General Studies 2024 GS Paper IV 20 marks 250 words Compulsory Examine

Q12

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?

हिंदी में प्रश्न पढ़ें

डॉ. श्रीनिवासन एक प्रतिष्ठित जैव-प्रौद्योगिकी कंपनी में कार्यरत एक वरिष्ठ वैज्ञानिक हैं। यह कंपनी फार्मास्युटिकल में अपने अत्याधुनिक शोध के लिए जानी जाती है। डॉ. श्रीनिवासन किसी नई दवा पर काम करने वाली एक शोध टीम का नेतृत्व कर रहे हैं, जिसका उद्देश्य एक नए वाइरस (विषाणु) से तेजी से फैलने वाले संक्रमित रोग का इलाज करना है। यह बीमारी दुनिया भर में तेजी से फैल रही है और देश में इसके मामलों की संख्या धीरे-धीरे बढ़ रही है। डॉ. श्रीनिवासन की टीम पर इस दवा के ट्रायल में तेजी लाने का बहुत दबाव है क्योंकि इसके लिए बाजार में काफी मांग है और कंपनी बाजार में पहला कदम रखने का फायदा उठाना चाहती है। टीम मीटिंग के दौरान, टीम के कुछ वरिष्ठ सदस्यों ने दवा के क्लिनिकल (नैदानिक) परीक्षणों में तेजी लाने और अपेक्षित अनुमोदन प्राप्त करने के लिए कुछ शॉर्टकट सुझाए। इनमें कुछ नकारात्मक परिणामों को बाहर करने के लिए डेटा में हेरफेर करना और चुनिंदा रूप में सकारात्मक परिणामों की रिपोर्ट करना, सूचित सहमति की प्रक्रिया को छोड़ देना और स्वयं का घटक विकसित करने के बजाए, प्रतिद्वंद्वी कंपनी द्वारा पहले से पेटेंट किए गए यौगिकों का उपयोग करना शामिल है। डॉ. श्रीनिवासन ऐसे शॉर्टकट लेने में सहज नहीं हैं, साथ ही उन्हें यह भी पता चला है कि इन तरीकों का उपयोग किए बिना लक्ष्यों को पूरा करना असंभव है। (a) ऐसी स्थिति में आप क्या करेंगे? (b) इसमें शामिल नैतिक प्रश्नों के प्रकाश में अपने विकल्पों और परिणामों का परीक्षण कीजिए। (c) ऐसे परिदृश्य में, डेटा नैतिकता और औषधि नैतिकता किस प्रकार बड़े पैमाने पर मानवता को बचा सकती हैं?

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Directive word: Examine

This question asks you to examine. The directive word signals the depth of analysis expected, the structure of your answer, and the weight of evidence you must bring.

See our UPSC directive words guide for a full breakdown of how to respond to each command word.

How this answer will be evaluated

Approach

The directive 'examine' requires critical inspection of options with evidence-based reasoning. Structure: Brief introduction acknowledging ethical dilemma → Part (a): State your course of action with justification (~80 words, 35%) → Part (b): Systematically examine 3-4 options with consequences using ethical frameworks (~90 words, 40%) → Part (c): Synthesise how data/drug ethics serve humanity (~60 words, 25%) → Conclusion on professional integrity. Ensure smooth transitions between parts.

Key points expected

Part (a): Clear personal stance refusing shortcuts, prioritising patient safety over commercial pressure; cites duty as scientist and citizen
Part (b): Examination of Option 1 (comply with shortcuts) showing consequences: harm to patients, legal liability under Drugs and Cosmetics Act, reputational damage; Option 2 (refuse and escalate) citing whistleblower protections, internal ethics committee; Option 3 (negotiate modified timeline) balancing innovation and safety
Part (b): Application of ethical frameworks—deontology (Kant's categorical imperative against using humans as means), utilitarianism (long-term harm outweighs short-term benefit), virtue ethics (scientific integrity)
Part (c): Data ethics—transparency, reproducibility, FAIR principles preventing pandemic of misinformation; Drug ethics—Helsinki Declaration, ICMR guidelines ensuring trust in public health systems
Part (c): Connection to humanity—COVID-19 lessons where rushed trials (ivermectin, hydroxychloroquine misinformation) eroded trust; contrast with Oxford-AstraZeneca transparent data saving millions

Evaluation rubric

Dimension	Weight	Max marks	Excellent	Average	Poor
Demand-directive understanding	20%	4	Correctly interprets 'examine' for (b) as critical inspection with evidence, not mere description; 'what would you do' in (a) as decisive action with reasoning; 'how can...save' in (c) as causal mechanism analysis; maintains analytical distance without collapsing into personal opinion only	Partially grasps 'examine'—lists options without deep consequence analysis; treats (a) as purely subjective without ethical grounding; (c) becomes generic praise of ethics rather than mechanism explanation	Misreads directives—describes situation instead of examining; (a) is vague 'I will think'; (c) drifts into unrelated topics; confuses 'examine' with 'enumerate'
Content depth & accuracy	20%	4	Demonstrates nuanced understanding of clinical trial phases, informed consent ethics, patent law conflicts; accurately cites ICMR National Ethical Guidelines, Schedule Y of Drugs and Cosmetics Rules; distinguishes between regulatory flexibility (accelerated approval) and ethical violations (data manipulation)	Basic awareness of trial ethics but conflates regulatory shortcuts with ethical violations; mentions informed consent superficially; generic reference to 'medical ethics' without specific frameworks or Indian regulations	Fundamental errors—confuses clinical trials with animal testing; unaware of informed consent requirement; suggests whistleblowing without knowing legal channels; treats patent violation as minor issue
Structure & flow	20%	4	Clear tripartite structure with visible (a)/(b)/(c) markers; logical progression from personal decision → systematic examination → societal implications; smooth transitions using signposting phrases; integrated conclusion that synthesises all three parts without repetition	Identifiable parts but uneven weighting—(b) underdeveloped or (a) excessively long; some repetition between (b) options and (c) implications; conclusion merely summarises without synthesis	Disorganised—parts merged indistinguishably; abrupt jumps; missing introduction or conclusion; significant word imbalance (one part dominates)
Examples / case-law / data	20%	4	Specific Indian examples: CDSCO guidelines, ICMR's COVID-19 vaccine trial protocols; international precedents like thalidomide disaster, Tuskegee study for informed consent importance; recent cases—Bharat Biotech's Covaxin transparency issues or Pfizer's 2021 data release; cites Drugs and Cosmetics Act provisions on ethics committees	Generic references to 'clinical trials' or 'big pharma'; mentions COVID-19 without specific trial names; vague 'whistleblower laws' without citing Whistle Blowers Protection Act 2014 or its limitations	No concrete examples; invented cases; irrelevant examples from unrelated fields; confuses patent law with copyright
Conclusion & analytical edge	20%	4	Synthesises personal integrity, institutional accountability and systemic safeguards; recognises tension between innovation urgency and safety without false resolution; proposes concrete institutional reforms (independent data monitoring committees, pre-registration of trials); ends on note of scientific social responsibility	Safe platitude about 'ethics important'; no tension acknowledged; generic call for 'strict laws' without specificity; conclusion restates points without advancing analysis	Missing conclusion; abrupt end; contradictory resolution; moralistic preaching without analytical grounding; suggests unethical compromise as pragmatic solution

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