73 Manufacturing and marketing of unapproved FDCs regarding 2025-Apr-11 223 KB

File No. 4-01/2023-DC (Misc. 3) Government of India Directorate General of Health Services Central Drugs Standard Control Organization (FDC Division)

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To, All State/ UT’s Drugs Controllers

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----- Start of picture text -----<br> FDA Bhawan, Kotla Road<br>New Delhi-110002<br>Dated: | A<br>IPR 2025<br>----- End of picture text -----<br>

Subject: Manufacturing and marketing of unapproved FDC’s - regarding.

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Sir/ Madam,

With reference to the letter issued by this office vide F.No. 4-01/2013-DC (Misc13-PSC) dated 15.01.2013, wherein concerns were raised regarding the grant of manufacturing licenses for sale of the Fixed Dose Combination (FDC) drugs that fall under the definition of a “New Drug’ in the country without due approval from Drugs Controller General (India). The same concern has been raised from time to time and multiple letters have been issued to the respective SLA’s that granted permission for manufacturing & marketing of unapproved FDC’s. The recent such letter was issued on 28.02.2025.

With reference to the above subject, it has come to the notice of this Directorate that certain Fixed Dose Combination (FDC) drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy as per the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940. This poses a serious risk to public health and safety. The approval of such unapproved FDC’s compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation. Upon issuance of show cause notices to the manufacturers, they have stated that these licenses were granted by the respective Drug Licensing Authorities and have not violated any Rules. This has resulted in a lack of uniform enforcement of the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940 across the country. In view of the above, all the State and Union Territory Drug Controllers are requested to review their approval process for such FDC’s and ensure strict compliance of the provisions of the Act and Rules. Public health and safety must remain the top priority. A list of unapproved FDC’s which were earlier licensed by State/ Union Territory Drug Controllers for manufacture, sale, and distribution without evaluation of safety & efficacy by CDSCO and later on cancelled by Drug Licensing Authorities (SLAs) or voluntarily surrendered by manufacturers following the issuance of show Cause notices is annexed for reference.

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Accordingly, all the State/ UT Drugs Controllers are requested to ensure that the FDC’s in annexure & any other unapproved FDC’s shall not be allowed for manufacture, sale, & distribution in the country and also conduct the investigation & take necessary action as per the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940 and the same shall be intimated to this office.

This matter may be treated as urgent & serious.

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----- Start of picture text -----<br> Yours Faithfully,<br>----- End of picture text -----<br>

(Dr. Rajeev Singh/Raghuvanshi) Drugs Controller General (India)

Copy forwarded to:-

1. All Zonal/Sub Zonal Offices of CDSCO

2. US (D), Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi.

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3. Website of CDSCO

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Annexure

List of Unapproved FDCs with Cancelled / Surrendered Product Permission

||(Sr.No.[|<br>1.|[|<br>————<CS™*~—‘“;~‘SNaameFDC<br>Combipack<br>of Each<br>film coated extended<br>release tablet contains:<br>Mirabegron 25mg and Each film coated tablet contains: Solifenacin|
|---|---|---|
|||Succinate 5mg|
||3.|Metformin<br>Hydrochloride<br>IP 500mg<br>(as extended<br>release form) +<br>Glimepiride IP 3mg + Dapagliflozin Propanediol Monohydrate IP eq. to|
|||Dapagliflozin 10mg film coated bilayered tablets|
||4.|FDC of: (i) Dextromethorphan Hydrobromide IP 10mg + Phenylephrine<br>Hydrochloride<br>IP<br>5mg<br>per<br>Smi<br>Syrup<br>&<br>(ii)<br>Diphenhydramine<br>Hydrochloride IP 12.5mg + Phenylephrine Hydrochloride IP Smg per|
|||5ml Syrup|
|||Tartrate 50mg film coated Bilayered tablet|
|||Ketoconazole<br>IP<br>2.0%w/w<br>+<br>NeomycinSulphatelP<br>O.5%w/w<br>+|
|||lodochlorhydroxyquinoline<br>IP<br>1%w/w<br>+<br>Tolnaftate<br>IP<br>1%w/w<br>+|
|||Clobetasol Propionate IP 0.05%w/w cream|
|,|Ubidecarenone (Coenzyme Q 10) BP 100mg capsules<br>[Ste<br>Cnn re Le<br>million<br>spores tablets<br>Aluminium Hydroxide Gel IP eq. to Aluminium Hydroxide 365mg +<br>Magnesium Hydroxide Paste<br>1 USP eq. to Magnesium Hydroxide 80mg<br>+<br>Simethicone USP 100mg<br>+<br>Deglycyrrhizinated<br>Liquorice<br>eq.<br>to||
|||Liquorice 400mg per 5mI oral suspension|
|||Apergillus oryzae) Digest not less than 22.5g of cooked starch, Papain<br>IP 15mg + Anise Oil |.P 1mg + Caraway oil IP 1mg + Cinnamon Oil BP|
|||1mg + Dill oil BP 1mg syrup|
||11.|Omega-3 fatty acids BP 300mg Eq. to EPA 90mg Eq. to DHA 60mg +<br>Wheatgerm<br>oilBP100mg+GreenteaextractsEq.toPolyphenols|
|||25mg + Zinc sulphate monohydrate IP eq. to elemental zinc 12.5mg +<br>Biotin BP 5mg + Lutein USP 5mg + Zeaxanthin 1mg + Copper sulphate<br>pentahydrate BP Eq. to elemental copper 1mg + Selenium Dioxide USP|
|||Eq. to elemental selenium 75mcg soft gelatin capsules|
|||2000IU + Mecobalamin IP 1500mcg tablet|
|||Fexofenadine Hydrochloride IP 120mg tablet|
|||4.5mg tablet|
|||100mgtablet|

	0.5mg tablets
	0.25mg tablets
18.	Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As Immediate<br>Release Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As
	Immediate Release Pellets) & Aspirin IP 150mg (As Gastro-Resistant
	Pellets) Capsule
19.	Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As Immediate<br>Release Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As
	Immediate Release Pellets) & Aspirin IP 150mg (As Gastro-Resistant
	Pellets)<br>Capsule
	and Ramipril IP 2.5mg Tablet
	Sodium Citrate IP 75mg Syrup
	400mg Tablets
25:	Cefixime<br>(as<br>Trihydrate)<br>IP<br>eq.<br>to Anhydrous<br>Cefixime 200mg	+
	Azithromycin Dihydrate IP eq. to Anhydrous Azithromycin 250mg	+
	Lactic Acid Bacillus 60 million spores film coated tablets
	Metronidazole 120mg + Simethicone IP 10mg suspension
—_ <br>28.	ElementalZinc5mguncoatedtablet
	form) 500mg and Voglibose IP 0.3mg Tablet
	Voglibose IP 0.2mg Tablet
	syrup
	10mg + Chlorpheniramine Maleate IP 2mg per S5ml syrup
34.	Ketoconazole IP 2.0%w/w + lodochlorhydroxyquinoline IP 1%w/w +<br>Tolnaftate IP 1%w/w + Clobetasol Propionate IP 0.05%w/w + Neomycin
	Sulphate IP 0.10%w/w cream base
	Injection