Why in the News?

India’s decentralised drug regulation system dominated by State Drug Regulatory Authorities causes inconsistent quality standards. Strengthening oversight is essential to ensure generics are as affordable and effective as branded drugs.

How Reliable Are Generic Medicines?

• Bioequivalence to Innovators: Generic medicines are bioequivalent to brand-name drugs, meaning they have the same active ingredient and are intended to work the same way.
• Affordability and Accessibility: Generics significantly lower healthcare costs, making treatment more accessible, especially for low-income populations.
• Challenges in Quality: Despite their potential, the reliability of generics has been questioned due to variability in therapeutic outcomes, often caused by differences in excipients, manufacturing processes, and bioequivalence thresholds.

What are the main quality concerns associated with it?

• Efficacy and Bioavailability: Studies have shown that while generics are bioequivalent to branded drugs, they may not always achieve the same therapeutic levels.
  • For example, a study on itraconazole showed that only 29% of patients using generic versions achieved the right drug levels in their body within two weeks, compared to 73% of patients using the original branded drug.
• Manufacturing Variability: The manufacturing processes for generics can differ significantly from those of branded drugs. Variations in excipients (binders, fillers) and production methods can lead to differences in tablet hardness, dissolution rates, and overall drug stability. This variability can result in inconsistent therapeutic outcomes.
• Regulatory Oversight: India’s decentralized drug regulation system contributes to inconsistent quality standards across states.
  • The Central Drugs Standard Control Organisation (CDSCO) has limited authority over State Drug Regulatory Authorities (SDRAs), leading to regulatory arbitrage where manufacturers exploit weaker oversight. Moreover, the lack of stringent enforcement of stability testing further jeopardizes the quality of generics available in the market.

What regulatory reforms are needed?  

• Centralisation of Drug Regulation: A comprehensive overhaul of India’s drug regulation system is necessary. Centralising oversight under the CDSCO would help enforce consistent quality standards across all states and reduce the risk of substandard drugs entering the market.
• Enhanced Stability Testing Protocols: Uniform stability testing protocols should be established to ensure that all generics maintain their quality under various climatic conditions. This would involve periodic reassessment of approved generics to uphold their efficacy over time.
• Stricter Impurity Standards: Aligning India’s Pharmacopoeia with international standards regarding permissible impurity levels would improve the overall quality of generic medicines available in the market.

How can patient and healthcare provider perceptions of generics be improved? (Way forward)

To enhance patient and healthcare provider confidence in generic medicines, several strategies can be employed:

• Public Awareness Campaigns: Educating patients about the efficacy and safety of generics compared to branded drugs can help dispel misconceptions that higher-priced medications are superior.
• Incentives for Healthcare Providers: Offering incentives for prescribing generics can encourage healthcare professionals to recommend these cost-effective alternatives more frequently.
• Strengthening Quality Assurance: Implementing stronger regulatory frameworks and ensuring compliance with quality standards can build trust among both patients and providers regarding the reliability of generics.

Mains PYQ:

Q Why is there so much activity in the field of biotechnology in our country? How has this activity benefitted the field of biopharma? (UPSC IAS/2018)

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