DCGI Enlists Procedures For Regularisation Of 83 FDCs

Bengaluru, 1 March 2019: The Drugs Controller General of India (DCGI) has enlisted procedures to be followed for regularisation of the 83 Fixed Dose Combination (FDC) drugs which were declared as rational by the DTAB. These 83 FDCs are among the controversial 294 FDCs licensed by the State Licensing Authorities without prior approval from DCGI. The industry must submit the applications before June, 2019.

The move follows after several requests from the Karnataka Drugs and Pharmaceutical Association too.

The DCGI has enlisted a 7-point guideline for approval of these 83 drugs which are on the CDSCO website. The first is that the applicant must submit Form 44 mentioning dosage form and strength filled, signed and stamped along with treasury challan of Rs. 15,000 for each FDC.

The second is to specify the name and composition of FDC. The third is to produce a copy of product permission issued by state licensing authority to any firm prior to November 28, 2007 as documentary evidence. The fourth is to submit a copy of manufacturing license in Form 25/28 and Form 29 for manufacturers who are not holding product permission from SLA and want to apply for these FDCs. The fifth is to indicate the serial number of the FDC as per the list available on the CDSCO website. The sixth is to present the stability studies data. The seventh is to provide the test specifications of the FDC along with Method of Analysis.

DCGI has also stated that all the manufacturers having licenses from State Licensing Authorities for such FDCs and did not obtain NOC from the regulator, need to submit the applications before June this year, failing which the applications will not be considered and their licenses will be considered as without legal validity.

“We welcome the circular which details the pathway to obtain the license by a subsequent manufacturer of these FDCs as well as gives an opportunity for existing manufacturers to regularize their licenses. This was the long standing demand of the industry. As a measure on ease of going business, it would be great if the procedure can be changed a bit in line with the circular of December 12, 2018 for FDCs approved by Kokate Committee. It is also not clear till what date these 83 FDCs will be continue to be treated as 'New Drug',” said Harish K Jain, secretary, KDPMA.

Since 2007, the DCGI received complaints from Consumer Associations regarding rationality of certain FDCs marketed in the country. As a part of follow up action of complaints, a list of 294 FDCs and directions were issued to all the state drugs controllers to withdraw these 294 FDCs which were licensed without approval of the regulatory authority.

But many drug manufacturers association got stay order from the High Court of Madras on this matter. After this the DTAB in the 55th meeting on January 16, 2008 constituted a sub-committee to examine these FDCs. Accordingly it was examined and a report was submitted to DTAB. In another DTAB meeting on February 16, 2015, the recommendations of Sub-Committee were upheld. After this all Court cases pending in the Madras High Court were transferred to the Supreme Court which accepted the report of DTAB as per court order of December 15, 2017.

DTAB judged the FDCs as rational and the list of these 83 FDCs is already available in CDSCO website.