UNIVERSITY OF THE PUNJAB

Examination: Doctor of Pharmacv (Pharm.D.)

i...R..o.l.l.N..o....,................................. :

Subject: Forensic Pharmacy

P

4

TIME ALLOWED: 3 hrs.

100

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

Question

Marks

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 of

drugs? 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 of

formdlation) under Drugs Act 1976?

4a Discuss following under Pharmacy.dct 1967

(a) Preparation and maintenance ofregisters

08 07

04 each

'

(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

b

6a

Explain the procedure ofsampling by an lnspector?

What are thi functions ofProvincial Quality Control Board

(PQCB)

and

10 07

District Quality Control Board (DQCB)?

b What are the conditions ofdrug sale license?

c What is Provincial Appellate Authority and its function?

7

Describe the following under Drug Act 1976

i. Cognizanceofoffences

ii. Pleas

iii. Offences and Penalties

Forensic PharmacY

mrny

FIVE questions. Au questions cnrry equor marks.

Question Give brief answers of the following

i. Define adulterated drug ii. Quatification of Covt' AnalYst iii. Seasonal factory iv. Landed cost v. DseisrvciucsessVcfoaorloidLdaictleivoninasneutfoacmtuarninug-faPcrtuarceticbeysw(aayMoPf)forermlauteladtitoond(esscihgendouflebuBil-dlli)ng and

Marks 4 each

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

related to owning premises, possession of offences given under Control of Narcotic

Substances Act 1997. What types of health and safety measures should be provided to workers under

Factory Act?

What

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ctoympepsosoitfiodnruagndsafulencltiicoennsseofaCree?ntHraol wPhyaormuawcyilCl oaupnpcliyl?-for

the

new

license of your PlrarmacY? What are condiiions of drug sale license related with

i) ScheduleB&Ddrugs ii) schedule E drug

Desciibe the following as under Drug Act 1976

i. Composition of Drug Registration Board' It Offences and Plnaltil

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Subject: Forensic PharmacY PAPER: 4

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

Q.No

t

Question

Give brief answers of the following under the Drugs Act 1976

i. Spurious drug

ii. Types of drug manufacturing licenses

iii. iv.

Qualification of Federal Inspector IMS data

v. Quarantine a) and Discuss bood Manufacturing

Practices

(AMP)

surrounding and size of builJing for License to

related to location manufacture by way

of

formulation (Schedule B-ll)

Is the advertisement of every

drug

legal?

Provide

a

list

of drug

Marks 4 each

l0 l0

categories that cannot be advertised. Defrne the following terms as per DRAP Act2012'

i) Drug ii) Medical devices

b)

iii) TheraPeutic goods What is the comPosition of Drug

Regularity Authority of Pakistan

l0

(DRAP)?

bescribe the

following

under

Drug

(labeling

and

packing)

Rules

1l*9o86t

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'

5+5

ii) SafetY of workers.

Discuss following under Pharmacy Act 1967

Al 24 Preparation ind maintenancaof registers utrder section

5+5

iii; eroceaure for registration under section 26

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

l0

i) (RMP) license of Your PharmacY?

What are ionditions of drug

sale

license

related

with

Registered MedicaiPractitioner

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

l0 l0

Final Prof: Annual - 2017

Examination: Doctor of Pharmacv

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

Give brief answers of following terms.

i. Counterfeit drugs

ii. Form 5 & 7 for alternative drugs

iii. iv. v.

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

4 Marks each

Describe the requirements of plant and equipment for

sterile dosage forms as given in Schedule B-l under Drugs Act 1976.

Give labeling requirements for external preparations under drugs labelling and packaging rules 19g6.

What type of drugs can be advertised under Drugs Act

7976 and rules framed thereunder? Describe the

conditions 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 local

manufacturing.

Give types of drug manufacturing Licenses, Briefly describe the condition of drug manufacturing License. Describe the procedure of peCB in a case of over pricing of drugs referred by provincial inspector of drugs. Mr."X" wants to start a business of sale of drugs. Discuss the conditions according to punjab Drugs Rules 2007 which are 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 registration under section 31 in pharmacy Act 1967?

i) Define the following terms as per DRAp Act 2012. Healttr and OTC products ii) Medicaldevices iii) Qualification of chief executive officer (CEO)

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

Describe the procedure for change of qualified person of a

Pha rrnacy.

final Prof: 2nd Annual - 2017

Examination: Doctor of Pharmacv (Pharm.D.)

Forensic Pharmacy

4

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.

4 Marks each

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.

10 marks each 10 Marks 10 Marks

10 Marks

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

10 Marks

5 Marks each

5 Marks each

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)?

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