.png
)
Centre Bans 16 Fixed Dose Combinations Under Section 26A of Drugs & Cosmetics Act
The Ministry of Health and Family Welfare has prohibited the manufacture, sale and distribution of sixteen irrational FDCs with immediate effect, citing absence of therapeutic justification and risk to human health. The ban covers antibiotics paired with enzymes, topical cosmetic blends, analgesics and a metabolic combination.
The Central Government, acting on the recommendations of the Drugs Technical Advisory Board (DTAB) and its Sub-Committee, has notified the prohibition of sixteen fixed dose combinations (FDCs) through separate S.O. notifications published in the Gazette of India Extraordinary on June 15, 2026. All bans carry immediate effect and apply uniformly across India.
"In the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of these fixed dose combinations as there is no therapeutic justification for the combination of these ingredients."
— DTAB Sub-Committee Report, 28 December 2024Background & Regulatory Process
Each of the sixteen combinations was first examined by an Expert Committee in 2021, which found that available peer-reviewed scientific evidence did not support their rationality. The DTAB thereafter constituted a Sub-Committee to review all such irrational FDCs in detail. Public notices were issued giving manufacturers and stakeholders the opportunity to submit precise data. The Sub-Committee submitted its consolidated report on 28 December 2024, and the DTAB concurred with the recommendation to prohibit all sixteen. The Central Government, satisfied that a ban is necessary and expedient in public interest, exercised its powers under Section 26A of the Drugs and Cosmetics Act, 1940.
Complete List of 16 Banned FDCs
| # | S.O. No. | Fixed Dose Combination (FDC) | Category | Key Reason for Ban |
|---|---|---|---|---|
| 1 | S.O. 3068(E) | Acetyl Salicylic Acid + Ethoheptazine | Analgesic | No scientific evidence supports this combination; safer alternatives available |
| 2 | S.O. 3069(E) | Aloe Vera + Jojoba Oil + Wheat Germ Oil + Tea Tree Oil | Topical | Irrational combination; no therapeutic justification for this fixed dose |
| 3 | S.O. 3070(E) | Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes | Antibiotic | Pharmacodynamically irrelevant; no sound clinical evidence of concurrent use; not per standard therapeutic guidelines |
| 4 | S.O. 3071(E) | Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide | Antispasmodic | Combining Dicyclomine (potent anti-cholinergic) with Clidinium (another anti-cholinergic) is unjustified; no supporting peer-reviewed evidence |
| 5 | S.O. 3072(E) | Amoxicillin + Serratiopeptidase | Antibiotic | Pharmacodynamically irrelevant; no sound clinical evidence; not per standard therapeutic guidelines |
| 6 | S.O. 3073(E) | Aloe Extract + Allantoin + Alphatocopherol Acetate + D-Panthenol + Vitamin A | Topical | No scientific or peer-reviewed evidence supports the rationality of this combination |
| 7 | S.O. 3074(E) | Aloe Extract + Vitamin E + Dimethicone + Glycerine | Topical | No therapeutic justification; combination considered irrational by Expert Committee |
| 8 | S.O. 3075(E) | Aloe Vera + Jojoba Oil + Vitamin E | Topical | No scientific evidence supports rationality; combination deemed irrational |
| 9 | S.O. 3076(E) | Aloe Vera + Orange Oil | Topical | No therapeutic justification; irrational per Expert Committee and DTAB Sub-Committee |
| 10 | S.O. 3077(E) | Aloe Vera + Vitamin E + Herbal | Topical | Evidence does not support rationality; product is not well-defined or characterised |
| 11 | S.O. 3078(E) | Dicyclomine + Paracetamol + Clidinium Bromide | Antispasmodic | Dual anti-cholinergic combination not scientifically justified; irrational per DTAB |
| 12 | S.O. 3079(E) | Paracetamol + Lignocaine | Analgesic | No therapeutic justification; risk identified with this fixed dose combination |
| 13 | S.O. 3080(E) | Gliclazide + Chromium Picolinate | National & international treatment guidelines for Type 2 DM do not recommend Chromium Picolinate; combination is irrational | |
| 14 | S.O. 3081(E) | Amoxicillin + Cloxacillin + Lactic Acid Bacillus + Serratiopeptidase | Antibiotic | Pharmacodynamically irrelevant; no clinical evidence for concurrent use; not per standard guidelines |
| 15 | S.O. 3082(E) | Cefadroxyl + Probenecid | Antibiotic | No pharmacokinetic data to substantiate the combination; dose titration for Probenecid not established |
| 16 | S.O. 3083(E) | Cefuroxime + Serratiopeptidase | Antibiotic | Pharmacodynamically irrelevant; no sound clinical evidence of concurrent use; not per standard therapeutic guidelines |
Industry Impact
A large portion of the banned combinations involve antibiotics paired with Serratiopeptidase — a proteolytic enzyme frequently marketed alongside penicillin-class and cephalosporin-class antibiotics in India. The DTAB Sub-Committee found no pharmacodynamic rationale for such pairings. Brands marketing Amoxicillin, Amoxicillin + Cloxacillin, and Cefuroxime with Serratiopeptidase must cease those SKUs immediately.
Several topical Aloe Vera–based combinations have also been struck down, which will impact OTC cosmeceutical and dermatology brands that marketed these under drug licences. Manufacturers of the antispasmodic combinations containing both Dicyclomine and Clidinium must discontinue those formulations with immediate effect.
The ban on Gliclazide + Chromium Picolinate is notable given the prevalence of chromium supplements in diabetes-segment marketing. It reinforces that combination products must align with evidence-based standard treatment guidelines, not just commercial rationale.
✅ What Manufacturers & Distributors Must Do Now
- Cease manufacturing of all 16 listed FDCs with immediate effect.
- Halt sale and distribution across all channels — retail, hospital supply, e-pharmacy and export.
- Conduct a stock audit and initiate recall procedures as per CDSCO guidelines.
- Notify State Licensing Authorities (SLAs) and update your product portfolio accordingly.
- Consult regulatory counsel before reformulating or relaunching any component ingredient separately.
- Exporters must verify the regulatory status in destination countries before continuing shipments.
- Non-compliance can attract prosecution under the Drugs and Cosmetics Act, 1940.
Legal Reference
All sixteen notifications are issued under Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), which empowers the Central Government to prohibit the manufacture, sale or distribution of any drug in the public interest. All orders are covered under File No. X.11035/53/2014-DFQC(Pt.- III) and were signed by Harsh Mangla, Joint Secretary, Ministry of Health & Family Welfare.
Source: Gazette of India Extraordinary · No. 2962 · June 15, 2026 · CG-DL-E-19062026-273649 | Published by the Controller of Publications, Delhi-110054
For informational purposes only. Verify with official Gazette before taking compliance action.
