Rational FDCs License Will Consider illegal, If Document not Submitted within 4 Month    

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The Drugs Controller General India (DCGI) has approved and issued a set of procedures to be followed for subsequently fixed dose combinations (FDCs) applicants declared as rational by Kokate Committee.

DCGI also released notice to instruct applicants to submit the application with relevant information and mention “Not applicable” for non-applicable boxes mentioned in Form 44.

In case of manufacturers who have already holding licenses from State Licensing Authority (SLA) for the proposed FDCs, needs to submit the documents, at least contain Form 44 (duly filled, signed and stamped); treasury challan of Rs. 15,000 duly signed by Bank of Baroda; name and composition of the FDC; product permission issued by SLA and copy of manufacturing license in Form 25/28; FDCs permitted for continued manufacturing & marketing under 18 months policy decision; SI No. of the FDC as per the list available on website, and name of FDC.

In case of new manufacturers for the proposed FDCs needs to submit the documents, at least contain Form 44 (duly filled, signed and stamped); treasury challan of Rs. 15,000 duly signed by Bank of Baroda; name and composition of the FDC; product permission issued by SLA and copy of manufacturing license in Form 25/28; FDCs permitted for continued manufacturing & marketing under 18 months policy decision; SI No. of the FDC as per the list available on website, and name of FDC; stability studies data (03 months accelerated); and test specifications of the FDC along with method of analysis.

“All the manufacturers who are already holding licenses from State Licensing Authorities for such FDCs and did not obtain NOC from DCG (I) are required to submit their applications to this Directorate at the earliest but not later than 4 months, failing which their applications will not be considered and their licenses will be considered as without legal validity”, the notice issued by the DCGI said.
Stakeholders requested DCGI to specify the number of the minimum documents required.

Rational FDCs Office Order

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