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DTAB sub-committee to evaluate Fixed Dose Combination drugs considered irrational


DTAB sub-committee to evaluate Fixed Dose Combination drugs considered irrational

New Delhi: The fate of Fixed Dose combinations considered irrational by the government have fallen once again in limelight as the Drugs Technical Advisory Board (DTAB) has once again constituted a sub-committee for further examine these drugs.

Recently, the Drugs Technical Advisory Board (DTAB) had invited manufacturers of certain Fixed Dose Combinations (FDCs) and concerned stakeholders to submit the required information for an evaluation of FDCs by the DTAB Sub-committee, which was earlier considered as irrational in the assessment report of the Prof. Kokate committee.

Medical Dialogues had earlier reported that they Kokate Committee,  on 2 April 2019 had submitted its report to the the Drugs Technical Advisory Board (DTAB), the highest decision-making body on technical matters related to drugs, recommending a ban on 324 FDC drugs

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Read Also : CDSCO expert committee suggests ban of yet another 324 FDCs

The Committee was headed by Prof. C. K. Kokate, Former Vice-Chancellor, KLE University, Belgaum, Karnataka for examining the Safety and Efficacy of unapproved FDCs which were licensed by State Licensing Authorities without due approval of DCGI.

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The FDCs declared as irrational in the assessment report of the Kokate Committee included combinations of Paracetamol IP, Diclofenac Sodium IP, Magnesium Trisilicate IP, Chlorpheniramine Maleate IP, Flavoxate HCl, Ofloxacin and others in various dosage form and strengths.

The matter was recently discussed in a DTAB meeting under the chairmanship of Director General of Health Services. After a detailed deliberation of the assessment report submitted by the Kokate committee, with respect to FDCs considered as irrational, DTAB constituted a sub-committee for further examination.

Also Read: NPPA fixes retail price of 20 drugs including FDCs for Blood pressure control, dual antiplatelet

Accordingly, a Sub-committee has been constituted under the Chairmanship of Dr Nilima Kshirsagar, the Chair in Clinical Pharmacology, ICMR, Mumbai, to examine the FDCs declared as irrational in the assessment report of the committee.

In this regard, a meeting of the Sub-committee of DTAB took place and in order to give an opportunity to the manufacturers of said FDCs and the concerned stakeholders for presenting the precise data with respect to these FDCs, the Sub-committee has desired that the manufacturers and other stakeholders submit the information in the prescribed format for further action.

Also Read: CDSCO to hire 754 Regulatory Officers especially to regulate Medical Devices in country:DTAB


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