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DCGI asks manufacturers of two FDCs to submit applications within 3 months
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Gireesh Babu, New Delhi
February 28 , 2025
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The Drugs Controller General of India (DCGI) has asked the manufacturers of two pre-1988 approved fixed dose combinations (FDCs), for which it has sought post marketing surveillance data a year ago, to submit applications for phase IV clinical trials within three months.
The Central drug regulator, in a letter on February 24, said that if the manufacturers fail to submit the application within three months from the date of issuance of the letter, appropriate regulatory action will be recommended from the Central Drugs Standard Control Organisation (CDSCO).
The communication is latest to the ongoing actions related to the FDCs approved by the State Licensing Authority prior to the year 1988, but without due approval from the Central Licensing Authority.
The CDSCO, on January 11, 2024 said that an expert committee chaired by Dr M S Bhatia has recommended two FDCs as rational with certain conditions and generation of data including safety and efficacy for three others.
The FDCs that were recommended to be declared as rational are a combination of antidepressant imipramine hydrochloride IP + diazepam IP (25 mg + 2mg and 25 mg + 5 mg) tablets and a cough syrup combination chlorpheniramine maleate IP + ammonium chloride IP + sodium citrate IP (2mg + 100mg+50 mg/ml & 2.5mg+125mg+55 mg/ml), subject to certain conditions. The CDSCO also released a pathway for grant of product license by SLAs for these FDCs.
The DCGI, in his latest communication, said that the manufacturers who are already holding licenses from state licensing authorities for such FDCs before October 1, 2012, and did not apply to DCGI were required to submit their applications for phase IV clinical trial protocol or active post marketing surveillance to the CDSCO within July 11, 2024.
Noting that this time limit has already expired and around 12 months has already passed from the date of the notice issued in January, 2024, the central drug regulator said that most of the firms have not submitted their application to the directorate.
"It has been decided that the manufacturers/stakeholders who were holding license prior to October 1, 2012 may submit their applications with regard to category 'd' FDCs within 03 months from the date of issuance of this letter," said DCGI Dr Rajeev Singh Raghuvanshi in a letter to the drug controllers of all state and Union Territories (UTs) and to the drug manufacturers associations and Forums in the country.
"...without prejudice to legal validity of such product licenses, all the concerned manufacturers/stakeholders may be requested to submit their application within 03 months from the date of issuance of this letter, failing which appropriate regulatory action will be recommended from CDSCO," added the official.
In January, 2024, while declaring plans to declare these formulations as rational, the Committee recommended that the antidepressant combination shall be indicated for co-morbid anxiety conditions and duration of the treatment should not exceed 6-8 weeks.
For the cough syrup, the committee recommended continued manufacturing and marketing with the condition that the firm should modify the prescribing information or label by clearly mentioning the dose schedule for adults and children keeping in view of the recommended dose range without exceeding the maximum permissible dose.
The expert committee under the chairmanship of Dr M S Bhatia, Professor & Head, Department of Psychiatry, University College of Medical Sciences, New Delhi, was examining the 19 FDCs approved before 1988 for their rationality.
The Committee noted that the firms are manufacturing the FDC in different strengths and that as per the literature available, sodium citrate is administered 0.3 gm to 1 gm in divided doses in a day and chlorpheniramine maleate is administered 4 mg to 16 mg in divided dose in a day. The manufacturing firms should adhere to this dose range.
These FDCs were among the 344 combinations banned by the Central government through an order in March 10, 2016, based on the recommendations of the Professor Kokate Committee, in public interest as use of these FDCs were mentioned as likely to involve risk to human beings when safer alternatives are available.
The Committee was appointed by the Centre following the 59th report of the Department-related Parliamentary Standing Committee on Health and Family Welfare observed that some state licensing authorities had issued manufacturing license for several FDCs without prior clearance from the Central Drugs Standard Control Organisation (CDSCO) and that this had resulted in availability of many FDCs in the market which have not been tested for efficacy and safety putting patients at risk.
With the matter related to the banning of the FDCs reaching the Supreme Court, the Apex Court while recommending to refer the banning of 349 FDCs to the Drugs Technical Advisory Board, and set aside banning of the FDCs that are pre-1988 approved as these cases were never meant to be referred to the Kokate Committee.
However, it will be open for the central government, if it so chooses, de novo, to carry out an inquiry as to whether such drugs should be the subject matter of a notification under Section 26A of the Drugs and Cosmetics Act, it added. Based on this advice, the ministry of health and family welfare constituted the expert committee under the chairmanship of Dr M S Bhatia.
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