Procedure Of Regularization Of FDC’s Declared As Rational By DTAB Committee Under CDSCO
by Dolly K. Digital Marketing ExecutiveThe 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.
Go To Read More Know Information: Drug license application process
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Created on Jan 23rd 2021 04:07. Viewed 158 times.