Glenmark gets CDSCO panel conditional nod to Minocycline Hydrochloride Topical Gel
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has opined for the grant of permission to Glenmark Pharma for Minocycline Hydrochloride Topical Gel 4% for Topical use. However, the permission comes with a couple of conditions, including, presentation of Phase IV CT protocol before the committee for further consideration.
This came after the drugmaker, Glenmark Pharma presented their proposal along with the In Vitro Permeation Test (IVPT) report and also submitted their justification for the waiver of Bioequivalence (BE) and Clinical Trial (CT) Study to the Subject Expert Committee (SEC) of CDSCO.
Minocycline, a tetracycline antibiotic is known for its usages in the treatment of a number of bacterial infections such as pneumonia. The drug is also used to treat acne vulgaris, other skin infections such as methicillin-resistant Staphylococcus aureus, Lyme disease, etc.
Glenmark Pharma presented the proposal along with the report of IVPT, a justification for BE, and CT study waiver.
Minocycline Hydrochloride Topical Foam 4% is already approved in the USA.
The SEC committee, in its 54th meeting held on 12.01.2021 at CDSCO HQ New Delhi reviewed all the proposals related to Dermatology and Allergy and made some recommendations regarding the same. Among these, Glenmark's proposal was examined as well.
After detailed deliberation of the proposal of Glenmark Pharma, the committee opined that grant of permission for Minocycline Hydrochloride Topical Gel 4% may be considered subject to the condition that the firm should submit the following:
1. Propionibacterium acnes sensitivity to minocycline and incidence of Hyperpigmentation in the Indian population.
2. The firm should present Phase IV CT protocol before the committee for further consideration.
A global research-led pharmaceutical company, Glenmark's key therapy focus areas globally are respiratory, dermatology, and oncology.