Govt Proposes Stricter Controls on Syrups, Seeks Removal From Schedule K

Under Rule 123 of the Drugs Rules, 1945, it states that:

“The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.”

The draft notification to remove “Syrup” from Schedule K is a policy response aimed at preventing future tragedies like the child deaths linked to contaminated or misused cough syrups in 2025.

In 2025, a series of tragic incidents occurred where children died or became severely ill after consuming certain cough syrups. Most notably, in Madhya Pradesh, formulations such as Coldrif were linked to acute kidney failure in young children. Laboratory tests found very high levels of diethylene glycol (DEG), an industrial solvent that is toxic when ingested, instead of safe pharmaceutical substances.

By subjecting syrups to stricter regulatory controls, authorities are trying to reinforce drug safety, improve manufacturing oversight, and protect vulnerable patients, especially children.

The draft amendment has been issued in exercise of the powers conferred under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB).

The proposal has been published for the information of all persons likely to be affected, and objections or suggestions have been invited within a period of 30 days from the date of publication of the Gazette.

Issued vide G.S.R. 927(E) dated December 29, 2025, the draft notification proposes to amend Schedule K of the Drugs Rules, 1945, which lists drugs and classes of drugs exempted from certain provisions of Chapter IV of the Act and the rules made thereunder.

As per the draft rules, in Schedule K, under Serial No. 13, in the column “Class of Drugs”, against Entry No. 7, the word “Syrup” is proposed to be omitted. The notification does not specify any other change to the existing entries under Schedule K.

The draft rules are proposed to be called the Drugs (…… Amendment) Rules, 2025, and shall come into force on the date of their final publication in the Official Gazette.

The Ministry has invited objections and suggestions from stakeholders, which may be submitted to the Under Secretary (Drugs), Ministry of Health and Family Welfare, at U-6, Work Hall – C Wing, First Floor, Kartavya Bhawan-1, New Delhi – 110001, or via email at drugsdiv-mohfw@gov.in , within the stipulated period.

In this regard, the Gazette notification states that the draft rules will be taken into consideration by the Central Government after the expiry of thirty days from the date on which copies of the Gazette containing the draft rules are made available to the public.

According to the new draft amendment proposed:

"1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025.

(ii) They shall come into force on the date of their publication in the Official Gazette.

2. In the Drugs Rules, 1945, in Schedule K, in the Serial No. 13, under the column “Class of Drugs”, in the Entry No. 7, the word “Syrup,” shall be omitted."

To view the official notice, click the link below: