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DTAB Agrees to Prohibit 16 FDCs Identified as Irrational

Delhi: In a major move to strengthen drug safety and rational prescribing practices, the Drugs Technical Advisory Board (DTAB) has recommended a ban on 16 fixed dose combinations (FDCs) that were previously flagged as irrational by the expert panel led by Prof. C.K. Kokate.
During its 92nd meeting held on April 24, 2025, DTAB reviewed a report submitted by a sub-committee chaired by Dr. Nilima Kshirsagar. The sub-committee was constituted specifically to re-evaluate these FDCs, which were among those considered irrational in the original Kokate Committee report. The official meeting minutes stated:
“The Board was apprised about the subcommittee report under Chairpersonship of Dr. Nilima Kshirsagar which declared all the 16 FDCs as irrational and recommended for prohibition as these may pose risk to the human beings."
Following detailed deliberation, the DTAB endorsed the sub-committee's recommendation, clearing the way for regulatory action that could lead to the withdrawal of marketing authorizations for these formulations. The Board noted;
“After detail deliberation, DTAB agreed with the recommendation of the subcommittee report."
The development is part of a broader initiative that began in April 2023, when the Central Drugs Standard Control Organisation (CDSCO) issued a notice requesting manufacturers to submit detailed information on the 16 FDCs for further evaluation. The aim was to provide manufacturers an opportunity to present data supporting the safety and efficacy of these combinations.
List of 16 FDCs in 294 FDCs recommended as irrational by Prof. Kokate Committee.
Sl.no. | Name of FDC |
1 . | Acet I salic lic acid + Ethoheptazine |
2. | Aloe extract + Allantoin + Alphatocopherol acetate + D-Panthenol + Vitamin A |
3. | Aloe extract + Vitamin E + Dimethicone + Gl cerine |
4. | Aloe vera + Jo•oba oil + Vitamin E |
5. | Aloe vera + Oran e oil |
6. | Aloe vera + Jo•oba oil + Wheat erm oil + Tea tree oil |
7. | Aloe vera + Vitamin E + Herbal |
8. | Dic clomine + Paracetamol + Clidinium Bromide |
9. | Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide |
10. | Gliclazide + Chromium Picolinate |
1 1 . | Paracetamol + Li nocaine |
12. | Amoxicillin + Serratiope tidase + Lactobacillus Sporo ens |
13. | Amoxicillin + Cloxacillin + Lactic acid bacillus + Serrapeptase |
14. | Amoxicillin + Serratiopeptidase |
15. | Cefadrox I + Probenecid |
16. | Cefuroxime + Serratiopeptidase |
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751