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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.
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751