he government on Saturday imposed restrictions on the manufacturing, sale and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age.
NEW DELHI — The government on Saturday imposed restrictions on the manufacturing, sale and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age.
Health Ministry, in a notification, mandated a clear warning that these medicines shall not be used in children below four years of age, in a significant step to safeguard the health and safety of young children.
The government directed manufacturers to clearly display the warning, “Fixed Dose Combination shall not be used in children below four years of age,” on the label, package insert and promotional literature associated with these formulations.
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and is effective from the date of its publication in the Official Gazette, said the ministry.
Earlier, the government had restricted certain FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, subject to the same age-specific warning.
The latest notification extends this requirement to all formulations containing these two ingredients.
The decision has been taken following the recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB).
The government said that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available.
In June this year, the Ministry of Health and Family Welfare prohibited the manufacturing, sale and distribution of 16 fixed dose combination (FDC) drugs for human use across the country.
The banned medicines belonged to different therapeutic categories, including certain dermatological products, pain-relief and antispasmodic drugs, as well as some antibiotic-based formulations. The Ministry said that these combinations were found to be irrational and not supported by sufficient scientific evidence.
The ban was imposed under Section 26A of the Drugs and Cosmetics Act, 1940. The decision follows directions issued by the Supreme Court, which had called for a comprehensive review of FDCs available in the Indian market.
Acting on these directions, the DTAB constituted an expert committee to examine various FDCs and assess their safety, efficacy and therapeutic value.