Voglibose and Metformin FDC Approved by CDSCO

In a significant development, the Directorate General of Health Services, under the Central Drugs Standard Control Organization (CDSCO), has issued an update regarding the manufacturing and marketing of Fixed Dose Combinations (FDCs). This update pertains specifically to the FDC of Voglibose 0.2 mg and Metformin Hydrochloride (as Sustained Release form) 500 mg. The announcement clarifies the approval status of this combination, which has implications for pharmaceutical manufacturers, healthcare providers, and patients alike.

Background

The CDSCO had previously issued a letter (File No. 4-01/2023-DC (Misc. 3) dated 11.04.2025) listing certain FDCs as unapproved. However, upon further review and legal proceedings, it has been determined that the FDC of Voglibose 0.2 mg and Metformin HCl (SR) 500 mg is, in fact, an approved combination. This decision was recorded during a hearing by the Hon’ble High Court of Delhi on 14.07.2025.

Key Update

The recent communication from CDSCO, dated 10th September 2025, explicitly states that the FDC of Voglibose 0.2 mg and Metformin HCl (SR) 500 mg has been approved by the CDSCO. As a result, this combination has been excluded from the list of unapproved FDCs mentioned in the earlier letter dated 11.04.2025.

This clarification is crucial for pharmaceutical companies involved in the manufacturing and marketing of this combination, as it ensures compliance with regulatory standards. It also provides clarity to healthcare providers who prescribe this combination for managing diabetes.

Implications for Stakeholders

Pharmaceutical Manufacturers: Companies producing this FDC can now proceed with manufacturing and marketing without concerns about regulatory non-compliance. This update reinforces the importance of adhering to CDSCO guidelines and staying informed about changes in approval statuses.
Healthcare Providers: Physicians and healthcare professionals can confidently prescribe this combination, knowing it has been approved by the regulatory authority. Voglibose and Metformin are widely used in the management of type 2 diabetes, and this update ensures continued availability of this effective treatment option.
Patients: For patients managing diabetes, this update ensures uninterrupted access to a combination therapy that helps control blood sugar levels effectively. The approval also underscores the safety and efficacy of the medication.

Conclusion

The CDSCO’s clarification regarding the approval of Voglibose 0.2 mg and Metformin HCl (SR) 500 mg is a welcome development for all stakeholders in the healthcare ecosystem. It highlights the importance of regulatory oversight in ensuring the availability of safe and effective medications. Pharmaceutical companies, healthcare providers, and patients are encouraged to stay updated on such regulatory announcements to ensure compliance and informed decision-making.

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Source: CDSCO

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