The Union Health Ministry has released a draft notification proposing to amend the Drugs Rules, 1945, to remove cough syrups from Schedule K, effectively reclassifying them as prescription-only medicines. The proposal seeks to enhance public safety by tightening regulatory oversight of cough syrup sales.

Under the draft amendment, the Ministry plans to delete 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 the amendment is finalised, cough syrups will no longer be sold over the counter and will require a prescription from a registered medical practitioner.

Schedule K had earlier allowed certain household remedies, including cough syrups, to be sold without a formal sales licence in small villages with populations under 1,000 where no licensed pharmacy was available. This exemption for syrups will now be withdrawn.

The proposed regulatory change follows reports of more than 20 child deaths in Madhya Pradesh in 2025 linked to contaminated cough syrups. It also addresses ongoing global concerns and World Health Organization (WHO) alerts regarding the presence of toxic contaminants such as diethylene glycol (DEG) and Ethylene Glycol (EG) in some Indian-manufactured cough syrups.

The Drugs Consultative Committee (DCC) has noted that many oral liquid formulations contain high-risk solvents like propylene glycol, which are particularly vulnerable to contamination, underscoring the need for stricter controls on their manufacture and sale.