FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation

The FDA has approved preodnisolone acetate ophthalmic suspension, USP 1%, for treating steroid-responsive ocular inflammation. Amneal Pharmaceuticals plans to launch the product in Q3 2025.

Prednisolone acetate ophthalmic suspension, USP 1% is a sterile, topical anti-inflammatory 0agent for ophthalmic use and is indicated for treating steroid-responsive ocular inflammation.

“Our Affordable Medicines portfolio continues to grow with a strong and diverse pipeline that supports broader access to high-quality treatments across the U.S. healthcare system,” said Andy Boyer, Executive Vice President and Chief Commercial Officer, Affordable Medicines. “The approval of prednisolone acetate ophthalmic suspension-a complex product to develop and manufacture-highlights the depth of our R&D capabilities and the strength of our manufacturing and supply operations.”

The most commonly reported adverse reactions for prednisolone acetate ophthalmic suspension in clinical studies were elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. For prescribing information, see package insert here.

According to IQVIA® U.S. annual sales for prednisolone acetate ophthalmic suspension for the 12 months ended April 2025 were approximately $201 million.

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COVID-19 Infection Linked to Higher Miscarriage Risk in Early Pregnancy: Study

A new study published in the journal of BMC Medicine showed women infected with COVID-19 before or during pregnancy faced a two to three times higher risk of miscarriage before 20 weeks of gestation. 

It is yet unclear how SARS-CoV-2 infection prior to or during pregnancy affects the course of the pregnancy. COVID-19 in late pregnancy or the peripartum period was associated with higher incidence of problems, including hypertensive disorders of pregnancy, preterm delivery, and maternal death, during the early waves of the pandemic (pre-Delta).

There is probably a complicated physiological link between maternal and newborn outcomes and SARS-CoV-2 infection at various periods of pregnancy or even before conception. Micaela Sandoval and colleagues therefore developed a tailored electronic health record (EHR)-based cohort of COVID-19 patients who experienced at least one pregnancy episode between 2019 and 2023 in order to investigate the association between COVID-19 and miscarriage.

Using a large, retrospective, electronic health record (EHR)-based cohort, this study investigated the association between COVID-19 and unfavorable pregnancy outcomes, like spontaneous abortion, ectopic pregnancy, and premature birth, between 2019 and 2023. Using generalized estimating equation modeling, risk variables for unfavorable pregnancy outcomes were determined. The following exposures were included in the study: age, race/ethnicity, comorbidity load, neighborhood-level social vulnerability, COVID-19 before pregnancy, and COVID-19 during pregnancy.

The risk of miscarriage was 6.3% among pregnancy episodes with a miscarriage, livebirth, or delivery result in the Southeast Texas Pregnancy and COVID Cohort (26,783 pregnancy episodes) (1514/ 24,119). A history of mild or moderate to severe COVID-19 before to pregnancy was linked to miscarriage in multivariable modeling (adjusted odds ratio (aOR) 2.48, CI 2.21–2.78 and aOR 2.81, CI 1.8–4.38, respectively).

Furthermore, miscarriage was linked to both mild and moderate to severe COVID-19 in the first trimester in the same model. Overall, COVID-19 was found to be a risk factor for spontaneous abortion both before and during pregnancy. These results emphasize how crucial COVID prevention is for expectant mothers and those preparing to become pregnant. 

Source:

Sandoval, M. N., Klawans, M. R., Bach, M. A., Mikhail, J., Graviss, E. A., Cao, T., Parchem, J. G., Husain, J., & Boerwinkle, E. (2025). COVID-19 infection history as a risk factor for early pregnancy loss: results from the electronic health record-based Southeast Texas COVID and Pregnancy Cohort Study. BMC Medicine, 23(1), 274. https://doi.org/10.1186/s12916-025-04094-y

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ASH and ISTH publish revised clinical practice guidelines for pediatric venous thromboembolism

The American Society of Hematology (ASH) and the International Society on Thrombosis and Haemostasis (ISTH) released new and updated clinical practice guidelines for the treatment of pediatric venous thromboembolism (VTE).

The guidelines, published in ASH’s peer-reviewed journal Blood Advances, were developed by an expert panel following a rigorous review process. They aim to improve health outcomes by providing evidence-based recommendations for managing VTE in children.

The new and updated pediatric VTE clinical guidelines incorporate the latest research in the field and mark the first update to the guidelines since their publication in 2018. In total, 16 recommendations were updated and four were added. One of the most notable changes is the new recommendation for direct oral anticoagulants over standard-of-care anticoagulants. Specifically, this recommendation advises clinicians to consider dabigatran or rivaroxaban over therapies such as low molecular weight heparin and vitamin k antagonist.

“These evidence-based guidelines are a key resource for clinicians to improve the quality of care for this vulnerable population,” said Belinda R. Avalos, MD, ASH president. “The recommendations are updated to incorporate the latest science, and we are glad to have collaborated with the ISTH on this project.”

“Collaborating with ASH on these updated pediatric VTE guidelines reflects the ISTH’s commitment to ensuring that children affected by VTE receive the most effective, evidence-based care,” said Pantep Angchaisuksiri, MD, ISTH president. “It’s critical that we continue advancing research and education in this area to support better outcomes for young patients worldwide.”

VTE sometimes manifests as deep vein thrombosis, when a blood clot forms in the deep veins, or pulmonary embolism, when a blood clot blocks an artery in the lung. Although the incidence of VTE in children at a population level is very low, it is higher in children who are hospitalized and can be life-threatening.

“Thrombosis in children is an increasingly common complication in children with complex illnesses and conditions and, if not managed well, can impact long-term outcomes for these patients,” said Paul Monagle, MD, MBBS, MSc, a pediatric hematologist and professor of pediatrics at the University of Melbourne and chair of the ASH ISTH Guidelines on Treatment of Pediatric VTE. “The care of children is important, and parents should know that there is a body of evidence that supports their child’s treatment options.”

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Sleep apnea more common than previously known in female athletes, suggests research

According to a new study, presented at the American College of Cardiology (ACC) Care of the Athletic Heart 2025 conference, sleep apnea may be more prevalent in younger female athletes than previously believed, especially among female athletes with higher levels of training. While obstructive sleep apnea has been observed in younger male athletes, the prevalence in female athletes and the association with cardiovascular risk is largely unknown.

Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder, impacting about 18 million Americans, and is prevalent in both men and women. It occurs when the throat muscles relax and block the airway, causing patients with OSA to repeatedly stop and start breathing when sleeping. Symptoms include excessive daytime sleepiness, loud snoring, waking during the night and gasping or choking. OSA increases the risk of high blood pressure and other cardiovascular issues, including arrhythmias, heart attack, heart failure and stroke.

“There is a lot of overlap in symptoms of sleep apnea and sleep deprivation, which is unsurprisingly quite common among these athletes. Some symptoms that might clue in an athletic trainer, coach or clinician that an athlete may be experiencing or at risk for sleep apnea include not feeling well-rested despite a full night of sleep, snoring very loudly, gasping or choking while sleeping,” said Austin Rim, MD, a cardiology fellow at Emory University in Atlanta and the study’s lead author. “There may be more subtle signs too, including difficulty concentrating or irritability. Accurately diagnosing sleep apnea is important, as a range of treatment options-such as CPAP, mandibular advancement devices, or even surgery-can significantly improve quality of life and, depending on disease severity, potentially reduce long-term cardiovascular risk.”

The study included 68 female collegiate athletes at two universities in the United States. Softball players made up the largest proportion of female athletes, followed by volleyball and basketball. According to the researchers, about 6 in 10 self-identified as White, a quarter as Black and the rest as Hispanic/Latino, Asian or another race/ethnicity. The average age of participants was 19 years old.

“We found in this cohort that sleep health, not even considering sleep apnea, was poor among athletes, with 36% reporting poor sleep quality and 22% reporting that they had trouble staying awake at least once in the past month while eating or engaging in social activities,” Rim said. “Ensuring good sleep hygiene among these athletes is low-hanging fruit for improving overall health in this population,”

The study recorded anthropometrics (the systematic measurements of the human body to define a person’s size and form), blood pressure and pulse wave velocity—a measurement that quantifies arterial stiffness, a precursor to hypertension. Participants also completed home sleep tests, which can detect abnormalities such as pauses in breathing during sleep. The primary outcomes were apnea-hypopnea index (AHI), systolic and diastolic blood pressure and pulse wave velocity.

AHI is a key metric to diagnose and assess the severity of sleep apnea by determining how many apneas and hypopneas occur per hour. An apnea is a complete pause of breathing lasting more than 10 seconds, and a hypopnea is a partial reduction in airflow lasting more than 10 seconds. OSA is diagnosed either by an AHI greater than five events per hour accompanied with associated symptoms like daytime sleepiness or unrefreshing sleep or an AHI score greater than 15 events per hour regardless of symptoms. According to Rim, between five events and 15 events per hour is “mild,” 15 to 30 is “moderate,” and anything over 30 is “severe.”

In this study participants ranged from 2.1 events to 7.7 events per hour and 25% were considered to have mild sleep apnea. No athletes had a measured AHI over 15 events per hour. Pulse wave velocity was higher in athletes with mild sleep apnea and was associated with higher AHI. The study found greater age and lean mass were independent predictors of sleep apnea, which the researchers said suggests sleep apnea may become more prevalent with higher levels of training in female athletes.

According to the researchers, while this is the largest study of sleep apnea among female athletes, it is limited in its generalizability given the small sample size. Future studies are needed to confirm the findings.

“Ideally, a future study would include multi-campus projects that track athletes over several seasons, compare men and women directly, and evaluate whether treating mild apnea reduces these early measures of cardiovascular risk. Treatment of OSA in older trials through CPAP haven’t always been shown to mitigate risk, so it would be helpful to see if treatment at a younger age could improve on this,” Rim said.

Reference:

Sleep apnea more common than previously known in female athletes, American College of Cardiology, Meeting: ACC Care of the Athletic Heart.

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Early Preemptive Kidney Transplants fail to Lower Mortality Risk in ESKD: Study

A new study published in the journal of Transplantation Proceedings showed that in individuals with end-stage kidney disease (ESKD), early preventive kidney transplants do not lower the chance of death.

Among other things, diabetes and high blood pressure can lead to end-stage kidney disease, sometimes referred to as renal or kidney failure. When starting dialysis, or even before, a patient with kidney failure needs a transplant. It is widely accepted that people with ESKD would fare better if they received a kidney transplant beforehand, before beginning dialysis, because dialysis strains the body and impairs immunity. With an emphasis on the mortality benefit of early preemptive transplants, Abhishek Kumar and colleagues therefore carried out this study to assess the present status of preemptive kidney transplants in the United States.

This research investigated patterns in preemptive kidney transplantation among first-time adult patients using the United Network of Organ Sharing database. Based on the estimated glomerular filtration rate [eGFR] at the time of transplant, they divided the population into 4 groups: ≥ 20 mL/min/1.73 m2, 10 to < 15 mL/min/1.73 m2, 15 to < 20 mL/min/1.73 m2, and < 10 mL/min/1.73 m2. The risk of ESKD was compared between the groups using the cumulative incidence competing risk (CICR) approach, and the difference in mortality was evaluated using multivariable Cox regression.

About 18% of all kidney transplants are still preventive (33% from dead donors and 67% from current donors). Preemptive kidney transplants were more likely to be given to white individuals with private insurance and greater educational attainment. The four eGFR groups did not vary in terms of mortality. Again, there was no difference in mortality between the four groups in a subgroup analysis that focused solely on recipients of preemptive kidney transplants from live donors.

Overall, the findings of study shows that even though the “Kidney First Initiative” was started more than ten years ago, the rates of preventive kidney transplants have been clinically unchanged over the past 20 years. 24% of recipients of preemptive LDKTs, where the transplant date can be somewhat controlled, have an eGFR ≥ 15 mL/min/1.73 m2, which is overly early given that there was no survival advantage and that patients were exposed to the dangers of immunosuppression and lifestyle changes.

Reference:

Kumar, A., Bonnell, L., & Kuppachi, S. (2025). Early pre-emptive kidney transplant does not offer any mortality benefits: A study of trends in pre-emptive kidney transplantation over the last two decades. Transplantation Proceedings, 57(4), 538–543. https://doi.org/10.1016/j.transproceed.2025.02.032

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Colchicine May Raise Stroke Risk in Elderly Patients With Intracranial Artery Stenosis: CHANCE-3 Trial

China: A new subgroup analysis from the CHANCE-3 randomized clinical trial suggests that the anti-inflammatory drug colchicine may have varying effects on the risk of recurrent stroke depending on the presence of symptomatic intracranial atherosclerotic stenosis (sICAS) and the patient’s age. The findings, published in eClinicalMedicine, raise important considerations for personalized stroke prevention strategies, especially in older adults.

The study, led by Dr. Jiejie Li and colleagues from Beijing Tiantan Hospital and Capital Medical University, evaluated data from 7,567 patients who had experienced an ischemic stroke or transient ischemic attack. All participants underwent intracranial artery assessment at baseline and were randomly assigned to receive colchicine or a placebo for 90 days. The primary goal was to assess the risk of recurrent stroke during this period.

The following were the key findings of the study:

  • Among patients with symptomatic intracranial atherosclerotic stenosis (sICAS), 10.5% of those on colchicine had a recurrent stroke compared to 8.5% in the placebo group, with an adjusted hazard ratio (HR) of 1.30, indicating a statistically significant increased risk.
  • In patients without sICAS, the recurrence rate was 4.2% in the colchicine group and 5.2% in the placebo group, with an adjusted HR of 0.80, suggesting no significant benefit.
  • These findings indicate that the effectiveness of colchicine may vary based on the presence or absence of intracranial artery stenosis.
  • In patients aged 65 and older with sICAS, colchicine was associated with a significantly higher risk of recurrent stroke (adjusted HR 1.58).
  • Serious adverse events did not differ notably between treatment groups, suggesting colchicine was generally well-tolerated.
  • Gastrointestinal side effects, particularly diarrhea, were more common in patients receiving colchicine, affecting 1.8% of them compared to 0.5%–0.8% in the placebo group, regardless of sICAS status.

The authors acknowledged certain limitations, including the exclusion of roughly 10% of participants due to unavailable imaging data and the concentration of the study within a Chinese population, which may limit generalizability. Additionally, because the analysis was a predefined subgroup study, the results should be interpreted with caution and confirmed by further research.

The authors note, “Despite these limitations, the findings highlight the importance of tailoring stroke prevention strategies. Colchicine may offer benefits to patients without intracranial stenosis, but its use in older adults with sICAS warrants careful consideration.”

They concluded, “Future international trials are needed to explore these interactions further and to inform clinical decision-making in diverse populations.”

Reference:

Li J, Jing J, Meng X, Shi FD, Gu HQ, Jin A, Jiang Y, Li H, Johnston SC, Hankey GJ, Easton JD, Xie X, Jin WN, Chang L, Shi P, Wang L, Zhuang X, Li H, Zang Y, Zhang J, Sun Z, Liu D, Li Y, Yang H, Zhao J, Yu W, Wang A, Pan Y, Lin J, Li S, Niu S, Wang Y, Zhao X, Li Z, Liu L, Zheng H, Wang Y; CHANCE-3 Investigators. Colchicine for preventing stroke in patients with and without intracranial atherosclerotic stenosis: a prespecified analysis of a randomized clinical trial. EClinicalMedicine. 2025 May 19;84:103226. Doi: 10.1016/j.eclinm.2025.103226. PMID: 40496882; PMCID: PMC12149651.

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AI tool enables real-world assessment of eczema severity via smartphone photos, reveals research

A team of researchers from Keio University School of Medicine, Kyoto Prefectural University of Medicine, and Teikyo University, in collaboration with Atopiyo LLC, has developed a novel artificial intelligence (AI) model that can objectively assess eczema severity using smartphone images uploaded by patients. Their findings were recently published in Allergy, the official journal of the European Academy of Allergy and Clinical Immunology.

Atopic dermatitis (AD) is a common chronic skin condition that flares repeatedly and often requires long-term monitoring and treatment adjustments. In recent years, smartphone apps and social media platforms have made it easier for patients to track their symptoms, learn about their condition, and document changes over time. However, patient-reported symptoms like itch or sleep loss don’t always align with visible disease severity. This gap underscores the need for more standardized, objective evaluation tools-and highlights the growing potential of digital biomarkers to fill that role.

To address this, the research team leveraged data from Atopiyo, Japan’s largest AD platform, where over 28,000 users have shared more than 57,000 symptom photos and personal comments since 2018. The AI model developed in this study integrates three key algorithms: body part detection, eczema lesion detection, and severity scoring using the Three Item Severity (TIS) scale, which evaluates redness, swelling, and excoriation.

Using a training dataset of 880 images with self-reported itch scores, the AI model demonstrated high diagnostic accuracy. In a validation study using 220 test images, the AI-based TIS (AI-TIS) showed a strong correlation with dermatologist-assessed TIS scores (R = 0.73, P < 0.001) and a meaningful correlation with objective SCORAD scores (R = 0.53, P = 0.04).

“Many patients with eczema struggle to evaluate their disease severity on their own,” said Dr. Takeya Adachi, the study’s corresponding author. “Our AI model allows for objective, real-time tracking using just a smartphone, empowering patients and potentially improving disease management.”

Interestingly, the study also found that AI-derived severity scores correlated only weakly with self-reported itch scores, highlighting the discrepancy between perceived symptoms and observable inflammation. This supports the growing need for digital biomarkers that can enhance precision in dermatological care.

The researchers aim to expand the model’s utility by incorporating broader skin types, age ranges, and integrating additional clinical features from scoring systems like SCORAD and EASI. This work paves the way for AI-driven teledermatology solutions that support both patients and clinicians in real-world settings.

Reference:

Utako Okata-Karigane, Masakazu Hirota, Chiaki Takahashi, Akihiro Miyagawa, Ryotaro Ako, Saeko Nakajima, Masaki Futamura, Satoru Yonekura, Yasushi Ogawa, Takenori Inomata, Tetsuo Ishikawa, Yoshihiro Ito, Katsunori Masaki, Sakura Sato, Norito Katoh, Hideaki Morita, Takeya Adachi, AI-Based Objective Severity Assessment of Atopic Dermatitis Using Patient Photos in a Real-World Setting: A Digital Biomarker Approach, Allergy, https://doi.org/10.1111/all.16586.

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Intrathecal resiniferatoxin may decrease cancer pain intensity and reduce opioid consumption: NEJM

A new study published in The New England Journal of Medicine Evidence showed that for patients with unmanageable cancer pain, single dose of intrathecal resiniferatoxin (RTX), an opioid-sparing analgesic may be effective.

Even with thorough medical care, a significant portion of patients with advanced cancer experience refractory pain. A powerful member of the capsaicin-containing medication family, resiniferatoxin selectively and permanently kills the neurons (or their axons) that convey chronic pain. In a number of animal species, intrathecal injection of RTX has shown a high degree of safety, specificity, and effectiveness in alleviating severe pain.

In this study, Andrew Mannes and colleagues assessed resiniferatoxin (RTX), a nonopioid analgesic that selectively blocks nociceptive activity sent by a subset of dorsal root ganglion neurons. RTX is a strong agonist of the transient receptor potential vanilloid 1 (TRPV1) ion channel.

This is an interim analysis of a first-in-human, open-label, Phase 1 research in which 19 patients with lower extremity and/or abdominal refractory cancer pain received a single intrathecal RTX dosage. Safety was the main result. A numerical rating scale assessing the “worst pain” during a 24-hour period was used to evaluate effectiveness during the research, which produced secondary outcomes. On this scale, 0 represents “no pain” and 10 represents “worst pain imaginable.” The amount of opioids needed to manage pain was assessed in morphine equivalents.

A total of 213 treatment-emergent adverse events (AEs) were recorded in 19 patients treated over a period of 188 days following RTX injection, with 14 patients experiencing 37 significant AEs. Between 11 and 140 days following treatment, 9 fatalities happened on average 70 days later.

The progression of advanced cancer is associated with many of these occurrences, including death. All 19 patients experienced at least one adverse event. The dermatomes of three individuals (grades I and II) exposed to RTX lost their sensitivity to heat.

3 of the 7 patients had grade III urine retention, which lasted longer than 24 hours. 5 individuals experienced AEs (grades I and II) associated with a brief elevation in the electrocardiogram’s QT interval that went down in a day.

An unstageable decubitus ulcer was the sole grade IV adverse event. At posttreatment day 15, RTX was linked to a 38% reduction in “worst” pain intensity (pretreatment 8.4±0.4 vs. posttreatment 5.2±0.6) and a 57% reduction in opiate intake. Overall, intrathecal RTX, taken as a single dosage, acts as an opioid-free analgesic for cancer patients suffering from intractable pain. 

Source:

Mannes, A. J., Heiss, J. D., Berger, A., Alewine, C. C., Butman, J. A., Hughes, M. S., Rabbee, N., Hayes, C., Williams, T. S., Sapio, M. R., & Iadarola, M. J. (2025). Treatment of intractable cancer pain with resiniferatoxin – an interim study. NEJM Evidence, 4(6), EVIDoa2400423. https://doi.org/10.1056/EVIDoa2400423

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Lipid Accumulation Product Superior Predictor of Gout and Hyperuricemia Risk, reports research

Researchers have revealed in a new study that the Lipid Accumulation Product (LAP) — a combination of waist circumference and fasting triglyceride levels — is a better indicator of obesity-related health risks than BMI or waist circumference alone. LAP shows high potential in predicting the risk of gout and hyperuricemia, presenting a modifiable factor for prevention. This study was conducted by Dexian X. and fellow researchers and was published in PLOS One journal.

The study employed data from 10,871 adults who underwent the National Health and Nutrition Examination Survey (NHANES) from 2009 to 2018. Subjects reported by themselves their gout status, and hyperuricemia was ascertained using laboratory uric acid results. Each subject had the lipid accumulation product calculated using waist circumference and fasting levels of triglycerides to estimate visceral fat accumulation.

Multivariate logistic regression analysis estimated odds ratios (OR) for gout and hyperuricemia by LAP quartiles. Restricted cubic spline (RCS) modeling also examined dose-response and possible non-linear effects between LAP and these outcomes. Trends across LAP quartiles were estimated using P-trend tests.

Results

  • Prevalence of hyperuricemia was 20.9% among the 10,871 adults in the study, and gout occurred in 5.57% of participants.

  • After controlling for possible confounders, patients in the top LAP quartile had 271% increased risk of hyperuricemia as compared to the bottom quartile (OR = 3.711, 95% confidence interval [CI] 2.732–5.042, p < 0.001).

  • While LAP was treated as a continuous variable, a linear association with risk of hyperuricemia was noted (OR = 2.441, 95% CI 1.348–4.42, p = 0.005).

  • Both analyses indicated strong trends (p for trend < 0.001).

These findings support the position of visceral fat deposition, as reflected by LAP, as a central metabolic risk factor for gout and hyperuricemia. The high degree of correlation indicates that LAP may serve as an accessible clinical marker for the identification of high-risk individuals for developing these disorders. Since LAP is simple to compute from standard measurements, it provides an effective tool for risk screening in heterogeneous groups.

This research proved that the lipid accumulation product is a useful predictor of risk of gout and hyperuricemia. Management of the extent of visceral fat accumulation could provide a promising entry point for prevention and control of these conditions. These results indicate that LAP should be a significant marker in metabolic health evaluations targeted at lowering gout and hyperuricemia prevalence.

Reference:

Xian, D., Wang, W., Li, H., Song, G., Xu, D., Zhang, F., Wang, Z., Xu, W., Meng, H., & Peng, M. (2025). Lipid accumulation product: A novel marker for gout and hyperuricemia. PloS One, 20(5), e0324139. https://doi.org/10.1371/journal.pone.0324139

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Rs 21 Cr Cap, Intake Criteria Revised in DoP’s Medical Devices Skill Development Scheme

New Delhi: The Department of Pharmaceuticals (DoP), under the Ministry of Chemicals and Fertilizers, has issued a corrigendum modifying the operational guidelines of the sub-scheme “Capacity Building and Skill Development for Medical Devices” under the broader scheme “Strengthening of Medical Device Industry.”

The revisions were approved during a meeting of the Scheme Steering Committee (SSC) held on April 9, 2025.

According to the corrigendum dated June 9, 2025, amendments have been made to certain provisions of Chapter IV of the sub-scheme guidelines originally issued on November 8, 2024.

One of the key changes reaffirms the provision of continued financial assistance to Central Government universities and institutes for conducting multidisciplinary postgraduate courses in medical devices. The objective remains to build infrastructure for education and research in medical devices and to develop a skilled workforce aligned with the evolving needs of the sector.

The funding provision has been revised to clarify that the DoP will now provide up to 75% of the course cost or Rs 21 crore, whichever is lower, strictly on a reimbursement basis, as and when expenditure is incurred.

Additionally, the financial support per student—Rs 25,000 per month for diploma students and Rs 10,000 per month for certificate or skill development programs—will now be reimbursed to training institutes on a quarterly basis.

Another significant update relates to the refund mechanism. Institutions that discontinue the program midway or fail to comply with DoP-approved conditions will be required to refund the grant. However, the revised clause specifies that expenditure incurred and claimed toward non-recurring expenses will not need to be refunded.

To ensure the program’s effectiveness, the government has also introduced stricter conditions related to student intake. If actual admissions fall below 30% of the approved intake in the first year or below 50% in the second or third year, the continuation of financial support may be reconsidered.

The corrigendum confirms that all other clauses of Chapter IV remain unchanged and notes that the changes have been made with the approval of the Competent Authority.

For more details, check out the full notice:

https://medicaldialogues.in/pdf_upload/corrigendum-dated-962025-1-290671.pdf

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