By: IPP Bureau
Last updated : January 01, 2026 8:24 am
Once finalized, cough syrups will no longer be available for over-the-counter sale
The Union Health Ministry issued a draft notification to remove cough syrups from Schedule K of the Drugs Rules, 1945. This move aims to reclassify cough syrups from over-the-counter (OTC) remedies to prescription-only medicines to ensure public safety.
The Ministry proposes dropping the word "syrup" from Serial No. 13, Entry 7 of Schedule K, which currently exempts "syrups, lozenges, pills and tablets for cough" from certain licensing and prescription requirements.
Once finalized, cough syrups will no longer be available for over-the-counter sale and must be sold only under the prescription of a registered medical practitioner.
Previously, Schedule K allowed these "household remedies" to be sold without a formal sales license in small villages (population under 1,000) where no licensed dealer existed. This exemption for syrups will be terminated.
The decision follows the reported deaths of over 20 children in Madhya Pradesh in 2025 due to contaminated cough syrups.
The move addresses global concerns and WHO alerts regarding toxic contaminants like Diethylene Glycol (DEG) and Ethylene Glycol (EG) in Indian-manufactured cough syrups.
The Drugs Consultative Committee (DCC) noted that many oral liquid formulations use high-risk solvents like propylene glycol, which are prone to contamination.