Schedule K – Amendments to Drug Rules by Union Health Ministry
The Union Health Ministry has officially ended the over-the-counter (OTC) sale of all cough syrups in India. Moving forward, cough syrups can no longer be purchased as a household remedy without a valid doctor’s prescription.
This decision follows a series of tragic incidents, including the reported deaths of over 20 children in India in late 2025 due to contaminated cough syrups, alongside past global incidents involving toxic export batches. The regulation is designed to completely restrict consumer access to these medicines without direct clinical oversight.
Changes Introduced by The Union Health Ministry
Removal from Schedule K (Exempted Drugs): Previously, entry number 7 under serial number 13 of Schedule K of the Drugs Rules, 1945 exempted household remedies like “syrups, lozenges, pills, and tablets for cough” from requiring a prescription. This allowed retail stores and pharmacies to sell them OTC. The new amendment deletes the word “syrups” from this entry, effectively stripping oral liquid cough formulations of their exempt status.
Mandatory Prescription Status: By removing cough syrups from Schedule K, they now fall strictly under standard prescription norms, meaning retailers risk penalties if they sell them without a registered medical practitioner’s prescription.
Pediatric Restrictions: Alongside this rule, the government has reinforced strict directives for the medical community: cough and cold syrups should not be prescribed to children under 2 years old and are generally not recommended for children under 5 years old unless a thorough clinical evaluation is conducted.
The Official Notification Issued
The Legislative Mechanism: The Union Health Ministry issued the final notification on June 9, 2026, amending the Drugs Rules, 1945. This final notification officially came into force on the date of its publication in the Gazette of India.
The Process leading to the Notification:
A draft notification was subsequently released in December 2025 to seek public feedback and objections within a 30-day window. After evaluating the stakeholders’ responses, the final mandate was formalized in June.
The process began following a Drugs Consultative Committee (DCC) meeting on November 17, 2025, chaired by the Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi. The DCC approved the proposal to delete the exemption for cough syrups.
Scrutiny of Excipients (Solvents):
The underlying scientific trigger for the notification was the high risk of contamination in oral liquids. The CDSCO has been tasked by the DCC to conduct active consultations regarding the safety of Propylene Glycol—a commonly used solvent in syrups. The regulator is assessing the presence of highly toxic impurities like Diethylene Glycol (DEG) and Ethylene Glycol (EG) (which caused the poisoning cases) and is exploring transitioning the pharmaceutical industry toward safer, alternative excipients.
References :
The Draft Notification (Proposal)
Purpose: This initiated the formal legislative intent to amend Schedule K, proposing that the word “Syrup” be omitted from Entry No. 7 under Serial No. 13, and opened the mandatory 30-day window for public feedback and industry stakeholders to submit objections or suggestions.
Notification Reference: G.S.R. 927 (E)
Date of Issue: December 29, 2025 (Published in the Gazette of India Extraordinary on December 30, 2025)
The Final Gazette Notification (Enactment)
Legislative Title: Drugs (Fifth Amendment) Rules, 2026
Date of Final Notification: June 9, 2026
Purpose: Following reviews of public feedback and approvals from the Drugs Technical Advisory Board (DTAB), this final executive notification officially removed the over-the-counter exemption by deleting “Syrups” from Schedule K. It enacted prescription-only status nationwide immediately upon its publication in the Official Gazette of India.