DCGI Sets Common Cold Medication Warnings for Children Under Four Years

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A significant directive impacting the production and marketing of common cold fixed dosage combinations (FDC) including chlorpheniramine maleate IP 2 mg and phenylephrine HCL IP 5 mg per millilitre drops has been issued by the Drugs Controller General of India (DCGI) in a recent development. Prompted by suggestions from a Subject Expert Committee (SEC) focused on pulmonary issues, the directive requires manufacturers to advise against using this combination in children younger than four years old on the label, package insert, and promotional materials.


Based on the suggestion of the Prof Kokate Committee in 2015, the FDC in question—which contained 2 mg of chlorpheniramine maleate and 5 mg of phenylephrine HCI drop/ml—had previously been approved by the Central Drugs Standard Control Organisation (CDSCO). But later on, questions were made about the promotion of this anti-cold mixture for babies without the necessary authorization.

On June 6, 2023, after deliberations at the SEC – Pulmonary meeting, the committee recommended—in consultation with paediatric specialists—that children younger than four years old not get the FDC. Official requests have been made by DCGI Dr. Rajeev Singh Raghuvanshi to all State and Union Territory drug controllers to make sure that manufacturers include the warning that “FDC should not be used in children below 4 years of age” on labels, packaging inserts, and promotional literature.

This instruction is a part of a broader regulatory initiative that dates back to 2013, when the DCGI’s office first started working to verify the safety and effectiveness of FDCs that were approved by State Licencing Authorities without obtaining the necessary approval. Applications were evaluated by the Prof. Kokate Committee, which was essential in the process. Manufacturers who were judged reasonable under the 18-month policy decision were then granted NOCs.

The new mandate supports the DCGI’s continuous efforts to oversee and control pharmaceutical formulations in order to protect public health and safety. Manufacturers are expected to comply with this mandate as soon as possible, and state drug regulators are supposed to notify the DCGI’s office of their activities. This action highlights the pharmaceutical industry’s dedication to safety and transparency in India. Keep checking back for more information on this changing regulatory environment.

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