{"id":348730,"date":"2025-10-27T11:25:27","date_gmt":"2025-10-27T05:55:27","guid":{"rendered":"https:\/\/forumias.com\/blog\/?page_id=348730"},"modified":"2025-10-27T11:25:27","modified_gmt":"2025-10-27T05:55:27","slug":"answered-examine-the-necessity-of-a-holistic-framework-to-monitor-medicine-use-for-children-justify-the-need-to-recognize-and-enforce-the-health-rights-of-indias-children","status":"publish","type":"page","link":"https:\/\/forumias.com\/blog\/answered-examine-the-necessity-of-a-holistic-framework-to-monitor-medicine-use-for-children-justify-the-need-to-recognize-and-enforce-the-health-rights-of-indias-children\/","title":{"rendered":"[Answered] Examine the necessity of a holistic framework to monitor medicine use for children. Justify the need to recognize and enforce the health rights of India\u2019s children."},"content":{"rendered":"

Introduction<\/strong><\/h2>\n

According to UNICEF\u2019s State of the World\u2019s Children 2024 Report<\/strong>, nearly one in every five Indian children<\/strong> faces unsafe or irrational drug exposure\u2014highlighting the urgent need for a robust paediatric pharmacovigilance framework.<\/p>\n

The Context: A Crisis of Neglect in Child Health Governance<\/strong><\/h2>\n
    \n
  1. The recent tragedy of 25 child deaths due to contaminated cough syrup in Madhya Pradesh<\/strong> exposed deep structural weaknesses in India\u2019s drug regulation ecosystem.<\/li>\n
  2. Despite the Union Health Ministry\u2019s 2025 ban<\/strong> on certain paediatric syrups, lapses in enforcement and oversight underline a systemic failure to uphold children\u2019s constitutionally guaranteed health rights (Article 39(f))<\/strong>.<\/li>\n
  3. Children constitute 39% of India\u2019s population<\/strong>, yet the pharmacological frameworks governing medicine safety largely focus on adult physiology, leaving children\u2014whom Dr. Harry Shirkey termed \u201ctherapeutic orphans<\/strong>\u201d\u2014vulnerable to inappropriate dosages and unsafe formulations.<\/li>\n<\/ol>\n

    Why a Holistic Monitoring Framework is Necessary<\/strong><\/h2>\n
      \n
    1. Unique Pharmacodynamics and Clinical Gaps:<\/strong> Children are not small adults<\/strong>. Their metabolism, organ maturity, and drug absorption<\/strong> differ drastically, but clinical trials are rarely conducted on them due to ethical constraints. Consequently, most paediatric prescriptions are \u201coff-label\u201d or extrapolated from adult guidelines<\/strong>, increasing risks of toxicity and overdose.<\/li>\n
    2. Regulatory Fragmentation: <\/strong>The Central Drugs Standard Control Organisation (CDSCO)<\/strong> oversees major manufacturers, while State Drug Controllers<\/strong> regulate local producers. Lack of inter-agency coordination, delayed recall systems, and poor quality audits often lead to regulatory capture and accountability voids<\/strong>.<\/li>\n
    3. International Models of Oversight:<\/strong><\/li>\n<\/ol>\n