Making Affordable Generics More Reliable
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Source: This post on Making Affordable Generics More Reliable is based on article “ Making affordable generics more reliable” published in The Hindu on 19th December 2024.

UPSC Syllabus topic: GS 3- Indian Economy and issues relating to Planning, Mobilization of Resources, Growth, Development and Employment

Context: 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.

Why are generic medicines important for healthcare affordability?

  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.
  2. India leverages economies of scale and low production costs to supply affordable medicines both domestically and internationally.
  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.
  4. Through the Pradhan Mantri Bhartiya Janaushadhi Pariyojana, generic medicines worth ₹5,600 crore sold over a decade saved consumers an estimated ₹30,000 crore by August 2024.

What challenges do generic medicines face in India?

  1. Quality Concerns: Despite bioequivalence to branded drugs, quality control lapses have compromised their efficacy and safety in some cases.
  2. Therapeutic Variability: 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 6–8 weeks, dose escalation, or switching.
  3. Manufacturing Defects: Generic capsules showed defects such as fewer and unevenly sized pellets, impacting absorption and bioavailability.

Why do generic and innovator drugs differ in efficacy?

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

What are the regulatory challenges in India’s drug regulation system?

  1. Decentralisation: India’s drug regulation system is fragmented, with significant authority granted to State Drug Regulatory Authorities (SDRAs). This leads to inconsistent enforcement and quality standards.
    • The Central Drugs Standard Control Organisation (CDSCO) has limited authority and can only recommend actions to States.
  2. Inadequate Stability Testing: Stability testing, mandated in 2018, is inconsistently implemented. Additionally, generics approved before 2018 are not subject to retrospective testing, allowing substandard drugs to persist in the market.
  3. Lenient Impurity Standards: India’s Pharmacopoeia permits higher impurity levels than U.S. and EU standards. Stricter International Council for Harmonisation (ICH) guidelines were rejected due to cost concerns.

What reforms are necessary to improve generic drug reliability?

  1. Centralised Drug Regulation:
    1. Transfer regulatory authority from States to the Centre to ensure consistent enforcement of quality standards.
    2. Strengthen the CDSCO with additional resources, personnel, and central drug-testing laboratories.
  2. Enhanced Stability Testing:
    1. Enforce uniform stability testing protocols.
    2. Mandate periodic reassessment of all approved generics, including those approved before 2018.
  3. Stricter Impurity Standards:
    1. Align India’s Pharmacopoeia with global benchmarks by adopting stricter impurity guidelines.

What role should the CDSCO play in these reforms?

  • The CDSCO should be overhauled to implement robust regulatory safeguards, ensuring protection against substandard and counterfeit medicines.
  • Key actions include stringent regulatory protocols, effective inspections, and strong enforcement mechanisms.

What steps have been recommended historically to address these issues?

  1. Decades-old recommendations by the Bhatia (1954), Hathi (1975), and Mashelkar (2003) committees have called for centralised oversight of drug regulation.
  2. Implementing these recommendations is essential to restoring public confidence in generic drugs.

What is the key takeaway regarding generics and quality assurance?

  1. While generics are indispensable for equitable healthcare, equity must not come at the expense of quality.
  2. Centralising drug regulation, enforcing stricter testing protocols, and adopting stringent impurity standards are critical steps toward making generics more reliable and trustworthy.

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