India’s Drug Regulatory Authority Approves Eight New Medicines in 2025, Expanding Treatment Options Across Multiple Therapeutic Areas

The Central Drugs Standard Control Organisation (CDSCO) has approved eight new medicines in 2025, marking a significant step forward in India’s healthcare sector. These approvals encompass a range of therapeutic areas, including oncology, cardiology, infectious diseases, and chronic conditions, reflecting the country’s commitment to enhancing patient care and treatment accessibility.

1. Tafamidis – A medication approved for the treatment of transthyretin amyloid cardiomyopathy, a rare heart disease that can lead to heart failure.

2. Edoxaban – An oral anticoagulant for the prevention and treatment of deep vein thrombosis and pulmonary embolism.

3. Doravirine – An antiretroviral drug for the treatment of HIV-1 infection in adults.

4. Tucatinib – A targeted therapy for HER2-positive breast cancer, particularly in patients with brain metastases.

5. Finerenone – A non-steroidal mineralocorticoid receptor antagonist for chronic kidney disease associated with type 2 diabetes.

6. Ozempic (Semaglutide) – A GLP-1 receptor agonist for the treatment of type 2 diabetes and chronic weight management.

7. Wegovy (Semaglutide) – A higher-dose GLP-1 receptor agonist approved for chronic weight management in adults with obesity or overweight conditions.

8. Mounjaro (Tirzepatide) – A dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes and chronic weight management.

These approvals are expected to provide patients with more treatment options, particularly in areas where existing therapies are limited or less effective. The introduction of these medicines also underscores the growing collaboration between Indian regulatory bodies and global pharmaceutical companies to address the diverse healthcare needs of the Indian population.