Beta Drugs Limited (BDL), a leading Indian manufacturer of oncology medicines, has achieved a major milestone by receiving approval from the Drug Controller General of India (DCGI) to launch Methotrexate Oral Solution. With this approval, BDL becomes the first company in India to introduce the oral solution form of Methotrexate a convenient, patient-friendly, and bio equivalent alternative to the conventional tablet.
The newly approved Methotrexate Oral Solution is indicated for a range of conditions including acute lymphoblastic leukemia (ALL), lymphomas, several solid tumours, rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriasis, psoriatic arthritis, and pustular psoriasis.
Methotrexate is a globally established therapy used in both oncology and autoimmune disorders. Traditionally administered as tablets or injections, the drug often presents challenges in dosing and administration, particularly for paediatric, geriatric, and long-term care patients. The new oral solution form aims to address these limitations by offering accurate dosing, ease of administration, and improved patient compliance, all under medical supervision.
This first-of-its-kind approval marks a significant stride for BDL as it expands its reach beyond oncology into autoimmune therapeutic areas. With a strong presence in oncology and dermatology, the company views this launch as a pivotal move to strengthen its product portfolio and reinforce its leadership in these segments.
The global methotrexate market continues to grow due to the limited availability of alternatives offering similar therapeutic benefits for patients with ALL and autoimmune or inflammatory diseases. The introduction of the oral formulation opens new avenues in paediatric, hospital, and chronic-care markets, positioning BDL for strong domestic and export growth.
This achievement reaffirms Beta Drugs Limited’s commitment to innovation and patient-centric healthcare solutions. By offering differentiated and affordable therapies, the company continues to enhance treatment accessibility and improve the quality of life for patients across critical therapeutic areas.
