India plans red warning labels, school-age child pictorials on cough syrups to bar under-4 use

India’s drug regulator is considering a prominent red warning and pictorial label on cough syrup bottles to discourage their use in children under four, amid concerns over inappropriate prescribing and drug safety.

India plans to mandate a prominent red warning label and a pictorial depiction of school-age children on cough syrup bottles to discourage their use in children aged under four years, according to two officials and a document reviewed by Mint.

The proposal was taken up for consideration at a meeting held on Friday, 18 September, chaired by Drugs Controller General of India (DCGI).

The move comes against the backdrop of repeated complaints regarding the administration of cold and cough formulations to infants, as well as national and international incidents involving cough syrups contaminated with toxic substances, including diethylene glycol (DEG) and ethylene glycol (EG).

Globally, contaminated Indian-manufactured paediatric syrups were linked to the deaths of children in The Gambia in 2022 and Uzbekistan between 2022 and 2023. More recently, in late 2025, contaminated Coldrif cough syrup manufactured by a Chennai-based drug maker was linked to the deaths of at least 23 children across Madhya Pradesh and Rajasthan after laboratory tests detected lethal levels of diethylene glycol.

The proposal assumes significance for the Indian pharmaceutical industry, valued at $60 billion, with the cough syrup market valued at $680 million, according to a report by Kotak Institutional Equities.

Queries sent to the health ministry secretary and spokesperson on Friday remained unanswered till press time.

Red warning

"A complaint regarding rampant prescribing of cough syrups for infants below 2 years of age by doctors, even after directions issued by DGHS 03.10.2025 was deliberated in the Internal Technical Committee meeting of CDSCO held on 24/04/2026,” the document said.

“The committee observed that the matter may be discussed with ICMR and obtain information on any proposals of ICMR concerning cough syrups in the paediatric population, and a stakeholder consultation meeting shall be conducted with respect to regulatory and marketing feasibility of the complainant's suggestion regarding labelling on cough syrup packs,” it said.

The drug committee has now moved to amend Rule 96 of the Drugs Rules, 1945.

“The following warning may be prominently displayed in red on the bottle label: 'WARNING: Cough syrup should not be used in children below 4 years of age'".

The document added 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".

Earlier, the Directorate General of Health Services issued an advisory on 3 October 2025 titled Advisory on Rational Use of Cough Syrups in Paediatric Population. The DGHS directive stated that "Cough and cold medications should not be prescribed or dispensed to children under 2 years. These are generally not recommended for ages below 5 years and above that any use should follow careful clinical evaluation with close supervision and strict adherence to appropriate dosing, the shortest effective duration and avoiding multiple drugs combinations".

The proposed labelling requirement would therefore set a specific warning at four years, while the existing DGHS advisory says such medicines should generally not be recommended below five years.

Doctors' view

“…as a paediatric pulmonologist, I frequently see young children receiving cough and cold syrups unnecessarily. Cough is a symptom, not a disease. In most young children, acute cough is caused by a viral respiratory infection and improves with time, hydration and supportive care. Suppressing every cough with medication is neither necessary nor always safe. The proposed prominent warning — “WARNING: Cough syrup should not be used in children below 4 years of age” — can help prevent inappropriate self-medication. Restricting pictures on packaging to older, school-age children is also important. Parents often interpret the picture of a small child on a bottle as an indication that the medicine is safe for that age group,” said Dr Dhiren Gupta, senior consultant and co-director, pediatric Intensive Care Unit at Sir Ganga Ram Hospital, New Delhi.

“However, regulation should be accompanied by public education. Parents need to understand that cough in a child may have many causes, including viral infections, asthma, allergies, pneumonia or occasionally an inhaled foreign body. The correct approach is to identify and treat the cause rather than automatically giving a cough suppressant. Clear labelling, responsible advertising, avoidance of unnecessary drug combinations and better counselling by doctors and pharmacists can together significantly reduce inappropriate cough-syrup use in young children,” Dr Gupta added.

Industry response

The industry has opposed blanket curbs, instead calling for ingredient-specific rules and stakeholder consultation on labelling compliance.

“It is scientifically reasonable to restrict and discourage the use of many cough syrup products in children below 4 years of age. Many ingredients are not suitable for this age group. This restriction may be applied based on the ingredients (APIs) of the formulation, after due scientific review of ingredients rather than a blanket restriction. The labelling changes may be done after stakeholders consultations including consultation with the industry, considering financial impact on stocks in the market, feasibility, patient impact and scientific justification,” said Dr Viranchi Shah, national spokesperson, Indian Drugs Manufacturers Association (IDMA), representing 1,200 member companies.

About the Author

Priyanka Sharma is a journalist at Mint, where she covers the Union Ministry of Health and the pharmaceutical industry. Her work focuses on explaining government policies and how they impact healthcare and the medicine market in India. With 12 years of experience in journalism, she has built a reputation for providing clear and honest news on important health topics that affect the entire country.<br><br>Her educational background includes a journalism degree from the prestigious Indian Institute of Mass Communication (IIMC) and specialized training in public health from the Public Health Foundation of India. Before her current role at Mint, Priyanka worked with India Today, The Pioneer, and ANI. She also served as a lead consultant for the National Health Authority, which gave her firsthand knowledge of how the government manages large-scale health programmes.<br><br>Priyanka is based in New Delhi and is an avid traveller who loves visiting the mountains. She has a great interest in regional flavours, particularly South Indian food.