The Central Drugs Standard Control Organisation (CDSCO) has issued a pathway for regularisation of 19 fixed dose combinations (FDCs) out of the 294 FDCs which require further generation of data and were licensed by State Licensing Authority (SLA) without prior approval from the Drugs Controller General (India).

Manufacturers who have the state license, but did not obtain a no-objection certificate from DCGI are required to submit their applications to CDSCO within six months.

The drug regulator, in another communication, said that another 31 FDCs have been considered as rational under the 294 FDCs category.

For the 19 FDCs, the CDSCO has requested the state drug regulators to direct all concerned stakeholders to follow the procedure for clearance of the cases and to ensure that product licenses in respect of these 19 FDCs are issued after approval of DCG(I) in favour of the applicant.

The manufacturers were requested to follow the pathway for clearance of such applications by submitting Form CT21 duly filled, signed and stamped; requisite fees through Bharatkosh; name and composition of the FDC; copy of product permission issued by SLA to any firm prior to November 28, 2007 as available or the documents in supporting strength and dosage form of FDC; copy of manufacturing license of the applied product issued by SLA in Form 25/28; series number of FDC as per the Annexure-A and stability studies data as per earlier communication in this regard.

Further, the test specifications of the FDC along with method of analysis and phase IV trial protocol/commitment for conducting active post marketing surveillance study as the case may be, should be submitted for clearance.

In case of applicants who are not holding manufacturing licenses of the applied product from the SLA and what to apply for these FDCs, they can apply with data generated on Form 29 with the above pathway.