Mumbai University Solved Question Papers
Law and Medicine
Previous Year Question Paper with Solution
LLB 3 years · Sem 6
May 2019 Examination
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LLB 3 years Sem 6 Law and Medicine May 2019 Question Paper with Solutions
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First published on munotes.in on 24 October 2026.
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Model answers written and edited by the munotes.in editorial desk.
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The University does not publish an official answer key for this paper. The answers in this volume are model answers, written to show how a full-mark answer is built. They are a study aid, not an authority on what an examiner marked.
The question paper reproduced here is the paper as set by the University of Mumbai at the May 2019 examination.
Contents
The questions below are the paper as the University of Mumbai set it at the May 2019 examination, in the order it was set.
MarksPage
MarksPage
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The Paper as Set
The questions in this volume are the questions asked at the May 2019 examination, reproduced as the University of Mumbai set them, in the order it set them. Nothing has been reworded, added or left out. Only the answers are ours. See the original question paper.
Duration 3 hours · Total marks 100 · 25 questions answered
Instructions printed on the paper
- N.B: 1. All questions are compulsory. 2. Cite relevant case laws wherever necessary. 3. Figures to the right indicate maximum marks.
How to use this volume
Solve the paper first, under exam conditions and against the clock. Then read the answers here and mark your own. Reading a solution before attempting the question feels productive and teaches very little, because recognising an answer is not the same as being able to write one.
Q.1
Q.1: Answer the following in not more than two sentences
20 Marks - 2 marks each
(a)What is a good clinical trial?[2]
Answer
A good clinical trial is a study of a new drug in human subjects that is scientifically sound and ethically run. It follows Good Clinical Practice. In law it must also have the permission of the Central Licencing Authority and the approval of a registered Ethics Committee.
The meaning of clinical trial. It is "any systematic study of such new drug or investigational new drug in human subjects" to generate data on its clinical and pharmacological effects (rule 2(j), New Drugs and Clinical Trials Rules, 2019).
What makes it "good". Good Clinical Practice is "a standard for clinical studies or trials that encompasses the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of the studies". Its "fundamental tenet" is that "the interest of science and society should never take precedence over considerations related to the well being of the study subject" (Central Drugs Standard Control Organisation, Good Clinical Practice Guidelines).
The legal requirements. No trial may be conducted except with the Central Licencing Authority's permission, and with its protocol approved by a registered Ethics Committee (rule 19(1)). Each subject must give "freely given, informed, written consent". Why this matters is shown by Swasthya Adhikar Manch, Indore v. Union of India, Writ Petition (Civil) No. 33 of 2012. On 10 March 2014 the Supreme Court recorded that 506 subjects had suffered serious adverse effects in trials held from January 2005 to June 2012. For them, "neither any compensation has been provided nor paid".
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