[KZ 816] OCTOBER 2011 Sub.

Code: 3816

DOCTOR OF PHARMACY (PHARM. D) DEGREE EXAMINATION

THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code: 383816
Time: Three Hours Maximum: 100 marks
Answer ALL questions in the same order.
I. Elaborate on : Pages Time Marks
(Max.) (Max.) (Max.)
1. Explain about the Patents and designs act 1970. 17 40 min. 20

2. Compare the manufacture of alcoholic preparations in

bonded and non bonded laboratory including the export 17 40 min. 20
under the relevant act.

II. Write notes on :

1. Define the terms “Advertisement”, “Magic remedies”
and “Psychotropic substances”. 4 10 min. 6

2. Describe the functions of Pharmacy Council of India. 4 10 min. 6

3. Administrative agencies under the Drugs and Cosmetics act. 4 10 min. 6

4. Describe the functions of Narcotics and Psychotropic

consultative committee. 4 10 min. 6

5. Give a note on Drugs Price Control Order, 1995. 4 10 min. 6

6. Prevention of cruelty to animals act. 4 10 min. 6

7. Salient features of New Drug Policy. 4 10 min. 6

8. Loan license. 4 10 min. 6

9. Essential commodities act. 4 10 min. 6

10. Give a note on prescription and non prescription products. 4 10 min. 6

*******
[LA 816] APRIL 2012 Sub. Code: 3816

DOCTOR OF PHARMACY (PHARM. D) DEGREE EXAMINATION

THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code: 383816
Time: Three Hours Maximum: 70 marks
Answer ALL questions in the same order.
I. Elaborate on : Pages Time Marks
(Max.) (Max.) (Max.)

1. Explain about the constitution and functions of State and

Central Pharmacy Council including registration procedures
and educational regulations? 17 40 min. 20

2. Discuss in detail about the Narcotics and Psychotropic

substances act and rules? 17 40 min. 20

II. Write notes on :

1. Write about the code of pharmaceutical ethics formulated by PCI? 4 10 min. 6

2. Give a note on the Schedule C & C1, M, F111, R, V, X. 4 10 min. 6

3. Loan license 4 10 min. 6

4. Advisory agencies under the Drugs and Cosmetics Act 4 10 min. 6

5. Bonded laboratory. 4 10 min. 6

6. Essential commodities act. 4 10 min. 6

7. Prevention of cruelty to animals act. 4 10 min. 6

8. Write about the conditions in the Grant of Patents and

Rights of Patentees? 4 10 min. 6

9. Salient features of New Drug Policy. 4 10 min. 6

10. Mention about the diagnostic aids and applications available

in the market. 4 10 min. 6

*******
[LB 816] OCTOBER 2012 Sub. Code: 3816

DOCTOR OF PHARMACY (PHARM. D) DEGREE EXAMINATION

THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code: 383816
Time: Three Hours Maximum: 100 marks
Answer ALL questions in the same order.
I. Elaborate on : Pages Time Marks
(Max.) (Max.) (Max.)
1. Discuss in detail about manufacture of alcoholic preparations in
bonded laboratories. 17 40 min. 20

2. Write about the salient features of drugs and magic remedies

act and its rules. 17 40 min. 20

II. Write notes on :

1. Explain about loan and repacking licence. 4 10 min. 6

2. Write about the offences and penalities of narcotic and

psychotropic substances act. 4 10 min. 6

3. Discuss about Patents and Design act 1970. 4 10 min. 6

4. What are the cautionary labels needed for the following drugs
according to D & C act? 4 10 min. 6
(a) Schedule G (b) Schedule H (c) vertinary drugs

5. Discuss in brief about the Drug Technical Advisory Board

and Drug consultative committee of Drugs and Cosmetics act. 4 10 min. 6

6. Explain brief about sale of drugs under Drugs and Cosmetics act. 4 10 min. 6

7. What are the Labelling requirements for the following drugs? 4 10 min. 6
a. Alcoholic preparations.
b. Colored preparations.
c. Medicine for external use.
8. Explain the Qualifications and duties of government analyst. 4 10 min. 6

9. Write notes on non prescription drugs. 4 10 min. 6

10. What are the ethics of pharmacist in relation to his trade? 4 10 min. 6

*******
[LC 816] APRIL 2013 Sub. Code: 3816

DOCTOR OF PHARMACY (PHARM. D) DEGREE EXAMINATION

THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code: 383816
Time: Three Hours Maximum: 100 marks
Answer All questions
I. Elaborate on: (2 x 20 = 40)

1. Explain about the objectives of pharmacy act and about constitutions and functions of
Pharmacy Council of India.

2. Write in detail about the import of drugs and cosmetics act.

II. Write notes on: (10 x 6 = 60)

1. Write in short about warehousing of alcoholic preparations.

2. Explain briefly about cultivation, production and sale of opium under Narcotic and
Psychotropic substances act.

3. What are the duties of a drug inspector?

4. What are the codes of ethics of a pharmacist in relation to his job?

5. Discuss in brief about Essential commodities act in relevant to Drug price control
order.

6. Write about central drugs laboratories.

7. Write notes on National Drug Policy (current).

8. Explain about manufacture of drugs under schedule x drugs under Drugs and cosmetics
act.

9. Write about import export and shipment of narcotic and psychotropic substances act.

10. What is the role of excise commission in alcoholic preparations premises under
medicinal and toilet preparations act?

*******
[LD 816] OCTOBER 2013 Sub. Code: 3816

DOCTOR OF PHARMACY (PHARM. D) DEGREE EXAMINATION

THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code: 383816
Time: Three Hours Maximum: 70 marks
Answer All questions
I. Elaborate on: (2 x 20 = 40)

1. What is the objective of Drugs and Cosmetics Act?

Write a detail note on import of drugs under the act.

2. Give a detailed note on Patent and Drugs Act 1970.

II. Write notes on: (10 x 3 = 30)

1. What is schedule H, J and B in Drugs and Cosmetics act.

2. Write the difference between manufacture of alcohol in bond and outside bond.

3. Pharmacist’s oath.

4. Write the offences and penalties under Pharmacy Act.

5. Labeling requirements of Schedule G, H and X drugs.

6. Warehousing of alcoholic preparations.

7. Code of ethics for pharmacist in relation to his job.

8. Loan license.

9. Repacking license.

10. Write the objectives of Excise Duties Act.

*******
[LE 816] APRIL 2014 Sub. Code: 3816

DOCTOR OF PHARMACY (PHARM. D) DEGREE EXAMINATION

THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code: 383816
Time: Three Hours Maximum: 70 marks
Answer All questions
I. Elaborate on: (2 x 20 = 40)

1. Define patents. Write the provisions for getting the patents rights quoted in Patents Act.

2. Discuss in detail about manufacture of alcoholic preparations in bonded laboratories.

II. Write notes on: (10 x 3 = 30)

1. Write the role of pharmacist as a member of a health care team.

2. Joint State Pharmacy Council.

3. Outline about Repacking license.

4. Schedule J.

5. Write the functions of Drugs consultative committee.

6. Give an account on experimentation of animals under Prevention of Cruelty to Animals

Act.

7. What are the sale conditions of Schedule H?

8. Give the details of narcotic drugs prescribed in Narcotic and Psychotropic Substances
Act.

9. Salient features of New Drug Policy (current).

10. Mention the labeling requirements of Ayurvedic medicines.

*******
[LF 816] OCTOBER 2014 Sub. Code: 3816

DOCTOR OF PHARMACY (PHARM. D) DEGREE EXAMINATION

(2009-2010 Regulation)
THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code: 383816
Time: Three Hours Maximum: 70 marks
Answer All questions
I. Elaborate on: (4 x 10 = 40)

1. Give a brief note on various licenses required for the manufacture of drugs under
Drugs and Cosmetics Act.

2. Give an account on the functions of Pharmacy Council of India constituted under the
Pharmacy Act, 1948.

3. Discuss the manufacture of alcoholic preparations – Outside bond.

4. Discuss briefly about Drugs and Magic Remedies Act and Rules.

II. Write notes on: (6 x 5 = 30)

1. Drug Technical Advisory Board as per Drugs and Cosmetic Act.

2. List out the patentable and non patentable inventions.

3. Draw a model label of Schedule H and X drugs including all the labeling requirements.

4. Experimentation on animals under Prevention of Cruelty to Animals Act.

5. Drug Price Control order.

6. Pharmaceutical Legislation in India.

*******
[LG 816] APRIL 2015 Sub. Code: 3816

DOCTOR OF PHARMACY (PHARM. D) DEGREE EXAMINATION

(2009-2010 Regulation)
THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code: 383816
Time: Three Hours Maximum: 70 marks
Answer All questions
I. Elaborate on: (4 x 10 = 40)

1. State the objective of Medicinal and Toilet Preparations (Excise Duties) ACT 1955.
Explain the procedure to obtain license to manufacture Medicinal and
Toilet Preparations.

2. Define Patent. Write the provisions for getting the patent rights under patent Act 1970.

3. What are the qualification for the appointment of drug inspectors and explain the duties

of drug inspectors.

4. Write in detail about the categories of licenses for the manufacture of drugs.

II. Write notes on: (6 x 5 = 30)

1. Joint State Pharmacy Council.

2. Distinguish Bulk drugs from Formulations.

3. Schedule – M.

4. Pricing of essential commodity.

5. Significance of permission to conduct experiments on Animal from CPCSEA.

6. Mention the labeling requirement of ayurvedic medicines.

*******
[LH 816] OCTOBER 2015 Sub. Code: 3816

PHARM. D DEGREE EXAMINATION

(2009-2010 Regulation)
THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code : 383816
Time: Three Hours Maximum: 70 marks
Answer ALL questions
I. Elaborate on : (4 x 10 = 40)
1. What is the objective of Pharmacy Act? Write about the constitution of Pharmacy
Council of India.

2. Give a brief account on Narcotic and Psychotropic Substances Act.

3. Write down the various Schedules of Drug and Cosmetics Act.

4. Code of ethics for pharmacist in relation to his job.

II. Write notes on : (6 x 5 = 30)

1. Write a note on the classes of drugs prohibited for import of drugs.

2. List out the different kinds of licenses issuable for wholesale and retail sale of drugs.

3. Warehousing of alcoholic preparations.

4. Qualifications and duties of government analyst.

5. Drug Price Control Order.

6. Essential Commodities Act.

*******
[LI 816] APRIL 2016 Sub. Code: 3816

PHARM. D DEGREE EXAMINATION

(2009-2010 Regulation)
THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code : 383816

Time : Three hours Maximum : 70 Marks

I. Elaborate on: (4 x 10 = 40)

1. Discuss briefly about Drugs and Magic remedies Act and Rules.

2. Write briefly about manufacturing of alcoholic preparation in bonded and non-

bonded laboratory.

3. Discuss salient features of DPCO 1995 and give the calculation for fixing the
retail price of formulations.

4. Explain about the objectives of Pharmacy Act including registration procedures of

pharmacist and educational regulations?

II. Write notes on: (6 x 5 = 30)

1. Short notes on prevention of cruelty to animals act 1960.

2. Write a note on Adulterated drugs.
3. What are the Labelling requirements for the following drugs and give its specimen
label?
a) Amoxicillin 250mg b) Insulin 10 cc
4. Mention the procedure of Drugs inspector for taking samples of drugs and their
despatches to government analyst.
5. Write briefly about Non-prescription products.
6. Write briefly about New Drug Policy (current).

*******
[LJ 816] OCTOBER 2016 Sub. Code: 3816

PHARM. D DEGREE EXAMINATION

(2009-2010 Regulation)
THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE
Q.P. Code: 383816

Time : Three hours Maximum : 70 Marks

I. Elaborate on: (4 x 10 = 40)

1. Write down the constitution and functions of State Pharmacy Council.

2. Write in detail about import of drugs under Drugs and Cosmetics Act.

3. Discuss about the pharmaceutical legislation of India.

4. Write about the prevention of Cruelty and Animals Act - 1960.

II. Write notes on: (6 x 5 = 30)

1. Code of ethics of pharmacist in relation to his job.

2. What is schedule H, X and F?
3. Write a note on spurious drugs.
4. What is the difference between bonded and non bonded laboratory?
5. Mention some of the advertisements prohibited under Drugs and Magic Remedies
Act and Rules.
6. Write a note on main features of Education Regulation (ER).

********
[LK 816] MAY 2017 Sub. Code: 3816

PHARM. D DEGREE EXAMINATION

(2009-2010 Regulation)
THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE

Q.P. Code: 383816

Time : Three hours Maximum : 70 Marks

I. Elaborate on: (4 x 10 = 40)

1. Write briefly about the bonded laboratory under medicinal and toilet preparations
(Excise duties) Act 1955.

2. Explain in detail about various schedules under the Narcotic drugs and
Psychotropic substances Act 1985. Mention the operations controlled by the
central Government.

3. Write briefly about Drug Inspectors qualification, inspection of premises and for
taking samples of drugs from manufacturer and their despatches to Government
analyst.

4. Discuss briefly about objectives and salient features of national drug policy 2002
(current).

II. Write notes on: (6 x 5 = 30)

1. What is the objective of drugs and cosmetics Act?

2. Give a note on the schedule C and C1, M and N.
3. Write short note on loan license.
4. Mention the labeling requirements of schedule X drug with specimen label.
5. Write a short note on pharmacist in relation to his trade.
6. Write short note on warehousing of alcoholic preparations.

********
[LL 816] OCTOBER 2017 Sub. Code: 3816

PHARM. D DEGREE EXAMINATION

(2009-2010 Regulation)
THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE

Q.P. Code: 383816

Time : Three hours Maximum : 70 Marks

I. Elaborate on: (4 x 10 = 40)

1. Discuss in detail about manufacturing of alcoholic preparations in bonded and non

bonded laboratories.

2. Write briefly about Drug Technical Advisory Board.

3. Write briefly about the role of central government to permit, control and regulate
under the Narcotic drugs and psychotropic substances.

4. Write briefly about prohibited advertisement and exempted advertisements.

II. Write notes on: (6 x 5 = 30)

1. What are the duties of a drug inspector?

2. Short notes on non-prescription drugs.
3. Write a note on supply of Schedule X drugs.
4. Mention the duties of Government analyst and procedure to be followed on receipt
of sample.
5. Essential Commodities Act.
6. Write the calculation for fixing the retail price of finished formulations.

********
 THE TAMIL NADU DR. M.G.R. MEDICAL UNIVERSITY

[LM 816] MAY 2018 Sub. Code: 3816

PHARM. D DEGREE EXAMINATION

(2009-2010 Regulation)
THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE

Q.P. Code: 383816

Time : Three hours Maximum : 70 Marks

I. Elaborate on: (4 x 10 = 40)

1. Write in detail about the requirements of drug manufacturing units as per schedule
M under drug and cosmetic ACT 1940 and rules there under.

2. Discuss about constitution of pharmacy council of India (PCI). Give the functions
and duties of PCI.

3. Give a note on Drugs Price Control Order 1995.

4. Write in detail about the salient features of prevention of cruelty to animals Act
1960.

II. Write notes on: (6 x 5 = 30)

1. Mention the labeling requirement of ayurvedic medicines.

2. Write briefly on pharmaceutical Legislation.
3. Write about central drugs laboratories.
4. Write the difference between manufacture of alcohol in bond and outside bond.
5. Give a note on prescription and non prescription products.
6. Offences and penalties under drugs and magic remedies Act.

*********
 THE TAMIL NADU DR. M.G.R. MEDICAL UNIVERSITY

[LN 816] OCTOBER 2018 Sub. Code: 3816

PHARM. D DEGREE EXAMINATION

(2009-2010 Regulation)
THIRD YEAR
PAPER IV – PHARMACEUTICAL JURISPRUDENCE

Q.P. Code: 383816

Time : Three hours Maximum : 70 Marks

I. Elaborate on: (4 x 10 = 40)

1. Describe the labeling conditions specified in the Drugs and Cosmetic Rules.

2. Justify the enactment of Drugs and Magic Remedies Act in safeguarding the
health of the public.

3. Explain the minimum requirements for smooth running of pharmacy as per

schedule N of drugs and cosmetic Act.

4. Write the rules and regulations to be followed for essential commodities under
Essential commodities.

II. Write notes on: (6 x 5 = 30)

1. Write the objectives of Excise Duties Act.

2. Joint State Pharmacy Council.
3. Pricing of bulk drugs.
4. Mention the offences and penalties under Narcotic and psychotropic substances
act.
5. Ethics of pharmacist in relation to his profession.
6. Functions of CDL.

*********