35 Unapproved Fixed Dose Combinations (FDCs) Under Scrutiny

Last Updated on April 24, 2025 by The Health Master

FDCs: Fixed Dose Combinations

Breaking News: The Drugs Controller General of India (DCGI) issued a letter on 11-04-2025 to drug controllers across all States and Union Territories regarding 35 unapproved fixed dose combinations (FDCs).

The national drug regulatory body is demanding immediate action on a list of 35 fixed dose combinations (FDCs) that have been granted permissions by state authorities.

The DCGI has not only flagged these 35 specific FDCs but has also urged state and UT drug controllers to review their existing approval of these FDCs.

A List of Unapproved Drug Combinations

The DCGI has released a list of these 35 unapproved FDCs, which were previously granted permissions by State Licensing Authorities (SLAs) for manufacturing, sale, and distribution.

Following the issuance of show-cause notices, some of these licenses were either cancelled by the SLAs or voluntarily surrendered by the concerned manufacturers.

The list includes several commonly used drug combinations, raising concerns about their widespread availability without proper central approval.

Some examples include:

Diabetes Management:

• Metformin hydrochloride 500 mg (extended release) + Glimepiride 3 mg + Dapagliflozin 10 mg

Cough and Cold Syrups:

• Dextromethorphan hydrobromide 10 mg + Phenylephrine hydrochloride 5 mg per 5 ml syrup
• Diphenhydramine hydrochloride 12.5 mg + Phenylephrine hydrochloride 5 mg per 5 ml syrup

Cardiovascular:

Rosuvastatin calcium IP (equivalent to rosuvastatin 20 mg immediate release), Clopidogrel bisulphate IP (equivalent to clopidogrel 75 mg immediate release), and Aspirin 150 mg (gastro-resistant pellets)

In a formal letter addressed to all State and UT drug controllers, DCGI Dr. Rajeev Singh Raghuvanshi explicitly stated, “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.

Dr. Raghuvanshi pointed out that there is a lack of uniform enforcement of the provision of the NDCT Rules 2019 under the Drugs & Cosmetics Act, 1940 across the country and the urgent need for standardized and stringent regulatory oversight.

Stricter Review and Compliance

Considering the gravity of the situation, the DCGI has urged all state and UT drug controllers to take immediate and decisive action.

They are urged to:

Review their approval processes: Conduct a thorough examination of their current mechanisms for granting permissions for drug manufacturing, particularly for FDCs.

Ensure compliance: Enforce the provisions of the Drugs & Cosmetics Act, 1940, and the NDCT Rules, 2019.

The DCGI has also highlighted that these 35 FDCs, along with any other unapproved FDCs, must not be allowed for manufacture, sale, and distribution within the country.

Drug controllers of the states and UTs are also required to conduct investigations into the said matter and take necessary action as per law.

List of 35 FDCs

Sr. No.	Name of FDC
1	Combipack of Each film coated extended release tablet contains: Mirabegron 25 mg and Each film coated tablet contains: Solifenacin Succinate 5 mg
2	Nefopam Hydrochloride 30 mg + Paracetamol 325 mg tablets
3	Metformin Hydrochloride IP 500 mg (as extended release form) + Glimepiride IP 3 mg + Dapagliflozin Propanediol Monohydrate IP eq. to Dapagliflozin 10 mg film coated bilayered tablets
4	FDC of: (i) Dextromethorphan Hydrobromide IP 10 mg + Phenylephrine Hydrochloride IP 5 mg per 5 ml Syrup & (ii) Diphenhydramine Hydrochloride IP 12.5 mg + Phenylephrine Hydrochloride IP 5 mg per 5 ml Syrup
5	Cilnidipine IP 20 mg + Metoprolol Succinate IP 47.5 mg eq. to Metoprolol Tartrate 50 mg film coated Bilayered tablet
6	Ketoconazole IP 2.0% w/w + Neomycin Sulphate IP 0.5% w/w + Iodochlorhydroxyquinoline IP 1% w/w + Tolnaftate IP 1% w/w + Clobetasol Propionate IP 0.05% w/w cream
7	Dehydroepiandrosterone SR 75 mg + Melatonin BP 3 mg + Ubidecarenone (Coenzyme Q 10) BP 100 mg capsules
8	Cefixime IP 200 mg + Ofloxacin IP 200 mg + Lactic acid bacillus 60 million spores tablets
9	Aluminium Hydroxide Gel IP eq. to Aluminium Hydroxide 365 mg + Magnesium Hydroxide Paste 1 USP eq. to Magnesium Hydroxide 80 mg + Simethicone USP 100 mg + Deglycyrrhizinated Liquorice eq. to Liquorice 400 mg per 5 ml oral suspension
10	Alpha amylase IP (1:800): 28.125 mg (fungal Diastase derived from Apergillus oryzae) Digest not less than 22.5 g of cooked starch, Papain IP 15 mg + Anise Oil I.P 1 mg + Caraway oil IP 1 mg + Cinnamon Oil BP 1 mg + Dill oil BP 1 mg syrup
11	Omega-3 fatty acids BP 300 mg Eq. to EPA 90 mg Eq. to DHA 60 mg + Wheat germ oil BP 100 mg + Green tea extracts Eq. to Polyphenols 25 mg + Zinc sulphate monohydrate IP eq. to elemental zinc 12.5 mg + Biotin BP 5 mg + Lutein USP 5 mg + Zeaxanthin 1 mg + Copper sulphate pentahydrate BP Eq. to elemental copper 1 mg + Selenium Dioxide USP Eq. to elemental selenium 75 mcg soft gelatin capsules
12	Pregabalin (SR) IP 75 mg + Nortriptyline HCl IP 10 mg + Vitamin D3 IP 2000 IU + Mecobalamin IP 1500 mcg tablet
13	Acebrophylline (SR) 200 mg + Montelukast Sodium IP 10 mg + Fexofenadine Hydrochloride IP 120 mg tablet
14	Dehydroepiandrosterone 75 mg (as sustained release) + Folic Acid IP 4.5 mg tablet
15	Dehydroepiandrosterone 75 mg + Melatonin BP 5 mg + Ubidecarenone BP 100 mg tablet
16	Sertraline Hydrochloride IP eq. to Sertraline 50 mg + Clonazepam IP 0.5 mg tablets
17	Sertraline Hydrochloride IP eq. to Sertraline 50 mg + Clonazepam IP 0.25 mg tablets
18	Rosuvastatin Calcium IP eq. to Rosuvastatin 20 mg (As Immediate Release Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75 mg (As Immediate Release Pellets) & Aspirin IP 150 mg (As Gastro-Resistant Pellets) Capsule
19	Rosuvastatin Calcium IP eq. to Rosuvastatin 10 mg (As Immediate Release Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75 mg (As Immediate Release Pellets) & Aspirin IP 150 mg (As Gastro-Resistant Pellets) Capsule
20	Tamsulosin Hydrochloride IP 0.4 mg & Finasteride IP 5 mg Tablet
21	Metoprolol Succinate USP 23.75 mg eq. to Metoprolol Tartrate 25 mg and Ramipril IP 2.5 mg Tablet
22	Bisoprolol Fumarate IP 5 mg & Cilnidipine IP 10 mg tablets
23	Chlorpheniramine Maleate IP 4 mg + Codeine Phosphate IP 10 mg + Sodium Citrate IP 75 mg Syrup
24	Rifaximin BP 200 mg & Metronidazole Benzoate IP Eq. to Metronidazole 400 mg Tablets
25	Cefixime (as Trihydrate) IP eq. to Anhydrous Cefixime 200 mg + Azithromycin Dihydrate IP eq. to Anhydrous Azithromycin 250 mg + Lactic Acid Bacillus 60 million spores film coated tablets
26	Norfloxacin IP 125 mg + Metronidazole Benzoate IP eq. to Metronidazole 120 mg + Simethicone IP 10 mg suspension
27	Cyproheptadine HCl IP 4 mg + Zinc Sulphate Monohydrate IP eq. to Elemental Zinc 5 mg uncoated tablet
28	Meropenem 1 gm + EDTA for injection Injection
29	Glimepiride IP 1 mg & Metformin HCL IP 500 mg Tablet
30	Glimepiride IP 2 mg, Metformin Hydrochloride IP (As Sustained Release form) 500 mg and Voglibose IP 0.3 mg Tablet
31	Metformin Hydrochloride IP (As Prolonged-Release) 500 mg Voglibose IP 0.2 mg Tablet
32	Ofloxacin IP 50 mg, Ornidazole IP 125 mg and Racecadrotril IP 15 mg syrup
33	Ambroxol Hydrochloride IP 20 mg + Dextromethorphan Hydrobromide IP 10 mg + Chlorpheniramine Maleate IP 2 mg per 5 ml syrup
34	Ketoconazole IP 2.0% w/w + Iodochlorhydroxyquinoline IP 1% w/w + Tolnaftate IP 1% w/w + Clobetasol Propionate IP 0.05% w/w + Neomycin Sulphate IP 0.10% w/w cream base
35	Meropenem 1000 mg + Avibactam (Sterile) IP eq. to Avibactam 500 mg Injection

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