Archive · 2 Jan 2026
India Proposes Stricter Cough Syrup Sales Rules
The Indian government wants to make cough syrups only available with a doctor's prescription.
This is because some cough syrups have made children very sick, even causing deaths.
The World Health Organization warned about this problem.
Doctors say this change will help keep children safe by stopping people from giving them medicine without a doctor's advice.
The government is asking people to share their thoughts on this new rule before it becomes official.
Previously, some medicines, including cough syrups, could be sold without a formal licence in small villages, but this is being changed to make sure they are safer.
India's Union Health Ministry proposes making cough syrups prescription-only to prevent misuse.
Draft notification under the Drugs and Cosmetics Act, 1940, seeks to remove 'syrup' from Schedule K of the Drugs Rules, 1945.
Public consultation period of 30 days for objections or suggestions before finalization.
WHO issued an alert in October 2025 about serious side effects and deaths linked to Coldrif cough syrup.
At least 26 children died in Madhya Pradesh, with over 20 deaths nationwide due to contaminated syrup.
- Who
- Union Health Ministry of India, WHO, Medical Experts
- What
- Proposal to make cough syrups prescription-only due to child deaths from contaminated medicines.
- When
- Draft notification published for public consultation, effective upon Gazette publication.
- Where
- India, specifically Madhya Pradesh’s Chhindwara and Betul districts.
- Why
- To curb over-the-counter sales and prevent misuse leading to child deaths and disabilities.
- Proposed Rule Change
- Removing 'syrup' from Schedule K of the Drugs and Cosmetics Act, 1940, to make them prescription-only.
- Public Consultation Period
- 30 days to submit objections or suggestions.
- WHO Alert
- Issued in October 2025, warning of serious side effects and deaths linked to Coldrif cough syrup.
- Confirmed Deaths
- At least 26 children in Madhya Pradesh’s Chhindwara and Betul districts, over 20 nationwide.
- Expert Opinion
- Medical experts support the move, citing misuse and lack of medical supervision.
- Impact on Children
- Survivors left with lasting disabilities, including blindness and paralysis.
- Effective Date
- Upon publication in the Official Gazette.
- Previous Exemptions
- Household remedies, including cough syrups, were allowed to be sold without a formal sales licence in villages with a population of not more than 1,000 people, provided there is no licensed dealer nearby.
