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Generic Drugs
Context:
A study by doctors from the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, published in Mycoses, examined the efficacy of itraconazole in treating chronic pulmonary aspergillosis.
What Are Generic Drugs?
- A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
- The key difference lies in the inactive ingredients, which may vary, leading to differences in appearance, taste, and packaging.
- Approval Process: Before a generic drug can be marketed, it must undergo a rigorous approval process by regulatory authorities such as the FDA (U.S. Food and Drug Administration).
- The generic drug must demonstrate bioequivalence to the brand-name drug, meaning it works in the same way and provides the same clinical benefit.
Importance of Generic Drugs:
- Generic drugs are vital for improving healthcare affordability, especially in regions with significant income disparities.
- They are bioequivalent to branded drugs but offer cost-effective alternatives, providing equitable access to medicines.
- India capitalises on economies of scale and low production costs to produce and supply affordable generics both domestically and internationally.
Impact on Healthcare Expenditure:
- In 2021-22, 39.4% of health expenditure in India was out-of-pocket.
- Generics help reduce this financial burden and improve adherence to treatments.
- Pradhan Mantri Bhartiya Janaushadhi Pariyojana has saved consumers an estimated ₹30,000 crore by selling generics worth ₹5,600 crore by August 2024.
Challenges:
- Quality Control Lapses: Despite being bioequivalent to brand-name drugs, generics can sometimes fall short in terms of efficacy and safety due to quality control issues.
- For instance, a study by the PGIMER found that only 29% of patients using a generic version of itraconazole achieved therapeutic drug levels within two weeks, compared to 73% for the innovator drug.
- Manufacturing Variability: Differences in excipients (binders, fillers, coatings) and manufacturing processes can lead to variability in therapeutic outcomes. Variations in tablet hardness, particle size, and porosity can affect drug absorption and bioavailability.
- Decentralised Regulation: India’s decentralised drug regulation system, which grants significant authority to State Drug Regulatory Authorities (SDRAs), leads to inconsistent enforcement and quality standards. This regulatory arbitrage allows manufacturers to exploit weaker oversight.
- Bioequivalence Thresholds: Regulatory standards often allow pharmacokinetic parameters to fall within 80%-125% of the innovator drug’s range. For medications with a narrow therapeutic index, even minor deviations can lead to subtherapeutic effects or adverse reactions.
Recommendations for Improvement:
- Centralise Drug Regulation: Strengthening oversight by centralising drug regulation under the Central Drugs Standard Control Organisation (CDSCO) can help enforce consistent quality standards across all states.
- Enhanced Stability Testing: Establishing uniform stability testing protocols is essential to ensure that generics maintain their quality under various climatic conditions.
- Periodic Reassessment: Regular reassessment of approved generics is necessary to uphold their efficacy over time.
- Investment in Resources: Providing more resources, personnel, and central drug-testing labs to the CDSCO can improve regulatory enforcement.
