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Combinations of Anti-Cold Medications for Children Less than Four are Prohibited

M3 India Newsdesk Jan 22, 2024

The article outlines Indian drug regulators' prohibition of certain cold medications for children under four due to safety concerns, following expert committee recommendations.

The administration of anti-cold fixed drug combinations to children younger than four years of age has been strictly prohibited by the Central Drugs Standard Control Organisation (CDSCO).

The Drugs Controller General of India (DCGI) has requested that all states and Union territories' drug regulators direct the producers of fixed drug combinations (FDCs) containing 2 mg of chlorpheniramine maleate and 5 mg of phenylephrine HCL drop/ml to include a warning on the label and package insert/promotional literature of the drug stating that the product "should not be used in children below 4 years of age.

According to the DCGI's letter, the Professor Kokate Committee deemed the FDC to be reasonable, and this office issued an NOC on July 17, 2015, allowing the FDC to continue being manufactured and marketed by the 18-month policy decision.

Concerns have since been raised about the advertising of unapproved anti-cold medication formulations for young children. The subject was discussed at the June 6 Subject Expert Committee (SEC-Pulmonary) meeting.

The committee advised against using the FDC on children younger than four, and as a result, the manufacturers should include caution about this on the label and box insert.

The DCGI's letter dated December 18 states:

"Therefore, you are requested to direct all the manufacturers of said FDC under your jurisdiction to mention warning 'FDC should not be used in children below 4 years of age' on label and package insert/promotional literature of the drug."

  1. The use of an anti-cold fixed-drug combination by children below the age of four is prohibited by the Indian drugs regulator.
  2. This combination comprises two drugs, phenylephrine and chlorpheniramine maleate.
  3. Phenylephrine functions as a decongestant, whereas chlorpheniramine maleate acts as an anti-allergic agent.

The Central Pharmaceutical Standard Control Organisation (CDSCO), the Indian pharmaceutical regulator, has outlawed the use of anti-cold fixed medication combinations for children less than four. The two medications in this typical cold-fixed drug combination (FDC) are phenylephrine and chlorpheniramine maleate.

The Subject Expert Committee's (SEC) recommendations, which stressed that children under the age of four should not take this medication combination, served as the basis for this conclusion.

The common cold fixed-dose combination (FDC) that contains phenylephrine HCL IP 5 mg per millilitre drop and chlorpheniramine maleate IP 2 mg has prompted all manufacturers to include a warning on the label and packaging stating that the product "should not be used in children below 4 years of age. 

Prohibition of anti-cold medication formulation

  1. This decision follows the deaths of at least 141 children abroad related to cough syrups made in India.
  2. According to the regulator, who was cited by news agency Reuters, concerns over the advertising of an unapproved anti-cold medicine composition in newborns sparked a debate and eventual advice not to use the combination for that age group.
  3. The World Health Organisation (WHO) has recommended against giving children under the age of five access to over-the-counter cough syrups or medications to treat their colds and coughs.


Disclaimer- The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of M3 India.

About the author of this article: Dr Monish Raut is a practising super specialist from New Delhi.

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