A Study of Quality Assurance and Prescribing Practices in Generic Medicine Use in India
Year: 2026
Type: article
Abstract: Generic medicines support affordable healthcare in India, but their appropriate use depends on pharmaceutical quality, regulatory oversight, and informed prescribing and dispensing practices. This study examines how quality-assurance systems and healthcare professionals’ decisions influence the acceptance and use of generic medicines, with particular attention to pharmaceutical equivalence, bioequivalence, laboratory standards, and substitution practices. It employs a descriptive and analytical design based exclusively on published scientific studies, official pharmaceutical guidelines, regulatory publications, and government reports. Purposively selected documentary evidence is examined through qualitative interpretation and descriptive comparisons; no primary survey, laboratory experiment, or original inferential analysis is undertaken. The findings show that lower prices do not necessarily indicate inferior pharmaceutical quality. In a comparative investigation in Kerala, all 131 sampled branded and generic medicines satisfy the assessed pharmacopoeial parameters, while generic products cost an average of 48.6% less. However, results from selected samples cannot establish nationwide quality compliance. Evidence on prescribing reveals differences in professional confidence: approximately 84% of government physicians and 64% of private physicians in one study consider generics equally safe and effective, while substantial proportions request further information on bioequivalence. Pharmacy-level evidence highlights the importance of patient counselling, medicine availability, and coordination with prescribers. The introduction of 121 new monographs in Indian Pharmacopoeia 2026 and government-supported batch testing illustrate continuing quality-assurance efforts. The study concludes that wider, appropriate generic medicine use requires transparent product-quality evidence, stronger professional education, consistent regulatory monitoring, and legally compliant substitution practices. These measures promote clinical confidence, patient safety, and access to affordable treatment.
Institution: Sunrise University
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W7222869645
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