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The Central Drugs Standard Control Organisation (CDSCO) has released a pathway for the grant of product license to be followed by the State Licensing Authorities (SLAs) for a disinfectant and antiseptic fixed dose combination (FDC) declared as rational by its expert committee.
The pathway has been advised by the CDSCO, with the approval of the Ministry of Health and Family Welfare, for the FDC Chloroxylenol 4.80 % w/v+Terpinol 9.0% v/v + absolute alcohol 13.1% v/v (Denatured) Gel.
The combination was considered by the sub-committee of Drugs Technical Advisory Board (DTAB) under the Chairmanship of Dr Nilima Kshirsagar, in its report submitted on December 28, 2021 and decided by the DTAB meeting held on September 26, 2022 for approval as rational, with certain conditions.
Now, the CDSCO said that the applicants shall submit the requisite fees preferably through Bharatkosh for FDC to the central drug control organisation as specified in the Sixth Schedule of New Drugs and Clinical Trial (NDCT) Rules, 2019.
The applicant shall submit application to the concerned SLA as per the provisions of Drugs and Cosmetics Rules, 1945 for grant of product manufacturing license giving the details of FDC, stability studies data (six months accelerated), test specification of the FDC along with Method of Analysis as well as label and other documents as required for grant of product license under the Drugs and Cosmetics Rules.
"State Licensing Authority (SLA) shall grant the product license of such FDC without NOC from DCG(I), if conditions of license under the Drugs and Cosmetics Rules, which need to be verified by SLA, are found to have been fulfilled. The SLAs shall verify the quality of such FDC of each applicant/manufacturer, before grant of license," added the CDSCO.
Every manufacturer permitted to manufacture this FDC shall submit the periodic safety update reports (PSURs) as per the NDCT Rules, to the Central Licensing Authority as defined in the Rules.
"Failure to submit the PSURs shall be considered as contravention of these Rules," said the CDSCO.
Manufacturers shall also comply with the recommendation o the expert committee with regard to revision of the prescribing information or label, it added.
The CDSCO requested all SLAs to direct the concerned stakeholders to follow the procedure for obtaining the manufacturing license with regard to this FDC declared as rational.
It may be noted that the CDSCO has in 2013, sought all SLAs to ask the concerned manufacturers in their State to prove the safety and efficacy of FDCs - which were permitted by the SLAs without due approval from the office of the Drugs Controller General of India (DCGI) - within 18 months.
Prof Kokate Committee was formed the look into the rationality of hundreds of such combination drugs and the Committee submitted its report. The Committee also submitted a second assessment report to the central government on some of the FDCs which could not be assessed in the first lot and based on its recommendations, the FDCs declared as irrational were referred to the sub-committee headed by Dr Kshirsagar.
It was in this sub-committee report, the recommendation to declare the disinfectant formulation was submitted.
The FDC comprising Chloroxylenol 4.80 % w/v+Terpinol 9.0% v/v + absolute alcohol 13.1% v/v (Denatured), in liquid form is widely available in the market already, including under the well known brands such as Dettol.
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