Government of India Keeping in mind the safety of children, has banned some medicines for children under 4 years of age. The drugs that the government has banned was being used extensively in the treatment of cough. The drug regulator of the Government of India has also instructed the drug -making companies to write a clear warning on the label and package. Among the phlegm syrup used in the treatment of cough, the medicines of many well -known companies are also included. Actually, the formulations from which these medicines are made can be harmful to children under 4 years of age. Keeping this in mind, this step has been taken.
Ban on chlorpheniramine mallet and phenylfrene hydrochloride
According to government notifications, the sale, production and distribution of all formulations of the fixed dose combination (FDC) of chlorpheniramine mallets and phenylphrin hydrochloride has been banned. A notification in April 15 states that if the drug makers should continue their work if the drug makers mention the labeled and package inserts as well as the labeled and promotion of “Fixed Dose Combinations should not be used in children under four years of age” in the warning.
Decision taken after recommendation of DTAB and subject expert committee
According to an ET report, the decision has been taken after checking the FDC by the Drug Technical Advisory Board (DTAB) and the subject expert committee and recommended that all formulations of similar combinations should be banned in children under 4 years of age. Banned FDC is a commonly used formula that is found in many over-the-counter (OTC) drugs and syrup used to treat cold and allergies.
The notification states, “The central government is satisfied that regulating these drug manufacturing, sales and distribution through the ban for human use in the country is essential and reasonable in public interest.”
See notification here
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