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DTAB sub-committee to hold meeting with stakeholders on 16 FDCs declared as irrational earlier
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Gireesh Babu, New Delhi
March 30 , 2024
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The sub-committee constituted by the Drugs Technical Advisory Board (DTAB) for evaluation of 16 fixed dose combinations (FDCs) considered as irrational by the Prof. Kokate Committee earlier, will be hearing the stakeholders through an online meeting on April 5, for further deliberation and recommendation.
The FDCs division of Central Drugs Standard Control Organisation (CDSCO) has said that following a notice issued to the stakeholders in March last year, some of the stakeholders have submitted the information in prescribed format, which needs to be deliberated with the DTAB sub-committee headed by Dr Nilima Kshirsagar, former chair in clinical pharmacology, ICMR, Mumbai, and in order to evaluate the responses, a meeting has been scheduled on April 5, 2024.
During the meeting, the stakeholders will be asked to make a presentation before the committee for further recommendation on such FDCs, said the FDC division, requesting the stakeholders to attend the video-conference before the DTAB sub-committee.
“In the event that the stakeholders do not attend the hearing, the committee reserves the right to make its decision on the basis of information available before it,” it added.
On March 31, 2023, the FDC Division had issued a notice seeking all the manufacturers of the 16 to submit the information in a prescribed format for further evaluation.
It may be noted that 86th meeting of the DTAB on April 13, 2021, examined the expert committee report of Prof. Kokate Committee with respect to the FDCs considered as irrational and in principle agreed to the recommendations of the Committee while recommending that the sub-committee under Dr Nilima Kshirsagar shall examine the 16 irrational FDCs in detail as per the procedures.
The list of 16 FDCS considered as irrational among the 294 FDCs recommended by the Prof Kokate Committee include combination of acetyl salicylic 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; and cefurosime with serratiopeptidase.
The issues with the FDCs started when the drug regulator received complaints from Consumer Associations in the year 2007 regarding FDCs not approved by the DCG(I) bug marketed in the country and as part of follow up action of complaints the DCG(I) prepared a list of 294 FDCs and directions were issued to all State and Union Territory drug controllers to withdraw these 294 drugs which were licensed without the approval of the central drug regulator. The manufacturers association, however, got a stay from the High Court of Madras in respect of the directions.
The matter was then placed in the DTAB in its 56th meeting held on January 16, 2008 and a subcommittee was constituted by the Board to examine these FDCs. According to the sub committee report, out of the 294 FDCs, for 17 it was reported that the data provided by the manufacturer was inadequate to prove its rationality, safety and efficacy, while for 49 it was reported that further data generation in terms of safety and efficacy by conducting clinical trial and other studies.
The Central government directed that these issues may also be dealt with by the Prof Kokate Committee and once the committee submits its report, it may be placed before the DTAB for further necessary action. Besides, another three FDCs were directed by the High Court of Maharashtra, Nagpur Bench, to be referred to the Prof. Kokate Committee.
Thus, the Committee examined these 17+49+3 FDCs and categorised them into three categories - 33 FDCs considered as rational, 20 FDCs requiring further data generation and 16 FDCs considered as irrational. The irrational combinations are proposed, not to be allowed for their continued manufacturing and marketing in the country.
The DTAB examined the Committee report dated March 12, 2021, in its 86th meeting and in principle agreed to the recommendations. It also recommended that the sub-committee under Dr Nilima Kshirsagar should quickly look at the 33 rational FDCs and 20 FDCs which need further deliberations, to see if there are any inconsistencies and revert to the Chairman of the DTAB. However, the sub-committee shall examine the 16 irrational FDCs in detail as per the earlier procedures, it added.
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