Making affordable generics more reliable

Syllabus : GS2/Health

In News

Now it has been observed that ensuring the quality of generic medicines in India is vital to make them affordable and effective as innovator drugs

About Generic drugs 

• They are marketed under a non-proprietary or approved name rather than a proprietary or brand name.
•  Generic drugs are equally effective and inexpensive compared to their branded counterparts.

Importance of Generic Drugs:

• Generic drugs are crucial for making healthcare affordable, especially in countries with significant income disparities.
• They are bioequivalent to branded drugs and offer cost-effective alternatives.
• India uses economies of scale and low production costs to supply affordable generic medicines both domestically and internationally.
• Economic Impact of Generic Medicines: In 2021-22, out-of-pocket healthcare expenditure was 39.4% of total health expenditure in India.
  • Generic medicines reduce financial burdens and improve treatment adherence.
  • By August 2024, the Pradhan Mantri Bhartiya Janaushadhi Pariyojana saved consumers ₹30,000 crore through generic medicines worth ₹5,600 crore.

Issues and Concerns

• Quality Concerns with Generic Drugs: Quality control lapses sometimes compromise the efficacy and safety of generics.
  • A study by PGIMER, Chandigarh, found that generic itraconazole formulations were less effective in treating chronic pulmonary aspergillosis than the innovator drug.
• Issues with India’s Decentralized Drug Regulation: State Drug Regulatory Authorities (SDRAs) have significant control over drug regulation, leading to inconsistent enforcement and quality standards.
  • The Central Drugs Standard Control Organisation (CDSCO) lacks the authority to enforce regulations effectively at the state level.
• Regulatory and Testing Gaps: The decentralised system allows regulatory arbitrage, where manufacturers exploit weaker state oversight.
  • Stability testing, required by CDSCO in 2018, is inconsistently implemented, undermining compliance.
  • Drugs approved before 2018 are not subject to mandatory stability testing, allowing substandard drugs to remain in the market.

India’s Pharmacopoeia Standards:

• India’s Pharmacopoeia allows higher impurity levels in drugs compared to U.S. and EU standards.
• The CDSCO and the Pharmacopoeia Commission (PC) have rejected stricter ICH guidelines due to cost concerns, leading to lower quality standards.

Suggestions and Way Forward

• Centralizing drug regulation and strengthening the CDSCO is essential to ensure consistent quality control and protect patients from substandard drugs.
• A more robust regulatory system with centralized oversight would help build confidence in generics and ensure drug safety.
• India must centralize drug regulation, enforce uniform stability testing protocols, and reassess all approved generics periodically.
  • Centralized oversight is crucial to implement stringent regulations and safeguard public health.
    • Committees like Bhatia (1954), Hathi (1975), and Mashelkar (2003) have  also called for centralized control over drug regulation to improve drug quality and public confidence in generics.

Source: TH