Making affordable generics more reliable

(Source – The Hindu, International Edition – Page No. – 9)

Topic: GS2 – Social Justice – Health

Context

● Generic medicines are crucial for healthcare affordability, especially in a country with high out-of-pocket expenses. ● However, inconsistent quality control, decentralised regulation, and inadequate enforcement of standards undermine their efficacy and safety. ● Strengthening India’s regulatory framework and centralising oversight are essential to ensure generics’ quality and equitable healthcare access.

 

Challenges in Generic Drug Quality

• Quality control lapses in generics occasionally compromise their efficacy and safety despite their bioequivalence to branded drugs.
• A PGIMER Chandigarh study revealed that innovator itraconazole achieved therapeutic levels in 73% of cases within two weeks, compared to only 29% for generics, which showed significant defects in formulation.

Importance of Generic Drugs

● Generic drugs are bioequivalent to branded drugs and offer cost-effective alternatives to ensure healthcare affordability. ● India leverages economies of scale and low production costs to supply affordable generics both domestically and internationally. ● With out-of-pocket healthcare expenditure at 39.4% in 2021-22, generics reduce financial burdens and improve treatment adherence. ● By August 2024, the Pradhan Mantri Bhartiya Janaushadhi Pariyojana saved consumers an estimated ₹30,000 crore through the sale of generics worth ₹5,600 crore over a decade.

Reasons for Variability in Generic Drugs

• Excipients and Manufacturing Processes:
  • Generic drugs use different ingredients (like binders, fillers, or coatings) that can affect how the medicine dissolves, stays stable, and is absorbed in the body.
  • Differences in how the drugs are made (e.g., pressure used, mixing methods) can impact how quickly or effectively the medicine works.
• Bioequivalence Thresholds:
  • Rules allow generic drugs to work within 80%–125% of the original drug’s performance.
  • For medicines that need very precise doses, this range might not be enough to ensure safety or effectiveness.
• Stability Issues:
  • Generics are not always tested well enough to confirm they remain effective in different weather conditions.
  • This lack of testing can shorten their shelf life or make them less reliable.

Weaknesses in Regulatory Oversight

• India’s decentralised drug regulation system grants significant authority to State Drug Regulatory Authorities (SDRAs), leading to inconsistent enforcement.
• The Central Drugs Standard Control Organisation (CDSCO) lacks centralised control and sufficient resources to enforce uniform standards.
• The absence of retrospective stability testing for pre-2018 generics perpetuates substandard drug availability.

Recommendations for Improvement

• Centralise drug regulation to address regulatory arbitrage and ensure uniform standards.
• Strengthen the CDSCO with more resources, personnel, and central drug-testing labs.
• Enforce stability testing protocols and mandate periodic reassessment of approved generics.
• Make India’s Pharmacopoeia standards more stringent to align with global benchmarks.

Conclusion

• Generics are essential for equitable access to medicines, but quality must not be compromised.
• Centralisation of drug regulation and robust safeguards are needed to restore public confidence in generics.
• Recommendations from the Bhatia (1954), Hathi (1975), and Mashelkar (2003) committees for centralised oversight must be implemented without delay.

Practice Question:  What are the key challenges in maintaining the quality of generic medicines in India? Propose reforms to address regulatory gaps and ensure the efficacy and safety of generics. (250 Words /15 marks)