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.
The notification became operational on 19 August 2026, requiring compliance with the newly expanded warning-label requirements.
Key Highlights:
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Exercising powers under Section 26A of the Drugs and Cosmetics Act, 1940, the Central Government has restricted the manufacture, sale and distribution of all fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
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Such formulations may be manufactured, sold or distributed only if manufacturers display the following warning:
“fixed dose combination shall not be used in children below four years of age”
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The prescribed warning must be mentioned on:
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the label of the drug;
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the package insert; and
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promotional literature relating to the drug.
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Earlier, through a notification dated 15 April 2025, the Ministry required the warning only on medicines containing the specific fixed-dose combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride. The present notification extends the same warning requirement to all fixed-dose combination medicines that contain Chlorpheniramine Maleate and Phenylephrine Hydrochloride, even where they are combined with other drugs.
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The Government observed that other fixed-dose combinations containing these ingredients may also involve risks for children below four years of age.
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The Ministry’s Expert Committee examined such formulations and recommended extending the warning requirement to all fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride that are manufactured, imported or marketed in India.
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The Drugs Technical Advisory Board (DTAB) considered the proposal in its meeting held on 16 February 2026 and agreed that such formulations should not be used in children below four years of age.
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The Government had earlier noted that other fixed-dose combinations containing these ingredients pose a risk to children below four years, and that safer alternatives are available. On the basis of the DTAB’s recommendations, the Government concluded that restricting these formulations is necessary and expedient in the public interest.
Also Read: Health Ministry Ends Over-the-Counter Sale of Cough Syrups; Prescription Now Mandatory
[Ministry of Health and Family Welfare Notification, dated 18-8-2026]
