Availability and Policy Alignment of Oral Hypoglycaemic Agents in India: A Cross-sectional Study

Introduction: “Oral Hypoglycaemic Agents” (OHAs) are central to the pharmacological management of Type 2 Diabetes Mellitus (T2DM). While evidence-based treatment guidelines increasingly recommend newer therapeutic agents, essential medicine lists and public procurement systems may not always reflect evolving evidence, potentially limiting equitable access to optimal diabetes care. Aim: To assess the availability of Research Society for the Study of Diabetes in India (RSSDI) recommended OHAs in national and state public medicine lists in India. Materials and Methods: A cross-sectional study was conducted in Government Medical College, Thiruvananthapuram, Kerala, India between January 2025 and March 2025. All OHAs recommended in the RSSDI clinical practice recommendations 2022 were included. A total of eight guideline-recommended OHA drug classes and 24 individual OHAs were assessed for inclusion in the National List of Essential Medicines 2022 of India (NLEM 2022), availability in the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) catalogue, and presence in State Essential Drug Lists (EDL) from Kerala, Tamil Nadu, Maharashtra, and Assam. Data were analysed using descriptive statistics. Results: Among the eight guideline-recommended OHA drug classes, 3 (37.5%) were included in the NLEM. State-level analysis of 24 OHAs showed that only 2 (8.3%), metformin and glimepiride, were listed across all four states, while 12 (50%) were not included in any of the reviewed State EDL. Assessment of the PMBJP catalogue showed that 19 of 21 OHAs (90.5%) were available. Conclusion: Substantial gaps exist between the RSSDI guidelines 2022 recommendations and public sector availability of OHAs in India, with marked inter-state variability. In contrast, the Jan Aushadhi scheme demonstrated wider inclusion of recommended OHAs, highlighting its potential role as a complementary access pathway. Strengthening the alignment between clinical guidelines and public procurement policies may support more equitable guideline-concordant diabetes care.