← All questionsGS4 · 2024 · Case Studies — Individual Morality ·Dr. Srinivasan and Shortcut Drug Trials (Case)
QUESTION 12
GS4
20 marks

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?

WRITE IN
14 min
250 words

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.

Case studyName the stakeholders and the issues, weigh the options, and say what you would do and why.

Demand-wise check

  1. 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. 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. 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

Facts(a) action(b) options with consequences(c) data and drug ethicsConclusion

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

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