Centre Bans Cold And Cough Drug Combination For Children Under 4, Orders Mandatory Warning
Summarized by AI; it may make mistakes. Check important info
Summarized by AI; it may make mistakes. Check important info
The Central government has prohibited the manufacture, sale and distribution of fixed-dose combination medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years, citing potential health and safety risks to young children.
Under the new order issued by the Union Health Ministry, pharmaceutical companies must also carry a prominent statutory warning stating: “Not for use in children below the age of 4 years” on the packaging and other prescribed material for such medicines.
Warning Mandatory On Packs, Labels And Promotional Material
The government has directed manufacturers to clearly print the warning on every pack, label, package insert and promotional material relating to medicines containing the Chlorpheniramine Maleate-Phenylephrine Hydrochloride combination.
The restrictions apply to all relevant fixed-dose combination (FDC) products, including syrups, drops and other formulations containing the two drugs.
The move expands restrictions that were earlier applicable to only certain medicines and now brings all such FDC products under the prescribed regulatory framework.
Why Has The Government Taken This Decision?
The combination has commonly been used to provide relief from symptoms associated with the common cold, including a blocked or runny nose, sneezing and allergies.
However, an expert committee and the Drugs Technical Advisory Board (DTAB), after reviewing the safety of the combination, found that its use in infants and children below four years could pose serious side effects and health risks.
The review also noted that safer treatment options are available for children in this age group, leading authorities to restrict the use of the combination.
Order Issued Under Drugs And Cosmetics Act
The Centre issued the order by exercising its powers under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the government to regulate or prohibit drugs in the public interest.
The order has come into force with immediate effect following its publication in the Official Gazette and applies across the country.
Drug manufacturers, distributors and retailers have been directed to comply with the new requirements. Failure to follow the order could invite action under the applicable provisions of the Drugs and Cosmetics Act and related rules.
