Alembic pharma's Proposal for Azithromycin to prevent maternal infection rejected by CDSCO panel
New Delhi: Citing that the data was not adequate, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has denied the request presented by the drug major Alembic Pharmaceuticals for the additional indication of the macrolide antibiotic Azithromycin for "the maternal infection in women undergoing planned vaginal delivery ".
This came after the firm presented the proposal for the additional indication of Azithromycin tablets 500 mg i.e. “To prevent maternal infection in women undergoing planned vaginal delivery”.
The firm presented published literature and the results of international clinical trial data with a subset of Indian patients and requested a local clinical trial waiver along with the justification.
Azithromycin is a macrolide antibiotic which inhibits bacterial protein synthesis, quorum-sensing and reduces the formation of biofilm.
Azithromycin binds to the 23S rRNA of the bacterial 50S ribosomal subunit. It stops bacterial protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis and by inhibiting the assembly of the 50S ribosomal subunit. This results in the control of various bacterial infections. The strong affinity of macrolides, including azithromycin, for bacterial ribosomes, is consistent with their broad‐spectrum antibacterial activities
Azithromycin is an antibiotic medicine. It's used to treat infections including chest infections such as pneumonia. ear, nose, and throat and nose infections such as sinus infections (sinusitis). Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.
At the recent SEC meeting for Reproductive and Urology held on 20th July 2023, the expert panel reviewed the proposal presented by the drug major Alembic Pharmaceuticals for the additional indication of Azithromycin tablets 500 mg i.e. “To prevent maternal infection in women undergoing planned vaginal delivery”.
After detailed deliberation, the committee did not recommend approval of the proposed additional indication of Azithromycin tablets 500 mg as data was not adequate.
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