Restriction of FDCs

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-21082026-275640 EXTRAORDINARY PART II—Section 3—Sub-section (ii) PUBLISHED BY AUTHORITY No. 4415] NEW DELHI, WEDNESDAY, AUGUST 19, 2026/SHRAVAN 28, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 18th August, 2026 S.O. 4595(E).— Whereas, the Central Government has issued a notification vide S.O. No. 1717 (E), dated the 15th April, 2025, which was published in the Gazette of India, Extraordinary, Part II, Section 3, sub-section(ii), restricting the manufacture, sale or distribution of all formulations of fixed dose combination of Chlorpheniramine Maleate + Phenylephrine Hydrochloride, subject to the condition that the manufacturers shall mention the warning "fixed dose combination shall not be used in children below four years of age" on the label and package insert or promotional literature of the drug; And whereas, the Central Government is satisfied that the use of other drug fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride is likely to involve risk to children below four years of age and whereas safer alternatives to such drugs are available; And whereas, the Expert Committee constituted by the Ministry of Health and Family Welfare, Government of India examined the fixed dose combinations of other drugs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, and the said Expert Committee further recommended that the same warning should be applicable on all formulations of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride manufactured or imported and marketed in India; And whereas, the Drugs Technical Advisory Board also examined the proposal in its meeting held on the 16th February, 2026 to restrict the manufacture for sale or for distribution of all formulations of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, in addition to the said notification S.O. No. 1717 (E), dated the 15th April, 2025, and after detailed deliberation, the Drugs Technical Advisory Board agreed that such formulations shall not be used in children below four years of age; And whereas, on the basis of the said recommendations of the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of restriction, the manufacture for sale or for distribution for human use of such drug in the country. Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby restricts the manufacture, sale or distribution of all formulations of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, subject to the condition that the manufacturers of such drugs shall mention the warning "fixed dose combination shall not be used in children below four years of age" on the label and package insert or the promotional literature of the drug. 2. This notification shall come into force on the date of its publication in the Official Gazette. [F. No. X.11035/132/2024-DR] HARSH MANGLA, Jt. Secy. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.