The Drugs Controller General India (DCGI) has issued a set of procedures to be followed for subsequent applicants in respect of fixed dose combinations (FDCs) declared as rational by Kokate Committee and approved by the DCGl office.
According to the notice issued in this regard by the DCGI office, the applicant shall submit application in Form 44 by giving relevant information and clearly mentioning "Not applicable" where such information is considered not applicable by the applicant.
In case of manufacturers already holding licenses from State Licensing Authority (SLA) for the proposed FDCs, the documents required shall 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.
Documents required in case of new manufacturers for the proposed FDCs shall 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.
This notice issued by the DCGI is in continuation to the earlier notice of even number dated 16.03.2017 whereby pathway for clearance of cases with respect to subsequent applicants in respect of FDCs declared as rational by Prof. Kokate Committee and approved by DCG (I) was explained for submission of the applications. But there subsequent requests from various stakeholders to the DCGI office to specify the minimum documents required to be submitted along with applications.