Health Ministry Bans 16 FDCs Including Amoxicillin, Serratiopeptidase; See Full List
Expired Medicine
New Delhi: In a major regulatory action aimed at improving drug safety and promoting rational use of medicines, the Ministry of Health and Family Welfare has prohibited the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs for human use with immediate effect under Section 26A of the Drugs and Cosmetics Act, 1940.
The prohibitions cover a wide range of fixed-dose combinations, including Acetyl Salicylic Acid + Ethoheptazine; Aloe vera + Jojoba oil + Wheat germ oil + Tea tree oil; Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes; Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide; Amoxicillin + Serratiopeptidase; Aloe Extract + Allantoin + Alphatocopherol Acetate + D-Penthenol + Vitamin A; Aloe Extract + Vitamin E + Dimethicone + Glycerine; Aloe Vera + Jojoba Oil + Vitamin E; Aloe vera + Orange oil; Aloe vera + Vitamin E + Herbal; Dicyclomine + Paracetamol + Clidinium Bromide; Paracetamol + Lignocaine; Gliclazide + Chromium Picolinate; Amoxicillin + Cloxacillin + Lactic acid bacillus + Serratiopeptidase; Cefadroxyl + Probenecid; and Cefuroxime + Serratiopeptidase.
The government has ordered an immediate halt to their manufacture, sale and distribution across the country.
The notifications, issued on June 11, 2026, follow a long regulatory review process involving expert committees, the Drugs Technical Advisory Board (DTAB), and a DTAB Sub-Committee that examined several allegedly irrational FDCs.
According to the government, these combinations are likely to pose risks to patients while safer alternatives are available. The authorities also concluded that the available scientific evidence and peer-reviewed literature do not support the therapeutic rationale of these combinations.
The scrutiny of these FDCs began in 2021 when an Expert Committee reviewed their safety, efficacy and therapeutic relevance. The committee found that the available data failed to justify the combinations and classified them as irrational.
Subsequently, the DTAB examined the findings and referred the matter to its Sub-Committee for a detailed assessment. Manufacturers and stakeholders were provided opportunities to submit supporting data through public notices.
After reviewing the evidence, the DTAB Sub-Committee submitted its report on December 28, 2024, concluding that these combinations lacked therapeutic justification and should be prohibited in the larger public interest. The DTAB endorsed these recommendations, following which the Central Government issued the prohibition orders.
While most of the banned FDCs were found to lack scientific evidence and therapeutic justification, the Expert Committee made specific observations in certain cases.
It noted that antibiotic-serratiopeptidase combinations such as Amoxicillin + Serratiopeptidase and Cefuroxime + Serratiopeptidase are not supported by standard treatment guidelines and lack sound clinical evidence. For Dicyclomine-based combinations, the committee highlighted unjustified duplication of anticholinergic activity. In the case of Gliclazide + Chromium Picolinate, it observed that diabetes treatment guidelines do not recommend chromium picolinate. For Paracetamol + Lignocaine, the committee flagged a potential risk associated with the combination. The remaining Aloe Vera- and Aloe Extract-based combinations were found to be irrational due to a lack of supporting scientific evidence and therapeutic rationale.
The following fixed-dose combinations have been banned:
| S.O. No. | Fixed Dose Combination |
|---|---|
| 3068(E) | Acetyl Salicylic Acid + Ethoheptazine |
| 3069(E) | Aloe vera + Jojoba oil + Wheat germ oil + Tea tree oil |
| 3070(E) | Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes |
| 3071(E) | Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide |
| 3072(E) | Amoxicillin + Serratiopeptidase |
| 3073(E) | Aloe Extract + Allantoin + Alphatocopherol Acetate + D-Penthenol + Vitamin A |
| 3074(E) | Aloe Extract + Vitamin E + Dimethicone + Glycerine |
| 3075(E) | Aloe Vera + Jojoba Oil + Vitamin E |
| 3076(E) | Aloe vera + Orange oil |
| 3077(E) | Aloe vera + Vitamin E + Herbal |
| 3078(E) | Dicyclomine + Paracetamol + Clidinium Bromide |
| 3079(E) | Paracetamol + Lignocaine |
| 3080(E) | Gliclazide + Chromium Picolinate |
| 3081(E) | Amoxicillin + Cloxacillin + Lactic acid bacillus + Serratiopeptidase |
| 3082(E) | Cefadroxyl + Probenecid |
| 3083(E) | Cefuroxime + Serratiopeptidase |
To view the official notice, click the link below:
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