The Centre has banned 16 fixed drug combinations (FDCs), including antibiotics and topical and cosmetic combinations, after a review concluded that they may pose health safety risks.
The Union Health Ministry issued a gazette notification prohibiting the manufacture, sale and distribution of these FDCs, which are drugs containing a combination of two or more active pharmaceutical ingredients (APIs) in a single form, usually manufactured and distributed in a fixed ratio.
According to the notification, the decision follows a multi-year review by an expert committee, the Drug Technical Advisory Board (DTAB) and its sub-committee, which collectively concluded that the combinations lacked therapeutic justification.
Initiated in 2021, the review found that peer-reviewed scientific evidence did not support the rationality of any of the 16 FDCs. Manufacturers and other stakeholders were also invited to submit scientific and clinical evidence supporting these products through public notices issued by the authorities.
After reviewing the responses, the expert sub-committee submitted its final report on December 28, 2024, recommending that all 16 FDCs be prohibited in the public health interest.
Among the topical and cosmetic products covered by the ban is a combination of Aloe Extract, Allantoin, Alpha-tocopherol Acetate, D-Panthenol and Vitamin A, commonly used in skin creams and lotions. The committee said the product posed risks to human health and that safer alternatives were available.
Other combinations include FDCs of Aloe Vera with Jojoba Oil, Vitamin E, Orange Oil and other herbal ingredients.
The review also barred the sale of antibacterial combinations including Amoxicillin, Serratiopeptidase and Lactobacillus Sporogenes. The committee stated that the combination lacked a sound therapeutic rationale, noting that adding Serratiopeptidase to Amoxicillin was not supported by robust clinical evidence or recognised treatment guidelines.
Similar concerns led to the prohibition of the two-drug combination of Amoxicillin and Serratiopeptidase.
Another formulation containing Amoxicillin, Cloxacillin, Lactic Acid Bacillus and Serratiopeptidase was also deemed irrational, as the committee found no clinical justification for combining Serratiopeptidase with antibiotic therapy.
Likewise, combinations of Cefuroxime and Serratiopeptidase were considered pharmacodynamically inappropriate and inconsistent with established treatment protocols.
The panel also recommended a ban on Cefadroxyl and Probenecid, citing a lack of pharmacokinetic evidence to support the inclusion of Probenecid or establish suitable dosing parameters.
The expert body raised similar concerns over certain antispasmodic combinations.
Formulations containing Dicyclomine, Paracetamol, Clidinium Bromide and Chlordiazepoxide were considered irrational because Dicyclomine already provides significant anticholinergic and smooth-muscle relaxant effects, making the addition of Clidinium Bromide unnecessary.
The three-drug variant comprising Dicyclomine, Paracetamol and Clidinium Bromide was rejected on the same grounds.
