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Arguments evaluation (drug licensing and local trials): Should all drugs patented and manufactured in Western countries be tried on a sample basis in India before licensing for sale to the public? Evaluate—(I) Yes: dosage and duration may differ for the Indian population, making local evaluation necessary; (II) No: it is not feasible to implement—determine which argument(s) are strong.

Difficulty: Medium

Correct Answer: Only argument I is strong

Explanation:


Given data

  • Policy under consideration: Local sample trials before licensing foreign-patented drugs.
  • Argument I: Necessary due to possible population-specific differences in dose/response.
  • Argument II: Not feasible, hence cannot be implemented.


Concept / Approach
Public-health safety and pharmacovigilance support context-specific evaluation. Feasibility objections, without evidence or alternatives, are not strong by themselves.


Step-by-step evaluation
Step 1: I appeals to clinical relevance (ethnicity, environment, comorbidities) and is logically strong.Step 2: II asserts infeasibility but provides no substantive reason or mitigation; it is weak as a basis to deny a safety measure.


Verification / Alternative
Regulatory norms often require bridging studies or Phase IV surveillance—consistent with argument I.


Common pitfalls

  • Letting administrative convenience override patient safety in principle-level questions.


Final Answer
Only argument I is strong.

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