Last Updated on May 23, 2025 by The Health Master
DTAB
India’s Drugs Technical Advisory Board (DTAB) joins other regulators in support of a subcommittee’s detailed report asserting that 16 fixed-dose combinations (FDCs) are “irrational” with the intention of banning such combinations.
Furthermore, the noteworthy aspect is that the subsequent findings determined these mixtures to be unsafe for human health, regardless of marketing ploys that suggest convenience in taking one compounded pill versus multiple separate options.
Subcommittee Reports Findings Supported by DTAB
In the 92nd meeting of DTAB on April 24, 2025, the subcommittee chaired by Dr. Nilima Kshirsagar’s subsequent finding to ban FDCs reported that safety was not established for all 16 FDCs and compounded action would be detrimental to patients.
Thus, the DTAB stated it “agreed with the recommendation of the subcommittee report.”
More Drug Combinations for Scrutiny Going Forward
But the efforts do not end with these 16 FDCs.
Another 29 FDCs have already been forwarded to the Kshirsagar sub-committee for review relative to the Prof. Kokate Committee’s assessment of FDCs that deemed these other combinations irrational as well.
Therefore, the Indian drug regulator is attempting to take several steps to ensure that these combinations do not exist in a clouded market.
Steps Already Taken to Alleviate Problem
These actions are not new, as the Indian drug regulator has been involved in this arena relative to irrational FDCs and a review panel.
In April 2021, the DTAB reviewed the findings of the Prof. Kokate Committee relative to irrational FDCs and, in principle, accepted the suggestions.
Therefore, the recommendation to forward 16 FDCs to Dr. Kshirsagar’s subcommittee for scrutiny was part of that determination.
Thus, the subcommittee had much to gain from manufacturers and assessed many factors relative to these combinations before bringing their recommendation back to this board.
Vitamins and Minerals on the Chopping Block Months Later
Also mentioned in relation to a few other issues at the DTAB meeting was the irrationality of FDCs with vitamins and minerals.
These were also found to be irrational by the Prof. Kokate Committee, so this set of 29 FDCs is passed to Dr. Nilima Kshirsagar’s subcommittee for the same in-depth analysis—which is necessary—whereas the others from the Kokate Committee can be passed through regular channels/transferred to appropriate authorities.
In Depth Analysis of the Kokate Committee
The Prof. Kokate Committee reviewed these 17 + 49 + 3 FDCs, and after an assessment and possibility of rationalization, split findings into 3 categories.
Of the findings, 33 FDCs were rational, 20 FDCs needed more information, but more significantly, 16 FDCs were irrational.
These 16 FDCs determined to be irrational were suggested to not be permitted manufacture and marketing in India.
Names of the 16 FDCs Banned from Being Marketed:
- Acetylsalicylic acid with ethoheptazine
- Aloe extract with aloe extract with allantoin, alpha tocopherol acetate, D-panthenol and vitamin A
- Aloe extract with vitamin E, dimethicone and glycerine
- Aloe vera with jojoba oil and vitamin E
- Aloe vera with orange oil
- Aloe vera with jojoba oil, wheat germ oil and tea tree oil
- Aloe vera with vitamin E and herbal
- Dicyclomine with paracetamol and clidinium bromide
- Dicyclomine with paracetamol, clidinium bromide and chlordiazepoxide
- Gliclazide with chromium picolinate
- Paracetamol with lignocaine
- Amoxicillin with serratiopeptidase and lactobacillus sporogenes
- Amoxicillin with cloxacillin, lactic acid bacillus and serrapeptase
- Amoxicillin and serratiopeptidase
- Cefadroxil and probenecid
- Cefurosime with serratiopeptidase
Q. What are fixed-dose combinations (FDCs)?
A. Fixed-dose combinations are those formulations in which two or more active pharmaceutical ingredients (APIs) are put in one dosage form.
Q. What is the Drugs Technical Advisory Board (DTAB)?
A. The Drugs Technical Advisory Board (DTAB) is the highest statutory authority constituted under the Drugs and Cosmetics Act, 1940. It recommends to the Central Government and State Governments on technical matters related to the Drugs and Cosmetics Act implementation.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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