Nagpur, 25

Apr (HS): Cough syrups containing chlorpheniramine maleate and phenylephrine

hydrochloride have been banned for children under four. The Government of India

banned Fixed Dose Combination of these drugs, follows recommendations from the

Drug Technical Advisory Board (DTAB) and the Subject Expert Committee, citing

safety and efficacy concerns in young children.

According to media

reports, several well-known medicines fall under the new restriction, including

brand names like Ascoril Flu Drops and select products from brands like Alex

(Glenmark), T-Minic (Haleon, formerly GlaxoSmithKline), and Maxtra (Zuventus

Healthcare). The companies must now update their labels and package inserts

with the warning: “Combination of FDC shall not be given to children below four

years of age.”

Glenmark and

Zuventus Healthcare challenged the government’s notification, issued on April

15, arguing that applying it with retrospective effect was unlawful. The

Delhi High Court, however, ruled that the ban would be applied sequentially—meaning

it would not affect stocks manufactured before April 15.

Despite this

exemption, the court directed the companies to issue formal advisories and

publish public notices in widely circulated newspapers, clearly stating that

these FDC cough syrups should never be given to children below the age of four

under any circumstances.

Additionally,

the court directed the manufacturers to submit affidavits detailing the

quantities of FDC cough syrup stocks produced and distributed before the new

guidelines came into effect, to ensure compliance and maintain transparency in

the process.

The Indian Pharmaceutical Association (IPA) has approached the Drugs Controller

General of India (DCGI), seeking clarity on whether the remaining supply should

be recalled or can be sold until the existing stock is exhausted.

—————

Hindusthan Samachar / Ajay Vasant Mardikar