In a significant development that highlights the increasing scrutiny over the safety of pharma products, India's Central Drugs Standard Control Organisation (CDSCO) has identified 186 drugs and formulations as Not of Standard Quality (NSQ) in its surveillance report for May 2025. These identified drugs encompass widely prescribed drugs like paracetamol as well as diabetes drugs, triggering grave concerns over the safety of drugs in one of the world's largest pharmaceutical markets.
The action, the CDSCO says, is its part of regular regulatory vigilance aimed at detecting and eliminating unsafe drugs in the market so that patients are not inadvertently left consuming substandard or spurious medicines.
The list, published by the country's national drug regulator on 27 June, 2025, contains common drugs like paracetamol and insulin used to treat diabetes, prompting critical questions on drug safety, regulatory scrutiny, and public health in one of the biggest pharma markets in the world.
The CDSCO's recent warning follows central and state drug testing laboratories in India reporting scores of samples from pharmacies and distribution centers across the country. Of the total 186 failed quality test samples, 128 were detected by state drug testing laboratories, and 58 by central labs. All this aggressive monitoring forms part of CDSCO's constant vigilance to ensure the quality of drugs being sold to Indian consumers.
Of the 186 substandard drug samples, 128 were identified by state drug testing labs and 58 by central labs, as per the official notification. All these drugs failed one or more of the quality parameters such as potency, dissolution rate, microbial load, or content uniformity, and hence were not fit for use by patients.
In a statement that released with the move, CDSCO sought to point out that one failed batch of drug is unique to that batch and does not always mean all batches of the same brand or product are unsafe. Still, the detection of even a single poor batch can have implications for public health, particularly in the case of life-saving and chronic disease drugs.
The CDSCO also established that two of the Bihar drug samples were spurious, i.e., produced by unauthorized parties with the brand name of a different licensed company. These results suggest counterfeit operations in India's huge and intricate drug distribution system.
The regulator has assured that the incidents are being investigated and action would be taken under the Drugs and Cosmetics Act and the accompanying rules.
This is not a one-off case. CDSCO reported 900 samples as substandard and 20 as spurious in the year 2024 alone, all of them selected from pharmacies, hospitals, and distribution outlets throughout the nation.
CDSCO defines NSQ as an occurrence of failure to satisfy one or more of the stipulated quality parameters during laboratory testing. The parameters would involve potency, purity, dissolution, and contaminants or impurities. Significantly, the regulator points out that a failed batch does not necessarily incriminate all the products of the same brand or company.
Aside from NSQ medicines, the CDSCO also marked two samples from the state of Bihar as "spurious." These were discovered to have been produced by illegal manufacturers with the use of the brand name of another firm—a grave offense which is being investigated. Adulterated and spurious medicines are especially threatening since they can have the wrong or harmful ingredients and therefore directly threaten patient safety.
India's pharma industry is one of the biggest in the world, serving not just the domestic market but also exports to more than 200 nations. With such a huge market, maintaining drug safety is no small effort. The CDSCO, along with state regulators, regularly takes drug samples from sales and distribution points. The samples are tested thoroughly in the laboratory, and the findings are made available on the CDSCO portal on a monthly basis.
This openness achieves several functions: it warns medical professionals and the general public to possible danger, raises responsibility on manufacturers, and preserves the level of trust for the healthcare system. In the words of Dr. Rajeev Singh Raghuvanshi, India's Drugs Controller General, only roughly 1.5% of drugs tested in recent surveys turned out to be less effective, indicating that the overwhelming majority of medicines available are safe. Still, a small proportion can add up to potentially great public health threats in view of India's population and the magnitude of drug use.
India has been commonly referred to as the "pharmacy of the world," exporting generic drugs to more than 200 nations. Any quality lapse not only impacts Indian consumers but also tarnishes world confidence in Indian pharmaceuticals. Paracetamol and anti-diabetics are consumed by millions — any compromise on their effectiveness or safety can be devastating health-wise.
Substandard or counterfeit drugs are one of the greatest dangers to contemporary medicine," an independent pharmacovigilance expert in New Delhi said. "They may not treat the disease, may worsen patient outcomes, or lead to antimicrobial resistance."
The public, clinicians, and policymakers need to address CDSCO notifications not as run-of-the-mill bureaucracy but as canary-in-the-coal-mines warnings of broader systemic problems in manufacturing regulation, supply chain integrity, and quality control procedures.
Awareness is the best defense for patients. The CDSCO's medicine alert system seeks to inform consumers and healthcare providers about possible dangers of certain drugs. Patients must go see their doctors or pharmacists if they have issues with their medication and avoid buying drugs from unofficial sources.
Healthcare professionals, on their part, must remain up to date on the current CDSCO reports and advisories, particularly when dispensing or prescribing high-risk drugs. Keeping an eye on the CDSCO portal regularly and being subscribed to alerts can help ensure that patients receive only safe and effective medicines. Patients must:
In addition, hospitals and states should institutionalize pharmacovigilance programs in order to identify adverse trends early.
The CDSCO's forward-looking attitude—constant vigilance, open reporting, and rapid enforcement against violators—is reflective of India's seriousness in protecting public health. Nevertheless, the challenge persists. As the pharmaceutical sector continues its expansion, so must regulatory capability, laboratory facilities, and public awareness.
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When it comes to tackling chronic disease, the United States is lagging behind its peers. A new study published in The Lancet reveals that among 25 high-income Western countries, the US has shown the slowest progress in reducing deaths from noncommunicable diseases such as cancer, heart disease, stroke, and diabetes.
The research, led by Imperial College London, analyzed mortality data from 185 countries between 2010 and 2019. While most nations reported overall declines in the probability of dying before age 80 from chronic disease, the US not only saw smaller reductions compared with other wealthy countries but also a troubling rise in deaths among younger adults aged 20 to 45.
The data show that between 2010 and 2019, deaths from chronic disease decreased in most US age groups but increased among young adults, a rare and alarming trend for a high-income country. Researchers describe this as “a rare phenomenon in high-income Western countries,” suggesting that the problem is systemic, not just demographic.
Majid Ezzati, the study’s senior author and professor of global health at Imperial, explained that while older Americans benefited from improved treatments and detection for heart disease and cancer, younger generations faced new and worsening risks including obesity, alcohol use disorders, and neuropsychiatric conditions like dementia.
The global picture provides a stark contrast. Roughly 80 percent of countries saw reductions in chronic disease mortality during the past decade, covering more than 70 percent of the world’s population. Denmark led the high-income group with the steepest decline, followed closely by Norway and Finland. Germany performed poorly as well, showing only slightly better results than the US.
While all high-income countries experienced a slowdown in the rate of decline compared to earlier decades, the United States stood out for its stagnation in working-age adults and actual increases in younger adults. Other countries managed to balance slower declines in older age groups with sharper improvements in working-age populations, but the US did not.
The study did not dive into root causes, but experts point to a combination of health system and social factors:
Healthcare access and disparities: Millions of Americans lack consistent primary care, delaying diagnosis and treatment of chronic conditions. Without a physician close to home, routine screenings often fall through the cracks.
Social determinants of health: Income inequality, food insecurity, and limited access to healthy lifestyles all disproportionately affect younger and working-age adults.
Rise in neuropsychiatric conditions: While cancer and heart disease deaths declined, increases in dementia, alcohol use disorders, and mental health-related conditions offset gains.
Obesity and lifestyle factors: Rising rates of obesity, poor diets, and sedentary behavior have made chronic diseases harder to control, particularly among younger people.
Ezzati emphasized that underinvestment in public health is a common denominator. “In both the US and Germany, there are segments of the population in which there has been less investment in public health, and these disparities in investment can lead to broad barriers to accessing care,” he said.
The US may be the slowest among wealthy nations, but it is not alone in struggling. Nearly two-thirds of all countries saw slower progress in reducing chronic disease mortality during 2010–2019 compared with the previous decade.
In northern Europe, for example, Denmark and Finland reported slower improvements among older adults, but these were offset by faster progress among working-age adults. That balance prevented them from stagnating as the US did.
Globally, the slowdown raises concerns about whether countries will meet the UN Sustainable Development Goal of reducing premature mortality from noncommunicable diseases by one-third by 2030.
So what sets top performers like Denmark apart? Researchers credit strong investment in preventive health, early detection, and broad access to primary care. Comprehensive strategies for cardiovascular disease prevention, aggressive anti-smoking campaigns, and early cancer screening programs have made a measurable impact.
By contrast, the US has struggled to implement nationwide preventive programs. Even when effective interventions exist — like lifestyle counseling, preventive screenings, and access to affordable medications, barriers in insurance coverage, geography, and affordability keep many Americans from benefiting.
Perhaps the most sobering aspect of the study is that progress is slowing not just in the US but worldwide. Improvements in diagnosis and treatment that once drove sharp declines in chronic disease deaths may be reaching their limits. Unless new strategies are adopted — especially those that reach disadvantaged populations — gains could stall entirely or even reverse.
For the US, where chronic diseases already account for 6 in 10 deaths, the message is clear: without significant investment in prevention and equitable healthcare access, the gap with peer nations will only widen.
Ezzati summed up the findings with a blunt warning, “The risk of dying from chronic diseases in most countries in the world is coming down. But we were doing better before.”
(Credit- Canva)
The All India Institute of Medical Sciences (AIIMS) in New Delhi has created a new mental health program called "Never Alone." The program was launched on World Suicide Prevention Day to directly address the serious issue of student suicides and to improve mental health awareness.
"Never Alone" is an AI-based tool designed to help students who may be struggling with suicidal thoughts and other mental health challenges. Its main goal is to reduce the negative social stigma that often prevents people from seeking help and to make it easier for them to access professional support.
The "Never Alone" app is a very secure and personalized program that students can use anytime, day or night. It works through a web app that can be easily accessed via WhatsApp. For a very low cost of just 70 paisa per student per day, institutions can subscribe to the service and offer it to their students.
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The app provides a secure mental health screening and gives students access to both online and in-person consultations with trained mental health experts. This setup makes getting help more convenient and private, which can be very important for students who might feel uncomfortable talking about their struggles in person.
Growing Crisis Among Young Adults
This program was launched to tackle a serious national problem. According to government data, in 2022, more than 1.7 lakh people died by suicide in India. What's especially concerning is that a large portion of these deaths—35%—were among young adults between the ages of 18 and 30.
Experts say a big reason for this is that many people with mental health issues don't get the help they need. This is often due to a lack of awareness and the fear of being judged by others. The "Never Alone" app aims to fill this gap by providing a confidential and accessible way for students to get support.
Credits: iStock
Kerala, an Indian state located in the south and famous for its backwaters and green scenery, is now in the midst of increasing fear. Five individuals—children as young as three months old—have died in the last month alone due to a rare but deadly infection referred to as amoebic meningoencephalitis. The infection, brought on by "brain-eating" amoebae present in tainted water, has shocked the region and attracted worldwide attention to the dangers represented by emerging pathogens.
The newest victim, 56-year-old Malappuram district resident Shobhana, died on September 9 while receiving critical care at Kozhikode Medical College Hospital (MCH). Only a few days ago, another patient, Ratheesh, from Sulthan Bathery had passed away. Three others—a three-month-old infant, a nine-year-old girl, and a 52-year-old woman—also perished in the recent weeks. At least 11 other patients, including children, are still under observation at the state's biggest tertiary care center.
The perpetrator is neither a virus nor a bacterium, but free-living amoebae like Naegleria fowleri, Acanthamoeba, and Balamuthia mandrillaris. These are microscopic organisms that live in hot, stagnant freshwater and inadequately maintained sources like rivers, ponds, and untreated wells. The disease occurs in two forms:
Primary Amoebic Meningoencephalitis (PAM): Due to Naegleria fowleri, commonly referred to as the "brain-eating amoeba." It enters via the nose, migrates along the olfactory nerve, and directly infects brain tissue. Symptoms—headache, fever, nausea, stiff neck, seizures—rise within days, frequently terminating in death.
Granulomatous Amoebic Encephalitis (GAE): Due to Acanthamoeba and Balamuthia, these infections spread more slowly, reaching the brain via blood through inhalation or skin injury.
Worldwide, amoebic meningoencephalitis has a case fatality of as much as 97 percent. Infections were rare, having been first reported by India in 1971. But in the past two years, Kerala has witnessed a surge: 36 confirmed cases and nine deaths in 2023 alone, a sharp contrast to eight in the six years that had transpired.
What concerns professionals is not only the increasing figures but also systemic failures. Kerala's public health activists mention lack of coordination between state authorities, local health bodies, and hospitals. There is no unified database available that records confirmed cases, recoveries, or deaths, making health workers and the population oblivious.
Drugs essential in the treatment of patients are not produced locally and have to be imported, in most cases resulting in delays in treatment. Kozhikode MCH officials confirmed that drugs for specialty have been ordered from overseas, but medical practitioners assure that prognosis is still bleak, particularly among patients with comorbid conditions.
Why is Kerala seeing such an upsurge now? Scientists and doctors think that climate change could be responsible. Temperature increases and unpredictable rainfall patterns are leading to more stagnant water bodies where amoebae can grow.
Dr. Abdul Rauf, a pediatric intensivist from Baby Memorial Hospital at Kozhikode, says that most recent cases have had delayed onset of symptoms—sometimes two weeks—are indicative of other amoebae like Acanthamoeba or Balamuthia as the causative agents. He further states that dirty water with high coliform content, associated with sewage and poor drainage, also raises chances of infection.
This brings into question larger environmental issues. With fast development, poorly designed drainage systems, and houses located near waste disposal grounds, citizens are being subjected to situations that could trigger the spread of unusual pathogens.
In northern Kerala—specifically Malappuram, Kozhikode, and Wayanad districts—people are going out of their way to shun ponds and rivers. Parents don't want to let children swim, and villages have gone so far as to declare temporary prohibitions against bathing in communal water bodies. The fear is palpable: each new case contributes to a sense of vulnerability, given how low the survival rates are.
Kerala notched up its very first survivor of PAM in July 2024—a boy of 14 from Kozhikode who became one of only 10 known survivors globally. Although that was celebrated as a rare triumph, it highlighted how slim the chances of survival are.
While amoebic meningoencephalitis is uncommon, Kerala's outbreak highlights a global reality: climate-sensitive diseases once relegated to "medical curiosities" are no longer only found in textbooks. With freshwater sources heating up and sanitation infrastructure coming under strain, more communities around the world may be vulnerable.
For public health officials, the Kerala crisis is a reminder that rapid response, early detection, and open data-sharing are not choices—the choice is lifesaving. For residents, it's a stern call to re-think common interactions with natural water sources.
Kerala's health department has now launched special treatment protocols, pressed local governments to keep a watchful eye on water quality, and stepped up awareness campaigns. Experts caution, however, that these steps need to go beyond firefighting. Long-term investment in sanitation, drainage, and access to clean water will be critical.
Worldwide, experts emphasize the immediate need for stronger surveillance and increased investment in treatment for free-living amoeba infections. Treatments available today are restricted and in some cases, experimental. A more powerful drug pipeline, in addition to prevention with measures such as chlorination of water supplies and improved environmental sanitation, may decrease mortality.
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