- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
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.
The FDC gel combines two active ingredients frequently prescribed for acne treatment:
Clindamycin, a lincosamide antibiotic that inhibits bacterial protein synthesis, and
Benzoyl Peroxide, a keratolytic and bactericidal agent known to reduce acne-causing bacteria and inflammation.
M. Pharm (Pharmaceutics)
Parthika Patel has completed her Graduated B.Pharm from SSR COLLEGE OF PHARMACY and done M.Pharm in Pharmaceutics. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751