The Drugs Technical Advisory Board (DTAB) reviewed the 2nd assessment report by Prof. Kokate Committee on Fixed Dose Combinations (FDCs). The DTAB declared certain FDCs as rational with conditions and outlined a pathway for manufacturers to obtain product licenses. Manufacturers must submit applications, fees, and required documents to State Licensing Authorities (SLAs) and comply with safety update reports and revised prescribing information.
The Drugs Technical Advisory Board (DTAB) examined the 2nd assessment report submitted by Prof. Kokate Committee regarding Fixed Dose Combinations such as Chlorxylenol 4.80% w/v + Terpinol 9.0% v/v + Absolute Alcohol 13.1% v/v (Denatured) Gel & other 6 FDCs.
The report, which assessed FDCs not evaluated in the first lot, led to the declaration of certain FDCs as rational with specific conditions.
The DTAB outlined a pathway for manufacturers to obtain product licenses from State Licensing Authorities without requiring a No Objection Certificate from the Drugs Controller General (India).
Manufacturers must submit applications, fees through Bharatkosh, stability studies data, test specifications, and other required documents to SLAs.
Additionally, manufacturers must comply with the recommendations of the expert committee regarding revised prescribing information and submit periodic safety update reports to the Central Licensing Authority.
Failure to comply with these requirements will result in the invalidation of licenses. This regulatory update aims to ensure the safety and efficacy of FDCs while streamlining the licensing process.