Lupin's TB Drug Isoniazid Dispersible Tablets Cleared for Launch by CDSCO Panel

The recommendation follows the firm’s submission for approval to manufacture and market Isoniazid Dispersible Tablets 100 mg—an additional dosage form—intended for use in combination with other anti-tuberculosis medications for the treatment of tuberculosis (TB) caused by Mycobacterium tuberculosis, including drug-resistant TB regimens. The submission included the BE study report (Study No.: LBC-23-043, Version No.: 00, Date: 14 Dec 2023), conducted under fasting conditions.

Isoniazid belongs to a class of medications known as antituberculosis agents. It acts by killing the bacteria that cause tuberculosis. While primarily used to treat pulmonary tuberculosis, it is also effective against extrapulmonary TB, including meningitis and genitourinary forms of the disease. The drug is known for its complete and rapid absorption after oral administration.

At the recent SEC meeting for Antimicrobial and Antiviral held on 14th May 2025, the expert panel reviewed the marketing of Isoniazid Dispersible Tablets 100 mg (additional dosage form) for indicated in combination with other tuberculosis medicines for the treatment of tuberculosis due to Mycobacterium tuberculosis, including in regimens for drug resistant tuberculosis along with Bioequivalence study report (Study No.: LBC-23-043, Version No.: 00, Date: 14 Dec 2023) under fasting conditions.

After detailed deliberation, the committee recommended to accept the Bioequivalence study report and recommended for grant of permission to manufacture and marketing of Isoniazid Dispersible Tablets 100mg.

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