IGNOU PGDPSM MVE 4 Drugs Regulatory Affairs Solved Assignment ENGLISH

Please make sure your assignment questions match your current IGNOU session

MVE 004 (January 2026 - July 2026) - ENGLISH

Course Code: MVE-004

Assignment Code: MEV 004/TMA 2026

Maximum Marks: 100

SECTION A

Answer all the questions given below. All Questions carry equal marks.

Q1.In a tabular form explains the different phases in the evolution in Indian Pharmaceutical Industry.

Q2. Enlist the tasks performed by Central Drugs Standard Control Organization.

Q3. What is the Composition of Genetic Engineering Approval Committee (GEAC)?

Q4. Briefly explain 'Prevention of Cruelty to Animal Act', 1960?

Q5. Write the terms of reference of Chopra committee.

Q6. Discuss the various storage conditions prescribed by Indian Pharmaceutical Industry.

Q7. What are the Special Products?

Q8. Give the full form of the following

i) NDPS

ii) DCC

iii) IND

iv) ICAR

v) DTAB

SECTION B

Answer all four Questions. All Question carry equal marks.

(15x4= 60)

Q9. (a) Explain the Approval process of Vaccines in India.

(b) Discuss the process of getting the permission to import new drug.

Q10. (a) What are drugs and Magic Remedies Act 1954?

(b) Discuss the salient features of NDPS Act 1985.

Q11. As per the Drug and Cosmetics Act explain the following terms

i) Cosmetic

ii) DCC

iii) Adulterated Drugs

iv) Shelf Life

v) Cold place

Q12. Explain the following terms

i) RDAC

iii) Drugs Prices Control Order (DPCO)

v) Post Marketing Surveillance (PMS)

ii) Toxicological studies

iv) Expiry Dates

MVE 004 (January 2025) - ENGLISH

MVE 004: Drugs Regulatory Affairs

Course Code: MVE-004

Assignment Code: MEV 004/TMA 2025

Maximum Marks: 100

Last Date: August 30, 2025

SECTION A

Answer all the questions below.

(5 x 8 = 40)

Q1. Give the different phases of evolution in the Indian Pharmaceutical Industry in tabular form.

Q2. List the agencies responsible for enforcement of the NDPS Act.

Q3. Define genetic engineering and microorganisms.

Q4. What are Education Regulations (ER) and who sets them?

Q5. Give a brief account of toxicity studies in tabular form.

Q6. Describe the vaccine approval process.

Q7. Indicate whether the following statements are True (T) or False (F).

i)The first council of PCI was constituted in 1948.

ii) Opium crops must be tendered to the central government at prices fixed by the government

Heart diseases don't fall under the Drugs and Remedies Act.

iv) Recombinant DNA Safety Guidelines are issued by GEAC.

v) The Department of Biotechnology (DBT) comes under the Ministry of Fertilizers and Chemicals.

Q8. Give the full form of the following

i) CRAMS

ii) IPA

iii) GEAC

iv) IRFA

SECTION B

Answer all four questions. All questions carry equal marks.

Q9. Explain the procedure adopted by the NPPA for price fixing of drugs.

Q10. Give an overview of the governing body of the Indian Council of Medical Research.

Q11. What are the different phases in the clinical evaluation of a drug in humans?

Q12. Give a brief account of the Poisons Act and the MTP Act

MVE 006 (January 2025) - ENGLISH

Post Graduate Diploma in Pharmaceutical Sales Management

Assignment - I

Tutor Marked Assignment

Course MVE 001: Introduction to Anatomy, Physiology and Pharmaceutical Chemistry

Course Code: MVE 001

Assignment Code: MEV 001/TMA/2025

Maximum Marks: 100

Last Date: 30th August 2025

Answer all the questions given below.

1. (a) What are the main features of a muscle tissue? Differentiate between skeletal, smooth and cardiac muscle tissues.

(b) Describe with the help of a well labeled diagram the structure of a cell membrane.

2. (a) Differentiate between systolic and diastolic blood pressure.

(b) Describe any two disorders of the respiratory system.

3. (a) Describe the role of Liver and Pancreas in the process of Digestion.

(b) Write a short note on the anterior pituitary gland and its hormones.

4. (a) List the three main layers of the human eye and explain the physiology of vision.

(b) Draw the structure of a Kidney and explain the role of a Nephron.

5. (a) Describe the process of acute Inflammation.

(b) Differentiate between the terms hypoglycaemia and hyperglycaemia.

6. a) What are topical agents? Discuss briefly their categories.

b) Describe briefly any 5 major physiological ions.

7. a) What do you understand by SAR? How is it important?

b) Write short note on Neoplasm.

8. a) Give common uses and possible side effects of the following herbs: -

(i) Garlic

(ii) Ginger

(iii) Licorice

(iv) Ginkgo

(v) Ginseng.

b) What is herbal-drug interaction? Give example.

9. What do you understand by 'Adulteration of Drugs'? Briefly discuss types of deliberate adulteration.

10. (a) What do you understand by the terms GLP, GMP and GCP? Explain briefly.

(b) Describe briefly two Quality control tests for Parenteral dosage forms.

Assignment - IV

Tutor Marked Assignment

MVE 004: Drugs Regulatory Affairs

Course Code: MVE-004

Assignment Code: MEV 004/TMA 2025

Maximum Marks: 100

Last Date: 30th August 2025

SECTION A

Answer all the questions given below.

Q1. Give different phases of evolution in Indian Pharmaceutical Industry in tabular form.

Q2. Enlist the agencies responsible for enforcement of NDPS Act.

Q3. Define Genetic engineering and microorganisms.

Q4. What is Education Regulations (ER) and who frames it?

Q5. Give a brief account of Toxicity studies in a tabular form.

Q6. Describe approval process of Vaccine.

Q7. Indicate whether the following statements are True (T) or False (F).

i) The first council of PCI was constituted in 1948.

ii) Opium crop must be tendered to the central Government at prices fixed by the Government. 

iii) Heart diseases don't fall under Drugs and magic Remedies Act.

iv) Recombinant DNA Safety Guidelines are issued by GEAC.

v) The Department of Biotechnology (DBT) comes under Ministry of Fertilizers and chemicals.

Q8. Give the full form of the following

i) CRAMS

ii) IPA

iii) GEAC

iv) IRFA

v) CBER

SECTION B

Answer all four Questions. All Question carry equal marks.

Q9. Explain the procedure adopted by NPPA for Price Fixation of Drugs.

Q10. Give an overview of the governing body of the Indian Council of Medical Research.

Q11. What are different phases in clinical evaluation of a drug in human beings?

Q12. Give a brief account of Poisons Act and MTP Act.

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