New Delhi: The Drugs Controller General of India (DCGI) has mandated all manufacturers of common cold fixed dose 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 directive comes 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.
DCGI Dr Rajeev Singh Raghuvanshi in a letter to all State and Union Territory drug controllers, 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.
The DCGI said that 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.
The DCGI’s office considered the recommendation, and extended the request to the state drug regulators to direct all the manufacturers to carry the warning in their label and package insert or promotional literature. “Action taken in this regard may be intimated to this office,” added the drug regulator.
The issue dates back to 2013, when the DCGI issued a letter on January 15, 2013 whereby all the state/UT Drugs Controllers were requested to ask the concerned manufacturers in their State to prove the safety and efficacy of FDCs within 18 months which were permitted by State Licensing Authorities without due approval from the office of DCGI.
After examination of such applications received, in consultation with Prof. Kokate Committee constituted by the ministry of health and family welfare, concerned manufacturers were issued NOC for continued manufacturing and marketing in case of FDCs held as rational.
Subsequently, the DCGI office received representations from various stakeholders for issuance of permission to subsequent applicants of such FDCs which have been held to be rational and approved by DCGI, i.e. those manufacturers who have license from SLA, but did not obtain NOC from DCGI or those manufacturers who intend to manufacture these FDCs henceforth.
The matter was then examined by the DCGI in consultation with the ministry of health and family welfare and accordingly a pathway was finalised in 2017, to be followed by manufacturers for subsequent applications.
