Government Amends Drugs Rules, Removes ‘Syrups’ from Schedule K Exemption List
The Central Government has notified the Drugs (Fifth Amendment) Rules, 2026, introducing a key change to the Drugs Rules, 1945 by removing the word “Syrups” from a category of medicines listed under Schedule K.
The amendment was issued by the Ministry of Health and Family Welfare through a notification published in the Gazette of India. The revised rules came into effect immediately upon their publication in the Official Gazette.
According to the notification, the amendment follows a public consultation process initiated in December 2025. A draft proposal to amend the Drugs Rules, 1945 was published on December 30, 2025, inviting objections and suggestions from stakeholders and the public. After reviewing the feedback received and consulting the Drugs Technical Advisory Board (DTAB), the government finalized the amendment.
Under the new rules, the term “Syrups” has been omitted from Item No. 7 under Serial No. 13 in Schedule K of the Drugs Rules, 1945. Schedule K contains provisions relating to specific classes of drugs that are exempt from certain requirements of the Drugs and Cosmetics Act and Rules under prescribed conditions.
While the notification does not elaborate on the immediate operational implications of the amendment, experts believe the change could have regulatory significance for the manufacture, sale, distribution, or licensing requirements applicable to certain syrup-based pharmaceutical products.
The Ministry stated that the amendment has been made under the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940. These provisions empower the Central Government to frame and amend rules governing the regulation of drugs and cosmetics in India.
The notification was signed by Joint Secretary Harsh Mangla on behalf of the Ministry of Health and Family Welfare.
The Drugs Rules, 1945, which form the backbone of India’s pharmaceutical regulatory framework, were originally notified on December 21, 1945. Since then, they have undergone numerous amendments to align with evolving healthcare requirements, pharmaceutical standards and regulatory practices.
The latest amendment comes shortly after another revision to the Drugs Rules notified on June 1, 2026. Regulatory observers say the government continues to review and update pharmaceutical regulations to strengthen oversight and ensure the safety, quality and efficacy of medicines available in the country.
The amendment is expected to be closely examined by pharmaceutical manufacturers, distributors, healthcare professionals and regulatory authorities for its impact on compliance requirements and drug administration practices.
