UPSC Mains 2024 · GS Paper IV · Q12

UPSC Mains 2024 GS4 Q12: model answer

Dr. Srinivasan is a senior scientist working for a reputed biotechnology company known for its cutting-edge research in pharmaceuticals. Dr. Srinivasan is heading a research team working on a new drug aimed at treating a rapidly spreading variant of a new viral infectious disease. The disease has been rapidly spreading across the world and the cases reported in the country are increasing. There is huge pressure on Dr. Srinivasan’s team to expedite the trials for the drug as there is significant market for it, and the company wants to get the first-mover advantage in the market. During a team meeting, some senior team members suggest some shortcut for expediting the clinical trials for the drug and for getting the requisite approvals. These include manipulating data to exclude some negative outcomes and selectively reporting positive results, foregoing the process of informed consent and using compounds already patented by a rival company, rather than developing one’s own component. Dr. Srinivasan is not comfortable taking such shortcuts, at the same time he realises meeting the targets is impossible without using these means.
(a) What would you do in such a situation?
(b) Examine your options and consequences in the light of the ethical questions involved.
(c) How can data ethics and drug ethics save humanity at large in such a scenario?

20 marks250 wordsDirective: Case study

What the question wants

A scientist under pressure to fake data, skip consent and use patented compounds.

How to structure it

Intro: urgency of a pandemic vs research integrity. Body: (a) what to do: refuse shortcuts, seek fast-track lawful routes; (b) options and consequences: accept shortcuts, resign, ethical acceleration; (c) how data and drug ethics protect humanity. Conclusion.

How to structure the answer
IntroductionUrgency of a pandemic vs research integrity
Main body
  1. 1(a) what to do: refuse shortcuts, seek fast-track lawful routes
  2. 2(b) options and consequences: accept shortcuts, resign, ethical acceleration
  3. 3(c) how data and drug ethics protect humanity
ConclusionSum up with a balanced way forward

Model answer

A fast-spreading disease creates real urgency, but the suggested shortcuts (data manipulation, no informed consent, using a rival's patent) are illegal and dangerous.

(a) What I would do

  • Firmly reject all three shortcuts and record my position in writing.
  • Present management with lawful ways to speed up: adaptive trial designs, parallel phases, more trial sites, rolling submissions and emergency use pathways under the New Drugs and Clinical Trials Rules, 2019.
  • Explore licensing the rival compound legally, or collaboration.
  • If pressure continues, escalate to the ethics committee and board.

(b) Options and consequences

  1. Accept shortcuts: faster launch, but patients may be harmed by an unsafe drug; legal action, recall and loss of reputation will follow.
  2. Resign: keeps personal integrity but leaves the project to others who may cut corners.
  3. Ethical acceleration: may miss the first-mover target, but gives a safe drug and lasting trust. Best option.

Ethical questions: honesty, non-maleficence, respect for autonomy, and respect for others' intellectual property.

(c) How data and drug ethics save humanity

  • Honest data reveals side effects early; the thalidomide tragedy shows the cost of ignoring them.
  • Informed consent (Nuremberg Code, Helsinki Declaration, ICMR guidelines) protects human dignity.
  • Open sharing of trial results speeds global response, as with COVID-19 vaccines.
  • Public trust in medicine, essential during pandemics, rests on integrity.

In a crisis, speed matters, but a drug built on false data only spreads another disease: distrust.

Keywords, cases and data to drop in

informed consent data integrity NDCT Rules 2019 Helsinki Declaration non-maleficence

Where most answers lose marks

  • Accepting shortcuts because of urgency.
  • Ignoring the patent issue.

Fresh examples from current affairs

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Learn the concept

Question text as printed in the official UPSC question paper: https://www.upsc.gov.in/sites/default/files/QP_CSM_2024_GenStud_IV_03102024.pdf The model answer is original Battle IAS work; use it to learn structure, not to memorise.