Ministry of Health notifies removal of “Syrups” from Schedule K exemptions under Drugs Rules, 1945

The Ministry of Health and Family Welfare (“MoHFW”) has now notified the Drugs (Fifth Amendment) Rules, 2026 (“Amendment”) to remove syrup formulations from the exemptions available under Schedule K to the Drugs Rules, 1945 (“Rules”). The Amendment have gained effect on the date of their publication in the Official Gazette, i.e., 15^th June 2026.

By way of the Amendment, the Central Government has amended Schedule K to the Rules by deleting the word “Syrups” from Item No. 7 under Serial No. 13 in the “Class of Drugs” column. Consequently, syrup formulations covered under the said entry will no longer be eligible for the exemptions available under Schedule K. Prior to this amendment, syrup formulations falling within the scope of the relevant Schedule K entry benefitted from certain exemptions from licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940 and the Rules. Following the omission of the term “Syrups”, such products will now be subject to the applicable regulatory framework and compliance requirements prescribed under the Act and the Rules, including any licensing obligations that may apply to their manufacture, sale and distribution.

Source: E-Gazette