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.



