New Delhi, August 22, 2026 (Yes Punjab News)
The government has restricted the manufacture, sale and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age, the Health Ministry said on Saturday.
Under a notification issued in the interest of public health, manufacturers have been directed to prominently display a warning stating, “Fixed Dose Combination shall not be used in children below four years of age” on the labels, package inserts and promotional literature accompanying these medicines.
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, and takes effect from the date of its publication in the Official Gazette.
The latest order extends an existing age-specific restriction on certain FDCs containing the two ingredients to all formulations comprising Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). The government said such combinations could pose risks to children below four years, while safer alternatives are available.
The move comes amid wider government scrutiny of FDCs marketed in India. In June, the Health Ministry prohibited the manufacture, sale and distribution of 16 FDC drugs for human use across the country.
The prohibited combinations belonged to various therapeutic categories, including dermatological products, pain-relief and antispasmodic medicines and certain antibiotic-based formulations. The ministry said those combinations were considered irrational and lacked adequate scientific evidence supporting their use.
The June action was also taken under Section 26A of the Drugs and Cosmetics Act, following directions from the Supreme Court for a comprehensive review of FDCs available in the Indian market.
The DTAB had constituted an expert committee to examine various FDCs and assess their safety, efficacy and therapeutic value.
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