CDSCO Panel Recommends Phase IV Trial for Acne FDC Gel by Precise Biopharma
New Delhi: The Subject Expert Committee (SEC) under the Dermatology and Allergy division of the Central Drugs Standard Control Organisation (CDSCO) has recommended to conduct Phase IV clinical trial for a fixed-dose combination (FDC) topical gel developed by Precise Biopharma Pvt. Ltd.
The formulation combines Clindamycin Phosphate IP 1.2% w/w (equivalent to Clindamycin 1% w/w) and Hydrous Benzoyl Peroxide IP (equivalent to anhydrous Benzoyl Peroxide 3.75%), a combination widely used in dermatological therapy for acne.
As per the condition outlined in Form CT-23 dated 11.01.2024, the company was required to submit its Phase IV clinical trial protocol for regulatory review. The firm presented the protocol during the 6th meeting of the SEC (Dermatology & Allergy) held on June 11, 2025, at CDSCO Headquarters in New Delhi.
Following a detailed evaluation, the expert panel recommended to conduct Phase IV study. The committee emphasized that the trial results must be submitted to CDSCO for further review upon completion.
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