NEW DELHI: Akums Drugs & Pharmaceuticals has received India’s drug regulator’s approval for Colchicine 0.5 mg tablets, marking a first-time-in-India regulatory milestone for this application.
The company said the approval by Drugs Controller General of India (DCGI) is significant as Colchicine targets the inflammatory component of cardiovascular risk, with the formulation indicated to reduce the risk of heart attack, stroke, coronary revascularisation and cardiovascular death in appropriate adult patients.
The pharma company, which is the largest contract development and manufacturing organisation (CDMO), said cardiovascular treatment is increasingly moving beyond the management of conventional risk factors towards a more comprehensive approach to cardiovascular risk reduction.
Colchicine is a well-established anti-inflammatory agent that works through mechanisms including inhibition of microtubule polymerisation and modulation of inflammatory signalling pathways.
The approved 0.5 mg formulation is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularisation and cardiovascular death in adult patients with established atherosclerotic disease or multiple cardiovascular risk factors.
The product information identifies mechanisms including inhibition of NLRP3 inflammasome activation, reduction of neutrophil activation and migration, and suppression of endothelial inflammation and pathways associated with vascular inflammation and atherosclerotic plaque vulnerability.
Sanjeev Jain, Managing Director, Akums Drugs & Pharmaceuticals Ltd., 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. We are leveraging our scientific, regulatory and manufacturing capabilities to support the availability of relevant therapeutic options for physicians and patients.”
Sandeep Jain, Managing Director, Akums Drugs & Pharmaceuticals Ltd., said, “The continued growth of the cardiac therapy segment reflects growing emphasis on chronic disease management. Colchicine 0.5 mg strengthens our cardiovascular portfolio by addressing the inflammatory component of cardiovascular risk.”
“This approval is aligned with our broader strategy of developing and enabling high-quality pharmaceutical solutions in therapeutic areas where there is significant unmet or evolving healthcare need.”
The market opportunity is supported not only by India's growing cardiovascular disease burden but also by the country's expanding focus on early screening, diagnosis and chronic disease management. "The union government has increasingly strengthened its NCD infrastructure and preventive-health programmes, creating a broader ecosystem for long-term management of cardiovascular and metabolic diseases," the statement said.
The company’s Colchicine 0.5 mg formulation is positioned as an additional therapeutic option for appropriate adult patients, alongside established cardiovascular management approaches, as determined by physicians.
Akums said that the approval comes at a time when India’s pharmaceutical market continues to witness strong growth, particularly across chronic therapies.
According to Pharmarack, the Indian Pharmaceutical Market (IPM) grew 10.7% year-on-year in August 2026 to ₹23,272 crore. Chronic therapies continued to be an important growth driver, reflecting the increasing demand associated with long-term disease management.
The cardiac segment has emerged as one of the key contributors to this growth.
In July 2026, the cardiac therapy market recorded 14.7% year-on-year growth and sales of approximately ₹3,299 crore, according to Pharmarack.
The underlying disease burden further highlights the opportunity for cardiovascular prevention and long-term management.
Government data released in March 2026 reported that more than 40.87 crore people had been screened for hypertension in India, of whom over 7 crore had been diagnosed, and 5.57 crore were receiving treatment as of February 2026.