Cipla Gets CDSCO Panel Nod to Study Plazomicin Injection
New Delhi: The drug major Cipla has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the phase IV clinical trial of the antimicrobial drug Plazomicin Injection 500 mg/10 ml.
This came after the drugmaker Cipla presented the Phase IV clinical trial protocol before the committee. Phase IV trials are done after a drug has been shown to work and has been licensed. Phase 4 trials aim to find out: more about the side effects, including the rarer side effects and safety of the drug.
Plazomicin is an aminoglycoside antibiotic used to treat complicated urinary tract infections. Plazomicin exerts a bactericidal action against susceptible bacteria by binding to the bacterial 30S ribosomal subunit. Aminoglycosides typically bind to the ribosomal aminoacyl-tRNA site (A-site) and induce a conformational change to further facilitate the binding between the rRNA and the antibiotic. This leads to codon misreading and mistranslation of mRNA during bacterial protein synthesis.
At the recent SEC meeting for antimicrobials and antivirals held on June 26, 2023, the expert panel reviewed the Phase IV clinical trial protocol before the committee.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase IV clinical trial with the new drug Plazomicin injection 500 mg/10 ml as per the protocol presented.
