:4(Part-[)

Attempt lhis Poper on Separote Answer Sheet provided.

Q2 Give brief answers of following terms. 5 Marksi. Spurious drug as per Drugs Act L976. eachii. controlled derivery under contror of Narcotic Act 1997.iii. Landed cost as per pricing poticy.

iv. Pharmacy Services under DRAp Act 2012.

a) Describe the requirements of storage area as given in schedure 10B under Drugs Act 1976.

b) Enlist various categories of drugs/remedies that can be 10advertised without permission from Government.

a) Describe Prohibitions as given under section 23 of Drugs Act 101,976.

b) Give procedure of sampring by an rnspector as described under 10section 19 of Drugs Act 1.976, .

a) write note on Drug discounts and price adjustment Rures 2006. 10b) Describe the procedure of registration of drugs for rocar 10manufacturing.

Q3

Q4

Q5

a)Q6 Mr."X" want to start a business of sale of drugs includingcompounding and dispensing. Discuss the extra conditionsaccording to Punjab Drugs Rules 2007 which he has to fulfill toget permission for such service.

Describe the functions of Drug Regurarity Authority of pakistan(DRAP).

Discuss the inspecting stafrand their powers under Factory AcrI 934.

Describc tlre follorvirrg under pharrnacy Act 1967.i) Prohibition of practice withoui registration

ii) Bye laws made by central and provincial council.

10

10b)

b)

Q710

5 Marks

each

UNIVERSI TY OF THE PⅢ J AB●・・・ ° ° ° ° ° ° o● oooooooOooooo。

Subjech F'orensic pharmacyPAPER:4 (Part-Ig

l 1191rI ?l ∵ : ∵: : D: ∵ : ∵ : ∵ : LofMAX. TIME32 Hrs. 30 Mi neMAXo MARKS: 80

Fi nal Pro■ 2nd Annual … 2018

Q2 5レ l arkseach

Q3 a)

Q6 a)

Give brief answers of the followingi. Define Adulterated drr_rg uncler Drugs Act 1976ii. Qualification of Covt. Analyst r.rnder Drugs Act 1976iii. Define OpiLrm under Narcotic Substances Act 1997iv. Manufacturing cost as per pricing policy.

Describe the requrirements of plant and equipment for tablet dtsageforms as given in Schedule B-l r-rnder Drigs Act 1976.

cive Qualiticatiorl and duties of provincial inspector under. DrugsAct 1976.

what type of drugs/renredies cannot be acivertised under Drugs Act1976 and rules framed thereunder?

cive labeling requirernents for external preparations under drugstabelling and paol<aging rules 1986.

cive procedure of'registration of a clrug intendeti to lrc ir,portecl.

Give types of drug manulfacturing Licenses. Briefly describe thecorrdition of drLrg rnanufacturing License.

Describe the procedure of pecB in a case of spuriours drugs or urn-registered drr"rgs referred by provincial inspector of clrugs.

Describe the Drug Discount a,cl p.ice adjust,rent Rules 2006.

what types of precautionary measures should be takerr in case of fireurrder Factory Act 1934?

what is the conrposition ancl functions of central pharrnacy c.uncil

'*::tl":.ry Act :',_:"

10

０

　　０

　　０

ｋυ　　　ａ　　　ｂ

４Ｑ

０

　　　０

10

０

　　　０

　　　０

ａ

ｂ

５Ｑ

ｂ

　　　ａ　　ｂ

７Ｑ

ヽ）　　　´

UNIVERSI TY OF THE PUNJ ABFi nal Pro■ 2nd Annual … 2018

Ex旦璽i nat i on: DOct or of Pharmacv_f PLarm. Dめ

｀`、Rol l Nooi n F導 …………………・…ヽヽ

、`Rol l Nooi n Wordsiヽヽ

Subjecfi Forensic PharmacyPAPER: 4 Part-I (Compulsory)

MAX. TIME830MAXo MARKS:

( l x20=20)iQ.l. Encircle the right answer cutting and overwriting is not allowed.

l. S;lurious drugs means a drug tliat contains

A. Deconrposed substance

B. Contaminated things

C. No active irrgredient

D. Putrid substance

2. Under Drugs Act 1976 "prescribed" means

A. Prescribed by physicians

B. [)resr'.ribed by lrarliament

C. Prescribed by tlLrles

D. Prescribed by Pharmacy cor"rncil

3. To conduct examinations for the purpose of registration as pharmacists is the

function ofA. Central Pharrnacy corrncil

B. Provincial Phalnracy council

C. FederalCovernment

D. Provincial Covernment

4. As per Factory Act 1934 child means who has not cornpleted his

A. l8t'' years

B. l5t' years

C. i6t'' years

D. 20th years.

5. Which orre is NOT a cognizable of'tensc under Drugs Act I976.

A. Sale of expired drugs

B. Sale of spurious drugs

C. ManufactLrring of un-registered drug

D:Yr,|a?.11rrne_ gf aruss without License

6. Which staternent is correct?

A. Couslitution is iranred under the ActB. Act is framed under the Rules.

C. Rules are fi'amed under the Acti D. All of above

7. Maximunr age lirnit for appointment of CEO of DRAP isA. 53 years

B. 56 years

C. 58 years

D. 65 years.

8. Price of drugs are fixed by

A. Provirrcial Government

B. Federal Goverurnenl

C. Both o[aboveD. None of above

9. llnlistnrerrt certi ficate 1'or rnairufhctures ol'alterrrativc dlrrgs is issued t'rn

A. Forur 5

B. Form 6

C. Forrri 7

D. Fornr 8

及

PoT。0.

Pl ea

｀｀｀、、、、

ゝ（

10. Federal lnspector of DrLrgs take hor.r, many portions of a sarnple of drugs fbr its

aniilysis under DI(AP Act 2012

A. Three

B. Four

C. f-ive

D. Six

I L which is Nor the f,nction of provincial euality control Board.A.'l'raining programs fbr Covt, AnalystB. Annual validatiorr of instruments at Drug T'esting Laboratories.c. To advise the Provincial covernment on euality control of drugs.D. To enlist the alternative medieines.

12. Cross.contanrination means contamination ofA. starting rraterialsB. lnternied iate product

C. Finished product

D. All of'above13. Regrrlation of rvhich of following firnction is primarily dealt by provincialGovernment under Drugs Act 1976.

A. Registration of drLrgs

B. Export of'drugsC. Sale of drugsD, Manufacturing of drugs.

14. Minirntrm ur.o ,:.qui,=nl.nt folU*i, irrstallatiorr for fillirrg of Irard gelatiricapsi,lcunder schedule B-l under Drugs Act 1976 is

A. 100 square feet

ll. 200 square lretC. 300 square feetD. 400 square feet

15. Under drug discounts and price adjustment Rules 2006; sum of all discountsgiven by finn cannot exceed

A. l5oh of prinred MRp8.25% olprinted MRPC.40% of printed MRpD.50% of prinred MRP

16. As per pricing policy CPI rneans

A. Clorrrnercial product infcrrnrationB. Clonsuurer price indexC. Conventional price impactD. Corrsurner price irnpact

17. Drug Inspectors exercise powers under rvhicrr sebtion of Drugs Act 1976A. Section lB

B. Section 2lC. Section 23

D. Section 39

18. Drug Appellate Boar.d listen the appeals againsr decisions ofA. Provirrcial Qualiti, control Board

B. Registration ancl i.iccnsing Boarrcl.

C. Pharruacy CouncilD. All of above.

19. which is Nor function of central phannacy council under pharmacy Act 1967A. To approve coLlrses of study in pharrnacyB. To recognize de_eree in plrarnracy

C. lnspectiorr o{' pharmacy institutionsD. To mairrtain registers o1'pharmacists.

20. lrr case of ittconsistertcy betweert DRAP Act 20 l2 arrd Drugs Act I976. pr.ovi-siorrol'which Act \.vill prevail

´

、ヽく

A. Dlr"rgs Act 1976

B. DRAP Act20l2C. Pharnracy Act 1967

D. AII of above

UNIVERSi TY OF THE PUNJ ABDoctor of Pharmacy (Pharm.D.) Final Prof: Annual-2019

Subject: Phamacy P.actice - Vll (Foronsic Pharmacy)- Paper: 4 Part - I (Compul$ry) (New Couree)

、`P‖ No. h t t g. … …………

、`Ro‖ No. i n Word6. . . . . ・・・・̈・・

Time: 30 Min. Marks: 20 '.

b) Have resemblance of label

d) Manufactured by false manufacturer

iii. Dispensing the wrong medication, compounding errors, failure to detect interactions,

failure to iontact prelcribers about excessive dosages, and failure to warn patients

Q.'l. Encircle the correct oPtion.

i. Spurious drugs means a drug that is contains

a) Decomposed substance b)

c) No active ingredient d)

l i Mi sbranded drug rneans t hat i sa) Labened cOnspi cuousi yc) Not ! abe‖ ed as prescnbed

about side effects are the examples of:

a) Pharmacy crimes

c) Prescription errors

a) Registrar Supreme Court

c) Federal lnspector of Drugs

a) Fifteenth yearc) Seventeenth year

Medication errorPharmacist malpractices

b) PrOVi nci al Drugs i nspect ord) BOth B and c

b) Si Xt eent h yeard) Ei ght eent h year

b) SChedu! eBd) SChedul e F

b) Government Hospital

d) Government lnstitution

b) Form 5d) Fo「m7

( 20xl =20)

Cont ami nat ed t hi ngsPut ri d subst ance

S`i gnat ure of Supdt . :

ｂ

ｄ

iv. Which is NOT the function of central pharmacy council?

a) Approval of examinations in pharmacy

b) To conduct examinations for registration of pharmacists

c) To recognize diploma in Pharmacy for registration as pharmacist

d) To Lay down standard of teaching in pharmacy

v. Who can launch prosecution in

drug under Drugs Act 1976

Drugs Court Located in Punjab for offense of Expired

vi. Under Factory Act 1934 is an adult is a person who has completed his:

vii. The factory premises for the manufacture of drugs shall comply with the conditions

specified in which schedule:a) Schedule Cc) Schedule E

viii. A person can be registered as an apprentice in pharmacy who has obtained

certification from which organization to be a qualified compounder and dispenser?

a) Federal Hospitalc) Central Council

ix. Certificate of drug registration is issued on:

a) Form 4c) Form 6

P. T, 0.

x. Process of CTD format for registration dossier submission has been initiated byDRAP; and CTD stands for:a) Correct testing document b) Cumulative tracking documentc) Comprehensive tabulated document d) Common technical document

xi. Duration of validity of registration certificate of drug is:

a) One Year b) Three Yearsc) Five Years d) Ten Years

xii. Under Drugs Act 1976; Provincial Drug lnspector can inspect:a) Warehouse of Veterinary medicine b) Store of imported medicines

c) Pharmaceutical manufacturer d) All of above

xiii. Enlistment certificate to manufacture alternative drugs is issued on:

a) Form 5 b) Form 6c) Form 7 d) Form 9

xiv. According to national health vision of Pakistan; Health Technology Assessment (HTA)

will be created at:

a) Federal level b) District level

c) Both A and B d) lnternational level

xv. Obtaining controlled substances for misuse is termed as:

a) Quackery b) Health care Fraud

c) Scientific Fraud d) Drug Diversion

xvi. Forensic Pharmacist engage in professional work relating to:

a) Litigation b) Criminal Justice System

c) Regulatory process d) All ofabove

xvii. On which Form; Federal lnspector of Drugs requiring a person not to dispose of the

stocks in his possession.

a) Form'l b) Form2c) Form 4 d) Form 5

xviii. Under Clause'e' of sub-section 1 of section 18 under Drugs Act 1976 lnspector of

Drugs can:

a) Seal the medical store b) Take samples

c) Seize the drug d) Call for personal appearance

xix. Application of drug registration to manufacture a patented drug is given on:

a) Form 5-B b) Form 5-Cc) Form 5-D d) Form 5-E

xx. Subject to nature of the case; Federal Drug lnspector can forward cases ofcontravention of Drugs Act to:a) Registration Boardb) Central Licensing Boardc) Any other authority specified for the purpose

d) All of above

8Subject: Pharmacy Practice - Vll (ForenElc Pharmacy) (New Course)

T: me: 2 Hrs. 30 Mi n. Marks: 80

UN: VERSi TY OF THE PUNJ ABDoct or of Pharmacy( Pharm・ Di l Fi na: Pro■ Annua卜2019

: ° AI i I I I I・ 1ヽ . ・・ ・ ・・ ・・ ・ ● ● ● ● ● ● ● ● ● ● ●

Paper:4 Part-ll

Q2

Q3

Note: Attempt any FOUR questions' Each question carries equal marks'

Give brief answers ol followlng

i. Define misbranded drug as per Drugs Act 1976'

ii. Give key objectives of national drug policy'

iii. Define Drug under DRAP Act 2012'

iv. What type of drugslremedies cannot be advertised

under Drugs Act 1976 and rules framed thereunder?

a) Describe the requirements of plant and equipment for the

production of tablets as described in Schedule B-l of drugs

Licensing, Registration and Advertising rules 1975'

bl What are essential drugs? Describe the measures adopted in

National drug policy to promote the rationate use of drugs?

a) Write down the duties of Federal lnsPector of Drugs under the

rules framed under Drugs Act 1975,

b) How lnspector will distribute the portions of a sarnple taken

from a Pharmacy under Drugs Act 1975? What procedure an

lnspector will adopt under Drugs Act 1976 upon receipt of

report of a sample; declared substandard by Drug Testing

Laboratory?

Q 5 al Give composition of Drug Registration Board' 10

b) Define Forensic Pharmacy, what is the role of forensic 10

pharmacist in criminal cases?

5 Marks

each

10

10

10

10

Q4

Q5 a) Write down the list of minlmum requirements

Pharmacy under Puniab Drugs Rules 2q)7.

to establish a 10

Authority of 10b) Wri t e dOwn t he composi t i on of Orug Re8ui at oryPaki st an( DRAP) .

q 7 a) What is the composition and functions of Prpvincial Pharmacy

Council under PharmacY Act 1967 ?

b) Describe the following under Factory Act 1934'

i) Precautions against dangerous fumes

ii) Restrictions on working hours of a child'

10

5 Marks

each

一訴邑》呻中

UNIVERS: 丁Y OF THE PUNJ ABDoct or of PharmaCy( Pharm. D. ) Fi nai Pro, Annual - 2019

、`Fo‖ No, i n Fi g. ・ . … ……………・｀`

、Ro‖ No. i n Words. . . . . … …・・・・

Forensic Pharmacy (Old Course)

Part - I (Compulsory) Ti me: 30 Mi n. Marks: 20｀ 、

S`i gnat ure Of Supdt =

ヽ

Q,1. Encircle the correct oPtion'

a) Homeopathic

c) Contaminated

a) TWOc) Four

v Pri ces of Drugs are f i xed by:

a) SChedul e BC) SChedul e D

a) 1l hrsc) 13 hrs

a) One year

c) One month

a) Provisional quality control board b)

c) Central license board d)Provincial GovernmentFederal Government

( 20xl =20}

i. Under Drugs Act 1976, prescribed means

a) PreJcribed by physicians b) Prescribed by Rules

ci prescribed by toistitution d) All of the given options are correct

ii. lmitation product means a product that isb) A‖ opat hi cd) ReSembl es wt t h some drug

iii. Who can launch prosecution in Drug Courts located in Punjab?

a) Federal lnspector of Drugs b) Provincial lnspector of Drugs

ci Both A and B d) None ofA, B and C

iv. - Under Drugs Act 1976, how many portions of a drug sample is collected by Federal

inspector of Drugs from manufacturing unit:

b) Threed) Fi ve

vi. A Pharmacy has to fulfill the requirements given if following schedule if have to

dispense the compounded prescriptions.

vii. Daily working hours for adult worker in a seasonal factory are:

b) SChedu! eFd) SChedul e G

b) 10 hrsd) 12 hrs

b) Twoweeksd) Oneweek

b) Two months

d) Four months

is required for basic installation to manufacture hard gelatin

b) 200 square f eetd) 500 square f eet

viii. Notice of an examination for registration as pharmacist under Pharmacy Act '1967

shall be published for a continuous period of not less than:

ix. The certificate of fitness for employment in a factory by authorized practitioner shall be

valid for a period of:

a) One monthc) Three months

x. How much minimum area

capsules?a) 100 squarefeetc) 300 square feet

P. T. 0.

xi. lf penalty of an offense is inconsistent in Drugs Act 1976 and DRAP Act 2012, than

penalty mentioned in which Act will prevail?

a) PharmacyAct 1967 b) Drugs Act 1976

c) DRAP Act 2012 d) All of above

xii. Under Drugs Act 1976; Provincial Drug lnspector can inspect:

a) Warehouse of Veterinary medicine

b) Store of imported medicinesc) Pharmaceutical manufacturerd) All of above

xiii. Drugs Courts are established under which section of Drugs Act 1976.

a) Section 22 b) Section 25c) Section 28 d) Section 31

xiv. A person sentenced by the Drug Court may prefer an appeal to a bench of:" a) Supreme Court b) High Courtc) Session Gourt d) Civil Court

xv. Which statement is correct?a) Constitution is framed under Act b) Rules are framed under Actc) Act is framed under Rules d) None of above

xvi. Drug Appellate Board listen the appeals against decisions of:

a) Provincial Quality Control Board b) Registration and Licensing Board

c) Pharmacy d) All of above

xvii. Which is NOT the function of Provincial Quality Control Board?a) Training programs for Govt. Analystb) Annual validation of instruments at Drug Testing Laboratoriesc) To advise the Provincial Government on Quality control of drugsd) To enlist the alternative medicines

xviii. Enlistment certificate for herbal drug issued on:

a) Form 4 b) Form 5

c) Form 6 d) Form 7

xix. Which one is NOT a cognizable offence?a) Sale of expired drug b) Sale of spurious drugc) Sale of un-registered drug d) Manufacturing of drugs without License

xx. Under Clause f of sub-section 1 of section 18 under Dugs Act 1976 lnspector of Drugs

can:

a) Seal the medical store b) Take samples

c) Seize the drug d) Call for personal appearance

妙Subject:Paper: 4

UNIVERSI TY OF t tHE PUNJ ABDoct or of Pharmacy( Pharm・ D. ) Fi nal P『of : Annual - 2019

: Rο ‖ No. … ……. . . . … …・・ :・ヽ・・・・・・・・ ●● ●● ●● ● ● ●● ●

Forent i C Pharmacy ( Ol d Course)Part― ‖

Ti me: 2 HrS. 30 Mi n, Marks型

Note: Attemptany FOltRquestions. Each question carries equal marks'

Give brief answers

i. Define Drug as Per DRAP 2012.

ii. Conditions6f diug sale license related to schedule C drugs

iii. Hcalth and OTC Products

iv. Misbranded Drug

v. Form 6 for Altemative medicine

vi. LandedCost

What are the requiremenr of Planl and Equipment (Schedule B'l for

manufacturing of lablets?

Explain provision of rhe Drugs Act 1976 related to the advenisement of

drugs? What type of drugs can be advertised undcr this Act?

what are the labelling requirements for suspelsions?

Discuss following under Pharmacy Act 196?

(a) Preparation and maintenance ofregisters

(b) Procedure for registration

(c) certificate of registration

(d) Elecrion of Vicc'President under seclion

(e) Furnishing of information

Discuss the following under Factory Act:

i. Seasonal factorY

ii. Restriction on the working hours ofa child

０６

０２

は

い

。２

“

08

C

4 a

( ) 8

04

04 cach

5 a

b Explain the procedure of sampling by an lnspeclof? What procodure an

lnspector toill udopt under Drugs Act 19?6 upon receipt of report of a

sample; declared spurious by Drug Testing Laboratory?

a What are the funclions of Provincial Quality Control Board (PQCB) and

Distriu Quality Control Board (DQCB)?

b What are lhe condilions of drug sale license?

c What is Provincial Appellate Authority and its function?

Describe the following under Drug Act 1976

i. Drug Courts

ii. Pleas

iii. Offences and Penalties

一卜

く・　

一〇

〇

０

‥

07

０^　̈ヽ♪

１

　０

ヽ■７

ｂ^

０

０

０

うる

7