Procedure Of Regularization Of FDC’s Declared As Rational By DTAB Committee Under CDSCO

On September 8 2020, DCGI instructed all manufacturers to follow a definite procedure for regularization of FDCs or fixed-dose combinations. It has directed all to follow a specific pathway for submitting applications of the rational FDCs. CDSCO or the Central Drugs Standard Control Organization has allotted six months to all existing as well as new manufacturers for submission of application for getting the manufacturing as well as marketing approval for FDCs that has been declared rational by DTAB committee

The letter depicts that if a manufacturer gives the copy of the product license that has been issued by an SLA to any of the firm specifying that the product in a specified dosage form, as well as strength, has obtained a license before November 28 2007, the same is considered for issuing permission by CDSCO office as per defined pathways. The whole procedure is the same for all FDC including the 3 that have been added recently in the rational FDC list.

The pharma market of India is filled with irrational FDCs and is one of the important points for analysis. India requires some regulatory laws for FDCs after analysis of whether they are rational and needed for the whole health care system. This is the reason certain efficient measures were proposed to stop the menace. It is a good decision for the pharma industry as more FDC were added and the date for applying also increased. The notices have been issued for all old license holders and it has not given any clarification regarding the process that should be followed by new applicants for these FDCs. Perhaps the new applicants still have to approach CDSCO and go through the tedious process But for old license holders, they will only have to apply with state licensing authority to get an expedited license.

Now have a look at the detailed procedure with documents to be followed for regularization of FDCs that has been finalized by CDSCO.

●     Form 44 Application must be Duly signed and with a stamp. The dosage and the strength along with INR 15000 must be deposited for every FDC.

●       Name as well as the composition of FDC.

●   A copy of the product permission that has been issued by SLA to any of the firms before 28.11.2007.

●       The manufacturing license copy in form 25/28/29 for all those manufacturers who do not have product permission from SLA and wish to apply for FDCs.

●       The serial number of FDC according to the list that is available on the CDSCO website.

●       Test specialization along with the analysis methods of the FDC.

●       Manufacturers having a license from SLA but no NOC, are required to apply within 4 months.

So, this is all about the documents and the procedure to be followed for regularization of FDCs.

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