Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) has noted that that despite the guidelines issued for FDCs (fixed dose combinations) declared rational by Prof Kokate panel and approved by DCGI, there are still several issues that need to be resolved.

Following the directive from the DCGI about the clearances of subsequent applications, the contenders who wish to manufacture such FDCs need to submit Form 44 with a fee of Rs.15,000 to the Central Licensing Authority (CLA) through TR (6) challan.

Lauding the move by the government as a major step forward in resolving issue of FDCs, KDPMA observed there are still lot of issues remain to be solved. These include the resolving the status of 294 drugs case pending in High Court of Madras as well as drugs banned last year. There is also the issue of unapproved FDCs which were licensed by various SLAs after Oct 2012. In addition to the concerns on the approval of FDCs categorised as 'b' & 'd' by Prof. Kokate Committee.

“Another is the issue of unapproved FDCs for which safety and efficacy applications were not filed. Yet another Damocles sword is the payment of fees of Rs.15,000 per product remains a pain point specially for small and medium enterprises (SMEs), Harish K Jain, Hon. Secretary, KDPMA told Pharmabiz.

“Our Association is always of the view that industry and regulators need to sit together and resolve the issue to the satisfaction of all stake holders. Setting aside the differences, emphasis on patient safety, level playing field and ease of doing business should be the only criteria to move forward, he added.

Every since October 2012, when the issue of unapproved FDCs cropped up and subsequent report submitted by expert committee headed by Prof Kokate, there was no clarity on the licensing procedure to be followed for unapproved FDCs. Companies that were licensed earlier continued to market the FDCs whereas new entrants were deprived of marketing these unapproved FDCs. Some of these unapproved FDCs are available in market since decades. Some state licensing authorities continued to issue licenses for unapproved FDCs inspite of the directive of Rule 33P given out by the Union ministry of health, he pointed out.

However, in this regard the Karnataka Drugs Controller is following the directive in letter and spirit and manufacturers of this state were feeling deprived of their right to obtain license. At the same time companies from outside Karnataka were marketing these FDCs throughout the country including Karnataka, he informed.

KDPMA had been pursuing this issue over the last three years with all relevant authorities at various forums including recently concluded CEOs meet at India Pharma 2017 in Bengaluru. Minister for Chemicals & Fertilizers and Parliamentary Affairs, Shri Ananth Kumar, senior officials of Department of Pharmaceuticals, K L Sharma, Jt. Secretary, Ministry of health and Shri G N Singh, DCGI along with the Karnataka government’s Additional Chief Secretary, representatives from the Department of Industries & Commerce, Principal Secretary, Health & Family Welfare Department and Karnataka Drugs Controller enabled in resolving this issue, he said.

KDPMA has finally succeeded in bringing about clarity in licensing procedure to be followed for issue of licenses for FDCs approved by Prof Kokate Committee. We welcomes this move in the current circumstances, noted Jain.