Torrent Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC

New Delhi: Reviewing the justification presented by the drug major Torrent Pharmaceutical, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to manufacture and market the fixed-dose combination (FDC) Alogliptin Benzoate eq. to Alogliptin 25mg/25mg plus Pioglitazone Hydrochloride USP eq. to Pioglitazone 15mg/30mg film-coated tablet.

This came after the drug maker Torrent Pharmaceutical presented their proposal along with justification for clinical trial and bioequivalence (BE) waiver based on the BE study conducted on higher strength i.e. Fixed-Dose Combination of Alogliptin 25 mg and Pioglitazone 45 mg Tablet for export purposes in 2016 before the committee.

In addition to the above, the firm stated that the said FDC is already approved in other countries i.e. USA, Australia, Japan, etc.

Alogliptin is a selective DPP-4 inhibitor. DPP-4 inhibitors lower blood glucose by preventing the breakdown of glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide, thus prolonging the activity of these peptides. Alogliptin is used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes (a condition in which blood sugar is too high because the body does not produce or use insulin normally). Alogliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors.

Pioglitazone helps to control your blood sugar levels by helping your body make better use of the insulin it produces. Pioglitazone is only available on prescription. Pioglitazone improves glycaemic control in people with Type 2 diabetes by improving insulin sensitivity through its action at PPAR gamma 1 and PPAR gamma 2, and affects lipid metabolism through action at PPAR alpha.

At the recent SEC meeting for Endocrinology and Metabolism held on 21st March 2024, the expert panel reviewed the proposal presented by Torrent Pharmaceutical along with the justification for CT and BE waiver based on the BE study conducted on higher strength i.e. Fixed Dose Combination of Alogliptin 25 mg and Pioglitazone 45 mg Tablet for export purposes in 2016

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product after submission of data including dissolution data and justification for BE waiver as per the BE Study guideline with the condition that the firm should conduct Phase IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit a Phase IV clinical trial protocol to CDSCO within 03 months of approval for review by the committee.

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