The Indian government issued an order prohibiting the manufacture, distribution, and sale of fixed-dose combination (FDC) cough syrups for children under four years old that contain chlorpheniramine maleate and phenylephrine hydrochloride. This decision followed recommendations from the Drug Technical Advisory Board (DTAB) and the Subject Expert Committee, which raised concerns about the safety and efficacy of these products for young children.

The affected medications include well-known brands such as Ascoril Flu Drops, certain formulations of Alex by Glenmark, T-Minic by Haleon (formerly GlaxoSmithKline), and Maxtra by Zuventus Healthcare. Manufacturers are now required to include warnings on labels and package inserts stating: “Combination of FDC shall not be given to children below four years of age.”

Glenmark and Zuventus Healthcare challenged the government's notification, arguing that it was illegal to apply it retroactively. On April 24, 2025, the Delhi High Court ruled that the ban would be implemented sequentially, meaning it would not apply to stocks produced before April 15, which would be exempt.

However, the court mandated that these companies inform all healthcare professionals through formal advisories and public notices in widely circulated newspapers, emphasizing that these FDC cough syrups should never be administered to children under four years of age, regardless of the circumstances.

Additionally, the court instructed the manufacturers to provide sworn statements detailing the stocks produced and distributed before the new guidelines took effect to ensure compliance and transparency.

Pharmacists across the country have expressed concerns about managing the remaining stock of the banned cough syrups following the ban. The Indian Pharmaceutical Association (IPA) has consulted the Drugs Controller General of India (DCGI) to clarify whether the remaining inventory should be returned or can be sold until depleted. There is also a need for guidance on dispensing prescriptions for toddlers during this transitional period.

Stakeholders, including manufacturers, pharmacists, healthcare providers, and others, have suggested extending the adaptation period to facilitate a smooth integration of the new regulations.

These measures underscore the importance of ensuring the safety of medications for children. The restrictions on specific FDC cough syrups for very young children aim to prevent adverse outcomes and protect this vulnerable age group.

The public notices and warnings are intended to encourage healthcare professionals to focus more on targeted health services and therapeutics related to caregiving. As changes occur within the healthcare sector, it is essential for guardians, pharmaceutical practitioners, and regulatory bodies to collaborate closely to safeguard the well-being of young children while responsibly adapting to the new policies.