The list of fixed dose combinations (FDCs), previously released in February and deemed rational by the Prof. Kokate Committee, has been reissued by the Central Drugs Standard Control Organization (CDSCO) with some corrections. These corrections are related to the FDCs’ new drug status and the application process that applicants must follow when approaching the state licencing authority.
The CDSCO is correcting some typographical errors in five of the FDCs stated as being approved by the Central Government in the list, according to a recent letter from the Drugs Controller General (India). The DCGI has scored out the restriction that they are “for use only in cases of severe Acute Uveitis in adults only” for each of the five FDCs. It was further stated that for certain FDCs, the combination should not be administered continuously for longer than one week without a physician reevaluation.
The FDCs for which the correction has been made include clobetasol propionate 0.05%w/w+miconazole nitrate 2.00%w/w+neomycin sulphate 0.5% w/w+chlorocresol 0.10%w/w topical cream; clobetasol propionate USP 0.05%w/w+neomycin sulphate IP equivalent to neomycin 0.1%w/w+ miconazole nitrate IP 2.0% w/w cream; clotrimazole IP 1%w/ + beclomethasone dipropionate IP 0.025%w/w + neomycin sulphate IP eq. to neomycin 0.5%w/w cream; beclomethasone dipropionate 0.025%w/w + clotrimazole 1%w/w + neomyein sulphate Eq. to neomyein 0.5%w/i +chlorocresol IP (As preservative) 0.1%w/w cream; and clobetasol propionate USP 0.05%w/w + neomycin sulphate IPeq to neomycin 0.5%w/w + miconazole nitrate IP 2.0%w w cream.
The DCGI published an office letter in February listing the FDCs for which the central government has granted approval beginning in May 2015, based on a phased review and recommendations from the Prof. Kokate Committee. The letter detailed the steps to take in order to get manufacturing authorization directly from the State Licensing Authorities (SLAs) without first requesting DCGI consent. The DCGI asked the State and Union Territory drug controllers to take into account the four-year window from the date of authorisation, as permitted by the Central government, in determining whether or not to classify the FDC as a new drug.
The DCGI stated, “You are also requested to ensure that any applications of such drugs submitted to you should be considered as per the provisions of Drugs Rules, 1945 including New Drugs and Clinical Trial Rules, 2019,” if an FDC has already exceeded the period of four years from the date as mentioned above. The earlier list, which was released in February of this year, is being monitored by the current list. A total of 2,105 FDCs were approved by the central government between May 8, 2015, March 10, 2016, and September 20, 2016, along with 34 more on September 7, 2018 and October 16, 2019, and another 471 on March 16, 2020. The time of four years for the 2,105 FDCs approved between May 2015 and September 2016 has already ended.
According to the DCGI, a new drug should remain a new drug for a period of four years following the date of approval by the licencing authority or the central licencing authority designated by the Central government under the Drugs Regulations including New Drugs and Clinical Trial Rules, 2019. The drug regulator also cited a public notification from March 16, 2017, in which the application process was explained and it was stated that the four-year clock for certain FDCs begins on the day the Central government approved the Prof Kokate Committee’s recommendations with regard to the specific FDC.
