Inside Coldrif Scandal: Tamil Nadu Plant Used Paint-Grade Chemicals, Violated 300+ Drug Norms

Chennai: Officials from the Tamil Nadu Drugs Control Department uncovered horrific conditions at the Sresan Pharmaceuticals unit in Kancheepuram, where the now-banned Coldrif cough syrup was manufactured. The raid exposed open vats of boiling chemicals, leaking rusted pipes, and workers handling toxic substances without masks or gloves, a scene investigators described as a “factory of death.”

Acoording to a recent media report in the MoneyControl, batch SR-13 of Coldrif Syrup, linked to multiple child deaths in Madhya Pradesh’s Chhindwara district, was produced in May 2025 and carried an expiry date of April 2027. For months, the syrup had been in circulation before being flagged for contamination. During the inspection conducted on October 1 and 2, authorities found that the company was using industrial-grade chemicals meant for paints and adhesives instead of pharmaceutical-grade raw materials. Purchases were made from two Chennai-based dealers — Sunrise Biotech and Pandia Chemicals — through cash and Google Pay to avoid leaving financial trails.

Also Read: Factory manufacturing banned oxytocin injections busted in Lucknow, 4 arrested

The probe revealed that the propylene glycol used in the syrup contained diethylene glycol (DEG), a highly toxic compound commonly found in brake fluid and lubricants. Laboratory analysis later confirmed that 48.6% of the offending batch consisted of DEG — nearly 500 times the permissible limit. Post-mortem samples from affected children confirmed kidney failure caused by DEG poisoning.

Inspectors catalogued 39 critical and 325 major violations of the Drugs and Cosmetics Act, 1940, at the Kancheepuram facility. The lapses included the absence of qualified chemists, unhygienic conditions, use of untreated water, missing quality control records, open drains, and lack of pest control. Investigators said the facility lacked any semblance of Good Manufacturing Practices (GMP), with safety protocols ignored and documentation falsified.

Batch SR-13 of Coldrif was distributed in Tamil Nadu, Odisha, Puducherry, and Madhya Pradesh. The children who consumed it developed fever and cough before suffering acute kidney failure. Reports indicate that at least 15 children have died so far. Following the findings, Tamil Nadu’s Drugs Control Department suspended Sresan Pharmaceuticals’ license and issued a show-cause notice. Meanwhile, in Madhya Pradesh, several drug inspectors and a deputy director were suspended, the state’s Drug Controller was transferred, and a local doctor was arrested for alleged negligence, reports Moneycontrol.

The revelations have sparked nationwide outrage and renewed scrutiny of India’s pharmaceutical manufacturing practices, exposing severe lapses in raw material procurement, quality assurance, and post-market surveillance.

Also Read: Coldrif Cough Syrup banned in Punjab amid child deaths

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Dupilumab use in Atopic Dermatitis may Reduce Risk of Otitis Media and Surgical Interventions: Study

According to a new study, Patients with atopic dermatitis (AD) treated with dupilumab have a lower risk of developing otitis media and needing related surgical procedures compared to those treated with pimecrolimus. The study was published in Pediatric Dermatology journal by Matthew H. and colleagues. The findings highlight dupilumab’s added benefit beyond skin disease management, underscoring its potential to reduce ear-related complications in AD.

This study was a retrospective cohort study that was carried out through the use of the TriNetX research network, a population-based large database. Outcomes between AD patients that received dupilumab and pimecrolimus were compared in the analysis. For comparability, propensity score matching for age at index, current age, sex, race, other atopic diseases, and tobacco smoke exposure was used.

The main outcomes measured were the 5-year risks of all otitis media, nonsuppurative OM, suppurative OM, and future surgical procedures. Cox proportional hazards regression models with 95% confidence intervals (CIs) evaluated relative differences in risk between the two treatment arms. An age-stratified analysis was also conducted to examine specifically children’s risks.

Results

The analysis revealed a reduced risk for dupilumab-treated patients compared to pimecrolimus:

  • All OM: Hazard ratio (HR) 0.60; 95% CI, 0.54–0.67; p < 0.001

  • Nonsuppurative OM: HR 0.60; 95% CI, 0.52–0.70; p < 0.001

  • Suppurative OM: HR 0.61; 95% CI, 0.55–0.69; p < 0.001

  • OM-related surgical procedures: HR 0.73; 95% CI, 0.58–0.90; p = 0.004

  • Notably, comparable reductions in risk were also seen in individuals younger than 18 years, indicating dupilumab has protective effects against complications of OM in all age groups.

This population-based study on a large cohort showed that dupilumab decreases the risk of 5-year otitis media and accompanying surgeries in patients with atopic dermatitis by more than pimecrolimus, with benefits seen consistently in both children and adults. The findings propose that dupilumab can provide additional protection against frequent ENT complications in AD, further endorsing its status as a first-line treatment option.

Reference:

Lanehart, M. H., Hayes, B., Zinn, Z., & Skoner, D. P. (2025). Dupilumab treatment for atopic dermatitis is associated with decreased risk of otitis media and related surgical procedures: A retrospective cohort study. Pediatric Dermatology. https://doi.org/10.1111/pde.16008

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Genetically engineered pig livers can support key hepatic functions in humans, xenotransplant study shows

A new study in the Journal of Hepatology reports on an auxiliary liver xenotransplant from a genetically engineered pig to a living human recipient.

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Tens of thousands of children aged under five suffering acute malnutrition in Gaza, recent estimates suggest

More than 54,600 children in Gaza are estimated to be acutely malnourished, including over 12,800 severely so, with few therapeutic options available to them. With measurements up to the middle of August 2025, the study comprehensively tracks wasting among children during the war, estimates population prevalence, and highlights unprecedented increases in child malnutrition following periods of blockades and severe aid restrictions.

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Prostate testing may not target those most likely to benefit, warn experts

Current prostate specific antigen (PSA) testing “may not effectively target testing to those most likely to benefit, raising concerns about overtesting” warn researchers from the University of Oxford in a study of over 10 million men across England published by The BMJ .

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Physicians investigate Reddit to better understand self-management of inflammatory bowel disease

Reddit’s popularity as a tool for self-managing inflammatory bowel disease highlights opportunities for improvements in clinical care, according to a paper published in Journal of Medical Internet Research.

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Faster lymph flow in the legs is linked to a better response to diuretics in acute heart failure patients

A new study published in the European Journal of Heart Failure reveals that the speed of lymph flow in the legs may determine how well patients respond to diuretics, a key therapy for acute heart failure (AHF).

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EMDR Therapy Shows Effectiveness in Treating Personality Disorders: JAMA

Netherlands: A new study has shown that eye movement desensitization and reprocessing (EMDR) therapy led to significant reductions in personality disorder (PD) symptoms, with nearly half of the participants achieving diagnostic remission, highlighting its potential as an effective treatment option.              

Personality disorders affect a substantial portion of the population and are frequently linked to adverse childhood experiences. While trauma-focused treatments are well established for posttraumatic stress disorder (PTSD), their role in managing personality disorders is less clear. Researchers from the Department of Personality Disorders at Parnassia Psychiatric Institute in The Hague, the Netherlands, sought to explore whether EMDR could offer meaningful symptom relief for this complex group of conditions. Their findings were published in JAMA Network Open.
The randomized clinical trial enrolled 159 adults who met diagnostic criteria for a personality disorder using the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD). Participants were randomly assigned to receive either EMDR therapy or to remain on a waiting list. The EMDR group underwent ten 90-minute sessions over five weeks, focusing on traumatic or adverse memories believed to drive personality-related symptoms. Assessments occurred before treatment, immediately after the program, and again three months later, using multiple validated scales to measure personality functioning and emotional regulation.
Participants had an average age of 35 years, and women represented roughly 82% of the study population. Seventy-nine individuals received EMDR, while 80 served as controls. Only a small fraction—about 5%—discontinued therapy, and no serious adverse events were reported.
The results were striking:
  • EMDR therapy significantly outperformed the waiting-list control on all major outcome measures both immediately after treatment and at the three-month follow-up.
  • Patients receiving EMDR showed marked improvements in overall personality disorder severity, emotional regulation, and level of functioning.
  • Remission rates were higher in the EMDR group, with 38.3% achieving remission post-treatment compared with 6.8% in the control group.
  • At three-month follow-up, 45.4% of EMDR participants remained in remission compared with 5.9% of controls.
  • A second diagnostic interview showed similar results, with nearly half of EMDR recipients maintaining remission three months later.
The authors emphasized that EMDR’s benefits extended to patients regardless of whether they also had PTSD, underscoring its potential as a broad intervention for personality disorders. They noted, however, that several limitations warrant caution. The trial relied on a waiting-list control rather than an active comparison treatment, which can exaggerate perceived effect sizes. Double-blinding was not feasible, and the follow-up period of three months was relatively short to judge long-term outcomes. Moreover, the sample was dominated by more common personality disorder types such as borderline, avoidant, and obsessive-compulsive, limiting the ability to generalize findings to rarer diagnoses.
Despite these caveats, the study provides compelling evidence that trauma-focused approaches like EMDR can substantially reduce the severity of personality disorder symptoms. The researchers call for further investigations comparing EMDR with established psychotherapies and examining its long-term effectiveness, which could help refine treatment options for individuals living with these challenging conditions.
Reference:
Hofman S, Hafkemeijer L, de Jongh A, Slotema CW. Eye Movement Desensitization and Reprocessing Therapy in Persons With Personality Disorders: A Randomized Clinical Trial. JAMA Netw Open. 2025;8(9):e2533421. doi:10.1001/jamanetworkopen.2025.33421

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Routine H. pylori Screening Offers No Benefit of curbing bleeding risk After Acute MI: JAMA

According to a new study published in JAMA, in unselected patients with acute myocardial infarction, routine Helicobacter pylori screening did not significantly lower the risk of upper gastrointestinal (GI) bleeding. The study was published by Robin H. and colleagues. Upper GI bleeding is an established complication following myocardial infarction and frequently attributed to the anticoagulant or antiplatelet therapy.

The objective of this study was to identify if routine H. pylori screening during hospitalization for myocardial infarction could decrease upper gastrointestinal bleeding and enhance clinical outcomes versus usual care. This multicenter, open-label, cluster randomized, crossover trial was performed at 35 Swedish hospitals, organized in 18 clusters. The trial lasted from November 17, 2021, to January 17, 2024, with follow-up on January 17, 2025. The hospital clusters were each subjected to two one-year periods: one with usual H. pylori screening of all patients admitted with myocardial infarction, and one with standard care, with a two-month washout interval between them.

During the periods of screening, patients received H. pylori testing with the urea breath test alongside routine post–myocardial infarction care. Information was obtained by means of a national clinical registry combined with Swedish health data registries. The end point was upper gastrointestinal bleeding and was analyzed with a negative binomial model in an intention-to-treat population.

Results

  • 18,466 patients (median 71 years, interquartile range 61–79 years) were enrolled, including 13,138 males (71%). 9245 of the patients had been hospitalized during the screening periods for H. pylori, and 9221 during nonscreening (usual care) periods.

  • At hospital admission, 2284 patients in the screening group and 2275 in the nonscreening group (both 24.7%) used proton pump inhibitors (PPIs).

  • Among 6480 patients (70%) screened during the screening periods, 1532 (23.6%) were positive for infection. After a median of 1.9 years’ follow-up, 299 patients in the screening group had upper gastrointestinal bleeding, compared with 336 in the control group.

  • The event rate was 16.8 events per 1000 person-years in the screening group and 19.2 events per 1000 person-years in the usual care group, yielding a rate ratio (RR) of 0.90 (95% CI, 0.77–1.05; P = 0.18).

  • Subgroup analysis found the effect of screening to differ depending on admission anemia status.

  • The rate ratio was 0.98 (95% CI, 0.80–1.21) among nonanemic patients, with no difference.

  • For those with mild anemia, RR was 0.64 (95% CI, 0.42–0.98), and for those with moderate to severe anemia, RR was 0.44 (95% CI, 0.23–0.87), suggesting benefit of screening among these subgroups (P for interaction = 0.03).

The study concluded that among hospitalized patients with acute myocardial infarction, routine Helicobacter pylori screening had no significant protective effect against upper gastrointestinal bleeding in comparison with standard care. Future studies might consider selective screening of high-risk subgroups to maximize gastrointestinal protection during cardiac therapy.

Reference:

Hofmann R, James S, Sundqvist MO, et al. Helicobacter pylori Screening After Acute Myocardial Infarction: The Cluster Randomized Crossover HELP-MI SWEDEHEART Trial. JAMA. 2025;334(13):1160–1169. doi:10.1001/jama.2025.15047

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FDA Approves Oral Remibrutinib as First BTK Inhibitor for Chronic Spontaneous Urticaria

The FDA has approved oral remibrutinib as the first BTK inhibitor for chronic spontaneous urticaria in adults not responding to antihistamines.

Rhapsido is a pill taken twice daily and does not require injections or lab monitoring. It is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. Rhapsido helps to inhibit the release of histamine and other proinflammatory mediators by targeting BTK, offering a unique approach to CSU treatment.

“CSU is a serious disease that can cause debilitating symptoms and unpredictable flares. It’s difficult to diagnose and manage,” said Mark Lebwohl, MD, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai and member of the steering committee for the remibrutinib REMIX Phase III clinical trial program. “Remibrutinib represents a new way of treating CSU. By blocking the activity of BTK, remibrutinib stops a key pathway of the immune response in CSU. This is an exciting new option that has the potential to help a broad range of patients get fast relief.”

CSU is a mast cell-driven condition thought to be caused by immune dysregulation. In people with CSU, the immune system can become activated through allergic (IgE) or autoimmune (IgG) pathways. This causes certain immune cells-mast cells and basophils-to activate the BTK protein. While not fully understood, it is believed that once activated, BTK leads to the release of histamine and other proinflammatory mediators that may cause the red, swollen, and itchy hives commonly seen in CSU.

CSU symptoms are unpredictable, recurring for six weeks or more without an identified cause. Diagnosis can take up to 24 months.8 Many CSU patients say their symptoms negatively impact their sleep, work, and mental health.9,10,11 Antihistamines are the first-line treatment, but over half of patients still have symptoms, even at higher doses. Injectable treatments exist for those who don’t respond to antihistamines, yet fewer than 20% of eligible patients receive them.

“The approval of remibrutinib is an important development in CSU care. It quickly reduces symptoms, offering patients control of the hives and itching that they experience on a daily basis,” said Giselle Mosnaim, MD, MS, an Allergist and Immunologist from Endeavor Health, Clinical Associate Professor at the University of Chicago Pritzker School of Medicine and REMIX trial investigator. “This is significant because it expands beyond existing injectable treatments and gives patients an oral option that can easily be incorporated into their daily lives.”

“Many CSU patients feel misunderstood and settle for treatments that don’t fully meet their needs,” said Lynda Mitchell, CEO of Allergy & Asthma Network. “We support new treatment options that empower patients to choose what works best for them. This convenient new oral therapy offers a promising new way to manage CSU and potentially improve daily life for those living with this challenging condition.”

Clinical data supporting approval

The FDA approval of Rhapsido in CSU is based on results from the Phase III REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) clinical trials in patients who remained symptomatic on second-generation H1 antihistamines. Rhapsido demonstrated superiority in change from baseline versus placebo in itch (ISS7), hives (HSS7), and weekly urticaria activity (UAS7) at Week 12. Significantly more patients treated with Rhapsido versus placebo achieved well-controlled disease (UAS7≤6) as early as Week 2 and at Week 12, and about one-third of patients achieved complete absence of itch and hives at Week 12. Rhapsido has a demonstrated safety profile that requires no lab monitoring.13 The most common adverse events (incidence ≥3%) were nasal congestion, sore throat, and runny nose (nasopharyngitis), bleeding, headache, nausea, and abdominal pain.

Novartis has completed regulatory submissions for Rhapsido for the treatment of CSU across many countries, including in the European Union, Japan, and China, with priority review granted in China. 

Transforming care in Immunology

“This approval of Rhapsido as the first and only BTK inhibitor in CSU is an important milestone in our journey to reshape care for overlooked immune-related conditions and offer more patients the potential to find fast relief,” said Victor Bultó, President, US, Novartis. “Building on our legacy in advancing the treatment of allergic, dermatologic, and rheumatologic conditions, we are deeply committed to further investing in innovative, patient-focused therapies across immunology.”

Discovered and developed by Novartis to target the BTK pathway as a driver of inflammation, remibrutinib is being investigated in ongoing clinical trials across a variety of immune-related conditions, including chronic inducible urticaria (CIndU), hidradenitis suppurativa (HS), and food allergy.

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