Submit in vitro study data and justify dose: CDSCO Panel Tells Akums Drugs on Veterinary Antibiotic FDC
New Delhi: Responding to the proposal presented by Akums Drugs and Pharmaceutical regarding the veterinary antibiotic combination amoxycillin 3 gm plus clavulanic acid 600 mg, the Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organization (CDSCO), has recommended the firm to submit and present the in vitro study data on efficacy, susceptibility, and justification for dose selection in target animals, maximum dose, schedule of dosing, and withdrawal period.
This came after Akum Pharmaceutical presented the proposal before the SEC committee.
Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Amoxicillin is a penicillin antibiotic. It is used to treat bacterial infections, such as chest infections (including pneumonia) and dental abscesses. It can also be used together with other antibiotics and medicines to treat stomach ulcers.
Clavulanic acid is a beta-lactam drug that prevents bacteria from destroying other antibiotics. It does this by binding to the active site of beta-lactamases, which are enzymes that break down antibiotics. This prevents the beta-lactamases from inactivating antibiotics like amoxicillin.
At the recent SEC meeting for veterinary held on 20th February 2025, the expert panel reviewed the proposal presented by Akums Drugs and Pharmaceutical.
After detailed deliberation, the committee recommended that the firm should submit the following and present the same in the next SEC meeting.
a) In vitro study data for efficacy, susceptibility, and minimum inhibitory concentration against the animal pathogens.
b) Justification for dose selection in target animals, maximum dose, schedule of dosing, and withdrawal period.
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