Mains Practice Questions

Introduction:

India is globally recognised as the “pharmacy of the world”, supplying over 20% of global generic drugs and 60% of vaccines. However, this pharmaceutical strength contrasts sharply with its weak regulatory framework for paediatric drugs. Despite children constituting over 40% of India’s population, drug development, clinical oversight, and ethical standards for paediatric use remain fragmented, underregulated, and poorly defined.

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Challenges in Regulating Paediatric Medicines in India

• Inconsistent and Weak Regulatory Oversight: India’s regulatory fragmentation between the Central Drugs Standard Control Organisation (CDSCO) and various state drug controllers continues to cause enforcement gaps.
  • During the 2025 Madhya Pradesh cough syrup crisis, regulators found 364 violations at Sresan Pharmaceuticals, the firm producing Coldrif, which contained diethylene glycol (DEG), a toxic substance found in industrial solvents.
• Absence of Dedicated Paediatric Pharmacovigilance: Existing laws (Pre-Conception and Pre-Natal Diagnostic Techniques Act, National Policy for Children 2013) do not address medicine safety for children specifically; Article 39(f) of the Constitution enjoins the State to protect children’s health and development but is insufficiently operationalized in pharmacovigilance.
  • Drugs are often only tested for use in adults, with pediatric doses extrapolated from adult data, resulting in unsafe and non-optimized treatments for children.
• Corruption, Negligence, and Poor Quality Control: A recurring pattern of toxic contaminations shows that the problem is systemic, not accidental.
  • In 2022–2023, around 70 childhood deaths in Gambia and 18 in Uzbekistan were traced to Indian-made syrups.
• Over‑the‑Counter (OTC) Misuse and Parental Unawareness: Studies indicate most paediatric medicine purchases in India occur without prescriptions, especially in urban slum areas and Tier‑2 towns.
• Absence of Comprehensive Paediatric Drug Policy: India still lacks a Paediatric Drug Regulation Authority or dedicated Child-Specific Medicines Code, despite repeated WHO and National Commission for Protection of Child Rights (NCPCR) recommendations.
  • Testing for toxins like DEG and EG became mandatory only for export syrups in 2023 after WHO alerts, not for domestic sales.

Measures to Strengthen the Regulatory Framework of Paediatric Medicines in India

• Establish a National Paediatric Drug Safety and Ethics Authority (NPSEA): India should create NPSEA under the Central Drugs Standard Control Organisation (CDSCO) to oversee paediatric drug licensing, formulation approval, and ethical trials.
  • The Mashelkar Committee Report (2003) highlighted the inadequacy of India’s drug regulatory infrastructure and called for greater budgetary allocation to establish a robust, “world-class” drug controlling authority.
• Zero Tolerance Regime and Criminal Accountability: Amend the Drugs and Cosmetics Act (1940) to include non-bailable offences for deaths caused by substandard paediatric medicines.
  • Introduce mandatory recall and disclosure policy, with real-time updates to public health portals.
• Create a National Paediatric Clinical Research and Data Ecosystem: Establish a national registry for Paediatric Clinical Trials (PCT-India) to collect pharmacodynamic and safety data.
  • Offer fiscal incentives to pharma companies undertaking ethical, India-specific paediatric R&D.
• Institutionalize Pharmacist and Caregiver Education: Introduce mandatory certification in paediatric dispensing protocols for pharmacists under the Pharmacy Council of India.
  • Run nationwide caregiver awareness drives on dosing and label reading through schools and Anganwadi centers.
  • WHO’s “Make Medicines Child Size” campaign (2007) improved medication literacy and pharmacist training in 40+ developing nations.
• Mandatory Batch Testing and Supply Chain Traceability: The approving agencies should ensure compulsory multi-lab toxicological testing (CDSCO + NABL-accredited labs) for all paediatric formulations before release.
  • The government should implement QR-based batch tracking to trace product origin to the raw chemical stage.
• International Benchmarking and Ethical Transparency: India’s global pharmaceutical role demands transparency aligned with WHO standards and UNCRC (Article 24).
  • India should commit to international drug safety frameworks such as OECD pharmacovigilance standards and ICH E11(R1) guidelines for paediatric medicine development.

Conclusion:

As the WHO emphasized, “Every child deserves safe, quality healthcare from the very beginning.” To realize this vision, India’s pharmaceutical governance must prioritize ethical regulation, rigorous testing, effective federal coordination, and transparent accountability. By adopting WHO-aligned quality standards, strengthening pharmacovigilance systems, and designing paediatric-focused drug policies, India can evolve from a reactive framework to a proactive guardian of children’s health rights.