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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Evaluation of certain pre-1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country without due approval from the Central Licensing Authority

11-Jan-2024 | File No. 4-01/2013-DC (Misc. 13-PSC) (Pt. II) (Sub Part-1)

Central Drugs Standard Control Organization (FDC Division) has issued a Notice regarding the Evaluation of certain pre-1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country without due approval from the Central Licensing Authority.

The key highlights are:

1. Paracetamol IP 500mg + Phenylephrine Hydrochloride IP 10mg + Caffeine Anhydrous 32mg tablets IP: The committee recommended continued manufacturing and marketing of the FDC with the condition of generating safety and efficacy data by way of conducting Phase IV Clinical Trial. Accordingly, a Phase IV Clinical Trial is required to be conducted to generate the data within the time frame of one year.

2. All the manufacturers who are already holding licenses from State Licensing Authorities for such FDCs before 01.10.2012 and did not apply to DCG (I) are required to submit their applications to this Directorate at the earliest but not later than 6 months, failing which their applications will not be considered and their licenses will be considered as without legal validity.

3. Manufacturers shall comply with the recommendation of the expert committee w.r.t. revision of the prescribing information/label.

For detailed information, please refer to the attached document.

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