Glenmark gets CDSCO panel conditional nod to Minocycline Hydrochloride Topical Gel

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.