IGNOU MVE-04
- Drugs Regulatory Affairs,
Latest Solved Assignment
(July 2024 - January 2025)

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.

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
ii) Toxicological studies
iii) Drugs Prices Control Order (DPCO)
iv) Expiry Dates
v) Post Marketing Surveillance (PMS)

Answer all the questions given below.1. Fill in the following blanks:
a) i) Bengal Chemical and pharmaceutical works Ltd. was established in…………
ii) The first pharmaceutical factory of Darjeeling was established n the year ……………
iii) Hindustan Antibiotic Ltd. manufactured……………….. in collaboration with WHO and UNICEF in 1954.
iv) In 1970, product patent revoked under ……………………………. Act.
v) ……………………………………………… in 1979 was introduced to control drug price.
b) What measures Indian Government took to reform the Indian pharmaceutical industries after 1995?

2. What are the functions of regulatory agencies? Give outline of their mechanism.

3. a) Describe the purpose and procedure of preclinical evaluation of Drugs.
b) What are the advantages and limitations of clinical trial?

4. a) Give any one function of the following
i) DRAC
ii) GEAC
iii) RCGM
iv) SBCC
v) DLC
b) Explain the following terms.
i) Biologics
ii) Schedule C
iii) Pathogen
iv) Special product
v) Cell hybridization

5. a) What are the objectives of developing new drug?
b) What are the different types of Investigational New Drugs? Describe briefly.
c) Define the following terms
i) Bulk Drug
ii) Schedule Y
iii) Clinical trial
iv) Pharmacological
v) Toxicological studies

6. What are the objectives and/or roles of the following?
i) Pharmacy Act 1948 ii) Drugs Act 1948
iii) PCI iv) State Pharmacy Councils
vi) DTAB

7. a) Differentiate between Adulterated drugs and Misbranded drugs.
b) List the factors which affect the potency of drug dealing storage.

8. a) List the penalties under the following Acts.
i) NTPS ii) Drug and magic remedies Act, 1954
iii) Poison Act, 1990 iv) Medical and toilet preparation Act, 1995
b) What are the legal conditions for termination of pregnancy?

9. a) Write the full form of the following
i ) TRIPS
ii) DPCO
iii) DGTD
iv) NPPA
v) IGMR
vi) DST
vii) SERC
viii) PSUR
ix) PMS
x) FDA
b) Explain the following terms.
i) Milepristone
ii) London Proof spirit
iii) Teratogenicity
iv) Histopathalogical
v) Oxytocin

10. Write down the aims and objectives of the following Acts.
i) The drug and magic remedies Act 1954
ii) Poison Act 1919
iii) MTP Act 1971
iv) Medical and toilet preparation Act 1995
v) NDPS Act