Glenmark gets CDSCO panel nod to revise phase 4 protocol for Minocycline Hydrochloride Topical Gel

New Delhi: Responding to the phase IV protocol for Minocycline Hydrochloride Topical Gel 4% for topical use presented by Glenmark Pharma, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has recommended the firm to submit revised protocol that includes Serum (Antinuclear antibody) ANA by Hep 2 method for all patients and justification regarding for sample size, time points, screening of the patient.

This came after the drugmaker, Glenmark Pharma, presented their proposal along with phase –IV CT protocol in accordance with the previous recommendation, at 57 th SEC (Dermatology & Allergy) meeting held on 09.06.2021 CDSCO.

Minocycline belongs to the tetracycline group of antibiotics, which is known for its usage 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.

Minocycline Hydrochloride is the hydrochloride salt of minocycline. It is a broad spectrum, long-acting derivative of the antibiotic tetracycline, with both antibacterial and anti-inflammatory activities. It is used 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.

Minocycline Hydrochloride treats acne by destroying bacteria that infects pores and reducing the natural oily material that causes acne.

Minocycline acts by binding to the bacterial 30S ribosomal subunit and interferes with the binding of tRNA to the ribosomal complex, thereby inhibiting protein translation in bacteria. Minocycline also suppresses the inflammatory enzyme 5-lipoxygenase (5LOX) and may reduce T cell-microglia interactions, which may contribute to the neuroprotective benefits of the drug. 

Earlier, the Medical Dialogues team had reported that in the 54th meeting held on 12.01.2021 at CDSCO, Glenmark Pharma had presented their proposal for Minocycline Hydrochloride Topical Gel 4% for Topical use 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. 

In response to this, previously the committee had 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 the incidence of hyperpigmentation in the Indian population.

2. The firm should present the Phase IV CT protocol before the committee for further consideration.

Accordingly, at the recent SEC meeting for Dermatology & Allergy, Glenmark Pharma presented the phase IV clinical trial protocol before the committee.

After detailed deliberation the committee recommended that the firm should submit revised protocol after including following:

1. Serum ANA by Hep 2 method for all patients.

2. Justification regarding for sample size, time points, screening of the patients.