·The Hindu·15 marks·250–350 wordsPolityS&T

Does immediate suspension of licences without a show-cause notice violate principles of natural justice? Analyse with reference to the right to health.

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In this answer
  1. Why it appears to violate natural justice
  2. Why the right to health prevails
  3. Safeguards to keep it fair

Natural justice, chiefly audi alteram partem (hear the other side), requires a show-cause notice before a licence is suspended. The Health Ministry's draft amendment to the Drugs Rules, 1945 proposes immediate suspension once a drug is declared Not of Standard Quality (NSQ) on specified critical parameters [1]. On balance, it narrows but does not violate natural justice: Article 21's right to health justifies acting first and hearing later.

Why it appears to violate natural justice

  • No prior hearing: the firm loses production and reputation before presenting its side, while existing rules require a show-cause notice first [1].
  • Risk of wrong results: a parliamentary panel flagged weak government labs, with too few analysts, poor instruments and unvalidated test methods [2].
  • MSME burden: small firms are least able to survive a shutdown while they contest a result.

Why the right to health prevails

  • Article 21: the Supreme Court reads the right to health into the right to life. An NSQ drug still in circulation threatens it, a risk the Ministry itself flags [1].
  • Post-decisional hearing: Maneka Gandhi v. Union of India (1978) held that in urgent cases a hearing may follow the action.
  • Proportionality: only failures on critical parameters trigger it, and suspension is temporary, not cancellation [1].
  • Scale of harm: the WHO estimates at least 1 in 10 medicines in low- and middle-income countries are substandard or falsified, causing treatment failure and antimicrobial resistance [3].
  • Delay is already costly: in Haryana, NSQ drugs had reached hospitals before the test report in 7,947 of 7,975 cases [4].
  • Existing practice: risk-based inspections of 400 premises have already led to more than 300 actions, including stop-production orders and suspensions [5].

Safeguards to keep it fair

  • List the critical parameters in the rule itself to prevent arbitrariness (Article 14).
  • Set deadlines for re-testing and appeal so a wrong lab result cannot shut a firm for months.
  • Pair suspension with batch recall, since suspension alone does not remove stock already sold.

Immediate suspension gives up the prior hearing to protect patients, but it keeps the hearing itself. With a clear list of critical parameters, quick re-testing and a time-bound appeal, the rule can satisfy both Article 21 and procedural fairness. It would also advance SDG 3.8's goal of access to safe, quality medicines for all.

Sources

  1. 1The Hindu: "Govt. seeks to cut access to substandard medicines" (5 Nov 2026)draft Drugs Rules amendment; immediate suspension on critical parameters; current show-cause procedure; NSQ drugs remaining in circulation
  2. 2Rajya Sabha Standing Committee on Health & Family Welfare: Report on the Drugs and Cosmetics (Amendment) Bill, 2007 (PRS)weaknesses of government drug-testing labs
  3. 3WHO Fact Sheet: Substandard and falsified medical products1-in-10 figure; treatment failure and AMR
  4. 4CAG Performance Audit on Public Health (Haryana), Chapter 4: Availability of Drugs, Medicines, Equipment and Other Consumables (2024)NSQ drugs issued before test reports arrived
  5. 5Rajya Sabha Unstarred Question 1731 (6 Aug 2024), answer on risk-based inspections400 premises inspected; more than 300 actions including suspensions
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