As per the notification by DCGI dated 01st July, Ref No. F.No. 4-01/2013 -DC(Misc13-PSC), Manufacturer should submit the safety and efficacy data of fixed dose combinations (FDCs) to DCG (I) office by 30.08.2013 in Form 44 application with requisite fees and supporting documents which is now extended for one month (30.09.2013). In case the applications of such FDCs are not submitted by any manufacturer by 30.09.13, it will be presumed that manufacturer is not willing to prove the safety and efficacy of such FDCs before the office of DCG(I). Please follow link for more detail –http://www.cdsco.nic.in/FDC%20Permitted-Sep%202013.pdf
Further draft Policy Guideline for Approval of Fixed Dose Combinations (FDCs) In India has also published which discuss the overall requirement for registration of these products. Please follow link to download the guideline –http://www.cdsco.nic.in/Report%20of%20Dr.C.K%20Kokate.pdf
List of approved FDCs (Fixed Dose Combilations) Approved by DCG (I) Since 1961 Till February, 2013 can be accessed from link below
http://www.cdsco.nic.in/Approved%20FDCs%20by%20DCG(I).pdf
Below is the process for filling the application for assessing the safety and efficacy of such FDCs:-
1. The concerned manufacturer(s) shall apply in Form 44 along with requisite treasury challan and supporting documents supporting the safety and efficacy of the FDC –Auriga research Ltd can offer all regulatory filing support as per the requirement.
2. The applications will be examined in consultation with expert committee. If considered necessary, the applicant may be asked to present their before the committee –Auriga research Ltd can frame suitable rationale and also do presentation to expert.
3. In case of requirement of clinical trial, protocol etc. should be submitted by the firm for approval by DCG(I). –Auriga research Ltd is complete solution CRO offering clinical trial and BA/BE services. We can assist in submission of BA/BE and Clinical Trial protocol as per the recent regulatory requirements.
4. In case of multiple applications for the same FDC, all such applicant will have option to conduct one such study (wherever necessary) sponsored by the firm(s, if required –We can identify the parties to collaborate for same FDCs
Auriga Research Ltd is offering all kind of services like Regulatory Supports, Analytical Services, Medical Writing, BA/BE studies and Phase I to IV clinical trials under one roof. Visit our website www.aurigaresearch.com and revert to this mail in case of any query.
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