New Delhi. The Central Government has issued important instructions regarding some medicines related to cold and cough. The government has imposed new conditions for the manufacture, sale and distribution of Fixed Dose Combination (FDC) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
Under the new rule, drug combinations containing these two components will not be used in children below four years of age. It will now be mandatory for pharmaceutical companies to place clear warnings in this regard on their product packaging, labels and related promotional materials.
Clear warning will have to be written on the medicine packet
The Government has directed drug manufacturers to clearly state on the labels and package inserts of products containing both chlorpheniramine maleate and phenylephrine hydrochloride that this FDC should not be used in children under four years of age. With this, parents and health workers will also be able to easily get information about age related precautions while purchasing medicines.
Steps were taken earlier also
The government has already taken steps regarding these drug combinations. An order regarding ban on certain prescribed fixed dose combinations containing these two components was issued on 15 April 2025. Now the scope of the new system has been expanded to include all those formulations which include both Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
Decision after expert advice
This decision has been taken on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board (DTAB). According to the government, the use of these drug combinations in children under four years of age may pose a risk. The availability of other treatment options for children has also been taken into account in this decision.
This order was issued in public interest
The Central Government has issued this notification under Section 26A of the Drugs and Cosmetics Act, 1940 keeping in mind public interest and public health. The new provision aims to increase clarity around the use of medicines and protect young children from potential risks.