DCGI Clears Akums’ Colchicine 0.5mg For Cardiovascular Risk Reduction

In a move that aims to bring an established anti-inflammatory drug into the growing area of preventive cardiology, Akums Drugs and Pharmaceuticals has received DCGI approval for colchicine 0.5 mg tablets for reducing the risk of major cardiovascular events in certain high-risk adults.

The approval covers adults with established atherosclerotic cardiovascular disease or multiple cardiovascular risk factors. The drug is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularisation and cardiovascular death. However, the approval does not mean colchicine should be viewed as a routine preventive medicine for everyone.

The development comes as cardiovascular disease remains a major health concern in India and treatment is increasingly moving beyond managing blood pressure, cholesterol and other conventional risk factors to addressing inflammation associated with atherosclerosis.

Colchicine is not a new drug. It has long been used as an anti-inflammatory medicine in conditions such as gout. Its possible role in cardiovascular disease has attracted increasing attention because inflammation is involved in the development and progression of atherosclerotic plaques.

The drug works partly by interfering with microtubule polymerisation and inflammatory signalling. The approved product information also identifies mechanisms involving inhibition of NLRP3 inflammasome activation, reduction of neutrophil activation and migration, and suppression of endothelial inflammation. These pathways are involved in vascular inflammation and may contribute to instability of atherosclerotic plaques.

The significance of the approval therefore lies in applying an established medicine to a different therapeutic setting — reducing cardiovascular risk in appropriately selected patients.

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.”

The approval also comes at a time when chronic therapies are driving growth in India's pharmaceutical market. According to various reports, chronic therapies remain an important contributor to the expansion, reflecting the continuing demand for medicines used in long-term disease management.

The cardiac therapy segment has also recorded strong growth. According to various reports, the segment grew 14.7% year-on-year in July 2026, with sales of around Rs 3,299 crore.

For India, the growing focus on cardiovascular prevention is particularly significant, as heart disease requires long-term management rather than treatment only after an event such as a heart attack or stroke. Risk reduction typically involves controlling established factors such as high blood pressure, diabetes and abnormal cholesterol levels, along with lifestyle measures and medicines prescribed according to an individual's risk.

The addition of an anti-inflammatory approach reflects the evolving understanding of cardiovascular disease. Atherosclerosis is not simply a problem of cholesterol accumulation. Inflammation also plays a role in the formation and progression of plaques within blood vessels.

However, the nod does not mean the tablet should be used as a routine preventive medicine for everyone. Its use is linked to specific patient groups covered by the approved indication, and the decision to prescribe it would depend on an individual's cardiovascular history, risk profile, other medicines and the treating physician's assessment.

This distinction is important because colchicine can interact with certain medicines and is not appropriate for all patients. Like other medicines used over the long term, its benefits have to be weighed against potential adverse effects and contraindications.

For patients, doctors say, prevention remains multidimensional. Controlling cholesterol and blood pressure, managing diabetes, avoiding tobacco, maintaining physical activity and following prescribed treatment continue to form the foundation of cardiovascular risk reduction. Newer approaches, including therapies targeting inflammation, are being added where evidence and regulatory indications support their use.