Last Updated on January 13, 2024 by The Health Master
The Drugs Technical Advisory Board (DTAB) has sought the Prof. Kokate Committee to apprise the Board about the report on the fixed-dose combinations (FDCs) related to vitamins, minerals, formulations, etc., considered irrational by the Committee for further course of action.
It has also agreed to the report submitted by the sub-committee under the chairmanship of Dr. Nilima Kshirsagar, an eminent scientist, on the 324 applications of FDCs corresponding to 177 FDCs which were declared as irrational by the Prof. Kokate Committee for further opinion.
Another report by an Expert Committee headed by Dr. M S Bhatia, professor and head of the Department of Psychiatry, University College of Medical Sciences, on the evaluation of certain pre-1988 FDCs afresh, licensed by the State Drug Regulators without due approval from the Central Licensing Authority (CLA), has also been agreed upon by the DTAB in its meeting held on September 26, 2022.
The Ministry of health and family welfare, in an order on September 16, 2014, constituted a Committee under the Chairmanship of Prof. C. K. Kokate, Former Vice-Chancellor of KLE University, Belgaum, Karnataka, to examine the safety and efficacy of unapproved FDCs which were licensed by State Drug Licensing Authorities without due approval of the Central Licensing Authority.
The Committee has submitted its report to the government from time to time, and the last such report was submitted related to vitamins, minerals, and micronutrient formulations along with other remaining FDCs.
The minutes of the DTAB meeting held in September 2022 stated that “The Board deliberated the report of the Committee and opined that the Prof. Kokate Committee may be requested to apprise the Board about the report for further course of action,” said the minutes of the DTAB meeting held in September 2022.
The Board also examined and agreed to the report submitted by the sub-committee headed by Kshirsagar, on the 324 applications of FDCs corresponding to 177 FDCs, which were declared as irrational based on the recommendations of the Prof. Kokate Committee.
The sub-committee submitted its report dated December 28, 2021, after holding a series of meetings as well as by providing hearings to the stakeholders.
“DTAB examined and agreed to the report submitted by the sub-committee and recommended further action in the matter with the additional suggestion that wherever generation of additional data is recommended by the sub-committee, a timeframe of one year may be provided to the applicants for the generation of data on such FDCs,” said the minutes of DTAB meeting.
The sub-committee report is yet not available in the public domain.
The Board added that the Expert Committee under the Chairmanship of Dr. M S Bhatia submitted its report on the 19 FDCs claimed to be pre-1988 with a license for manufacturing for sale without due approval from the Central Licensing Authority, after holding a series of meetings and hearings with the stakeholders.
“DTAB examined and agreed to the report submitted by the sub-committee and recommended further action in the matter with the additional suggestion that wherever generation of additional data is recommended by the sub-committee, a timeframe of one year may be provided to the applicants for generation of data on such FDCs,” it added.
DCGI notifies classification of 95 Medical Devices related to dental healthcare under MDR, 2017
NIPER gets patent for its invention for new anti-TB compound
CDSCO Panel gives nod to Manufacture, Market Progesterone SR Tablet
IPC cautions healthcare professionals against Piroxicam
Macleods recalls 2 drugs due to this reason
Govt begins anti-dumping probe against antibiotic Metronidazole imported from China
NPPA extends price revision of Heparin injection, LMO and Oxygen inhalation
Govt introduces registration certificate for sales of Medical Devices
Unichem recalls 18,960 bottles of this hypertension drug
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
