Over the Counter Sale of Cough Syrups Banned Under Amended Drugs Rules 1945

Context: Over the Counter Sale of Cough Syrups
The Union Government has amended the Drugs Rules, 1945 to prohibit over-the-counter sale of medicinal cough syrups. These will now require a doctor’s prescription.

Over-the-Counter Drugs

Over-the-counter drugs are medicines that can be purchased without a doctor’s prescription.

Drugs Rules, 1945

These rules govern:

  • Manufacture of medicines
  • Storage of medicines
  • Sale of medicines
  • Distribution of medicines

The rules have been amended to remove medicinal cough syrups from the OTC category.

Drugs and Cosmetics Act, 1940

This is the parent legislation regulating:

  • Import of drugs and cosmetics
  • Manufacture of drugs and cosmetics
  • Distribution of drugs and cosmetics
  • Sale of drugs and cosmetics in India

Ministry

Why This Matters

  • Improves regulation of cough syrup sales.
  • Reduces irrational self-medication.
  • Addresses safety concerns linked to contaminated or adulterated cough syrups.
  • Strengthens health governance and pharmaceutical regulation.
  • Protects vulnerable groups, especially children.
Over the Counter Sale of Cough Syrups
Over the Counter Sale of Cough Syrups
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Over the Counter Sale of Cough Syrups Banned Under Amended Drugs Rules 1945

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