CDSCO Panel denies approval to Clobetasol Terbinafine Ofloxacin and Paraben FDC

The Subject Expert Committee (SEC), operative under CDSCO, refused to grant permission to the firm regarding the FDC of Clobetasol Propionate 0.0500 % w/w +Terbinafine Hydrochloride 1.0000 % w/w + Ofloxacin 0.7500 % w/w + propyl Paraben 0.0200 % w/w +Methyl Paraben 0.2000% w/w cream.

Clobetasol propionate belongs to the class of steroids known as Corticosteroids. Applied to the skin as a cream, ointment, or shampoo, this drug helps get some relief from redness, itching, swelling, or other discomfort caused by certain skin conditions. The drug is known to be effective in the treatment of eczema, contact dermatitis, seborrheic dermatitis, and psoriasis.

Terbinafine is an antifungal medication and it is also used in the treatment of certain skin conditions including pityriasis versicolor, fungal nail infections, etc.

Ofloxacin belongs to the class of antibiotics treating bacterial infections. Its common usages include pneumonia, cellulitis, urinary tract infections, prostatitis, plague, diarrhea, etc.

Propylparaben is an n-propyl ester of p-hydroxybenzoic acid. Methylparaben, on the other hand, is the methyl ester of p-hydroxybenzoic acid. Both are preservatives and are known for their usages in cosmetic and personal care products including creams, lotions, and shampoos.

In light of earlier recommendations of the committee dated 05.08.2020, the firm presented justification for the proposed FDC of Clobetasol Propionate 0.0500 % w/w +Terbinafine Hydrochloride 1.0000 % w/w + Ofloxacin 0.7500 % w/w + propyl Paraben 0.0200 % w/w +Methyl Paraben 0.2000% w/w cream.

The SEC committee in n its 54^th meeting held on 12.01.2021 at CDSCO HQ New Delhi discussed all the Dermatology & Allergy related proposals and made some recommendations regarding the same.

After detailed deliberation, the committee opined that the firm did not present any additional information in support of the FDC. Committee also noted that FDC of Clobetasol+ Terbinafine + Ofloxacin + Ornidazole was prohibited.

The Committee further opined that-

1. There is no therapeutic justification/study advocating for combining the three drugs in this FDC.

2. The proposed FDC is not recommended in any standard therapeutic guidelines.

3. The proposed FDC is not approved internationally.

4. The proposed FDC may result in the emergence of bacterial and fungal resistance. Further, patients may also be unnecessarily exposed to adverse effects of potent steroids.

In view of the above, the committee did not recommend for the proposed FDC.