The government has amended the Drugs Rules, 1945, introducing stricter controls on the sale of cough syrups and other liquid medicinal formulations. As a result, consumers will now be required to present a doctor's prescription before purchasing these medicines from pharmacies.
The decision comes months after incidents in Madhya Pradesh and Rajasthan in which children reportedly died after consuming contaminated cough syrups. The incidents raised serious concerns regarding the safety, quality control, and regulation of commonly used liquid medicines. Following these cases, demands intensified for stricter monitoring, enhanced inspections, and tighter oversight of the manufacturing and distribution of medicinal syrups.
The notification, dated June 9, 2026, was issued after the government sought public feedback on a draft proposal released in December last year. As part of the amendment, the term "syrup" has been removed from the category of medicines listed under Schedule K of the Drugs Rules. This change effectively ends their over-the-counter availability and places them under a more stringent regulatory framework.
According to the notification, the Central Government exercised its powers under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, to amend the Drugs Rules, 1945. The notification states, "These rules may be called the Drugs (Fifth Amendment) Rules, 2026. They shall come into force on the date of their publication in the Official Gazette."
The amendment marks a significant shift in India's pharmaceutical regulatory landscape, bringing all medicinal syrups under stricter control in an effort to enhance patient safety, improve accountability in drug distribution, and address concerns arising from recent contamination-related fatalities.
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