{"id":321508,"date":"2024-12-19T21:00:44","date_gmt":"2024-12-19T15:30:44","guid":{"rendered":"https:\/\/forumias.com\/blog\/?p=321508"},"modified":"2024-12-28T21:08:18","modified_gmt":"2024-12-28T15:38:18","slug":"making-affordable-generics-more-reliable","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/making-affordable-generics-more-reliable\/","title":{"rendered":"Making Affordable Generics More Reliable"},"content":{"rendered":"

Source: <\/strong>This post on Making Affordable Generics More Reliable is based on article \u201c Making affordable generics more reliable\u201d<\/strong> published in The Hindu<\/strong> on 19th<\/sup> December 2024.<\/p>\n

UPSC Syllabus topic:<\/strong> GS 3- Indian Economy and issues relating to Planning, Mobilization of Resources, Growth, Development and Employment<\/p>\n

Context:<\/strong> The article delves into the critical role of generic medicines in addressing healthcare affordability in India. It underscores the importance of generic drugs in reducing healthcare costs, particularly in a country marked by vast income disparities and high out-of-pocket healthcare expenditure. However, it highlights the challenges associated with ensuring the quality, efficacy, and safety of generics, which are essential for their reliability and effectiveness.<\/p>\n

Why are generic medicines important for healthcare affordability?<\/strong><\/h2>\n
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  1. Generic drugs, being bioequivalent to branded drugs, are cost-effective alternatives crucial for addressing healthcare affordability, especially in countries like India with significant income disparities.<\/li>\n
  2. India leverages economies of scale and low production costs to supply affordable medicines both domestically and internationally.<\/li>\n
  3. With out-of-pocket healthcare expenditure at 39.4% of total health expenditure in 2021-22, generics significantly reduce financial burdens and improve treatment adherence.<\/li>\n
  4. Through the Pradhan Mantri Bhartiya Janaushadhi Pariyojana, generic medicines worth \u20b95,600 crore sold over a decade saved consumers an estimated \u20b930,000 crore by August 2024.<\/li>\n<\/ol>\n

    What challenges do generic medicines face in India?<\/strong><\/h2>\n
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    1. Quality Concerns:<\/strong> Despite bioequivalence to branded drugs, quality control lapses have compromised their efficacy and safety in some cases.<\/li>\n
    2. Therapeutic Variability:<\/strong> A study by PGIMER, Chandigarh, revealed that while an innovator itraconazole drug achieved therapeutic levels in 73% of patients within two weeks, generic formulations often required 6\u20138 weeks, dose escalation, or switching.<\/li>\n
    3. Manufacturing Defects:<\/strong> Generic capsules showed defects such as fewer and unevenly sized pellets, impacting absorption and bioavailability.<\/li>\n<\/ol>\n

      Why do generic and innovator drugs differ in efficacy?<\/strong><\/h2>\n
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      1. Excipients:<\/strong> Variations in binders, fillers, disintegrants, and coatings affect dissolution rate, stability, and drug delivery mechanisms.<\/li>\n
      2. Manufacturing Processes:<\/strong> Differences in compression force, granulation methods, and tablet hardness can influence drug disintegration and absorption rates.<\/li>\n
      3. Bioequivalence Thresholds:<\/strong> Regulatory standards allow pharmacokinetic parameters to vary between 80%-125% of the innovator drug\u2019s range. This variability can be problematic for drugs with a narrow therapeutic index.<\/li>\n
      4. Stability Issues:<\/strong> Generic drugs may suffer from reduced shelf life and reliability due to inadequate stability testing.<\/li>\n<\/ol>\n

        What are the regulatory challenges in India\u2019s drug regulation system?<\/strong><\/h2>\n
          \n
        1. Decentralisation:<\/strong> India\u2019s drug regulation system is fragmented, with significant authority granted to State Drug Regulatory Authorities (SDRAs). This leads to inconsistent enforcement and quality standards.\n