CDSCO Approves Gabapentin and New Insulin Formulation for Diabetes Care

The Central Drugs Standard Control Organization (CDSCO) announced significant approvals on August 10, 2026, aimed at expanding the therapeutic options available for patients in India. Among the key approvals is Gabapentin, which has been cleared as a bulk drug. This approval is expected to bolster the domestic supply chain for medications used in the management of neuropathic pain and certain seizure disorders, providing healthcare providers with more reliable access to essential treatments.

In addition to the bulk drug approval, the CDSCO has granted approval for a finished formulation of BIO Biphasic Isophane Insulin Injection IP (50/50 Biphasic). This insulin product, available in 100 IU/mL, 10 mL vials, is specifically indicated for the treatment of Diabetes Mellitus. The introduction of this biphasic insulin formulation offers a refined option for glycemic control, catering to the growing needs of the diabetic population in India.

These approvals reflect the ongoing efforts of the CDSCO to ensure the availability of high-quality pharmaceutical products in the Indian market. By approving both bulk drugs and finished formulations, the regulator is addressing both manufacturing and clinical needs. These additions to the approved drug list are expected to enhance the standard of care for patients suffering from chronic conditions, supporting the broader public health objective of improving access to essential medicines across the country.