New Delhi – The Ministry of Health and Family Welfare has issued a notification amending the Drugs Rules, 1945. The amendment, titled the Drugs (Fifth Amendment) Rules, 2026, was published in the Official Gazette and takes effect from the date of its publication.
According to the notification, the Central Government has modified Schedule K of the Drugs Rules, which lists categories of drugs exempt from certain regulatory provisions. The amendment specifically removes the word “Syrups” from this schedule under the classification of drugs.
Schedule K has historically included medicines that were exempt from some regulatory requirements, allowing relatively easier availability. With the omission of “Syrups” from this list, syrup-based medicines are no longer covered under these exemptions.
As a result of this regulatory change, syrup formulations -- including commonly used cough syrups; are expected to no longer be available over the counter. A prescription from a registered medical practitioner will be required for their purchase under the applicable drug regulations.
The notification itself does not explicitly detail consumer-level conditions such as prescription requirements. However, the removal from Schedule K implies that syrups will now be subject to stricter regulatory controls applicable to non-exempt drugs.
The amendment follows a draft notification issued in December 2025, during which the government invited objections and suggestions from the public. After considering the feedback received, the final rules have now been formally notified.
This development marks a significant regulatory shift in the classification and availability of syrup-based medicines in India. The practical impact will depend on implementation and enforcement across the pharmaceutical and healthcare sectors.
Sources: ANI
