Doctors' prescription now mandatory for cough syrups- Health ministry amends drug rules
New Delhi: Cough syrups will no longer be available as over-the-counter medicines as the Central Government has implemented a new amendment to the Drug Rules 1945, making it mandatory to have a doctor's prescription before buying any kind of syrups, including cough syrups, from pharmacies.
The Department of Health and Family Welfare issued a notification in this regard on June 9, 2025, after considering public comments on a draft proposal released on December 29, 2025.
Medical Dialogues had earlier reported that with an aim to reinforce drug safety, improve manufacturing oversight, and protect vulnerable patients, especially children, the Union Health Ministry had proposed amending the Drugs Rules, 1945, by removing "Syrup" from Schedule K, thereby subjecting this category to stricter regulatory control.
The draft amendment had proposed to omit the word “Syrup” from Schedule K, effectively removing this category from the list of drugs that enjoy regulatory exemptions. Schedule K specifies categories of drugs that are exempt from certain provisions relating to manufacture, sale and distribution under the Drugs and Cosmetics Act and Rules, subject to prescribed conditions.
Also Read: 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.”
Now, after considering the suggestions received from the public in this regard, the Health Ministry has amended the Drugs Rules, 1945. As per the Gazette notification dated 09.06.2026, under the Drugs (Fifth Amendment) Rules, 2026, the Government has removed the word "Syrups" from Schedule K.
Referring to the Draft, published last year, the Gazette notification mentioned, "Whereas a draft of certain rules further to amend the Drugs Rules, 1945 were published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 927 (E), dated the 29. December, 2025 published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), dated the 30. December, 2025 inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;
And whereas, copies of the said Official Gazette were made available to the public on the 30. December, 2025;
And whereas, objections and suggestions received from the public on the said draft mles have been considered by the Central Government..."
The Gazette further mentioned that, exercising powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, has made "Drugs (Fifth Amendment) Rules, 2026, to amend the Drug Rules, 1945. As per the new rules, the Government has implemented the following change:
"In the Drugs Rules, 1945, in Schedule K, in the column, under the heading Class of Drugs, against serial number 13, in Into number (7), the word "Syrups," shall be omitted."
"They shall come into force on the date of their publication in the Official Gazette," the gazette mentioned.
The Central Government's decision 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.
Last month, in a significant regulatory intervention, the Central Drugs Standard Control Organisation (CDSCO) began consultations with the pharmaceutical industry over the continued use of potentially toxic solvents in paediatric oral liquid formulations. This move has come amid growing regulatory concern over excipients such as propylene glycol and the possibility of contamination with toxic impurities like diethylene glycol (DEG) and ethylene glycol (EG).
Also Read: CDSCO Flags Toxic Solvents in Children's Syrups, Begins Industry Consultations
