{"id":396329,"date":"2026-09-16T13:00:19","date_gmt":"2026-09-16T07:30:19","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=396329"},"modified":"2026-09-16T12:38:22","modified_gmt":"2026-09-16T07:08:22","slug":"centre-mandates-chlorpheniramine-maleate-phenylephrine-warning","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2026\/09\/16\/centre-mandates-chlorpheniramine-maleate-phenylephrine-warning\/","title":{"rendered":"Centre expands ‘Not for Children Below 4’ warning to all Chlorpheniramine Maleate-Phenylephrine drug combinations"},"content":{"rendered":"
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On 18 August 2026, the Ministry of Health and Family Welfare notified expanded warning-label requirements for all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.<\/span><\/p>\n

The notification became operational on 19 August 2026, requiring compliance with the newly expanded warning-label requirements.<\/p>\n

Key Highlights:<\/p>\n

    \n
  1. \n

    Exercising powers under Section 26A<\/a> of the Drugs and Cosmetics Act, 1940<\/a>, the Central Government has restricted the manufacture, sale and distribution of all fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.<\/p>\n<\/li>\n

  2. \n

    Such formulations may be manufactured, sold or distributed only if manufacturers display the following warning:<\/p>\n

    “fixed dose combination shall not be used in children below four years of age”<\/p>\n<\/li>\n

  3. \n

    The prescribed warning must be mentioned on:<\/p>\n