Importance of Generic Drugs in Healthcare
Generic drugs are bioequivalent to branded medicines but offered at significantly lower prices, making healthcare more affordable, especially in a country with income disparities.
They are crucial in reducing out-of-pocket healthcare expenditure, which accounted for 39.4% of total health expenditure in 2021-22.
Through initiatives like Pradhan Mantri Bhartiya Janaushadhi Pariyojana, generic medicines have saved consumers an estimated ₹30,000 crore over a decade.
Challenges in Ensuring Generic Drug Quality
Despite being bioequivalent, generics sometimes suffer from quality control issues, impacting efficacy and safety.
A study found that generic itraconazole was less effective than the innovator drug, with only 29% reaching therapeutic levels compared to 73% for the original.
Differences in excipients, manufacturing processes, and bioequivalence standards can lead to inconsistent drug performance.
Regulatory Issues Affecting Drug Quality
India’s decentralised regulation results in inconsistent enforcement, allowing manufacturers to exploit weaker oversight in certain states.
Stability testing (to ensure drug quality under varying conditions) is not consistently enforced, leading to substandard drugs entering the market.
India’s Pharmacopoeia allows higher levels of drug impurities compared to international standards (e.g., the U.S. and EU), contributing to compromised quality.
Need for Centralised Drug Regulation
Centralising drug regulation and strengthening Central Drugs Standard Control Organisation (CDSCO) will ensure uniform quality standards and improve public confidence in generics.
Implementing uniform stability testing, central drug-testing labs, and addressing regulatory gaps is essential for drug safety.
Recommendations from past committees (Bhatia, Hathi, Mashelkar) stress the need for central oversight to balance affordability and quality.
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