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 a 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?
What the examiner wants
Under pressure to rush a drug for a spreading virus, Dr. Srinivasan's team proposes data manipulation, skipping consent and using a rival's patent. Decide what he should do and how data and drug ethics protect humanity.
Demand-wise check
- 1(a) What to do: refuse all shortcuts; speed up legitimately (adaptive trials, more sites, regulator's fast-track); tell management the risks≈65 words
- 2(b) Options and consequences: shortcuts give speed but risk harm, legal action, recall, loss of trust; ethical path is slower but safe and durable≈65 words
- 3(c) Data and drug ethics: honest data, informed consent, patient safety and fair access protect public health and trust in science≈65 words
Open in about 30 words and close in about 30.
Answer plan
Where marks usually go
- Allowing 'small' shortcuts because of the pandemic
- Ignoring the patent infringement issue
Draw this
- Table: shortcut → short-term gain → long-term harm
Value addition
- RuleNew Drugs and Clinical Trials Rules, 2019 require informed consent and ethics committee approval, and allow accelerated approval in emergencies.CDSCO
- ExampleThe Thalidomide tragedy (1950s–60s) led to modern drug safety and trial rules.Historical record
Mapped topper copies
Reviewed public-source references related to this PYQ. Same-syllabus references are labelled separately.
- Aakash Garg · AIR 5 · Page 33 ↗Same syllabus reference
- Shakti Dubey · AIR 1 · Page 37 ↗Same syllabus reference
- Aakash Garg · AIR 5 · Page 29 ↗Same syllabus reference
- Shakti Dubey · AIR 1 · Page 35 ↗Same syllabus reference
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