Drugs and Cosmetics Act, 1940 and its rules 1945
1) Define Cosmetics, Adulterated drug, Spurious Drug and Advertisement.05 ( 06/2014, 4/2017)
2) Define as per D & C act and rules i) Ayurvedic drugs ii) Spurious drugs iii) Adulterated drugs.(04/2015)
3) Differentiate pharmacy, drug store and chemist and druggists. 05 (6/2011)
4) What are schedules as per Drugs and Cosmetic Act? Give brief information on Schedule X and Schedule M. 05 (06/2011)
5) Give special labelling requirements for the following category: 05 (11/2018)
(i) Schedule G drugs, (ii) Schedule H drugs, and (iii) Ophthalmic preparations.
6) Give statements of (1) Schedule C (2) Schedule G (3) Schedule K (4) Schedule U (5) Schedule V (6) Schedule O. 06 (06/2014)
7) Give statement of i) Schedule Y ii) Schedule C iii) Schedule X iv) Schedule J v) Schedule N.05 (06/2011)/ i) Schedule M ii) Schedule X iii) Schedule U iv) Schedule T v) Schedule P (11/2013)
8) Give statement of i) Schedule Y ii) Schedule FF iii) Schedule X iv) Schedule J v) Schedule
S. 05 (12/2014). Schedule Y, G, U, N, C,Q (12/15,10/16)
9) (i) Enumerate various administrative agencies (under three distinct headings)
provided for efficient administration of Drugs and Cosmetics Act.06
(ii) Which information is provided by Schedule B, Schedule C and C1 and Schedule H. (12/2010)
10) Give the object of the drugs and cosmetic act 1940 06 (5/2014)
11) What are the conditions to be fulfilled for the import of schedule C/C1 drugs.
Enumerate the classes of drugs prohibited to import.06 (06/2014)
12) Discuss about the classes of drugs that are prohibited to be imported in India? 05 (11/2018)
13) Enumerate the classes of drugs prohibited to be imported and classes of drugs which can be imported under license or permit under Drugs and Cosmetics Act1940. 05 (01/2013, 4/16)
14) Write notes on drug classes prohibited to be imported 06 (05/2012, 12/2015,10/16)
15) Write a note on duties and qualification and responsibilities of government analyst. 05
(06/2011 11/2011, 06/2014, 04/2015, 12/15,4/16, 10/16, 11/2018)
16) What is drug technical advisory board? Give its constitution and functions. 05 (
06/2014, 6/2011, 11/2011, 05/2013, 05/2014, 04/2015, 12/15, 10/16, 4/2017,
11/2018)
17) Write a note on drug inspector and explain power and duties of drug
inspector.05(12/2010, 06/2011, 05/2013, 11/2013, 06/2014, 12/15,
12/15,10/16, 11/2018)
18) What are the qualifications for appointment as a Drug Inspector? Discuss their power
and duties. 06 (4/2017)
19) Discuss the requirements of factory premises given under schedule M of Drugs and
Cosmetics Act 1940.05 ( 01/2013, 06/2013, 12/15, 4/16, 10/16)
20) What is schedule ‘M’? Explain its provision in manufacturing of drugs.05 (06/11, 04/15)
21) Discuss the manufacturing provisions of cosmetics 05 (05/2012
22) Discuss the labeling and packaging requirements of Ayurvedic drugs 05 (05/2012)
23) Mention the particulars with which the containers of drugs and medicines of various
classes should be labeled. Also mention the additional particulars which should appear
on the label of ophthalmic solution and suspension.06 ( 01/2013, 12/2010,4/2016)
24) What are the special lablelling requirements for following category: (i) Schedule – G drugs (ii) Ophthalmic preparations 06 (6/2011, 05/2013)
25) Enumerate different types of Licences available for Manufacture of Drugs for sale.05
(6/2011)
26) What are the conditions for manufacture schedule C/C1 drugs? 05 (6/2011)
27) Explain the condition for the grant of licence to manufacturing schedule C and C1 drugs in India. 06 (4/2017)
28) State the object of Drugs and Cosmetics Act. Enumerate various types of licenses which can be granted for manufacture of drugs under the act. Discuss the conditions to be satisfied for the grant of license of for manufacture of drugs other than those specified in schedule C & C1, and schedule X.06 (01/2013)
29) Discuss the conditions to be satisfied for obtaining the license for manufacture of drugs other than those specified in Schedule C and C1 and Schedule X. 05 (12/10,11/13,
04/15, 11/2018)
30) What are the procedures followed by the drug inspector for the withdrawal of the
sample? 05 (6/2011
33) Write a note on loan license. 05 (12/15,10/16)
34) Explain the procedure and conditions for manufacturing under Loan Licenses. 05
(4/2017)
35) Write a note on “Schedule N”. 05 (4/2017)
36) Discuss the laws regarding introduction of new drugs. 05 (11/2018)
Pharmacy Act-1948
1) What is the constitution of Central Pharmacy Council/Pharmacy council of India? 06(11/2011, 06 / 2010, 05/2012, 05/2013, 11/2013, 5/2014, 12/2014,
04/2015,10/16, 4/2017)
2) State the object of Pharmacy Act 1948 and discuss the constitution of Central Council of
Pharmacy.06 (12/2012, 05/2012)
3) Explain the objectives of Pharmacy act 06 (12/2010, 11/2011)
4) Functions of Central Pharmacy Council/ PCI. 05(06 / 2010, 05/2012,11/2013, 5/2014, 12/2014, 04/15, 12/15, 4/16, 4/2017, 11/2018)
5) Describe the constitution and functions of state pharmacy council. 05 (12/2010, 11/2011, 05/2012, 12/2014, 4/2017)
6) Mention the minimum standards of education required for qualification of Pharmacist laid down under Pharmacy Act, stating clearly who has laid down these standards and collectively known as what? 05 (12/2012)
7) Describe the requirements and qualifications for subsequent registration of pharmacist as per Pharmacy act.05 (05/2012, 05/2013, 12/2014)
8) What are the qualifications required for registration of a Pharmacist? 05(06 / 2010,
5/2014)
9) Your friend intends to get himself registered as a registered pharmacist in Gujarat. Guide him with respect to following
(i) Where to apply? (ii) Minimum qualification required for registration and (iii) List of documents required to be submitted along with the application for registration.06 (12/2012)
10) Write a note on removal of name from register. 05(06 / 2010. 6/2011, 11/2013,
12/15)
11) Write a note on First Register of Pharmacist under Pharmacy Act. 05 (12/2012,
05/2012, 11/2013, 12/2014. 12/15, 4/2017, 11/2018)
12) Define: Registered Medical Practitioner and Registered pharmacist.05 (12/2014)
13) Write briefly on different statutory bodies regulating pharmacy education by granting
approval as well as affiliation to colleges imparting pharmacy education in Gujarat. 05 (11/2013)/ Define RMP. Discuss Role of PCI in terms of Education Regulation in India.05 (6/2011)
31) What are conditions for sale of Drug as per Drug and Cosmetic Act? 05
(11/2011,4/2016)
32) Write about law regulating the introduction of new drugs. 05 (04/2015,4/2016,
10/2016)
14) Give brief account of different statutory bodies regulating pharmacy education by granting approval as well as affiliation to colleges imparting pharmacy education in
Gujarat.06 (12/2012)
15) List 15 Pharmacy Colleges with their cities affiliated with GTU. 05 (05/2014)
16) Give brief review on Pharmaceutical Education in India. 05 (12/2010, 05/2013, 04/2015,12/15)
17) Give the Procedure, Requirement and Qualification for First Register Pharmacists.05(4/16, 10/16)
18) Explain the grounds and procedure for removal of names from register of pharmacists under The Pharmacists Act. 05 (4/2017)
19) Write the constitution and function of Pharmacy and Therapeutic Committee.06
(06/2014) (HPCP subject)
Medicinal and Toilet Preparations (Excise Duties) Act and Rules-1955
1) Write a note on warehousing of Alcohol/ alcoholic preparation. 05 (06/2010, 12/2012, 05/2013, 11/2013)
2) Differentiate between manufacturing in bond and outside bond. 06 (06/2010,5/2014)
3) Write a note on Bonded Laboratory. 05 (06/2010, 12/2010, 05/2013)
4) Write a note on manufacture in Bonded laboratories. 06 ( 11/2011, 11/2013, 5/2014,4/2016, 10/2016)
5) Write a note on manufacture in Non- Bonded laboratories as per Medicinal and Toilet Preparations Act.06 (12/2015)
6) Your relative desiring to engage himself in manufacture of preparations containing alcohol or other narcotic substances is required to obtain license for the said purpose.
You explain in detail the procedure required to be followed for obtaining license in context to the Medicinal and Toilet Preparations Act.06 (12/2012)
7) What is the licensing procedure for manufacturing of alcohol containing preparation? 05 (06/2010, 12/2010, 05/2012, 4/16)
8) Give the object of medicinal and toilet preparations (excise duties) act and rules. Explain the construction of a bonded laboratory.06 (12/2010, 05/2012, 04/2015)
9) Manufacture of alcoholic preparations 05 (11/2011)
10) Which are the conditions to be furnished for licensing procedure in Medicinal and Toilet Preparation act 1955?
11) Define: Medicinal preparation, Restricted preparation and Denatured alcohol. (12/2014)/ Absolute Alcohol, Rectified Spirit 05 (12/2014)
12) Write the powers, duties and responsibilities of Excise officer.05 (11/2013, 5/2014, 12/2014,10/2016)
13) Write offences and penalties related with the Medicinal & Toilet Preparation Act.05 (5/2014)
14) Explain the manufacturing in bonded laboratory. 05 (4/2017)
15) Write a note on manufacturing in bonded laboratories as per Medical and Toilet
Preparations (Excise Duties) Act, 1955. 06 (11/2018)
Narcotic Drugs and Psychotropic Substances Act – 1985 and Rules
1) Enumerate controlled operations by central Government and State Government under Narcotic & Psychotropic Drugs Act. 06 (06/2010)
2) Define (i) Psychotropic Drugs (ii) Opium Derivatives. 05 (06/2010, 12/2014)
3) Define Cannabis and Opium derivatives according to the act. 05 (11/2011)
4) Define Charas, Ganja, Hemp, Opium and Illicit traffic. 05 (5/2014, 4/2017)
5) Define the following under Narcotic Drugs and Psychotropic Substances Act:
6) Hemp (ii) Coca derivatives and (iii) Opium derivatives iii) Cannabis 06 (12/2012,
05/2013, 11/2013)
7) Explain following Terms (1) Adulterated Drug (2) Spurious Drugs (3) Chemists and
Druggists (4) Poppy Straw (5) Cannabis (Hemp) 05(10/2016)
8) Discuss the power of Central Government and State Government to permit, control and
regulate operations, each under separate heading in context to NDPS Act. 05 (12/2012,
05/2013)
9) State the objective of Narcotic Drugs and Psychotropic Substances Act. Define Psychotropic substances and mention the operations prohibited under said Act. 05
(11/2011, 12/2012, 11/2013, 4/2016, 11/2018)
10) Discuss the operations which are totally prohibited and controlled by central
government and state government under narcotic drugs and psychotropic substances
act. 06 (5/2012, 12/2014, 4/2016)
11) Offences and penalties under Narcotics drugs and psychotropic substances act. 05
(05/2012, 11/2013, 04/2015)
12) Write short note on sale of opium. 05 (11/2011, 05/2012)
13) Write the cultivation and production of opium.05 (12/2014)
14) Explain the procedure for cultivation and collection of opium. 05 (10/2016)
15) What are the special provisions for Opium? 05 (06/2011, 11/2013, 05/2014)
16) List drugs of Schedule I & II of the Narcotic Drugs and Psychotropic Substances Act. 05 (05/2014)
17) How the import, export and transshipment of narcotic drug & psychotropic substances are regulated. 05 (12/2015)
18) Define Hemp. Explain the offences and penalties under the Narcotic and Psychotropic substances Act. 05 (4/2017)
Study of Salient Features of Drugs and Magic Remedies Act and its Rules:
1) State the object of Drugs and Magic Remedies Act and define “Advertisements”, “Drugs” and “Magic remedies” under the act. 06 (11/2011, 01/2013, 05/2014)
2) Define advertisements, drugs and magic remedies as per The Drug and Magic Remedies Act, 1954. 06 (11/2018)
3) State the object of Drugs and Magic Remedies Act. Mention the classes of
Advertisements exempted under the said Act. 05 (12/2010, 05/2014, 4/2016, 11/2018)
4) What types and classes of advertisements are exempted under ‘The drug and Magic
remedies Act”? 05 (4/2017)
5) What classes of advertisements are prohibited under Drugs and Magic Remedies Act. 05 (06/2011, 05/2012. 06/2013, 05/2014, 06/2014, 04/2015, 12/15,10/16)
6) Which diseases and disorders of which advertisement under DMR of drug is
prohibited. 05 (5/2014)
7) What are the offences and penalties under DMR act?05 (11/2014)
Prevention of Cruelty to Animals Act – 1960
1) Write a note on Prevention of Cruelty to Animals Act.06 (06/2010, 05/2012, 12/2012, 05/2013, 04/2015)
2) Write a provision of Cruelty to Animal act 1960. 06 (12/2010, 11/2013, 12/15,10/2016)
3) Animal welfare Board of India. 06 (11/2011)
4) Role of Animal Ethics Committee. 05 (11/2011, 11/2013)
5) Explain the functions and constitution of committee of animal welfare board of India.
06 (12/2014, 4/2017)
6) Define: Animal and Cruelty. Give the constitution of welfare committee for prevention of cruelty to Animal. 06 (6/2011)
7) What is CPSCEA? Write constitution of IAEC. 05 (5/2014)
8) Write format of Part B under the provisions of Prevention of Cruelty to Animal Act. 05 (5/2014)
9) Write in brief about Prevention of Cruelty to Animals Act – 1960. 05 (11/2018)
National Pharmaceutical Pricing Authority (Drugs Price Control Order (DPCO) – 2013)
1) State the object of Drug Price control order 1995 and write a note on Calculation of retail price of drug formulation. 05 (12/2010, 01/2013, 05/2012, 06/2013, 11/2014, 12/15, 10/2016, 4/2017, 11/2018)
2) Define “Scheduled bulk drug”, “Ceiling price”, “Retailer”, “Local taxes” and “Non-
scheduled formulation” under DPCO 1995. 05 (01/2013, 06/2013)
3) Define Bulk Drugs, Formulation. Discuss the objectives and provisions under the drugs
price control order Act 1995. 05 (6/2011)
4) Define bulk drug and Leader price, formulation. Explain the formula for calculation of retail price of drug formulation. 06 (06/2014, 04/2015)
5) Define: I. Bulk drug; II. Formulation; III. Net worth; IV. Retail price; V. Leader price. 05
(11/2013)
6) Mention the main objectives of Drug Policy 2002 and Give full form of following short forms in context to the same.
(i)WTO (ii) NIPER (iii) CDSCO (iv) MAPE (v) PRDC and (vi) R&D 05 (12/2012)
7) Write provisions of Drug Policy 2002. 06 (11/2013)
8) Give the formula for calculation of price for the drug as per Drugs Price Control Order.
State in brief about various factors considered in the formula. 05 (11/2011,10/2016)
9) State the objectives of Drug Policy 2002 and discuss any six salient features of said policy. 08 (12/2010)
Pharmaceutical Legislations
1) What is law? Describe Pharmaceutical Legislation in India? 05 (06/2010, 05/2012)
2) What are the scope and objectives of pharmaceutical legislation?06 (12/2014,) OR Write on origin, development, scope, objective and nature of pharmaceutical
legislation?06 (04/2015)
3) Highlight the SWOT Analysis of Pharma Sector. 05 (12/2012)
4) When and under whose chairmanship Government of India appointed the Drug Enquiry committee? Discuss the report published by said committee highlighting a true picture of prevailing conditions in those days.05 (12/2012)
5) Write short note on Drugs Enquiry Committee/Chopra Committee. 05 (12/2010,
11/2011, 05/2012, 05/2013)
6) Write in brief of Indian drugs and pharmaceutical industries. 05 (12/2010, 05/2012, 05/2013, 11/2013)
7) Write Significance of Bhore Enquiry. 05 (11/2011)
8) Discuss “Pharmacy as a health care system”. 06 (12/2014)
9) What is Jurisprudence? Describe objectives of Forensic pharmacy. 06 (6/2011,
05/2013)
10) What is Forensic pharmacy? Describe various development committees in
pharmaceutical legislation. 06 (11/2013)
11) Write a note on health survey and development committees in India. 06 (4/2017)
12) Write the Scopes of Pharmacy in detail. 06 (05/2014)
13) Write the permeable of DMR Act and explain it in view of ‘Chopra’ and ‘Bhatiya’
Committee.06 (11/2014) Code of Pharmaceutical Ethics
1) What is Code of Ethics? Write differences between Ethics and Law. Discuss the role of
a pharmacist in relation to his job under code of ethics. 06(06/2010, 12/2010, 6/2011, 11/2011, (05/2012,05/2013, 11/2013, 5/2014, 12/2014, 12/15, 4/2016, 10/2016 )
2) Who formulated the code of pharmaceutical ethics? State the purpose of the same.
Discuss the role of pharmacist in Relation to his Trade in context to code of
Pharmaceutical ethics?05 (12/2012)
3) What are the codes of ethics for the pharmacist in relation to his trade and his job. 06 (4/2017, 11/218)
4) How is a Pharmacist responsible in handling prescription as per Ethics? 06 (6/2010, 5/2012)
5) Write notes on: (a) Education Regulation 06 (11/2011, 06/2010, 05/2012)
(b) Pharmacist’s oath 05 (06/2010, 05/2014, 12/2014)
Medical Termination of Pregnancy Act
1) What are the provisions of medical termination of pregnancy act? 05 (06/2011, 6/2014, 05/2012, 06/2013, 04/2015, 12/15, 4/16)
2) Write a note on Medical Termination Pregnancy Act. 05 (12/2010, 06/2011, 01/2013. 05/2013, 11/2013, 10/2016, 4/2017)
3) Write the requirements of performing MTP. 05 (11/2014)
