MVE-004 POST GRADUATE DIPLOMA IN PHARMACEUTICAL SALES MANAGEMENT tr) PGDPSM Term-End Examination
O O
June, 2012
MVE-004 : DRUGS REGULATORY AFFAIRS Time : 2 hours Maximum Marks : 50 Note :
(i) Answer any five questions. (ii) All carry equal (10 each) marks.
1.
(a) List any five conditions of Adulterated drugs 5x2=10 as per the Drugs and Cosmetics Act. (b) What are the details that should appear on the label of container of drugs ?
2.
What are the different phases of clinical trials ? 10 Discuss any one in detail.
3. Write short notes on any two 5x2=10 (a) The Drugs and Magic Remedis Act (b) Narcotic Drugs and Psychotropic Substances Act (c) Drugs Price Control Order (DPCO) 4.
(a)
What is the process of approval of vaccines 5x2=10 and other biologicals ? (b) What are the safety criterias to be complied for large scale experiments and manufacture ?
MVE-004
1
P.T.O.
5.
Discuss the functioning of CDSCO and its zonal 10 offices in India.
6.
Write short notes on any two : (a) Animal toxicity studies (b) Aims of Pharmacy Act 1948 (c) Drugs Enquiry Committee.
7.
Discuss the role of following government 10 organization in clinical research (a) ICMR (b) DBT (c) DST.
8.
Write short notes on any four : 2.5x4=10 (a) New Drug Approval (NDA) (b) Spurious Drugs (c) Informed Consent (d) Investigational New Drug (IND) (e) Drug Technical Advisory Board (DTAB).
Pharmaceutical Industry. ... MRT Act. Pharmacy Council of India. NDPS Act. (b) What is Drugs and Magic Remedies 4 ... Displaying Drugs Regulatory Affairs.pdf.
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