Regulatory Measures for Drug Formulations and Indications

“This document provides a summary of regulatory measures approved by the Pharmaceutical Committee to reduce drug use risks. Key points include:

1. Revocation and Adjustments:

• At the 4th meeting on July 31, 2024, the Pharmaceutical Committee revoked the registration of certain salad tablets and powders.
• Amendments were made to “”yum”” recipes for export and the cancellation of a 2 ml inverted container.

1. Revised Formulas and Indications:

• Calamine-Based Products: Formula adjustments included adding Zinc Oxide and removing Chlorpheniramine.
• Diphenhydramine Warnings: Added warnings for salads containing Diphenhydramine, especially for patients with conditions like chickenpox, septic rash, or sunburn. Dosage limits were also emphasized.
• Vaginal Suppositories: Products with Clotrimazole, Nystatin, and Dequalinium Chloride were updated for treating vaginitis caused by bran infections.
• Orphenadrine + Paracetamol: Revised dosage based on weight and added warnings for patients with liver, kidney issues, and other conditions. Monitoring of blood, liver, and kidney functions was advised for long-term use.

3.Sulfanilamide and Sulfadiazine: Indications for these powders were revised for treating superficial and small infectious wounds.

These measures are aimed at improving safety, reducing risks, and ensuring proper use of medications in various formulations and indications.
Source:https://drug.fda.moph.go.th/media.php?id=666445387514650624&name=%E0%B8%A1%E0%B8%B2%E0%B8%95%E0%B8%A3%E0%B8%81%E0%B8%B2%E0%B8%A3%E0%B8%A5%E0%B8%94%E0%B8%84%E0%B8%A7%E0%B8%B2%E0%B8%A1%E0%B9%80%E0%B8%AA%E0%B8%B5%E0%B9%88%E0%B8%A2%E0%B8%87-%E0%B8%84%E0%B8%A3%E0%B8%B1%E0%B9%89%E0%B8%87%E0%B8%97%E0%B8%B5%E0%B9%88%204-67.pdf##~https://drug.fda.moph.go.th/press-release/conclude-drugcommitee/

Region: Thailand