CDSCO declares 450 FDCs as rational, issues directions for manufacturers
New Delhi: Apex drug regulator, Central Drugs Standard Control Organization (CDSCO) has recently declared 450 more Fixed-Dose Combination (FDC) Drugs as rational and notified the process to be followed by all the manufacturers and stakeholders for obtaining the manufacturing license.
In this regard, the apex regulator released a list of FDCs and directed the State Licensing Authorities to ensure that no product license is granted in respect of the FDCs which are not mentioned in the attached list.
The FDCs were declared rational by the Kokate Committee and approved by the Drugs Controller General of India (DCGI), Dr V G Somani.
Last year, CDSCO had directed all the State Licensing Authorities to ask the concerned manufactures to follow the said procedure for obtaining manufacturing licenses directly from SLAs. The list of such rational FDCs containing 1681 FDCs was also forwarded with the letter issued earlier to the SLAs.
In continuation of the letter, CDSCO has now declared 450 more FDCs as rational and added them to the list.
"..it may be noted that apart from these 1681 FDCs, further there are 450 more FDCs(attached as Annexure-A) which have been declared as rational by Prof. Kokate Committee and report of the committee has been accepted by the Ministry." the notice stated
Accordingly, with the approval of the Ministry of Health and Family Welfare, it has been now decided to follow the following pathway for grant of product licenses by SLAs for these FDCs:-
- Applicants shall submit the requisite fees preferably through Bharatkosn for each FDC to CDSCO as specified under Drugs and Cosmetic Act,1940 and existing Rules thereunder.
- 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, S. No. of the FDC in the list, stability studies data (6months 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 Drugs and Cosmetics Rules.
- State Licensing Authority shall grant the product license of such FDCs without seeking NOC from DCG (I), if other conditions of the 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 FDCs of each applicant/manufacturer, before granting of License.
- Every manufacturer permitted to manufacture these FDCs shall submit the periodic safety update reports (PSURs) as per New Drugs and Clinical Trial Rules-2019 to the central Licensing Authority as defined in Rule '3' i.e. DCG(I). Failure to submit the PSURs shall be considered as contravention of these Rules.
The notice clearly said
In view of the above, you are requested to ask the concerned stakeholders to follow the above procedure for obtaining the manufacturing license w.r.t. FDCs declared as rational by Prof. Kokate Committee. You are, therefore, requested to ensure that no product license is granted in respect of the FDCs which are not mentioned in the attached list.
You can get the full list by clicking on the following link