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India Implements Stricter Regulations on Cough Syrup Sales for Public Safety

The Indian government is taking decisive action to enhance public safety by proposing stricter regulations on cough syrup sales. A draft amendment to the Drugs Rules of 1945 has been released, which includes the removal of the term 'syrup' from Schedule 'K'. Citizens are encouraged to provide feedback within 30 days. This initiative follows a warning from the World Health Organization regarding serious adverse effects linked to a cough syrup manufactured in Tamil Nadu. The proposed regulations aim to clarify pharmaceutical laws and protect public health.
By Narendra Chaudhary Jan 1, 2026, 16:33 IST

New Regulations Proposed for Cough Syrup Sales

In a significant move aimed at ensuring public safety, the Indian government has proposed stringent regulations concerning the sale of cough syrups. The Ministry of Health has released a draft amendment to the Drugs Rules of 1945, suggesting the removal of the term 'syrup' from Schedule 'K'. This initiative is intended to clarify and enhance the pharmaceutical regulations to safeguard public interest. Citizens are invited to submit their feedback and objections within a 30-day period.

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According to the notification issued by the central health ministry, these regulations may be referred to as the Drugs (Amendment) Rules, 2025, and will come into effect from the date of publication in the official gazette. The term 'syrup' will be eliminated from entry number 7 under the 'Class of Drugs' column in Schedule 'K' of the Drugs Rules, 1945. The Ministry of Health and Family Welfare has released a draft notification seeking public comments on these amendments, which have been issued under the Drugs and Cosmetics Act of 1940, following consultations with the Drug Technical Advisory Board.


Utilizing the powers conferred by subsection (1) of Section 12 and subsection (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the central government has published a draft of the proposed amendments to the Drugs Rules, 1945, for the information of all affected parties. It is noted that the draft regulations will be considered after the expiration of a 30-day period from the date copies of the official gazette are made publicly available.

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Any objections and suggestions received from individuals during the specified period will be reviewed by the central government. Recently, the World Health Organization issued a warning following the deaths of several children and serious adverse effects linked to the Coldrif cough syrup manufactured by Sri San Pharmaceuticals in Tamil Nadu, which occurred in October 2025.