Akums receives DCGI approval for Colchicine 0.5 mg tablets, expanding preventive cardiology portfolio

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Delhi-based Akums Drugs & Pharmaceuticals, a Contract Development and Manufacturing Organization (CDMO), has received DCGI approval for Colchicine 0.5 mg Tablets, marking a significant addition to its cardiovascular and preventive cardiology portfolio.

The approval represents a first-time-in-India regulatory milestone for this application and reinforces Akums’ focus on differentiated therapies addressing evolving healthcare needs.

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 Rs 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 Rs 3,299 crore, according to Pharmarack.

Colchicine is a well-established anti-inflammatory agent that works through mechanisms including inhibition of microtubule polymerisation and modulation of inflammatory signalling pathways. Akums’ 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—pathways associated with vascular inflammation and atherosclerotic plaque vulnerability.