Key Highlights:
- Akums Drugs & Pharmaceuticals has received CDSCO approval to manufacture colchicine, an off-patent anti-inflammatory drug indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization and cardiovascular death in adults with established atherosclerotic disease or multiple cardiovascular risk factors.
- Colchicine works by inhibiting neutrophil activity and inflammatory pathways, including the NLRP3 inflammasome, thereby reducing the release of pro-inflammatory IL-1β. The approval expands Akums’ portfolio in the cardiac therapy segment.
- Akums said the approval aligns with its broader strategy to strengthen its presence in chronic disease management, as the company continues to expand its pharmaceutical manufacturing and product portfolio.
Implications:
Akums’ CDSCO/DCGI approval to manufacture colchicine 0.5 mg for cardiovascular risk reduction is a “first‑time‑in‑India” regulatory milestone that lets India’s largest domestic‑focused CDMO enter the fast‑growing cardiac therapy segment and offer a differentiated, inflammation‑targeting option for secondary prevention in atherosclerotic disease. The move aligns with Akums’ chronic‑disease strategy, expands its preventive cardiology portfolio for branded‑partner launches, and positions it to capture recurring, long‑duration therapy volumes as India strengthens NCD screening and long‑term CVD management programs.
Source: ET Pharma
