In a significant regulatory move aimed at strengthening oversight of medicines, the Ministry of Health and Family Welfare has notified the Drugs (Fifth Amendment) Rules, 2026, bringing changes to the long-standing Drugs Rules, 1945. The amendment removes the word “Syrups” from a category of drugs listed under Schedule K, potentially changing the regulatory framework for certain syrup-based medicines in India.

The notification, issued by the Department of Health and Family Welfare on June 9, 2026, stated that the amendment was introduced after considering public objections and suggestions received following the draft rules published in December 2025.

Under the amended rules, the government has modified Schedule K of the Drugs Rules, 1945, where under serial number 13, item number (7), the term “Syrups” has now been omitted. The amendment officially came into effect from the date of its publication in the Official Gazette.

Schedule K of the Drugs Rules contains provisions related to certain categories of medicines that were earlier provided specific exemptions from some regulatory requirements. With the removal of “Syrups” from the listed category, manufacturers and stakeholders dealing with such formulations may need to follow updated compliance requirements as applicable under drug regulations.

The Ministry said the amendment was carried out using powers granted under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board (DTAB), the country’s key advisory body on technical matters related to drug regulation.

The move reflects the government’s continued efforts to update India’s pharmaceutical regulatory system and ensure stronger monitoring of medicines available to patients. The Drugs Rules, 1945, have undergone several amendments over the years to align regulations with evolving healthcare needs, manufacturing practices, and safety standards.