New Delhi: Amid concerns over the quality of medicines and patient safety, the Union Health Ministry has amended its rules to ban the sale of syrups, including cough syrups, without a doctor’s prescription across the country.
Officials said the move aims to place syrup-based formulations, including cough syrup, under stricter regulatory oversight.
The ministry said in a statement that earlier, before this amendment, Entry No. 13 in Schedule K allowed the sale of cough syrup in villages with a population of less than 1,000 without requiring compliance with certain retail license provisions.
With the word “syrup” deleted from the aforementioned entry, this exemption will not be available for cough syrups.
“Accordingly, the sale and distribution of cough syrup in small villages will now be required only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder,” the statement said.
The amendment was made through the Drugs Rules 2026 published in the Official Gazette.
Schedule K of the Drugs Rules, 1945 provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder for specified classes of drugs.
It specifies the categories of medicines that are excluded from certain provisions related to manufacture, sale and distribution under the Drugs and Cosmetics Law and Rules, taking into account the prescribed conditions.
The move follows a draft notification issued by the government in December last year seeking objections and suggestions from stakeholders.
The statement stated that the amendment was made to strengthen regulatory oversight of syrup formulations and align the exemption framework with contemporary public health and safety requirements.
“This measure is expected to promote responsible distribution and sale of cough syrup while ensuring greater compliance with regulatory standards across the country,” the Ministry of Health said.
“Manufacturers, distributors and retailers dealing with cough syrup are advised to ensure strict compliance with applicable licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945,” the statement read.
The decision comes against the backdrop of increased regulatory scrutiny of cough syrups and other oral liquid formulations in recent years following reports of child deaths linked to contamination in several countries.
According to sources, the latest amendment is expected to enhance traceability and regulatory oversight of syrup-based medicines by ensuring that manufacturers and sellers comply with more stringent licensing and quality control requirements.
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