Last Updated on June 22, 2026 by The Health Master
16 Fixed Dose Combination (FDC) Drugs
16 Fixed Dose Combination (FDC) drugs were banned. Download the notification; the link is given below in the article.
The Ministry of Health and Family Welfare, Government of India has banned the manufacture, sale and distribution of 16 Fixed Dose Combination (FDC) drugs with immediate effect.
The Drugs and Cosmetics Act, 1940, section 26A gives the Government of India the power to ban any drug in the public interest.
The Drugs Technical Advisory Board (DTAB) and a special sub-committee of experts have found that these drugs pose a health risk to human beings and do not offer any justification for their use in treatment.
Why Has the Government Banned These FDC Drugs?
Fixed dose combination (FDC) drugs contain two or more active ingredients in a single drug.
According to the official Gazette of India notifications S.O. 3068(E) to S.O. 3083(E)) dated June 11, 2026, a review of the FDC drugs by which 16 Fixed Dose Combination (FDC) Drugs were banned in India began in 2021 when an Expert Committee noted that these drugs lacked a therapeutic justification for their use in medicine.
Download banned notifications of 16 Fixed Dose Combination (FDC) Drugs
The specific reasons for which the Drugs and Cosmetics Act, 1940, section 26A was invoked by the DTAB include the following findings:
No Therapeutic Justification
Several FDC drugs contain ingredients that have not been proven, through peer-reviewed scientific journals, to work well together in the body.
Pharmacodynamically Irrelevant Combinations
For instance, antibiotics like Amoxicillin or Cefuroxime are combined with Serratiopeptidase in some FDC drugs, but there is no sound clinical evidence to back the use of these two ingredients together in medicine.
Increased Risk of Side Effects
Including these ingredients together in a single drug increases the risk of adverse reactions and side effects that could damage the body’s cells and lead to toxicity.
These side effects can also lead to antimicrobial resistance.
The DTAB sub-committee provided a wide range of opportunities to drug manufacturers to present the scientific data that supports the use of these ingredients in FDC drugs.
However, upon reviewing the final report submitted by the drug manufacturers on December 28, 2024, the sub-committee recommended the total ban of these drugs in India.
List of 16 Banned Fixed Dose Combinations (2026)
The list of drugs banned under the Drugs and Cosmetics Act, 1940 includes the following FDC drugs:
| Gazette Notification No. | Banned Fixed Dose Combination (FDC) Formulation | Primary Therapeutic Category / Reported Reason for Ban |
| S.O. 3068(E) | Acetyl Salicylic Acid + Ethoheptazine | Pain Management / Lack of therapeutic justification |
| S.O. 3069(E) | Aloe vera + Jojoba oil + Wheat germ oil + Tea tree oil | Topical/Dermatological Cream |
| S.O. 3070(E) | Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes | Antibiotic & Enzyme Combination; not aligned with standard therapeutic guidelines |
| S.O. 3071(E) | Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide | Antispasmodic/Sedative; combining two powerful anti-cholinergic agents (Dicyclomine & Clidinium) is medically unjustified |
| S.O. 3072(E) | Amoxicillin + Serratiopeptidase | Antibiotic & Enzyme; no sound clinical evidence for concurrent use |
| S.O. 3073(E) | Aloe Extract + Allantoin + Alphatocopherol Acetate + D-Panthenol + Vitamin A | Skincare / Irrational combination with no clinical backing |
| S.O. 3074(E) | Aloe Extract + Vitamin E + Dimethicone + Glycerine | Skincare / Irrational combination |
| S.O. 3075(E) | Aloe Vera + Jojoba Oil + Vitamin E | Topical Formulation / Lack of scientific data |
| S.O. 3076(E) | Aloe vera + Orange oil | Topical Formulation / Irrational mixture |
| S.O. 3077(E) | Aloe vera + Vitamin E + Herbal | Topical Formulation; product was found to be completely undefined and uncharacterized |
| S.O. 3078(E) | Dicyclomine + Paracetamol + Clidinium Bromide | Gastrointestinal/Antispasmodic; therapeutic risk of mixing duplicate anti-cholinergics |
| S.O. 3079(E) | Paracetamol + Lignocaine | Analgesic / Potential risk to human health with zero justification |
| S.O. 3080(E) | Gliclazide + Chromium Picolinate | Anti-Diabetic; national and international standard treatment guidelines for Type 2 Diabetes explicitly do not recommend Chromium Picolinate |
| S.O. 3081(E) | Amoxicillin + Cloxacillin + Lactic acid bacillus + Serratiopeptidase | Multi-ingredient Antibiotic formulation; pharmacodynamically irrelevant |
| S.O. 3082(E) | Cefadroxyl + Probenecid | Antibiotic; complete lack of pharmacokinetic study or data to justify the specific dose titration |
| S.O. 3083(E) | Cefuroxime + Serratiopeptidase | Antibiotic & Enzyme; concurrent use does not follow standard clinical therapeutic guidelines |
What Should Consumers and Patients Do Now?
There is no need to panic if you are currently taking any of the banned FDC drugs. However, there are a few actions that each patient should take to protect their health:
- Check your medicine strips to see if they contain any of the banned FDC drugs.
- Consult your doctor to receive a prescription for a safer, standalone alternative.
- Do not self-medicate with the remaining stocks of these unscientific drugs. Use the single-ingredient alternatives to target your symptoms.
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