Category Archives: pharmaceuticals

Tamil Nadu cancels licence of Sresan Pharmaceuticals, shuts down company

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The Tamil Nadu state health department has confirmed the shutdown of Sresan Pharmaceuticals following an investigation that revealed the presence of toxic contaminants, specifically Diethylene Glycol (DEG), in their product Coldrif syrup. This development comes after multiple deaths have been linked to the consumption of the adulterated medicine.

In response to the findings, the health department has ordered comprehensive inspections across all pharmaceutical manufacturing units throughout Tamil Nadu. Large-scale inspections are currently underway to ensure compliance with safety standards, ANI reported.

On October 9, the owner of Sresan Pharmaceuticals, Ranganathan, was arrested in Chennai by a Special Investigation Team (SIT) from Madhya Pradesh. He has been remanded in 10-day police custody by a Parasia court. Additionally, two senior drug inspectors have been suspended due to dereliction of duty, as reported by ANI.

The Tamil Nadu government has reiterated its directive for thorough inspections of all pharmaceutical manufacturing facilities in the state to prevent similar incidents from occurring in the future.

Bharatiya Janata Party (BJP) leader K Annamalai criticized the Tamil Nadu government’s handling of the crisis. He highlighted that despite the deaths of 23 people in Madhya Pradesh and three children in Rajasthan linked to the toxic Coldrif syrup, only two drug inspectors had been suspended. Annamalai accused the state government of attempting to shirk responsibility.

“A drug manufactured by a private pharmaceutical company in Kanchipuram has reportedly caused multiple deaths, yet the Tamil Nadu government is trying to create an illusion of having no connection or accountability,” he said. He also underscored the company’s history of quality violations and the apparent lack of proper inspections by state drug authorities.

Meanwhile, the Drugs Controller General of India (DCGI) has issued a directive to all states and Union Territories to ensure strict compliance with the Drugs and Cosmetics Rules, 1945. This includes mandatory testing of raw materials and finished pharmaceutical products before approval.

Earlier, the Enforcement Directorate (ED) conducted searches at seven locations in Chennai linked to the Sresan Pharmaceuticals case, addressing money laundering charges connected to the Coldrif syrup deaths. Multiple ED teams from the Chennai Zonal Office carried out simultaneous raids based on specific intelligence inputs.

According to officials, searches are ongoing at premises including the residences of senior officials from the Tamil Nadu Drug Control Office. The agency is investigating financial transactions and suspected proceeds of crime related to the production and distribution of the adulterated medicine.

The deaths caused by toxic cough syrups have raised national concern and prompted swift regulatory actions. Following these events, the Delhi government banned the sale, purchase, and distribution of Coldrif syrup after declaring it “not of standard quality,” according to an official order dated October 10.

The order stated:
“Coldrif Syrup (Paracetamol, Phenylephrine Hydrochloride, Chlorpheniramine Maleate Syrup), manufactured in May 2025 by Sresan Pharmaceuticals in Tamil Nadu, was found to contain Diethylene Glycol (46.28% w/v), a toxic chemical known to be hazardous to human health.”

All stakeholders were directed to immediately halt the sale, purchase, and distribution of the affected batch. The public has been strongly advised against consuming the product due to its potential health risks.

This incident underscores the critical importance of stringent quality control and regulatory oversight within the pharmaceutical industry to safeguard public health.
https://www.mid-day.com/news/india-news/article/cough-syrup-row-tamil-nadu-shuts-down-sresan-pharmaceuticals-after-cancelling-its-licence-23598484

11 children’s deaths: Drug watchdog urges strict action against Coldrif

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**11 Children’s Deaths: Drug Watchdog Urges Strict Action Against Coldrif**

*By Snehil Singh | Oct 05, 2025, 11:11 am*

The Central Drugs Standard Control Organisation (CDSCO) is gearing up to take stringent action against the manufacturers of Coldrif syrup following the tragic deaths of 11 children, allegedly due to contaminated cough syrups.

The CDSCO has directed the Tamil Nadu Food and Drug Administration (FDA) to initiate strict measures under serious offense regulations, according to a report by news agency ANI.

### National Conference and Government Response

In response to this crisis, the Union Health Secretary is set to hold a video conference with health officials from all states and Union Territories. The meeting’s objective is to discuss the rational use of cough syrups and enforce drug quality standards nationwide.

This step comes after the deaths of 11 children in Madhya Pradesh and Rajasthan were linked to the consumption of contaminated cough syrups, raising serious concerns about drug safety.

### Ongoing Investigation and Risk-Based Inspections

The CDSCO has launched risk-based inspections of drug manufacturing units across six states — Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra. Investigators have collected 19 samples from these states for thorough testing.

A multidisciplinary team of experts is currently analyzing the samples to pinpoint the exact cause behind the deaths reported in Chhindwara, Madhya Pradesh.

### Sample Analysis and Findings

Earlier this week, the CDSCO confirmed that six samples tested by them, along with three from the Madhya Pradesh Food and Drugs Administration, were free from toxic compounds such as Diethylene Glycol (DEG) and Ethylene Glycol (EG). These substances are known to cause severe kidney damage.

However, it was clarified that the tested samples did not include the two suspicious cough syrups, including Coldrif, which remain under scrutiny.

### Regional Actions Against Coldrif Syrup

In light of these developments, several states have taken proactive measures against Coldrif syrup. Kerala, Tamil Nadu, and Madhya Pradesh have imposed bans on its sale. Telangana has issued a public alert urging people to stop using the product immediately.

These actions are part of broader efforts to ensure drug safety and uphold quality standards across India, following the heartbreaking loss of children linked to contaminated cough syrups.

The investigation is ongoing, and authorities continue to monitor the situation closely to prevent further casualties.
https://www.newsbytesapp.com/news/india/drug-watchdog-urges-strict-action-against-coldrif-makers-report/story

11 children’s deaths: Drug watchdog urges strict action against Coldrif

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**11 Children’s Deaths: Drug Watchdog Urges Strict Action Against Coldrif**

*By Snehil Singh | Oct 05, 2025, 11:11 AM*

The Central Drugs Standard Control Organisation (CDSCO) is set to take stringent action against the manufacturers of Coldrif syrup following the tragic deaths of 11 children, allegedly caused by contaminated cough syrups.

According to reports from ANI, the CDSCO has directed the Tamil Nadu Food and Drug Administration (FDA) to initiate strict measures under serious offense provisions to tackle this grave issue.

—

**Union Health Secretary to Convene National Conference**

In response to the crisis, the Union Health Secretary will conduct a video conference with health officials from all states and Union Territories. The discussion will focus on the rational use of cough syrups and enforcing drug quality standards nationwide.

This move follows the deaths of 11 children in Madhya Pradesh and Rajasthan, which have been linked to contaminated cough syrups.

—

**Ongoing Investigations and Inspections**

The CDSCO has launched risk-based inspections targeting drug manufacturing units across six states: Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra.

Authorities have collected 19 samples from these regions for comprehensive testing. A multidisciplinary team of experts is currently analyzing the samples to uncover the cause behind the fatalities in Chhindwara, Madhya Pradesh.

—

**Sample Analysis Results**

Earlier this week, the CDSCO confirmed that six of its tested samples, along with three from the Madhya Pradesh Food and Drugs Administration, were free from toxic compounds such as Diethylene Glycol (DEG) and Ethylene Glycol (EG). These chemicals are notorious for causing severe kidney damage.

However, officials clarified that these tested samples did not include the two cough syrups under suspicion, including Coldrif.

—

**Regional Actions Against Coldrif Syrup**

In light of the findings, several states have taken immediate action against Coldrif syrup. Kerala, Tamil Nadu, and Madhya Pradesh have imposed bans on its sale. Meanwhile, Telangana has issued a public alert advising citizens to discontinue use of the product.

These measures are part of a larger effort to ensure drug safety and quality across India, following the heartbreaking loss of young lives allegedly linked to contaminated cough syrups.

—

*Stay tuned for further updates on this developing story.*
https://www.newsbytesapp.com/news/india/drug-watchdog-urges-strict-action-against-coldrif-makers-report/story

11 children’s deaths: Drug watchdog urges strict action against Coldrif

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**11 Children’s Deaths: Drug Watchdog Urges Strict Action Against Coldrif**

*By Snehil Singh | Oct 05, 2025, 11:11 AM*

—

The Central Drugs Standard Control Organisation (CDSCO) is set to take stringent action against the manufacturers of Coldrif syrup following the tragic deaths of 11 children, allegedly caused by contaminated cough syrups.

According to reports from ANI, the CDSCO has directed the Tamil Nadu Food and Drug Administration (FDA) to initiate strict measures under serious offenses to address the issue.

**National Conference to Address Drug Safety**

In response to the incident, the Union Health Secretary will conduct a video conference with health officials from all states and Union Territories. The meeting aims to discuss the rational use of cough syrups and enhance drug quality standards across India.

This initiative comes amid investigations linking the deaths of 11 children in Madhya Pradesh and Rajasthan to contaminated cough syrups.

**Ongoing Investigation and Risk-Based Inspections**

The CDSCO has commenced risk-based inspections of drug manufacturing units in six states: Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra.

Authorities have collected 19 samples from these regions for comprehensive testing. A multidisciplinary team of experts is currently analyzing these samples to determine the cause of fatalities in Chhindwara, Madhya Pradesh.

**Sample Analysis Results**

Earlier this week, the CDSCO confirmed that six tested samples, along with three from the Madhya Pradesh Food and Drugs Administration, were free from toxic compounds such as Diethylene Glycol (DEG) and Ethylene Glycol (EG). These substances are known to cause severe kidney damage.

However, officials noted that these tested samples did not include the two cough syrups currently under scrutiny, including Coldrif.

**Regional Actions Taken**

Following the CDSCO’s findings, several states have taken decisive steps against Coldrif syrup. Kerala, Tamil Nadu, and Madhya Pradesh have banned the sale of the product.

Meanwhile, Telangana has issued a public alert advising people to stop using Coldrif syrup immediately.

These actions form part of a broader effort to safeguard drug safety and quality in India after the unfortunate deaths linked to contaminated cough syrups.

—

*Stay tuned for updates on this developing story.*
https://www.newsbytesapp.com/news/india/drug-watchdog-urges-strict-action-against-coldrif-makers-report/story

What is lecanemab, the newly approved Alzheimer’s drug? Can it really slow down dementia

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New Alzheimer’s Drug Lecanemab Approved in Australia: What You Need to Know

Dementia is a condition characterized by progressive memory and thinking problems. It is now the most common cause of death in Australia. While there are many causes of dementia, Alzheimer’s disease accounts for about 60% to 80% of all cases.

Last week, Australia’s Therapeutic Goods Administration (TGA) approved a new drug for early Alzheimer’s disease: lecanemab, sold under the brand name Leqembi. This approval follows that of a similar drug, donanemab, earlier this year. Although lecanemab has been shown to slow disease progression in some people diagnosed early, its high cost may put it out of reach for many Australians.

How Does Lecanemab Work?

Lecanemab belongs to a class of drugs known as monoclonal antibodies. When our bodies face foreign invaders such as bacteria or viruses, the immune system produces antibodies—proteins that bind to the invader and mark it for destruction by immune cells.

A monoclonal antibody like lecanemab is produced in a laboratory to target a specific substance—in this case, the amyloid protein. Amyloid plaques are a microscopic hallmark of Alzheimer’s disease. By binding to amyloid, lecanemab helps the immune system to remove this protein from the brain, thereby limiting ongoing damage.

How Effective Is Lecanemab?

The TGA’s approval is based on a large clinical trial involving 1,734 participants over 18 months, funded by Eisai, the drug company. All participants had positron emission tomography (PET) scans confirming the presence of amyloid in their brains before the trial.

Results showed that patients with early Alzheimer’s or mild cognitive impairment due to early Alzheimer’s who received lecanemab experienced 27% less disease progression compared to those given a placebo over 18 months. This was measured using the Clinical Dementia Rating Sum of Boxes scale, which assesses both cognition and function. This slowing of decline equates to about five months less deterioration in those treated with lecanemab.

For patients continuing treatment, evidence suggests benefits may persist for up to four years. Participants also showed substantial reductions in amyloid levels as seen on PET scans. By the end of the trial, most participants were below the threshold indicating Alzheimer’s presence, although their symptoms were not reversed.

What Are the Side Effects?

Safety concerns have been raised by regulators. The TGA initially rejected lecanemab’s approval last year based on its risk-benefit profile. In the clinical trial, 12.6% of patients receiving lecanemab experienced brain swelling. This rate increased to 32.6% in individuals carrying two copies of the apolipoprotein E4 (ApoE4) gene, which promotes Alzheimer’s.

Among those with brain swelling, 22% experienced side effects such as headaches, dizziness, blurred vision, and balance problems. Most side effects were mild. However, a small number of participants on blood-thinning medications suffered serious brain bleeds, some of which were fatal.

The remaining 78% with brain swelling showed no symptoms. Due to these risks, patients on lecanemab require MRI brain scans every three months for monitoring.

Furthermore, 17.3% of patients treated with lecanemab experienced small brain bleeds (microhemorrhages), compared to 9.0% in the placebo group.

Following the initial rejection, the TGA appeal included new safety and efficacy data covering up to four years of treatment.

How Much Does Lecanemab Cost?

Lecanemab is not currently subsidized by Australia’s Pharmaceutical Benefits Scheme (PBS). The drug costs approximately A$40,000 per year, making it unaffordable for many potential patients.

The recommended dosing schedule consists of fortnightly infusions for an 18-month period, followed by monthly maintenance doses. Additional costs include required monitoring such as doctor visits, MRI, and PET scans.

As of now, the Pharmaceutical Benefits Advisory Committee (PBAC) has not yet reviewed lecanemab for PBS listing. The committee recently rejected a similar drug, donanemab, in July due to concerns about limited and uncertain benefits relative to treatment burdens.

Lecanemab and donanemab share similar mechanisms, efficacy, risk profiles, and costs.

Bottom Line

Lecanemab is approved only for early-stage Alzheimer’s disease. If you or a loved one experience early signs—such as consistent short-term memory loss or confusion about dates—it is important to seek medical advice promptly. Early diagnosis is essential to explore available treatment options.

It is important to understand that neither lecanemab nor donanemab cures Alzheimer’s disease. These drugs may slow disease progression but do not improve existing symptoms.

Additionally, lecanemab is not effective for dementia caused by conditions other than Alzheimer’s, nor for individuals with advanced stages of Alzheimer’s disease.

https://knowridge.com/2025/10/what-is-lecanemab-the-newly-approved-alzheimers-drug-can-it-really-slow-down-dementia/

Japan Approves Over-the-Counter Erectile Dysfunction Drug

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A ministry expert panel has endorsed an application by SS Pharmaceutical to manufacture and sell Cialis as a nonprescription medicine.

Pending final approval after a public comment period, the drug will become available to men aged 18 and older at pharmacies. Purchases will require face-to-face guidance from pharmacists to ensure proper use and safety.

Supporters of wider access argue that erectile dysfunction is a contributing factor to infertility. They emphasize that improving the availability of treatments like Cialis is essential to address this issue.

The ministry has been reviewing the matter carefully in response to these calls, weighing the benefits of increased accessibility alongside necessary safety considerations.
https://newsonjapan.com/article/146945.php