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The Health Ministry has notified a key amendment to the Drugs Rules, 1945, making cough syrups
June 16, 2026: The Union Ministry of Health and Family Welfare (MoHFW) has officially notified a major regulatory change that will impact the sale of cough syrups and other syrup-based medicines across India. Under the amended rules, these products will no longer be available over the counter and will now fall under stricter regulatory oversight. The move follows a draft notification issued in December, which has now been formally implemented after receiving no objections from stakeholders.
The amendment modifies the Drugs Rules, 1945, by removing the word “syrups” from a category of medicines that previously enjoyed certain exemptions under Schedule K. Specifically, syrup-based medicines have been removed from the exemption listed under Schedule K, Serial Number 13, Item Number (7). Schedule K contains a list of drugs that are exempt from specific provisions of the Drugs and Cosmetics Act and Rules under defined conditions.
The government’s decision comes in the wake of multiple incidents involving deaths linked to contaminated or faulty cough syrup formulations. Authorities believe stricter regulation of syrup-based medicines will help improve safety standards, strengthen monitoring mechanisms, and reduce the risk of harmful products reaching consumers. The notification marks another step in India’s efforts to tighten pharmaceutical quality control and protect public health.