No Safety Data On Indian Populations: CDSCO panel tells Alkem over Cefixime Oral Suspension

This came in line with the proposal presented by the drug maker Alkem for manufacturing and marketing Cefixime Oral Suspension IP 200mg/ml indicated in the treatment of pediatric patients 6 months of age or older with the following infections when caused by susceptible isolates of designated bacteria:

1. Otitis media caused by Haemophilus influenza, Moraxella catarrhalis, and Streptococcus pyrogens.

2. Pharyngitis and tonsillitis are caused by Streptococcus pyrogens.

3. Acute exacerbation of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenza.

4. Uncomplicated Urinary Tract infections caused by Escherichia coli and Proteus mirabilis.

5. For the treatment of enteric (typhoid) fever.

Furthermore, the firm presented the rationale for Bioequivalence and clinical trial waiver.

Cefixime is a third-generation cephalosporin used to treat susceptible Gram-negative and Gram-positive bacterial infections. Cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefixime interferes with an autolysin inhibitor.

Cefixime is used to treat certain infections caused by bacteria such as bronchitis (infection of the airway tubes leading to the lungs); gonorrhoea (a sexually transmitted disease); and infections of the ears, throat, tonsils, and urinary tract. Cefixime is in a class of medications called cephalosporin antibiotics.

At the recent SEC meeting for Antimicrobial & antiviral held on 30th January 2023, the expert panel reviewed the proposal presented by the drug major Alkem Lab for manufacturing and marketing the antibiotic drug Cefixime Oral Suspension IP 200mg/ml.

The expert panel noted that the firm did not have the safety data on Indian population.

After detailed deliberation, the committee recommended, " As the firm did not have the safety data on Indian population, the firm is required to conduct the Phase III clinical trial and submit the clinical trial protocol and relevant documents for further deliberation by the SEC committee."