Akums Drugs & Pharmaceuticals has received approval from the Drug Controller General of India (DCGI) for its Colchicine 0.5 mg Tablets, expanding the company’s cardiovascular and preventive cardiology portfolio.
The approved formulation is indicated to reduce the risk of heart attack, stroke, coronary revascularisation and cardiovascular death in adult patients with established atherosclerotic disease or multiple cardiovascular risk factors.
According to Akums, the approval marks a first-time-in-India regulatory milestone for this application.
Sanjeev Jain, Managing Director, Akums Drugs & Pharmaceuticals, said, “Cardiovascular disease represents one of the most important healthcare challenges facing India, and the focus of treatment is increasingly moving towards comprehensive and long-term risk management. The DCGI approval of Colchicine 0.5 mg reflects Akums’ commitment to enabling differentiated therapies that address evolving areas of medical need.”
Government data released in March 2026 showed that more than 40.87 crore people had been screened for hypertension in India as of February 2026. Of these, more than 7 crore had been diagnosed with hypertension, while 5.57 crore were receiving treatment.
Sandeep Jain, Managing Director, Akums Drugs & Pharmaceuticals, said the continued growth of the cardiac therapy segment reflects the increasing focus on chronic disease management.
“Colchicine 0.5 mg strengthens our cardiovascular portfolio by addressing the inflammatory component of cardiovascular risk,” he added.
Akums said the formulation is positioned as an additional therapeutic option for appropriate adult patients, alongside established cardiovascular management approaches, as determined by physicians.
The product information describes mechanisms of action including inhibition of NLRP3 inflammasome activation, reduction of neutrophil activation and migration, and suppression of endothelial inflammation —pathways associated with vascular inflammation and atherosclerotic plaque vulnerability.
The approval comes as India’s pharmaceutical market continues to expand, particularly in chronic therapy segments. According to Pharmarack, the Indian pharmaceutical market grew 10.7% year-on-year in August 2026 to Rs 23,272 crore.
Chronic therapies remained an important contributor to market growth, reflecting increasing demand associated with long-term disease management. The cardiac therapy segment was among the key contributors, recording 14.7% year-on-year growth in July 2026, with sales of approximately Rs 3,299 crore, according to Pharmarack.
