The Central Drug Standard Control Organization on 3rd August 2020 has revised the procedure for grant of manufacturing license for newly added fixed dose combination drugs.
The Applicant shall submit an application to the concerned state licensing authority as per the provisions under drugs and cosmetics rules for grant of product manufacturing license by providing details of FDC drug, stability study data, test specification of the FDC drug, etc.
The Application shall be submitted along with requisite fees and the state licensing authority shall grant license for such FDCs without seeking NOC from DCG, if the specified conditions are fulfilled.
Every manufacturer permitted to manufacture these FDCs shall submit the periodic safety update reports as per new drugs and clinical trial rules 2019 to the central licensing authority.
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