Enhancing Adherence to Perioperative Antibiotic Prophylaxis Guidelines: Key Step for Prevention of Surgical Site Infections

Recent qualitative study aimed to explore factors influencing perioperative antibiotic administration and assess the potential impact of a clinical decision support tool on improving adherence to Infectious Disease Society of America (IDSA) guidelines for surgical antibiotic prophylaxis. The researchers conducted semistructured interviews with a diverse group of perioperative personnel, including anesthesiologists, surgeons, nurses, residents, and pharmacists across the Yale-New Haven Health System. After 3 pilot interviews, 9 sessions were conducted with a total of 17 participants. Several key themes emerged from the interviews: 1. Limited familiarity with IDSA antibiotic guidelines – There was significant uncertainty regarding the existence and content of IDSA guidelines, with practitioners often relying on Surgical Care Improvement Project (SCIP) guidance instead. 2. Lack of standardization and optimization of the antibiotic decision-making process – While electronic health record resources and pharmacy consultation were available, access and usability were variable, leading to inconsistent workflows. 3. Challenges with managing beta-lactam allergies and optimizing vancomycin timing – Practitioners expressed uncertainty about appropriate antibiotic choices for patients with allergies and difficulty ensuring optimal timing of vancomycin administration. 4. Perceived benefit of a clinical decision support tool – Interviewees felt that a well-designed tool integrated into the electronic health record could enhance workflow and promote better adherence to perioperative antibiotic guidelines. The interviews provided important insights into the barriers to guideline adherence and potential opportunities for improvement through the development of a tailored clinical decision support tool. Key recommendations included improved visibility and accessibility of guidelines, better integration of pharmacy input, and more reliable processes for managing antibiotic administration, especially for challenging scenarios like vancomycin timing and antibiotic allergies.

Key Points

1. The study aimed to explore factors influencing perioperative antibiotic administration and assess the potential impact of a clinical decision support tool on improving adherence to Infectious Disease Society of America (IDSA) guidelines for surgical antibiotic prophylaxis.

2. The researchers conducted semistructured interviews with a diverse group of perioperative personnel, including anesthesiologists, surgeons, nurses, residents, and pharmacists across the Yale-New Haven Health System, and identified several key themes: – Limited familiarity with IDSA antibiotic guidelines, with practitioners often relying on Surgical Care Improvement Project (SCIP) guidance instead. – Lack of standardization and optimization of the antibiotic decision-making process, with variable access and usability of electronic health record resources and pharmacy consultation. – Challenges with managing beta-lactam allergies and optimizing vancomycin timing, leading to uncertainty about appropriate antibiotic choices and difficulty ensuring optimal timing of vancomycin administration. – Perceived benefit of a well-designed clinical decision support tool integrated into the electronic health record, which could enhance workflow and promote better adherence to perioperative antibiotic guidelines.

3. The interviews provided insights into the barriers to guideline adherence and potential opportunities for improvement, including improved visibility and accessibility of guidelines, better integration of pharmacy input, and more reliable processes for managing antibiotic administration, especially for challenging scenarios like vancomycin timing and antibiotic allergies.

4. The study highlighted the need for a tailored clinical decision support tool to address the identified barriers and improve adherence to perioperative antibiotic guidelines.

5. The findings suggest that a well-designed clinical decision support tool integrated into the electronic health record could enhance workflow and promote better adherence to IDSA guidelines for surgical antibiotic prophylaxis.

6. The study emphasizes the importance of addressing the identified barriers, such as limited familiarity with guidelines, lack of standardization in the antibiotic decision-making process, and challenges with managing complex scenarios, in order to improve adherence to perioperative antibiotic guidelines.

Reference –

Amit Bardia et al. (2024). Individual And System Level Factors Contributing To Guideline Non-Adherent Surgical Antibiotic Prophylaxis At A Tertiary Health Care System: A Qualitative Analysis.. *Anesthesiology*. https://doi.org/10.1097/ALN.0000000000005302.

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Lesion size critical predictor of clinically significant prostate cancer within PI-RADS 4 category: Study

A new study published in the journal of Research and Reports in Urology showed that lesion size was a crucial predictor of clinically significant prostate cancer (CSPCa) in the PI-RADS 4 category.

When diagnosing prostate cancer (PCa), magnetic resonance imaging (MRI) is a crucial diagnostic technique. The frequency of CSPCa with PI-RADS 4 is 33–41%, whereas PI-RADS 5 is 62–79%, per the most recent guidelines. The PI-RADS v2.1 score corresponds with clinically significant prostate cancer. Despite just being 15 mm apart, there is a noticeable variation in risk between both groups.

To assist with risk stratification and patient counseling in the pre-biopsy scenario, this study by Ali Hooshyari and team attempts to identify a size threshold linked with CSPCa within the PI-RADS 4 group. This threshold may be employed in conjunction with other prostatic characteristics, such as PSA density. In the event of a negative biopsy, this may also help with surveillance of smaller PI-RADS 4 lesions and prevent needless repeat biopsies unless prompted by a size threshold.

The data from a total of 407 individuals who had transperineal prostate biopsies (TPPBs) between April 2022 and November 2023 were used in a retrospective analysis. For analysis, a subset of patients with PI-RADS 4 was included. The result was a ROC-AUC.

The findings of this study found that the PSA density was 0.20 (interquartile range 0.13–0.28) and the median age was 67 (interquartile range: 61–71). There was a link between the PI-RADS score and CSPCa: 10% for PI-RADS 1 and 2, 20% for PI-RADS 3, 60% for PI-RADS 4, and 80% for PI-RADS 5 (Pearson correlation = 0.51, p < 0.001).

The results showed that the Receiver Operating Characteristic Area Under the Curve (ROC-AUC) was 0.664 [0.579–0.7499]. 8.5 mm was the ideal cut-off point. CSPCa risk was 2.31 times greater in those with lesions bigger than 8.5 mm. When PI-RADS 4 lesions reach the statistically significant size threshold of 8.5 mm, the probability of CSPCa is 2.31 [1.31–4.07] times greater than for lesions that fall below this threshold. Therefore, the size of a PI-RADS 4 lesion is important and may actually be used to predict the likelihood of a positive biopsy for CSPCa.

Overall, the study emphasized the significance of considering PI-RADS 4 lesions in size-specific groups. This is a helpful tool for increasing the precision of patient counseling and optimizing follow-up or monitoring tactics when paired with PSA density.

Source:

Hooshyari, A., Scholtz, D., Maoate, K., Robertson, S., Vermeulen, L., De Andrade, L. G. M., Kawano, P., Gilling, P., Fraundorfer, M., & Vasconcelos Ordones, F. (2025). Does size matter? A retrospective study analysing the size of PI-RADS 4 lesions and its associated prostate cancer positivity with transperineal prostate biopsy. Research and Reports in Urology, 17, 49–57. https://doi.org/10.2147/rru.s499930

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Unusual Presentation of Lateral Periodontal Cyst in Molar Region of Elderly Patient

USA: In a recent case report, the researchers have reported a rare presentation of a lateral periodontal cyst (LPC) in the interdental molar region in a 68-year-old patient, highlighting the need for careful diagnosis and timely management of such lesions in older individuals.

The case report was described in the Gerodontology Journal by John K. Brooks, Department of Oncology and Diagnostic Sciences, University of Maryland School of Dentistry, Baltimore, Maryland, USA, and colleagues.

LPC is a developmental odontogenic cyst that typically occurs along the lateral roots of mandibular canines and premolars. However, its presence in the molar region is highly uncommon, and reports of such cases in geriatric patients are even rarer. This case sheds light on an unusual location of LPC and reinforces the importance of considering it in differential diagnoses for cystic lesions in the posterior mandible.

The lesion was incidentally detected during routine extraoral and intraoral radiographic examinations. Initially, the researchers suspected it to be an infected odontogenic keratocyst or unicystic ameloblastoma due to its radiographic features. Given the potential for more aggressive pathologies, further investigation was necessary to determine the exact nature of the lesion.

Histopathological analysis of the excised specimen confirmed the diagnosis of an LPC, revealing a thin cuboidal epithelial lining with focal nodular thickenings and an underlying fibrovascular connective tissue wall. The patient underwent surgical removal of the lesion, and follow-up at six months showed no recurrence, with evidence of radiographic bone regeneration.

This case highlights the importance of considering LPC in the differential diagnosis of odontogenic cysts, even in atypical locations such as the inter-molar region. Preoperative cone beam computed tomography (CBCT) can be a valuable tool in optimizing surgical planning by providing detailed imaging of the lesion’s extent and relationship with surrounding structures.

Early identification and excision of cystic lesions, particularly in older patients, prevent complications such as infection, bone loss, or potential malignancy. The case emphasizes the need for dental professionals to remain vigilant when evaluating radiolucent lesions in geriatric patients, ensuring timely intervention to reduce postoperative complications and promote better outcomes.

“LPC should be considered in the differential diagnosis of developmental odontogenic cysts in the inter-molar region. A preoperative cone beam computed tomography scan can aid in optimizing the surgical approach,” the researchers wrote.

“Early removal of suspected cystic lesions, especially in older patients with infection, may help minimize postoperative complications and exclude the possibility of malignancy,” they concluded.

Reference:

Brooks, J. K., Portillo, N., Bhatti, A. K., Parsa, A., & Basile, J. R. (2025). Lateral periodontal cyst in an interdental molar site: Novel presentation in a geriatric patient. Gerodontology, 42(1), 124-128. https://doi.org/10.1111/ger.12759

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First-Trimester Ultrasound Effective for Screening for Fetal CHD, suggests study

Researchers have found in a new study that first-trimester ultrasound screening enables early prenatal diagnosis and consultation for fetal congenital heart disease (CHD). Further the standardized screening strategy used in the study demonstrated a high detection rate, supporting its effectiveness. However, while this approach is recommended for early diagnosis, it should not replace second-trimester fetal echocardiography.

A study was done to assess the performance of a standardized first-trimester ultrasound screening strategy for fetal congenital heart disease (CHD). This was a large retrospective study involving 74 839 consecutive mixed-risk pregnancies (77 396 fetuses). Routine ultrasound scans at 11 + 0 to 13 + 6 weeks’ gestation were performed in a single center from January 2015 to June 2023. All fetuses were examined using a predefined standardized ultrasound scanning strategy with adjustment of imaging parameters, which included assessment of the fetal heart. The ultrasound results (e.g. extracardiac congenital malformations), ultrasound markers (e.g. nuchal translucency thickening, reversed a-wave in the ductus venosus and tricuspid regurgitation), follow-up, genetic tests and diagnostic results were recorded and analyzed. RESULTS: In total, there were 831 cases of CHD, with an incidence of 1.07% (831/77 396). In the first-trimester scan, 590 fetuses were diagnosed with CHD, but four were confirmed as normal in later examinations. In addition, 245 cases were missed. The detection rate was 70.52%, with a sensitivity, specificity, false-positive rate and false-negative rate of 70.52%, 99.99%, 0.01% and 29.48%, respectively. In fetuses with negative ultrasound markers and no extracardiac malformations, the detection rate of CHD was 45.79% (185/404). There were 281 cases that underwent karyotyping and chromosomal microarray (245 fetuses) or whole-exome sequencing (36 fetuses). In total, 38.79% (109/281) had a positive genetic test result. There were 273/831 CHD cases associated with extracardiac malformations. The abnormal image patterns and abnormal features of each view in the scanning strategy were summarized. Ultrasound screening for fetal CHD in the first trimester of pregnancy enables earlier prenatal diagnosis and consultation. The standardized ultrasound screening strategy used in this study had a high detection rate for fetal CHD in the first trimester. Our proposed fetal heart screening strategy shows promising effectiveness for early diagnosis of CHD and we recommend its use. It is important to note, however, that first-trimester ultrasound screening for fetal CHD should not replace fetal echocardiography in the second trimester. © 2025 International Society of Ultrasound in Obstetrics and Gynecology.

Reference:

Yang, S, et al. “Evaluation of First-trimester Ultrasound Screening Strategy for Fetal Congenital Heart Disease.” Ultrasound in Obstetrics & Gynecology : the Official Journal of the International Society of Ultrasound in Obstetrics and Gynecology, 2025.

Keywords:

First-Trimester, Ultrasound, Effective, Screening, Fetal, CHD, suggests, study, Ultrasound in Obstetrics & Gynecology, Yang, S

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Early CPAP-Usage Patterns Predict Long-Term Adherence in OSA Patients: Study Reveals

UK: A recent study published in the BMJ journal Thorax has identified six early behavioural patterns of continuous positive airway pressure (CPAP) usage that can predict long-term adherence in patients with obstructive sleep apnoea (OSA).

The researchers found that early patterns of CPAP usage could help predict long-term adherence in patients with OSA. They identified six distinct behavioral patterns, with 62% of patients being non-adherent by the third month. Interestingly, 98% of those who failed to adhere to CPAP therapy showed signs of non-compliance within the first month. These findings suggest that making adjustments as early as the second week could enhance treatment outcomes.

The researchers note that high rates of non-adherence to continuous positive airway pressure therapy in obstructive sleep apnoea pose a significant challenge to achieving optimal clinical outcomes. Current recommendations categorize patients into two groups—adherent and non-adherent—and suggest follow-ups between days 7 and 90 after CPAP initiation to address adherence issues. However, this approach may not be sufficient to prevent long-term non-compliance.

To better understand this issue, Julia Dielesen, National Heart and Lung Institute, Imperial College London, London, UK, and colleagues investigated how early CPAP-usage behaviours relate to adherence at three months and examined how sleep centers’ treatment pathways—such as patient support strategies and procedural interventions—may influence CPAP adherence. By identifying distinct early usage patterns, the study aimed to improve adherence prediction and enable tailored interventions that enhance long-term treatment success.

For this purpose, the researchers conducted growth mixture modelling (GMM) using retrospective data from 1,000 patients across five UK sleep centres. They analyzed telemonitored CPAP usage data from the first night to the third month, selecting 200 patients per centre who initiated CPAP therapy in 2019 or 2020. Adherence was determined based on established criteria, defining it as an average CPAP usage of at least four hours per night for 70% or more of the monitored nights.

The following were the key findings of the study:

  • Researchers identified six distinct CPAP-usage behaviour patterns within the first month.
  • In 54% of patients, CPAP usage either increased or decreased over time.
  • The remaining 46% showed consistent CPAP usage or non-usage throughout.
  • By the third month, 62% of patients were non-adherent, despite following current recommendations.
  • Among those who were non-adherent at month 3, 98% had already shown signs of non-adherence by month 1.
  • Regression analysis on a separate dataset revealed that early CPAP usage behaviour accounted for 86% of the variation in CPAP non-adherence at month 3.

The researchers highlight that current follow-up recommendations (days 30–90) are too late to prevent CPAP non-adherence. Their findings show that assessing CPAP-usage behaviours by week 2 can predict non-adherence at month 3, enabling timely interventions. Despite CPAP being the most effective OSA treatment, adherence remains low, with only 38% of patients consistently using it after three months.

The researchers identified six behavioural patterns linked to long-term adherence and stressed the need for follow-ups within the first three weeks. Their classification offers valuable insights for future research, allowing tailored strategies to improve CPAP adherence and optimize patient outcomes.

Reference:

Dielesen J, Ledwaba-Chapman LJ, Kasetti P, et al. Six early CPAP-usage behavioural patterns determine peak CPAP adherence and permit tailored intervention in patients with obstructive sleep apnoea. Thorax Published Online First: 27 February 2025. doi: 10.1136/thorax-2024-221763

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One in five of pregnant and postpartum individuals experience depression and anxiety, very few take treatment: Study

Approximately one in five of pregnant and postpartum individuals experience depression and anxiety, yet less than 10 per cent receive proper treatment.

To address this problem, a team of interdisciplinary researchers from Canada and the United States investigated if talk therapy can be effectively delivered by non-mental health specialists and telemedicine to increase access. In a paper published today in Nature Medicine, they share results from the Scaling Up Maternal Mental health care by Increasing access to Treatment (SUMMIT) Trial, which reveals promising strategies to provide the necessary support and treatment more effectively and inclusively for pregnant and postpartum populations.

The SUMMIT Trial demonstrated that trained nurses, midwives, and doulas can deliver talk therapy as effectively as psychologists and psychiatrists. After receiving up to eight treatment sessions patients reported significant improvement in symptoms of depression and anxiety regardless of the treatment provider type. The sessions are not meant to replace therapy from trained specialists, but to offer important access to patients facing common but often untreated mental health conditions due to the shortage of specialist providers.

The study also investigated the effectiveness of delivering talk therapy through telemedicine compared to in-person sessions. While in-person sessions have long been the gold standard in psychotherapy, the study has shown that online therapy is equally beneficial.

“Talk therapy is effective but largely inaccessible. As our health systems grapple with a shortage of specialists and the rising costs of care, many pregnant and post-partum individuals suffer in silence. Leveraging simple, pragmatic solutions of task-sharing and telemedicine has the potential to transform health care and improve access to essential mental health services,” said Dr. Daisy Singla, the Lead Principal Investigator of SUMMIT. Dr. Singla is a Clinician Scientist at the Lunenfeld-Tanenbaum Research Institute, part of Sinai Health, a Senior Scientist at the Centre for Addiction and Mental Health (CAMH) and an Associate Professor of Psychiatry at the University of Toronto.

Conducted in hospitals across North America, including Mount Sinai Hospital, Women’s College Hospital and St. Michael’s Hospital in Toronto, the Women’s and Neuroscience Hospitals associated with the University of North Carolina (UNC) in Chapel Hill and Endeavor Health in Chicago, the SUMMIT study was among the largest psychotherapy trials in the world. Of the 1,230 participating pregnant and postpartum individuals, almost 50 per cent identified as racialized minorities.

Participants received between six and eight weekly sessions of Behavioral Activation, a form of talk therapy that encourages engaging in meaningful activities aligned with personal values and has been shown to alleviate symptoms of depression and anxiety.

Following treatment, depression scores decreased from an average of 16 to 9 on the Edinburgh Postnatal Depression Scale, moving below the mild depression threshold of 10. Anxiety scores also fell from an average of 12 to 7 on the General Anxiety Disorder-7 scale, dropping below the clinical threshold of 8. These improvements occurred regardless of symptom severity before the treatment.

“Our research shows that a collaborative model in real-world health-care systems involving both specialists and trained non-specialists could significantly reduce wait times and expand access to effective, quality mental health care,” said Dr. Samantha Meltzer-Brody, co-Principal Investigator of SUMMIT and Site Lead at UNC Chapel Hill.

The Behavioural Activation training program for non-specialist providers included comprehensive instruction on behavioral activation, supervision by mental health specialists, and practical role-play exercises, amounting to 20-25 hours of training.

According to Dr. Richard Silver, Chair of Obstetrics & Gynecology at Endeavor Health and Site Lead at Endeavor Health, talk therapy is often preferred over medication for common conditions such as depression and anxiety, especially for pregnant and postpartum people.

“Finding effective ways to treat these patients is critical – and specifically, ways that don’t involve medication, which some would rather avoid while pregnant or breastfeeding. We need a safe and effective alternative treatment — talk therapy can help fill this gap,” said Dr. Silver.

Untreated, depression and anxiety can lead to severe consequences, including maternal mortality, obstetrical complications and developmental problems in children. Dr. Singla added, “Investing in perinatal mental health means investing in a healthier, more equitable future for parents, their children and our communities at large.”

While research continues to determine whether the benefits of therapy delivered by non-specialists extend beyond three months, the team is also conducting a separate economic evaluation of these innovations within the Canadian and U.S. health-care systems. 

Reference:

Singla, D.R., Silver, R.K., Vigod, S.N. et al. Task-sharing and telemedicine delivery of psychotherapy to treat perinatal depression: a pragmatic, noninferiority randomized trial. Nat Med (2025). https://doi.org/10.1038/s41591-024-03482-w

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CCI clears hospital in false advertising, misrepresentation case

The Competition Commission of India (CCI) has dismissed a complaint filed against Victor Hospital, Margao, Goa, regarding allegations of misleading consumers by employing an unregistered surgeon and engaging in anti-competitive practices.
Presiding over the case, Ravneet Kaur, Chairperson; Sweta Kakkad, Member; Deepak Anurag, Member clarified that the allegations against Victor Hospital did not raise concerns under competition law. The commission stated that misleading consumers by misrepresenting a surgeon’s qualifications and engaging in false advertising, while serious, do not amount to anti-competitive behaviour under the Competition Act, 2002. It was noted that such issues should be dealt with by medical regulatory bodies rather than the CCI.

For more information, click on the link below:

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CDSCO Introduces Online Export NOC System on SUGAM Portal

New Delhi: Enhancing the ease of doing business, the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health & Family Welfare, Government of India, has streamlined the process of issuing export NOCs (No Objection Certificates) for unapproved or approved new drugs through the SUGAM Portal.

Further, with an aim to reduce the compliance burden, CDSCO has initiated the issue of a 1-year NOC, subject to prescribed conditions for such drugs.

Accordingly, the authority has introduced a revised Sugam checklist to streamline the application process for Export NOC.

“Application for Export NOC shall be submitted through the SUGAM Portal along with a prescribed checklist of documents,” the notice added.

The notice further mentioned, ” This modified system is now functional now on SUGAM Portal of (www.cocoonine.am.in)”

User Manual for SUGAM- An e-Governance solution Online Forms Submission NOC (Zone)- Export NOC by Central Drugs Standard Control Organization (CDSCO) has been published.

Explaining the registration process for the Online Form Submission NOC (Zone)-Export NOC, the notice mentioned that all the corporate users can submit online forms under NOC (Zone). Following are the steps involved in the same.

  • When the applicant logins using his credentials, he needs to switch his role to corporate by selecting corporate from the list of Switch Role dropdown present on his dashboard. For better understanding, here is the image.

  • After switching the role, the applicant needs to click on the Submit Application hyperlink present on the dashboard. The following popup will appear as mentioned below.

  • Once the Applicant confirms to switch role by clicking OK in the above screen, the Online Form Submission page will open as shown below.

  • There is a list of departments present in the Select Department dropdown. The Applicant needs to select NOC (Zone) form the list.

  • After selecting NOC (Zone) department, two options would be available for select Form: Export NOC and Dual Use NOC.

1. Export NOC

  • The Applicant selects Export NOC from the Select Form dropdown and clicking the checkbox, he can move further by clicking on Proceed button. The following screen will appear as shown below.

NOTE: All the license numbers present in the License No. dropdown are those licenses which have been added by the applicant. The Applicant can add more license numbers by following the below steps.

The Applicant needs to click on the Menu button present at the left corner of the screen. Then he can go to User Profile –> Add Wholesale/ Manufacturing License Details. Here is the screenshot for better understanding.

  • On this page, there are the following options available under Applying for NOC for the first time; below is a screenshot of the same. There is a two-option option if the user is applying Yes or No.

1. After selecting the desired option from Applying NOC for first time dropdown, the Applicant can see two options on the Applied for option from the dropdown: Approved New Drug and Banned new drug, Material transfer, Narcotics and Psychotropic Substances Drug (NDPS), Unapproved Drug. We will see these in detail in the further sections.

  • 1.1 After selecting the Approved New Drug
  • The user has to select Purpose of Application Bulk Drug API, Finished Formulation, R&D for BD, and R&D for FF as mention in below screen.
  • After selecting Bulk Drug API user have to select the License NO which was added in the drop-down by the User While clicking on the MENU button as screenshot added in the drop-down.
  • Now user has to add a License No (How to manufacturing license number please referee page No. 6).

  • After clicking Save and Continue Button by the user Page will be re-direct to the next page as per attached screenshots.
  • Now the drug details page will be visible where users have to fill the drug details as per attached screenshots.

  • Generic Name of drug (user have to entered correct drug name Pharmacopeia Monograph (can be select from the drop-down) Class of Drug (can be selected from the drop-down)
  • Shelf life (in the filed user needs to entered the value in the number and they have to select shelf in Days, weeks, Month, year)
  • Storage condition can be selected from the drop-down,
  • Now user, have to select the country from the drop-down where he has to export the Products from * Multiple country can be selected from the drop-down.

  • After clicking on save button drug details will be added successfully (user can add multiple drug) as per attached screenshots.

1.2 After selecting the Ban Drug

    • User has to select Purpose of Application Bulk Drug API, Finished Formulation, as mention in below screen.After selecting the Finished Formulation option and Licence No (How to manufacturing license number please referee page No. 6) from the drop-down user have to click on save and continue button for drug details entry as attached screenshots.
  • Generic Name of drug (user have to entered correct drug name) Brand Name(this field is optional for user)
  • Pharmacopeia Monograph (can be select from the drop-down) Class of Drug (can be selected from the drop-down)
  • Shelf life (in the filed user needs to entered the value in the number and they have to select shelf in Days, weeks, Month, year)
  • Storage condition can be selected from the drop-down.
  • Quantity (can be entered in number value and volume can be selected from the drop- down)
  • Now user, have to select the country from the drop-down where he has to export the Products from * Multiple country can be selected from the drop-down.
  • Dosage form (can be selected from the drop-down).
  • Strength can be entered in numeric value, and volume of strength can be selected
  • Composition can be selected from the drop-down

Note to add drug details, the user needs to click on the save button to add a drug detail (User can multiple drug details on same page after clicking on save button).

1.3 – After selecting the” Material Transfer from the drop-down”

  • Purpose of the applicant will be fixed to “Bulk Drug API”
  • Now user has to add a License No (How to manufacturing license numberplease referee page No. 6)

  •  Now the user has to enter NOC no and have to select the zonal name from the drop-down as shown in attached screenshots below mention.

** Note Details should be entered in NOC number should be correct and zonal name also.

After entering the details user has to entered purchase order number, purchase order date, API name and Quantity as shown below. 

1.4 After selecting the “NDPS”

  • Purposed can be selected from the drop-down (Bulk drug API or Finished Formulation).
  • Now user have to add an Licence No (How to manufacturing license number please referee page No. 6) from the drop-down.

  • After clicking on save and continue button drug details page will be visible.

  • Generic Name of drug (user have to entered correct drug name
  • Pharmacopeia Monograph (can be select from the drop-down) Class of Drug (can be selected from the drop-down)
  • Shelf life (in the filed user needs to entered the value in the number and they have to select shelf in Days, weeks, Month, year)
  • Storage condition can be selected from the drop-down,
  • Now user, have to select the country from the drop-down where he has to export the Products from * Multiple country can be selected from the drop-down.

1.5 After selecting the “Unapproved Drug from drop-down”

User can select multiple options from the drop as shown in below mention figure.

  • Now user has to add an Licence No (How to manufacturing license number please referee page No. 6).

  • While clicking on save and continue button drug details page will be visible.
  • Where user has to fill the entire fill as mention below screenshots.

  •  After clicking save button draft page will be visible.

  • After clicking Save and continue button checklist will be visible where user has to fill the entire checklist.

  • After clicking on Submit button your file will be submitted successfully.

To view the official notice, click the below link:

https://medicaldialogues.in/pdf_upload/export-noc-1-277772.pdf

Also Read:AstraZeneca Pharma India secures CDSCO nod to import, sell Durvalumab for small cell lung cancer

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Karnataka to set up NIMHANS-modelled institutes in Mysuru, Kalaburagi

After a long wait, Karnataka is set to establish two institutes modelled on the National Institute of Mental Health and Neurosciences (NIMHANS) in Mysore and Kalaburagi. Chief Minister Siddaramaiah announced the development during the state budget session on Friday.

The Institutes will be developed at a cost of ₹100 crore in Mysuru and Kalaburagi. The NIMHANS institute in Mysore will be set up at at Mysore Medical College and Research Institute (MMCRI), which is under the Department of Medical Education (DME).

For more information, click on the link below:

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Hetero Labs Gets CDSCO Panel Nod To study Semaglutide Injection for Type 2 Diabetes Mellitus

New Delhi: Hetero Labs has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study and Phase III clinical trial of Semaglutide Injection 2mg/1.5ml and 4mg/3ml (1.34mg/ml) (synthetic origin) for Type 2 Diabetes Mellitus.

In addition, the expert panel opined the firm to modify the protocol by including “Retinal examination (fundoscopy) shall be done periodically.”

The committee also recommended to the firm to submit the BE Study report to CDSCO and the BE report should be evaluated by the committee before the initiation of the Phase III clinical trial.

This came after Hetero Labs presented the BE study protocol, vide no. AZBE112405, Version No. 01, Dated 15.11.2024 and the Phase III CT study protocol (Protocol no. HCR/III/SEMADM/10/2024, Version No. 01, dated 02.11.2024) for Type 2 diabetes mellitus before the Committee.

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. It mimics the GLP-1 hormone, released in the gut in response to eating.

Semaglutide injection is used to treat type 2 diabetes. It is used together with diet and exercise to help control your blood sugar. This medicine is also used to lower the risk of heart attack, stroke, or death in patients with type 2 diabetes, obesity, and heart or blood vessel disease.

Semaglutide improves the efficiency of incretin function by activating GLP-1 receptors. It acts by numerous mechanisms, like augmented insulin secretion (glucose-dependent), inhibition of glucagon release and suppressed hepatic gluconeogenesis, thereby reducing both fasting and postprandial glucose.

At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the BE study protocol vide no. AZBE112405, Version No. 01, Dated 15.11.2024 and Phase III CT study Protocol (Protocol no. HCR/III/SEMADM/10/2024, Version no. 01, dated 02.11.2024) for type 2 diabetes mellitus.

After detailed deliberation, the Committee recommended the grant of permission to conduct the BE study and Phase III clinical trial with the following change in the CT protocol:

 Retinal examination (fundoscopy) shall be done periodically.

Furthermore, the expert panel suggested that the firm should submit the BE Study report to CDSCO and the BE report should be evaluated by the committee before the initiation of the Phase III clinical trial.

Also Read: Novo Nordisk Gets CDSCO Panel Nod To study CDR132L

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