Akums Secures First-in-India DCGI Approval for Colchicine 0.5 mg Cardiovascular Therapy
New Delhi: Akums Drugs & Pharmaceuticals has secured approval from the Drugs Controller General of India (DCGI) for its Colchicine 0.5 mg tablets, marking a first-time-in-India regulatory milestone for the application.
According to the company, the regulatory approval is significant as Colchicine addresses the inflammatory component associated with cardiovascular risk. The approved formulation is indicated for reducing the risk of myocardial infarction, stroke, coronary revascularisation and cardiovascular death in appropriate adult patients.
Akums Drugs & Pharmaceuticals, described as the country’s largest contract development and manufacturing organisation (CDMO), noted that cardiovascular treatment is increasingly moving beyond conventional risk-factor management towards a broader approach focused on comprehensive cardiovascular risk reduction.
Colchicine is an established anti-inflammatory medicine that acts through multiple mechanisms, including inhibition of microtubule polymerisation and modulation of inflammatory signalling pathways. The approved 0.5 mg formulation is intended for adult patients with established atherosclerotic disease or multiple cardiovascular risk factors, with the objective of reducing the risk of myocardial infarction, stroke, coronary revascularisation and cardiovascular death.
The product information describes several mechanisms underlying its anti-inflammatory activity. These include inhibition of NLRP3 inflammasome activation, reduction in 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., told the The New Indian Express that cardiovascular disease remains one of the major healthcare challenges in India, while treatment approaches are increasingly focusing on comprehensive and long-term management of cardiovascular risk.
He stated that the DCGI approval of Colchicine 0.5 mg demonstrates Akums’ efforts towards enabling differentiated therapies in evolving areas of medical need. He further said the company is using its 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., added that the continued expansion of the cardiac therapy segment reflects the increasing focus on chronic disease management. He added that Colchicine 0.5 mg expands Akums’ cardiovascular portfolio by addressing the inflammatory component of cardiovascular risk.
He further stated that the approval is consistent with the company’s broader strategy of developing and enabling high-quality pharmaceutical solutions in therapeutic areas where healthcare needs are significant or evolving.
The company further mentioned that the market opportunity is supported by India’s increasing cardiovascular disease burden as well as the country’s growing emphasis on early screening, diagnosis and chronic disease management. According to the statement, the Union government has progressively strengthened its non-communicable disease (NCD) infrastructure and preventive-health programmes, contributing to a broader ecosystem for the long-term management of cardiovascular and metabolic diseases.
Akums positioned its Colchicine 0.5 mg formulation as an additional therapeutic option for appropriate adult patients. The medicine is intended to be used alongside established cardiovascular management approaches, as determined by physicians.
The approval comes amid continued growth in India’s pharmaceutical market, particularly in chronic therapies, the company said. According to Pharmarack, the Indian Pharmaceutical Market (IPM) registered 10.7% year-on-year growth in August 2026, reaching ₹23,272 crore. Chronic therapies remained an important contributor to market growth, reflecting rising demand associated with long-term disease management
The cardiac therapy segment has also been among the key contributors to this expansion. Pharmarack data showed that the cardiac therapy market grew 14.7% year-on-year in July 2026, with sales of approximately ₹3,299 crore.
India’s cardiovascular disease burden further underscores the need for prevention and long-term disease management. Government data released in March 2026 showed that more than 40.87 crore people had been screened for hypertension in the country. Of these, more than 7 crore people had been diagnosed with hypertension, while 5.57 crore were receiving treatment as of February 2026.
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