In a major step toward patient safety and responsible medicine use, syrup-based medicines can no longer be sold without a valid prescription from a registered medical practitioner.
Why was this decision taken?
Recent incidents involving contaminated cough syrups containing Diethylene Glycol (DEG) and Ethylene Glycol raised serious safety concerns. These toxic chemicals have been linked to acute kidney injury, multi-organ failure, and even death, especially in children.
What’s Changed?
Under the Drugs (Fifth Amendment) Rules, 2026, the term “syrups” has been removed from Schedule K of the Drugs Rules, 1945.
This means all syrup-based medicines now require a prescription and cannot be sold over the counter (OTC).
Why does this matter?
- Improves patient safety, especially for children
- Reduces self-medication and irrational drug use
- Strengthens quality control and accountability
- Encourages responsible pharmacy practice
Role of Pharmacists
Pharmacists play a vital role in ensuring safe medicine use by:
• Dispensing medicines only against valid prescriptions
• Educating patients about proper medication use
• Reporting adverse drug reactions through pharmacovigilance programs
Clinical Pearl
Easy access to medicines should never compromise patient safety. The right medicine should reach the right patient in the right way.
What are your thoughts on this new regulation? Do you think stricter controls on OTC medicines will improve public health outcomes?
MBH/DB