Before giving cough syrup to your child, check the bottle: Sale still continues despite advisory for kids under 4; check what changes are being planned

India’s drug regulator is considering changes to cough syrup labels to discourage their use in children below four years of age. The proposal includes a prominent red warning on bottles as well as a pictorial representation of school-age children to make it clear that the medicines are intended for older children.

The move comes amid continued concerns over cough syrups being prescribed to infants and young children despite an October 2025 advisory from the Directorate General of Health Services (DGHS) urging caution over their use in paediatric patients.

New Warning Proposed On Cough Syrup Bottles

Cough syrup bottles could carry a prominent red warning stating: “WARNING: Cough syrup should not be used in children below 4 years of age”


The proposal also suggests adding an image of school-age children to the packaging.

“Additionally, a pictorial depiction of school-age children may be included on the bottle label to reinforce that the product is intended for older children and to discourage its use in children below the specified age.”

The proposal has been placed before the Drugs Consultative Committee (DCC) for consideration and seeks changes to Rule 96 of the Drugs Rules, 1945.

Why Is The Government Considering This Change?

The proposed labelling changes follow concerns that cough and cold medicines continue to be prescribed to very young children despite existing guidance.

An October 2025 DGHS advisory had called for greater caution in prescribing and dispensing cough and cold medicines to paediatric patients. It specifically advised against prescribing or dispensing these medicines to children below two years of age.

A subsequent complaint alleged that cough syrups were still being prescribed to infants below two. The issue was examined by an internal technical committee of the Central Drugs Standard Control Organisation (CDSCO) in April 2026.

The committee recommended consulting the Indian Council of Medical Research (ICMR) and seeking stakeholder views on the regulatory and marketing feasibility of changes to cough syrup labels. ICMR subsequently said it was not working on any proposal related to cough syrup labelling.

Syrup-Based Medicines Now Under Prescription Rules

In June 2026, the Union health ministry amended the drug rules to bring syrup-based medicines, including cough syrups, outside the over-the-counter category. This means consumers may now need a valid prescription to purchase medicines in syrup form that were previously available without one.

The change was introduced through the Drugs (Fifth Amendment) Rules, 2026, notified by the health ministry on June 9, and subsequently incorporated into the Drugs Rules, 1945.

‘Syrups’ Removed From Schedule K

Under the amended rules, the term "syrups" has been removed from Schedule K of the Drugs Rules, 1945.

Schedule K covers categories of medicines that are exempt from certain requirements under the Drugs and Cosmetics Act, 1940. With syrup formulations no longer included in this exemption, they are now subject to the applicable regulatory requirements.

In practical terms, people seeking to buy cough syrups and other syrup-based medicines that were earlier sold without a prescription will have to provide a valid prescription.

Government Sought Public Feedback

The amendment followed a draft notification issued on December 29, 2025. The government had invited suggestions and objections from stakeholders as well as members of the public before finalising the changes.

The final notification stated that the representations received during the consultation process were considered before the amended rules were issued.

Health Ministry Consulted Drug Advisory Body

According to the health ministry, the decision was taken after consultations with the Drugs Technical Advisory Board, the country's apex technical body dealing with drug regulation.

The Drugs Rules, 1945, were framed under the Drugs and Cosmetics Act and govern the manufacture, sale and distribution of medicines in India.

Officials said the latest amendment is aimed at strengthening regulatory oversight of syrup-based medicines by bringing them under the applicable regulatory framework.

[With TOI inputs]