New Delhi, January 2: With an aim to strengthen drug safety, improve manufacturing oversight and protect vulnerable patients—especially children - the Ministry of Health and Family Welfare has proposed a key amendment to the Drugs Rules, 1945. Through a recent Gazette notification, the Centre has suggested removing the word “Syrup” from Schedule K, a move that would bring medicinal syrups under tighter regulatory control.

What Is Schedule K and Why It Matters

Under Rule 123 of the Drugs Rules, 1945, drugs listed in Schedule K are exempt from several provisions of Chapter IV of the Drugs and Cosmetics Act, 1940, including licensing and manufacturing requirements, subject to specified conditions. At present, “Syrup” figures in this schedule, allowing certain formulations to enjoy regulatory exemptions. Cough-Syrup Related Deaths: Tamil Nadu Halts Production of Coldrif Syrup After Child Deaths in MP and Rajasthan.

The draft amendment proposes omitting “Syrup” from Schedule K, effectively ending this exemption and subjecting syrups to the same scrutiny as other pharmaceutical products.

Child Deaths Linked to Contaminated Cough Syrups

The proposed change follows a series of tragic incidents in 2025 in which children died or fell critically ill after consuming contaminated cough syrups. In Madhya Pradesh, formulations such as Coldrif were linked to acute kidney failure in young children. Laboratory tests later detected dangerously high levels of diethylene glycol (DEG) - a toxic industrial solvent used in place of safe pharmaceutical ingredients. Cough Syrup Deaths: DCGI Tells States and UTs To Take Measures To Ensure Testing of Cough Syrups Before Manufacture and Release of Batch to the Market.

These incidents highlighted serious gaps in oversight and quality control in syrup manufacturing.

Legal Basis of the Draft Amendment

The draft notification has been issued under Section 12(1) and Section 33(1) of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB).

Issued vide G.S.R. 927(E) dated December 29, 2025, the proposal seeks to amend Schedule K of the Drugs Rules, 1945.

What Exactly Will Change

As per the draft rules:

  • In Schedule K, under Serial No. 13, against Entry No. 7 in the column “Class of Drugs,” the word “Syrup” shall be omitted.

  • No other changes to existing entries under Schedule K have been proposed.

Once finalised, syrup formulations will no longer enjoy blanket exemptions from regulatory provisions.

Public Feedback Invited

The government has invited objections and suggestions from stakeholders within 30 days of the Gazette publication. Submissions can be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, at Kartavya Bhawan-1, New Delhi, or via email at drugsdiv-mohfw@gov.in.

When Will the Rules Take Effect

The proposed rules will be titled the Drugs (…… Amendment) Rules, 2025 and will come into force on the date of their final publication in the Official Gazette, after public feedback is considered.

By ending regulatory exemptions for syrups, the Centre aims to prevent future tragedies, enforce stricter quality checks, and ensure safer medicines for children and other vulnerable patients.

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(The above story first appeared on LatestLY on Jan 02, 2026 10:33 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).