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Drug Alert: CDSCO Flags 48 Formulations As Not Of Standard Quality

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New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has flagged 48 medicine batches for failing to qualify for a random drug sample test for August– 2024. These include Amoxycillin and Potassium Clavulanate Tablets (Mexclav 625) manufactured by Meg Lifscience, Calcium and Vitamin D3 Tablets IP Shelcal 500 (Shelcal) manufactured by Pure and Cure Healthcare, Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500) manufactured by Scott-Edil, Vitamin B Complex with Vitamin C Softgels manufactured by Asoj Soft Caps, Rifmin 550 (Rifaximin Tablets 550 mg) manufactured by Legen Healthcare, Paracetamol Tablets IP 500 mg manufactured by Karnakata Antibiotics, Montair LC Kid (Montelukast Sodium & Levocetirizine Hydrochloride Dispersible Tablets) manufactured by Pure & Care Healthcare, and others. Furthermore, the list includes popular medicines Amoxicillin and Potassium Clavulanate (Clavam 625) t...

NMC CBME Curriculum: 'Suicide Risk Assessment' skill now mandatory for MBBS students, Psychiatrists Welcome Move

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New Delhi:  The MBBS students now will have to learn "Suicide Risk Assessment" as a certifiable skill as the National Medical Commission (NMC) has included the same in the Competency Based Medical Education (CBME) Curriculum 2024 guidelines. As per the revised CBME 2024 guidelines, which were released recently, MBBS students are required to perform suicide risk assessment as it has been included in the Psychiatry syllabus. The teaching-learning method specified for learning this skill includes role play, bedside teaching etc. The integration of this skill in undergraduate medical education has been welcomed by the Indian Teachers of Psychiatry (IToP) and academic wing of Indian Journal of Psychological Medicine. Commenting on the matter, the Chief co-ordinator of IToP Kishor M., who is a Professor and Head of the Psychiatry Department of JSS Medical College in Mysuru, informed The Hindu that the approval from the Apex Medical Commission makes it mandatory for all the MBBS...

11 Formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert

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New Delhi: In line with the 'Not of Standard Quality' data provided by states, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), in its latest drug safety alert, has flagged 11 medicine batches for failing to qualify for a random sample test for August 2024. The list of drugs declared not of standard quality includes Paziva -40 manufactured by Gnosis Pharmaceuticals, Pantomed -40 manufactured by Digital Vision, Cefixime Oral Suspension IP (Dry Syrup) manufactured by Nestor Pharmaceuticals, Moxymed CV manufactured by Alexa Pharmaceuticals, Frusemide Injection manufactured by Nestor Pharmaceuticals and others. Many factors contributed to the drug samples' failure in the test, such as non-compliance with the IP requirements for the particular drug, failure of the dissolution test, pH, and some assays of the drug test, among others. In addition to the above, the alert mentioned that the Not of Standard Quality (NSQ) data was not ...

CDSCO Panel Approves Pfizer's Protocol Amendment Proposal to Study Aztreonam and Avibactam

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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by the drug major Pfizer to study Aztreonam and Avibactam compared to the best available therapy for serious gram-negative infections. This came after the firm presented protocol amendment 3 dated 10 June 2024 protocol No. C3601008. The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants. Aztreonam is the first member of a new class of beta-lactam antibiotics, the monobactams. Azitreonam is selectively active against Gram-negative aerobic bacteria and inactive against Gram-positive bacteria. The bactericidal action of aztreonam results from the inhibition of bacterial cell wall synthesis due to a high affinity of aztreonam for penicillin binding protein 3...

JnJ gets USFDA nod for Rybrevant plus standard of care chemotherapy for lung cancer treatment

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Raritan:  Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved RYBREVANT (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI). “RYBREVANT plus chemotherapy may address the most common mechanisms of treatment resistance to third generation EGFR TKIs, such as osimertinib, in the first line,” said Martin Dietrich*, M.D., Ph.D., Oncologist, Cancer Care Centers of Brevard. “This multitargeted combination extended progression-free survival and improved overall response compared to chemotherapy alone, offering an important and effective new second-line option for patients.” The five-year survi...

Sleep Disturbance in Preteens Linked to Future Suicidal Behavior, find JAMA study

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Researchers have found that high-level sleep disturbances in preteens tend to increase the odds of suicidal thoughts and behaviors in later life. A cohort study involving more than 8,000 children found that when children are reported to experience sleep problems at the age of 10, for example, that is the same age where those children were found to be more likely to report suicidal ideation or attempt. This study conducted by Joel Stoddard, MD, and his colleagues at the Children's Hospital Colorado and University of Colorado Anschutz Medical Campus points out the necessity for checking sleep as a potential risk factor for early intervention and suicide prevention. The study was published in JAMA Network Open . The cohort consisted of 10,136 children with no previous suicidal thoughts or attempts at baseline, recruited within the Adolescent Brain Cognitive Development Study. Data collection began June 2016 through January 2021. The study aimed to determine whether sleep disturbanc...

Danish Study Reveals Connection Between Diabetic Neuropathy, Retinopathy, and Severe Periodontitis

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Denmark: A cross-sectional analysis of Danish population-based data indicated that moderate and severe periodontitis was associated with certain diabetes complications. The findings were published online in the Journal of Dental Research on August 5, 2024. The study revealed that diabetic neuropathy and retinopathy, whether considered separately or together, were linked to moderate or severe periodontitis. Additionally, dyslipidemia further increases the risk of moderate or severe periodontitis among those with diabetic microvascular complications. "These insights could help in identifying at-risk subgroups for both diabetes-related microvascular complications and periodontitis, ultimately improving strategies to reduce the overall disease burden," the researchers wrote. Evidence on the relationship between diabetes-related microvascular complications and periodontitis remains inconsistent, with reliable estimates hampered by small sample sizes and residual confounding ...