|
The Union Health Ministry has restricted use of common cold drug combination Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age and asked the manufacturers to mention the related warning on the label and package insert of the drug.
The restriction has been imposed with the Central Government satisfied that the use of the particular drug fixed dose combination (FDC) is likely to involve risk to children below four years of age and there are safer alternatives to the said drug available.
A Subject Expert Committee (SEC) appointed by the Central Government has also earlier recommended such an action and advised that the manufacturers should mention a warning in this regard.
The matter was earlier examined by the Drugs Technical Advisory Board (DTAB) and recommended that the drug should be prohibited for use in children below four years of age.
"....on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of restriction, the manufacture for sale, sale and distribution for human use of the said drug in the country," said the Ministry in a notification issued on April 15, 2025.
"No, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby restricts the manufacture, sale or distribution of all formulations of fixed dose combination of Chlorpheniramine Maleate + Phenylephrine Hydrochloride subject to the following condition, that the manufacturers shall mention the warning 'fixed dose combination shall not be used in children below four years of age' on the label and package insert or the promotional literature of the drug," it added.
The notification shall come into force on the date of its publication in the Official Gazette.
Section 26A provides powers to the Central Government to regulate or restrict, manufacture etc. of drugs in public interest, by notification in the Official Gazette.
It may be noted that in 2023, the drug regulator has mandated all manufacturers of common cold fixed drug combination (FDC) of Chlorpheniramine Maleate IP 2mg with Phenylephrine HCL IP 5 mg per ml drops to mention a warning to restrict the use of the combination in children below four years of age, on the label and package insert and promotional literature. The mandate was issued after a Subject Expert Committee (SEC) which advises the drug regulator on matters related to drug approval and trials on pulmonary segment recommended such a measure observing that the combination should not be used in children below four years.
The Drugs Controller General (India) (DCGI) Dr Rajeev Singh Raghuvanshi in a letter to all State and Union Territory drug controllers in the end of 2023, requested to direct the manufacturers of the FDC under their jurisdiction to mention the warning "FDC should not be used in children below 4 years of age" on the label and package insert/promotional literature of the drug.
The FDC of Chlorpheniramine Maleate 2 mg and Phenylephrine HCI 5mg drop/ml was declared as rational by the Prof Kokate Committee and based on the recommendation of the committee, the Central Drugs Standard Control Organisation (CDSCO) issued No Objection Certificate (NOC) for continued manufacturing and marketing of the combination on July 17, 2015 under 18 months policy decision.
Subsequent to this, concerns were raised regarding promotion of unapproved anti-cold drug formulation for infants. The matter came up for discussion in the SEC - Pulmonary meeting and after discussions with specially invited pediatric expert, the Committee on June 6, 2023 recommended that the FDC should not be used in children below four years of age and accordingly, the manufacturers should mention warning in this regard on the label and package insert.
|