Beta Drugs Ltd Secures DCGI Approval for Methotrexate Oral Solution 2mg/mL, Expanding Oncology Product Portfolio

Beta Drugs Ltd has achieved a significant regulatory milestone by obtaining DCGI approval for Methotrexate Oral Solution (2mg/mL), a well-established medication widely used in oncological and autoimmune therapies. This approval enables Beta Drugs to legally manufacture and market the oral solution formulation, broadening its cancer treatment portfolio.

Methotrexate is a standard chemotherapeutic and immunosuppressive agent used in managing various cancers including leukemia, breast cancer, and autoimmune conditions such as rheumatoid arthritis. Approval signifies that Beta Drugs has met stringent regulatory standards for safety, efficacy, and quality as mandated by India’s Central Drugs Standard Control Organization (CDSCO).

The drug’s oral solution formulation offers advantages in dosing flexibility and patient compliance compared to other dosage forms, an important factor for chronic therapies. Receiving DCGI approval also opens pathways for Beta Drugs to participate more actively in government tenders and private market distribution channels.

The approval process involved comprehensive submission of clinical data and dossier evaluation by the Subject Expert Committee (SEC) on Oncology, which rigorously assessed bioequivalence and safety profiles. Beta Drugs complied with recommendations to ensure the product meets regulatory benchmarks.

Key Highlights:

Beta Drugs Ltd obtains DCGI approval for Methotrexate Oral Solution 2mg/mL.

Drug used broadly in chemotherapy and autoimmune disease management.

Oral solution improves dosing flexibility and patient adherence.

Regulatory clearance follows detailed clinical data and bioequivalence studies.

Approval enables manufacturing, marketing, and distribution in India.

Boosts Beta Drugs' portfolio in oncology therapeutics amid rising cancer burden.

Opens opportunities for government tender participation and private market growth.

Aligns with CDSCO regulations assuring safety, efficacy, and manufacturing quality.

Reflects Beta Drugs’ commitment to expanding cancer care solutions.

Strengthens India’s pharmaceutical ecosystem for accessible oncology treatments.

Beta Drugs Ltd continues to advance its position as a pharmaceutical innovator in critical therapy areas like oncology, reinforcing confidence among healthcare providers and patients.

Sources: DCGI Official Document, CDSCO Meeting Proceedings, NSE Archives