Regulatory requirements for antidiabetic drugs as per CDSCO in India comparison with USA

With India and the United States having the highest rates of the disease, diabetes mellitus is becoming a global public health concern. In India, which is expected to have the world's biggest diabetic population (more than 101 million by 2023), accessibility and price are major concerns. A significant component of the antidiabetic medication market, which is projected to reach a valuation of USD 1.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 3.5% to reach USD 2.01 billion by 2029[1]. The primary treatment for Type 2 Diabetes (T2DM) is still metformin, which is augmented by sulfonylureas, DPP-4 inhibitors, and more recently, SGLT2 inhibitors. With new limitations on illogical fixed-dose combinations, regulatory bodies such as the CDSCO are actively trying to guarantee the safety and effectiveness of pharmaceuticals [2]. Diabetes is a chronic, metabolic disease characterized by elevated blood glucose levels or hyperglycaemia, which results from abnormalities in either insulin secretion or insulin action, or both. According to the report from CDC’s National Diabetes Statistics Report, there are about 37.3 million cases of diabetes in the US which is 11.3% of the US population. The kind of drug most frequently used to treat type 1 diabetes Insulin. Insulin, alpha-glucosidase inhibitors, biguanides, dopamine-2 agonists, DPP-4 inhibitors, GLP-1 receptor agonists, meglitinides and SGLT2 inhibitors, sulfonylureas, thiazolidinediones, and other drugs are commonly used orally to treat type 2 diabetes [3]. Keywords: Antidiabetics, Diabetes Mellitus, Regulatory Bodies, CDSCO, FDA, United States