The recent decision by India's Central Drugs Standard Control Organisation (CDSCO) to ban a common anti-cold medicine combination for children under four has raised concerns and questions among pediatricians across the country. To address these queries and dispel any confusion, let's shed light on the key points:

Q1: What specific medication is banned?

A1: The banned medication is a fixed-dose combination (FDC) containing Chlorpheniramine Maleate IP 2mg and Phenylephrine HCI IP 5mg per ml drops. This combination is commonly used to treat cold symptoms like runny nose, sneezing, and cough in children.

Q2 : Why is it banned for children under four?

A2: While the FDC was previously approved for all ages, concerns emerged about its safety and efficacy in infants and young children. The Subject Expert Committee (SEC) on Pulmonary Medicine deliberated and recommended against its use in this age group due to potential risks and unapproved usage.

Q3 : Does this mean the medication is completely banned?

A3: No, the FDC remains approved for children four years old and above. The ban only applies to infants and toddlers under four.

Q4: What about existing stocks of the medication?

A4: Existing stocks can still be sold, but manufacturers are instructed to update their labels and package inserts with a clear warning stating: "FDC should not be used in children below 4 years of age.

Q5: Since the combination of Chlorpheniramine and Phenylephrine is banned, can I use these two components separately in children below four years of age?

A5: The ban specifically pertains to the fixed dose combination (FDC) of Chlorpheniramine and Phenylephrine. It does not restrict the individual use of Chlorpheniramine or Phenylephrine, provided that each component is prescribed and administered separately within the approved dosage guidelines for children below four years of age.

Q6: I've noticed combinations available in the market that provide Chlorpheniramine Maleate 1 milligram and Phenylephrine 2.5 milligrams. Can these combinations, with this concentration, be used safely in children below four years of age?

A6: As of the regulatory decision, the ban specifically targets the fixed dose combination (FDC) of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop/ml for children below four years of age. While the concentration you mentioned differs from the banned FDC, it's crucial to ensure that any medication used in pediatric patients is prescribed and administered within the recommended dosages and guidelines. If this combination complies with these guidelines and is considered safe by medical authorities, it may be an alternative for your patients.

Q7 : What alternative medications can be used for young children with colds?

A7:Saline nasal drops, steam inhalation, and humidifier use are often recommended for managing mild cold symptoms.

Q8: Where can I find more information about the CDSCO order?

A8: The official order from the CDSCO, dated December 18, 2023, is available for further reference on their website and can be accessed by clicking on the following link.

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA3Nzg=

Remember, always consult your child's pediatrician for any medical concerns and follow their prescribed treatment plan for optimal care.