Government bans cough syrups for children under age of 4 due to safety concerns

Government of India released an order to restrict manufacture, distribution and sale of fixed-dose combination (FDC) cough syrups for children under the age of 4. This decision was taken after the recommendation from DTAB and the subject Expert Committee, which emphasised the issues relating to safety and effectiveness of these products on young children.

The banned cough syrups are of popular brands like Ascoril Flu drops, Alex by Glenmark, T-Minic by Haleon and Maxtra by Zuventus Healthcare. These manufacturers have been given instructions to add label on package with warning that say, “Combination of FDC shall not be given to children below four years of age.”

Further the government has ordered the manufacturers to submit statements regarding the production and stock distribution to the new guidelines coming into effect, to maintain the transparency.

The manufacturers have requested the government to give them an adaption period to ensure that new regulations are integrated seamlessly.

The goal of this move is to protect small children and make sure that only safe, proven medicines are used for them. Doctors and pharmacists will now have to follow stricter rules when giving cough syrups to young kids.

Parents are always advised to check with a pediatrician before giving any medicine to children, especially those under the age of 4. This step is meant to reduce risks and improve child safe across the country.