Ketoconazole 2% w/w +Clioquinol 1% w/w + Tolnaftate 1% w/w + Neomycin 0.5% w/w + Clobetasolpropionate 0.05% w/w Cream.
This combination cream is an antifungal + antibacterial +very strong steroid combination was marketed for “skin infections”, “itching”,“ringworm” etc before banned.
Main regulatoryreason for the ban
This was an unapproved Fixed Dose Combination (FDC)” at thecentral level, meaning it was never properly evaluated and approved as a singlecombination by India’s central drug regulator. To know more please click the CDSCOUnapproved Drug information.
As per the Drug Technical Advisory Board (DTAB) and anexpert committee the risk is more than the possible benefit. To know more aboutthe fixed dose combination drugs over health risk concerns Click here
Medical and SafetyConcerns
Clobetasol risks:This super-potent steroid thins skin, causes stretch marks, acne, or colorchanges if misused. Long or large-area use can lead to hormone issues andbody-wide side effects.
Misuse in infections:Mixing with antifungals/antibiotics leads to wrong use on ringworm, face,groin, or kids. It hides symptoms, letting fungus spread and resist treatment(tinea incognito).
Other ingredientdangers: Neomycin triggers allergies or resistance; clioquinol/tolnaftateadd no proven benefits but increase side effect risks.
Real-world issues:Indian studies show high misuse and harm from this exact combo, causing skindamage and hard-to-treat infections.
To know more about the Topical steroid containingcombinations how it Burden of adverse effects... click here
What Doctors, Pharmacists,wholesalers, PCD Pharma Franchise Companies should know:
This exact FDC (KETOCONAZOLE + CLIOQUINOL(IODOCHLORHYDROXYQUIN) + TOLNAFTATE + NEOMYCIN + CLOBETASOL cream) has beenspecifically named among unapproved FDCs for which manufacturing, sale, anddistribution are prohibited in India.
Key regulatoryfindings:
AS there is no adequate evidence that this five‑drugcream gives better outcomes than standard, separate, approved treatments. Significant concerns of irrationaluse, masking of fungal infections, increased resistance, and steroid‑relatedadverse events in the community. To know more about Topicalantifungal-corticosteroid drug read this article bygov.
As an Ethical PCD Pharma Franchise Company Cafoli Lifecarefeels this a responsibility to Educate customers that the ban is for safety andlack of justification, not because the cream is “too strong” or “very good”.
Pharmacists and wholesalers must Discontinue stocking anddispensing this FDC Any remaining stock should be handled as per local drugauthority instructions for banned products.
These are the primaryreplacements for the banned FDCs in routine Tinea cases.
Luliconazole1%
Terbinafine1%
Clotrimazole1%
As an ethical or PCD pharma franchise you can Promotethese products based on compliance, efficacy, and adherence to non-steroiduse in tinea.
Also, there are Oral antifungal medicines in PCD Pharma Franchise whentopical treatment fails.
· Itraconazole(Capsules)
· Terbinafine(Tablets)
Also, some other options available in Cafoli PCD PHARMA FRANCHISE when theprimary issue is not fungal.
· BetamethasoneValerate
· Mupirocin
· Fusidic Acid
Cafoli Lifecare is dedicated to supporting your success as a valued PCDPharma Franchise Partner.
In the wake of the regulatory shifts banning multi-drug topical FDCs, ourfocus remains on supplying high-quality,clinically compliant monotherapy products that meet the current ethicalprescribing standards and physician demand.