Despite a 2025 advisory against cough syrups for very young children, prescribing continued; India now weighs a red warning on bottles saying they should not be used in children under 4
The use of cough syrups for children under the age of four continues despite the drug regulator’s guidelines. Now, India’s drug regulator is examining a proposal to make changes to cough syrup labels to discourage their use in children under four years of age.The proposed changes include a visual showing school-age children on the packaging, intended to make it clear that the medicine is meant for older children rather than infants and toddlers.The proposal comes amid continuing concerns over cough syrups being prescribed to infants and young children, despite an October 2025 advisory from the directorate general of health services (DGHS) advising against the practice.
New warning on cough syrup bottles
According to the proposal seen by ET, the bottle label could prominently carry a red warning stating: “WARNING: Cough syrup should not be used in children below 4 years of age”.It further proposes that “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 submitted to the drugs consultative committee (DCC) for consideration. It seeks changes to Rule 96 of the Drugs Rules, 1945.The DGHS advisory issued last year called for greater caution while prescribing and dispensing cough and cold medicines for paediatric patients. It specifically recommended that these medicines not be prescribed or dispensed to children below two years of age.However, a complaint was later received alleging that cough syrups were still being prescribed to infants below two years. “The practice has continued even after the DGHS issued specific directions against it in October 2025,” said a person familiar with the matter.The issue was taken up 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) to determine whether it was working on any proposals concerning cough syrup use among children. It also suggested consulting stakeholders on the regulatory and marketing feasibility of changes to product labelling.ICMR, however, said it was not undertaking any work related to cough syrup labelling.“Cough syrups are among the most commonly prescribed and over-the-counter purchased medicines in India, and their use in very young children has long been a concern among health experts,” said another person familiar with the matter.
Prescription guidelines
In June this year, the Union health ministry amended the drug rules to remove syrup-based medicines, including cough syrups, from the over-the-counter category. Buyers will now need a doctor’s prescription to purchase these medicines.The change has been introduced through the Drugs (Fifth Amendment) Rules, 2026, which were notified by the health ministry on June 9 and subsequently incorporated into the Drugs Rules, 1945.Under the amended provisions, the term “syrups” has been deleted from Schedule K. The schedule specifies categories of medicines that are exempt from certain requirements under the Drugs and Cosmetics Act, 1940. With syrup formulations no longer covered by this exemption, they will come under the relevant regulatory requirements.In practical terms, consumers who want to buy cough syrups or other medicines in syrup form that were earlier available without a prescription will now have to provide a valid prescription.The amendment follows a draft notification issued on December 29, 2025. Through that notification, the government had sought suggestions and objections from stakeholders as well as members of the public. The final notification said all representations received during the consultation process were considered before the amended rules were issued.According to the health ministry, the change was made 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 change is intended to strengthen regulatory oversight of syrup-based medicines by bringing them within the applicable regulatory framework.
