Indian pharma speeds up access to global therapies while targeting treatment gaps

India's pharmaceutical industry is charging ahead with a fast pace towards quicker access to internationally cleared drugs, along with filling crucial gaps in the treatment requirements of the country's health care system. The recent spree of approvals demonstrates a grown-up regulation system with the Central Drugs Standard Control Organization (CDSCO) clearing 35 new drugs between January 2024 and May 2025.

These approvals span across many therapy areas, including oncology, infectious diseases, metabolic conditions, and neurology, and are a gigantic step to advanced therapies. In the oncology space, six new medicines, like next-generation medicines like Selpercatinib and Brigatinib, bring enhanced survival to lung, breast, and thyroid cancer. Infectious disease also received a boost, with medicines like Plazomicin and Cefipime–Enmetazobactam addressing rising threats like antimicrobial resistance (AMR) and urinary tract infections (UTIs).

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India's regulatory system has also become more flexible, with most of the important approvals also being at international standards. In diabetes, Tirzepatide and Trelagliptin are the new entrants in the management of type 2 diabetes. The gastro segment also saw new entrants, including Vonoprazan and Elobixibat, in GERD and ulcers.

Indian local pharma players such as Cipla, Lupin, and Zydus, along with global giants such as Novartis and Merck, are propelling this shift. Clinical research contribution to India is increasing, with CDSCO approvals for 39 studies in 2024-2025, a milestone for post-marketing research. This trend reflects India's leadership position in global pharma innovation, from first-in-human to lifecycle management, reports Dr. Purav Gandhi, CEO at Healthark Insights.