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Are you looking to download a PDF soft copy of the Solved Assignment MVE-04 - Drugs Regulatory Affairs? Then GullyBaba is the right place for you. We have the Assignment available in English language.
This particular Assignment references the syllabus chosen for the subject of Pharmaceutical Sales Management, for the January 2024 - July 2024 session. The code for the assignment is MVE-04 and it is often used by students who are enrolled in the PGDPSM Degree.
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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
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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