Office of Drugs Controller General lays down the procedure for clearance of subsequent applications for Fixed Dose Drug Combinations
The FDC Division, Office of Drugs Controller General (India) issued a notice laying down the procedure to be followed by manufacturers who have a license from State Licensing Authority (“SLA”), but have not obtained NOC from the Drug Controller General (“DCG”) in respect of Fixed Dose Drug Combinations (“FDCs”).
Earlier, an office letter was issued on 15th January, 2013 whereby all the State / UT Drugs Controllers were requested to ask the manufacturers in their State to prove the safety and efficacy of FDCs within 18 months which were permitted by SLAs without due approval from the office of DCG.
After examination of applications received, in consultation with Prof. Kokate Committee constituted by Ministry of Health and Family Welfare (“Ministry”), the concerned manufacturers were issued NOC for continued manufacturing and marketing in case of FDCs held as rational.
Subsequently, representations were received from various stakeholders for issuance of permission to subsequent applicants of such FDCs which have been held to be rational and approved by DCG (i.e. those manufacturers who have license from SLA, but did not obtain NOC from DCG or those manufacturers who intend to manufacture FDCs henceforth).
After examining the matter, in consultation with the Ministry, following pathway has been prescribed for clearances of such subsequent applications are enlisted below:
- Applicants intending to manufacture FDCs are required to apply in Form 44 with a fee of Rs. 15,000 to the Central Licensing Authority (“CLA”) through TR-6 challan clearly specifying whether he is already holding product permission from State Licensing Authority (“SLA”), indicating the date of permission or his intension to obtain fresh permission.
- The NOC will be issued by the Drug Controller General within 30 working days, failing which the NOC will be deemed to be granted.
- The SLA will permit manufacturing of FDCs, on verifying the compliance to the provisions under the Drugs and Cosmetics Rules, 1945 (“Rules”) if required. The SLAs will also verify the quality of such FDCs submitted by each applicant/manufacturer, before grant of license under the Rules.
- Every manufacturer permitted to manufacture these FDCs are required to submit the periodic safety update reports (PSURs) as per Schedule Y of the Drugs and Cosmetics Rules to the Licensing Authority (Please refer to the Schedule Y, attached herewith, for your reference). Failure to submit the PSURs are will be considered as a contravention under the Drugs and Cosmetics Rules, 1945.