Last Updated on October 9, 2024 by The Health Master
Download the updated list of 2610 FDCs, the link is given below: The Central Drugs Standard Control Organisation (CDSCO) has re-issued the list of fixed dose combinations (FDCs), declared as rational by the Prof Kokate Committee earlier and was released in February in connection with their new drug status and the procedure to be followed by the applicants when approaching the state licensing authority, with some corrections.
In a latest letter, the Drugs Controller General (India) said that the CDSCO is clarifying certain typographical errors in five of the FDCs listed as approved by the Central Government in the list.
In all the five FDCs, the DCGI has scored out the condition that they are ‘for use only in conditions of severe Acute Uveitis in adults only’.
For these FDCs, it added, that the combination shall not be used continuously for more than one week without re-evaluation by the physician.
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;
- 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, in February, released an office letter with a list of FDCs for which the central government has issued approval from May 2015, in a phased manner based on phased scrutiny and recommendations by Prof Kokate Committee.
The letter clarified the procedure for obtaining manufacturing permission directly from the State Licensing Authorities (SLAs) without seeking prior approval from the DCGI.
The DCGI requested the State and Union Territory drug controllers to consider the period of four years from the date of approval as accorded by the Central government for the purpose of ascertaining the status of the FDC as to whether it shall be categorised as a new drug or not.
“You are also requested to ensure that if a FDC has already crossed the period of four years from the date as mentioned above, 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,” said the DCGI.
The Central government has approved a total of:
- 2,105 FDCs across May 8, 2015, March 10, 2016 and September 20, 2016;
- 34 FDCs in September 7, 2018 and October 16, 2019;
- 471 FDCs for which the approval was issued on March 16, 2020.
The batch of 2,105 FDCs approved from May, 2015 to September, 2016 has already completed four year period.
The DCGI said that as per the Drugs Rules including New Drugs and Clinical Trial Rules, 2019, a new drug shall continue to be a new drug for a period of four years from the date of approval by the licensing authority or the central licensing authority appointed by the Central government.
The drug regulator also pointed to a public notice issued in March 16, 2017 wherein the process of application was elaborated and also clarified that the period of four years for such FDCs is to be reckoned from the date of approval of the Prof Kokate Committee recommendations by the Central government in respect of the particular FDC.
Forms: All types of Clinical Trials
Schedules: All types of Clinical Trials
Notifications: New Drugs, FDC, Clinical Trial
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