The deaths of 25 children linked to contaminated cough syrup has shocked the conscience of the nation. In a news cycle that often highlights ‘man bites dog’ sensationalism, the general public is largely aware of two things: that 25 children died, and that a paediatrician in Madhya Pradesh who defiantly prescribed the syrup to the children is said to have received a paltry commission of ₹2.54 a bottle; thus the cost of each of those young lives was ₹2.54.
That all this happened despite the Union Health Ministry having banned certain cough syrup formulations for children under the age of four years — as recently as April 2025 — citing the risk of contamination, is shocking. There has also been much discussion on responsibility — which agency failed in its duty to monitor and prevent the distribution of the syrup. The regulatory agencies in India responsible include the Central Drugs Standard Control Organisation under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India which handles large manufacturers of drugs and export approvals, and State drug control officers who handle the regulation, care, manufacture, sale and distribution of drugs by small- and medium-scale manufacturers.
Where the focus needs to be
Rather than apportion blame, it would be wise to allow the law to take its course. The focus must be on the regulatory framework behind the distribution of paediatric medicines in India, and the challenges India faces in ensuring the protection it has guaranteed to its children in Article 39(f) of the Constitution, which is also listed as an important Directive Principle of State Policy.
Children (the age group under 18 years) make up 39% of India’s population. There are a catena of laws and policies in India — approximately 13 — that are specifically designed to protect children, from the seminal National Policy for Children 1974 to the India Newborn Action Plan 2014. There are also about 10 pieces of legislation with special provisions for children such as the Pre-Conception and Pre-Natal Diagnostic Techniques Act to The Aadhaar (Targeted Delivery of Financial and Other Subsidies, Benefits and Services) Act.
Significantly, while these are critical interventions, they focus heavily on protecting children in the workforce (labour laws), and preventing and punishing the sexual exploitation of children. There are important initiatives for children in health and education, but the specific area of pharmacovigilance in the dissemination of paediatric drugs requires far more oversight and also the development of robust infrastructure.
In a similar context, Dr. Harry Shirkey called children “therapeutic orphans”. Children are not small adults. The pharmacodynamic responses of children and adults are vastly different due to a spectrum of different physiologies. Further, clinical trials of drugs are usually conducted on adults and for ethical and other reasons almost never on children, resulting in an alarming lack of paediatric guidelines of dosage and administration. All too often, the dosage and administration of drugs for children are extrapolated from guidelines for adults, leaving children in much danger of overdosage and more serious consequences. Special development strategies of drugs for children are a cornerstone of their health-care needs, particularly public health care.
Overseas, the regulatory framework for children-related pharmaceuticals is an eye-opener. In the European Union, it is under the Paediatric Use Marketing Authorisation and in the United States, under the Best Pharmaceuticals for Children Act (BCPA). Inter alia, such legislation also provides incentives for research into paediatric drugs. India does not have a specific policy or legislation and operates on general guidelines. Since children are totally dependent on their parents or guardians for their health needs, it is necessary that the government frames clear guidelines.
Health-care-related financial burdens often cause many impoverished families to fall into deeper poverty, making it even more vital that the pharmaceutical needs of children are made affordable.
The essential medicine concept
Therefore, the introduction of the essential medicine concept in the health-care sector contributes significantly to the greater availability and affordability of life-saving medicines. Essential medicines are those which satisfy the priority health-care needs of the population, are intended to be available in all health-care systems and are of quality and affordable. Several years ago, the World Health Organization (WHO) introduced an essential Medicine list for children (EMLc). This is used by policy makers to update the EMLc lists in their own countries. Although EML for adults are periodically revised, the EMLc for children is not addressed regularly. This requires immediate attention of policymakers.
Other basic safe practices in the distribution of children’s pharmaceuticals include constant education for care-givers and pharmacists, and making it mandatory to read the label, dispense the correct dosage and watch for side-effects particularly when buying over-the-counter medication.
Regulation of over-the-counter medication for children especially for cough, cold and fever is an important dimension of public health care. The use of OTC medication varies in rural and urban areas, but is more common in an urban setting.
Public health-care outlets are another area of focus where clear guidelines need to be enforced in dispensing pharmaceuticals to children. A zero tolerance policy must be adopted against substitute or substandard medication. In the case of teenagers, attention must be paid to prevent the misuse of drugs.
Over the last three years, WHO has issued several warnings on contaminated cough syrup. Some of these are related to cough syrup made in various places in India. Children have also died in the Gambia, Uzbekistan, Indonesia and Cameroon as a result of these contaminated syrups. India has emerged as the pharmacy to the Global South with huge exports of cough syrups, but this carries with it a responsibility to ensure the absolute safety of the medicines exported.
Need for India data
India’s health policy with regard to paediatric medicines cannot be framed only on the basis of data on children available from other countries. Our genetics are unique to us and our research needs to be based on wholly Indian data. Nor should data on paediatric medicines be extrapolated from data that is related to adults.
We owe a fiduciary duty to our children to take care in framing a health policy for them. We expect responsible policymakers to take into account diverse factors including awareness of environmental pitfalls such as how toxicity of a cough syrup may be exacerbated by malnutrition in children.
Thus, adult medicines modified during administration to children can only be considered as off label and unlicensed. They should not be used at all since they are contraindicated in terms of formulation, age and indicators.
Clearly, monitoring safe medicine use in children is of utmost importance. The use of medicines not proven to be safe for children is a violation of the rights of voiceless children. India urgently needs a robust and holistic infrastructure to monitor and promote awareness of safety protocols with regard to medicines given to children.
Jayanthi Natarajan is a former Union Minister, an advocate and a columnist
Published – October 25, 2025 12:16 am IST
