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DCGI issues procedure for subsequent applicants for FDCs declared rational by Kokate panel, approved by DCGI
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Ramesh Shankar, Mumbai
June 27 , 2017
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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.
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