Paediatric Medicine Safety and Regulation in India

The deaths of 25 children from contaminated cough syrup in 2025 have raised urgent concerns about paediatric medicine safety in India. Despite a recent ban by the Union Health Ministry on certain cough syrups for children under four, contaminated products still reached vulnerable populations. This tragedy has spotlighted gaps in India’s drug regulatory framework, especially concerning children’s medicines.

of Paediatric Drug Safety

Recently, the Union Health Ministry banned specific cough syrup formulations for young children due to contamination risks. Nevertheless, these medicines continued to be prescribed and sold. The incident revealed systemic failures in monitoring and enforcement by regulatory bodies such as the Central Drugs Standard Control Organisation and State drug control officers. It exposed the urgent need for stronger oversight and accountability in paediatric drug distribution.

Regulatory Framework and Challenges

India’s drug regulation involves multiple agencies at central and state levels. The Central Drugs Standard Control Organisation oversees large manufacturers and exports. State drug control officers regulate smaller producers and local distribution. However, coordination gaps and resource constraints limit effective supervision. Unlike the European Union and the United States, India lacks dedicated legislation for paediatric medicines. Current guidelines rely on adult drug regulations, which do not address the unique needs of children.

Pharmacovigilance and Paediatric Drug Development

Children’s physiological responses to drugs differ from adults. Clinical trials rarely include children due to ethical and practical challenges. This results in a lack of paediatric-specific dosage and safety data. Drugs are often prescribed off-label, increasing risks of overdose and adverse effects. Globally, acts like the EU’s Paediatric Use Marketing Authorisation and the US Best Pharmaceuticals for Children Act incentivise research into child-specific medicines. India has yet to adopt similar policies.

Legal and Policy Landscape for Child Protection

India has about 13 laws and policies aimed at child welfare, including the National Policy for Children (1974) and the India Newborn Action Plan (2014). These focus on labour rights, education, health, and protection from exploitation. However, paediatric pharmacovigilance is not adequately covered. Article 39(f) of the Constitution of India mandates protection of children’s health, but implementation gaps remain, especially in drug safety.

Essential Medicines and Affordability

The concept of essential medicines ensures availability of affordable, quality drugs for priority health needs. The World Health Organization’s Essential Medicines List for Children (EMLc) guides national policies. India’s EMLc requires regular updates and greater emphasis on paediatric formulations. Education of caregivers and pharmacists on safe dispensing and dosage is critical. Over-the-counter medicines for children must be regulated strictly to prevent misuse or contamination.

Global Implications and India’s Role

India is a major supplier of medicines to the Global South. Contaminated cough syrup incidents have occurred not only in India but also in countries like Gambia, Uzbekistan, Indonesia, and Cameroon. This marks the global responsibility India holds in ensuring drug safety. Indian health policy must be based on indigenous data, considering unique genetics and environmental factors such as malnutrition that affect drug toxicity.

Need for Robust Infrastructure and Awareness

India urgently requires a comprehensive system for monitoring paediatric drug safety. This includes better data collection, stricter regulation, public awareness campaigns, and training for healthcare providers. Off-label use of adult medicines in children must be eliminated. Protecting children’s right to safe medication demands a holistic approach integrating policy, science, and enforcement.

Questions for UPSC:

1. Point out the challenges in India’s drug regulatory system and suggest measures to improve pharmacovigilance for children.
2. Critically analyse the role of the Directive Principles of State Policy in safeguarding children’s health with suitable examples.
3. Estimate the impact of contaminated medicines on public health and discuss the importance of essential medicines policy in India.
4. Underline the differences in paediatric drug regulation between India and developed countries and explain how India can bridge this gap.

Answer Hints:

1. Point out the challenges in India’s drug regulatory system and suggest measures to improve pharmacovigilance for children.

1. Multiple regulatory agencies (CDSCO at central and State drug control officers) with overlapping roles cause coordination gaps.
2. Resource constraints and lack of robust monitoring systems limit effective supervision of paediatric drug manufacturing and distribution.
3. Absence of dedicated paediatric drug legislation; current guidelines are based on adult drug regulations, ignoring children’s unique needs.
4. Inadequate clinical trials on children lead to off-label use and unsafe dosing practices.
5. Weak enforcement of bans and poor surveillance allow contaminated or banned syrups to reach children.
6. Measures – Establish a centralized paediatric pharmacovigilance authority, mandate clinical trials for children, strengthen inter-agency coordination, enforce strict penalties, and increase public and professional awareness on safe drug use for children.

2. Critically analyse the role of the Directive Principles of State Policy in safeguarding children’s health with suitable examples.

1. Article 39(f) mandates the State to ensure children’s health and protection, reflecting constitutional commitment to child welfare.
2. Directive Principles guide policies like the National Policy for Children (1974) and India Newborn Action Plan (2014) focusing on child health and nutrition.
3. However, these principles are non-justiciable and lack enforcement mechanisms, leading to implementation gaps.
4. Existing laws emphasize child labour, exploitation prevention but inadequately address paediatric pharmacovigilance and drug safety.
5. Example – Despite the ban on certain cough syrups, contaminated medicines still reached children, showing weak policy enforcement.
6. Hence, while Directive Principles set a vision, stronger legal frameworks and effective execution are needed to safeguard children’s health fully.

3. Estimate the impact of contaminated medicines on public health and discuss the importance of essential medicines policy in India.

1. Contaminated medicines cause morbidity and mortality, exemplified by 25 child deaths from cough syrup in India and similar incidents globally.
2. Such events erode public trust in healthcare systems and increase healthcare costs due to additional treatments.
3. Essential Medicines List (EML) ensures availability of safe, quality, affordable medicines addressing priority health needs.
4. WHO’s Essential Medicines List for Children (EMLc) guides policy but requires regular updating and emphasis in India.
5. Implementing EMLc promotes rational drug use, reduces misuse of OTC medicines, and prevents adverse drug reactions in children.
6. Thus, essential medicines policy is critical to improve access, affordability, and safety of paediatric drugs, reducing public health risks.

4. Underline the differences in paediatric drug regulation between India and developed countries and explain how India can bridge this gap.

1. Developed countries like EU and USA have specific paediatric drug laws (EU’s Paediatric Use Marketing Authorisation, US Best Pharmaceuticals for Children Act) incentivizing child-specific drug research.
2. India lacks dedicated paediatric legislation; relies on adult drug regulations and general guidelines.
3. Clinical trials involving children are routine in developed countries, ensuring safer dosing and formulations; India rarely conducts such trials due to ethical and infrastructural challenges.
4. Developed countries have robust pharmacovigilance systems and strict enforcement; India faces monitoring and enforcement weaknesses.
5. To bridge the gap, India needs to enact specific paediatric drug laws, incentivize research, mandate child-focused clinical trials, strengthen regulatory capacity, and build awareness among healthcare providers.
6. Developing indigenous data reflecting India’s unique genetics and environmental factors is essential for effective policy formulation.