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[SITUATION] · [QUIET] · [HEALTH]

2 clusters · 15 sources · 3 days · First seen about 1 month ago · Last updated 28 days ago

India pediatric drug combination restrictions

Overview

The Indian Health Ministry has implemented restrictions on the manufacturing, sale, and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under the age of four.

Acting under Section 26A of the Drugs and Cosmetics Act, 1940, and following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), the government requires manufacturers to include a prominent warning on labels, package inserts, and promotional materials. The warning must state: ‘Fixed Dose Combination shall not be used in children below four years of age.’

The measure aims to mitigate health risks to young children, with officials noting that safer therapeutic alternatives are available. Medical professionals have further advised that children should not be treated as ‘smaller adults’ when prescribing medication.

Entities

Drugs Technical Advisory Board · Ministry of Health and Family Welfare · India · Government of India

Timeline

28 days ago

[HEALTH] 3 sources
India restricts specific cold medicines for children under four
India has restricted the use of fixed-dose combinations containing chlorpheniramine and phenylephrine in children under four, mandating warning labels on all such formulations.
about 1 month ago

[HEALTH] 12 sources
India restricts specific drug combinations for children under four
India's Health Ministry has restricted all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under four, mandating clear safety warnings on packaging.

Sources

assamtribune.com · bhaskarlive.in · bilkulonline.com · businessnewsthisweek.com · cargoinsights.co · ibtimes.co.in · indtoday.com · insightsonindia.com · kalingatv.com · mangalorean.com · morungexpress.com · newsable.asianetnews.com · thecsrjournal.in · thelivenagpur.com · timesnownews.com