India relies on the weak oversight of developing countries that make up the bulk of its exports – that’s how it can continue to push substandard and often deadly medicines there. — Bloomberg
FOR a nation that seeks to claim the mantle of “pharmacy to the world,” India is scandalously short on regulatory oversight.
In the last six months, its generic cough syrups have killed dozens of children, its eye drops have caused blindness and its chemotherapy drugs have been contaminated.
The children who died – mostly under the age of five years – were given Indian-made over-the-counter products contaminated with industrial solvents and antifreeze agents that are fatal in even small amounts.
The eye drops that contained extensively drug-resistant bacteria? So far 68 patients across 16 US states have been affected. Three people died, several had to have their eyeballs removed, some went blind, the Centres for Disease Control and Prevention reported on March 21.
The Indian company, Global Pharma Healthcare, issued a voluntary nationwide recall for the drops. India is the largest provider of generic medicines, producing 20% of the world’s supply, according to the government’s Economic Survey.
Its US$50bil (RM220bil) drug-manufacturing industry exports medicines to over 200 nations and makes 60% of all vaccines. It boasts “the highest number” of US Food and Drug Administration or FDA-compliant plants outside America, and indeed, some of its generic pharmaceutical companies produce high-quality medicines.
That may well provide consumers with a level of comfort, but history suggests it is unwise to trust that feeling.
The latest drug recalls just add to a long line of scandals that have tainted the sector.
In 2013, a US subsidiary of major Indian drug manufacturer Ranbaxy Laboratories Ltd pleaded guilty to US federal criminal charges and agreed to pay US$500mil (RM2.2bil) lion for selling adulterated generic drugs, fabricating data, and committing fraud. Serious flaws in the FDA compliance regime allowed these breaches to go undiscovered, until a years-long investigation laid bare the endemic corruption.
A generic drug made in India and modelled on Lipitor sold in the US to treat high cholesterol, for example, was contaminated with shards of blue glass, as journalist Katherine Eban documented in her book, Bottle of Lies: The Inside Story of the Generic Drug Boom. Her book draws in part on the experience of whistleblower Dinesh Thakur, who worked at Ranbaxy.
You would think such a damning indictment would prompt India to develop a safer, better pharmaceutical oversight regime. Think again.
The systemic fraud exposed by the investigation – where data was routinely falsified to fool inspectors, increase production and maximise profit – did not result in a regulatory overhaul.
Still, a two-day “brainstorming session” held in February appeared to acknowledge the system’s inherent weaknesses, with Health Minister Mansukh Mandaviya telling participants India needed to “move from generic to quality-generic drugs.”
Discussions involved “how to make the country’s drugs regulatory systems transparent, predictable and verifiable,” according to a health ministry media release.
Consumers shouldn’t hold their breath, though. A national law on drug recalls has been under discussion since 1976 without resolution, and the government – at least publicly –remains in denial: Since the Ranbaxy scandal, Thakur has campaigned for the reform of India’s main regulator, the Central Drugs Standard Control Organisation, and, with lawyer T. Prashant Reddy, has written his own book, The Truth Pill: The Myth of Drug Regulation in India, which was published in October.
They note that adulterated Indian drugs aren’t just killing children in developing-world export markets like Gambia and Uzbekistan. They’re also killing children at home: In 2019, at least 11 infants died in the state of Jammu because of cough syrup containing diethylene glycol.
The World Health Organisation (WHO) sent alerts in October and January, asking for the cough medicine to be removed from the shelves. (It also issued a warning last year for cough syrups made by four Indonesian manufacturers sold in that country, where 203 children died in similar circumstances.)
Maiden Pharmaceuticals, whose medicines were sold in Gambia and linked by the WHO to the deaths of at least 70 children, has denied wrongdoing. And India’s regulator rejected the WHO’s findings, saying no toxic substances had been found in samples taken from Maiden’s plant.
It shouldn’t have taken more deaths for Prime Minister Narendra Modi’s administration to act. The red flags have been there for years. What’s lacking is political will, and transparency. The FDA publishes different reviews of new drug applications on its website, along with detailed notes.
So why does contamination with such deadly substances occur so regularly?
“The simple answer is that Indian pharmaceutical companies quite often fail to test either the raw materials or the final formulation before shipping it to market,” Thakur said.
India relies on the weak oversight of developing countries that make up the bulk of its exports – that’s how it can continue to push substandard and often deadly medicines there.
In the absence of a global framework for pharmaceutical safety, what can be done to make the generic drugs that consumers around the world have come to rely on safer and effective?
For a start, the WHO’s prequalification programme, which facilitates the purchase of billions of dollars’ worth of medicines through international agencies such as Unicef, must be overhauled. Then there’s the question of holding these companies to account for the harm they cause inside and outside India via legal avenues and victims’ compensation. — Bloomberg
- Ruth Pollard is a Bloomberg Opinion columnist. The views expressed here are the writer’s own.
Liver Health: 4 Worst Damaging Habits- Thomas DeLauer… http://www.ThomasDeLauer.com for all your business, health, and fitness answers. The number one over the counter medication responsible for wrecking our livers is acetaminophen. Join Celebrity Trainer, Author & Organic Foods Expert, Thomas DeLauer to find out what other habits may be contributing to the health and function of our livers. Learn how the liver plays a big role in our metabolism, how we burn fat, how we get into shape, and detoxification.
1) Too much self-medication:
One of the main functions of the liver is to break down substances that we take by mouth, including medications, herbs and supplements. This process usually takes place efficiently and without causing any harm. When new medications are developed, they are extensively tested to make sure they are safe before being approved for general use. Acetaminophen, when used as directed, is extremely safe even for people with liver disease. However, taking too much acetaminophen at once, or taking a high dose of acetaminophen continuously over several days can cause damage to the liver.
How it Damages the Liver: A dose of Tylenol is absorbed by the gastrointestinal system and released into the bloodstream, where it alleviates pain and symptoms of fever. The liver filters the blood, which is responsible for metabolizing Tylenol into compounds that can be excreted by the body. About 90% is metabolized into harmless substances and excreted in the urine by the kidneys. Another 2% is removed without being metabolized. Between 5-10% is metabolized into a toxic compound called N-acetyl-p-benzoquinoeimine (NAPQI). Normally, the liver can safely remove NAPQI by combining it with gluthathione and converting it into a water-soluble product that is excreted in bile. However, after an overdose, the liver does not have enough gluthathione to combine with the NAPQI. Excess amounts of the toxic chemical cause rapid cell death, necrosis, tissue damage, and potentially deadly acute liver failure. (1,2,3)
2) Alcohol abuse:
The liver can only handle a certain amount of alcohol at any given time, so if you drink more than the liver can deal with by drinking too quickly, or drinking too much, your liver cells struggle to process it. When alcohol reaches the liver, it produces a toxic enzyme called acetaldehyde, which can damage liver cells and cause permanent scarring.
3) Smoking:
Though cigarette smoke does not directly come into contact with the liver, it does indirectly affect the liver. The chemicals in cigarette smoke eventually make their way to the liver. These chemicals cause oxidative stress on the liver, which leads to damage to the liver cells and fibrosis. Oxidative stress is involved in the aging of all the organs of the body. Oxidation produces free radicals that damage the cells of the body.
4) Lack of Sleep:
If you want to keep your body — and particularly your liver – in good condition, it is important that you get enough sleep. During sleep, the body repairs and renews its cells, so lack of sleep will interfere with that. In turn, if the liver cannot repair and renew itself as you sleep, it can’t function properly when you’re awake. A study published in the Journal of Anatomy found that sleep deprivation can cause oxidative stress to the liver. It was found that livers weren’t processing fat efficiently and instead allowed fat to accumulate (which proves that the body cannot function well without a properly working liver) (8)
8) Sleep deprivation predisposes liver to oxidative stress and phospholipid damage: a quantitative molecular imaging study. (n.d.). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/arti...
Why Healthy Liver Function is Essential to Maintain a Balanced Life
The liver is extraordinary! Responsible for over 500 functions, it's important that the liver is needed for overall health and wellbeing.
The liver function is quite extraordinary. The liver is made up of 2 lobes and is located on top of the stomach. As the “Commanding General” of the body, it is also the largest solid organ with over 500 important functions. To name a few liver functions, it regulates chemical levels in the blood, excretes bile, promotes healthy absorption and digestion, and ensures good circulation of qi, our vital energy.
As we can see, it’s imperative that the liver functions properly for overall health and wellness in the body. We share more about liver functions, what happens when issues arise, and herbal remedies to help maintain optimal health.
What is the Function of the Liver?
One vital liver function is to regulate the distribution of our life force for organs nourishment.
Most people know the liver as one of our vital organs. While it’s true from the perspective of modern anatomy, the liver has a vast basis of functions that affect the other organs. Let’s take a look at the different liver functions based on Western medicine and Traditional Chinese Medicine (TCM).
Liver function in Western medicine
There are many things that our liver does on the daily basis. It’s considered the largest organ and gland inside the human body. Interestingly, it’s the only organ that can regrow and replace its tissue.
Inside a liver, there are hundreds of tasks on progress every single day. But mostly, here are five major functions of the liver, based on its anatomical structure.
Production of bile
Made of mainly bilirubin, cholesterol, and bile acids, bile is essential for our digestion. It breaks down fats into fatty acids and turns ammonia, which is poisonous, into the urine.
Regulation of blood levels
The liver helps to regulate our blood of amino acids, regulates our blood for proper clotting and healing, helps to clear the body of drugs or harmful substances, and helps to store resist infections by removing bacteria from the bloodstream.
Conversion of excessive glucose
The liver converts excessive glucose (sugar) into glycogen. This is used for storage that can be converted back for energy and additional glucose.
Clearance of bilirubin
Our liver also works to ensure that we don’t have excessive bilirubin from our red blood cells. Having this condition makes our eyes and skin yellow.
Stores vitamins and minerals
The liver also stores vitamins A, D, E, K, and B12. The liver is also the storage center of iron and copper.
Liver function in TCM
In TCM, the liver is one of the five Zang organs with one primary function: to store and distribute jing (essence) and qi. Rather than referring to liver in anatomy, TCM regards liver as a part of a complex web connecting multiple systems and organs. TCM sees liver functions as essential in four main areas.
Beyond its anatomical concept, our liver is a part of a complex web connecting multiple systems and organs. According to TCM, the main liver function is to control the movement of qi that sustains the organs and tissues of the body.
TCM sees liver function as essential in four main areas:
Distribution of qi
Regulation of digestive system
Management of emotional health
Modulation of the female reproductive system
The balance of qi in our liver will ensure the proper functioning of other organs inside the body. Therefore, we all need a healthy liver to function and thrive.
Problems with Poor Liver Function
In today’s fast-paced society, people who struggle to achieve work-life balance may be more susceptible to poor liver function and imbalances. Here are some problems that can arise with liver issues.
Liver disease
Western perspective: According to the Centers for Disease Control and Prevention, liver disease, also called hepatic disease, affects 4.5 million Americans. The result of substance abuse, obesity, autoimmune diseases, cancer, or viruses such as hepatitis can lead to the disruption of the liver. This is very serious that can lead to a life-threatening condition called cirrhosis. Over time and if untreated can lead to hepatic encephalopathy, esophageal varices, abdominal ascites, liver failure, or liver cancer.
Issues with the liver can also be genetic such as Hemochromatosis, Wilson’s Disease, and Alpha 1 Antitrypsin Deficiency. Hemochromatosis is signified as an iron disorder where the body absorbs too much iron from the food you eat; whereas Alpha 1 Antitrypsin Deficiency is the lack of a certain enzyme, and Wilson’s Disease prevents the body from removing copper in the liver.
Early awareness and a healthy lifestyle — such as limiting alcohol intake, adapting to a healthy diet, and doing regular exercises — are essential to keep the liver functioning properly. Some symptoms to look out for include yellowish and/or itchy skin, swelling of the body, excessive tiredness, pale stool, dark urine, or a loss of appetite, to name a few symptoms. Seek guidance from your doctor who can further assess your symptoms.
TCM perspective: TCM regards the liver as an army general of our body that regulates the movement of ‘qi’ to all organ systems. That’s why any imbalances in the liver can affect the activities of other organs and cause many health issues.
Digestive system disorders
Stomach issues can be related to problems with the liver.
Western perspective: During the early onset of liver diseases like cirrhosis, a person may experience appetite loss. This can make them lose more weight. According to a 2014 study, around 80% of liver cirrhosis patients are having at least one symptom of gastrointestinal diseases (GI). The symptoms include abdominal pain, bloating, diarrhea, belching, and constipation — leading to malnutrition. The causes could be raised toxin levels and insulin resistance due to problems in liver function.
TCM perspective: From a TCM perspective, a disrupted balance in the liver, spleen, stomach, and gall bladder causes digestive system disorders. As a result, people who are prone to qi imbalances are likely to present with various symptoms, such as belching, heartburn, a poor appetite, and a thin white- or yellow-colored tongue coating.
TCM uses a classical formula known as 柴胡舒肝散 (Chai Hu Shu Gan San) to treat imbalances in the stomach and liver. It consists of several ingredients that work in tandem to regulate stomach and liver imbalances. The most basic ingredients of this formula are licorice root, bupleurum, bitter orange, aged tangerine peel, nutgrass galingale rhizome, Sichuan lovage root, and peony root.
Combining Toosendan fruits and Corydalis rhizome with this formula can relieve pain by improving the effect on liver qi. Meanwhile, adding decocted inula flower and hematite — the natural mineral form of iron oxide — can promote better downward movement of qi and relieve the counterflow.
Physical and emotional disordersWestern perspective: Liver dysfunction can be hard to diagnose since there are almost no visible symptoms early on. However, as the liver function becomes more impaired, it will cause physiological changes like an electrolyte imbalance and portal hypertension. In turn, patients will start experiencing physical and emotional symptoms. These include muscle cramps, breathlessness, itchy skin, trouble sleeping, depression, andanxiety.
TCM perspective: Our emotional and physical health are interconnected. For example, excessive anger or irritability is linked to various ailments. This includes dizziness, headaches, dry mouth, and redness of the face and eyes.
Similarly, TCM also believes that emotional imbalances can act as both the symptoms and causes of physical problems. Liver imbalances, specifically, link to anger, irritability, and mental health conditions such as sleeplessness, ddepression,and chronic stress.
A sleep formula known as Suan Zao Ren Tang is especially effective in treating insomnia. Sour jujube seeds — one of the ingredients of this classic formula — is particularly beneficial for improving sleep quality. It works by calming the mind, preventing excessive sweating, nourishing the liver, and soothing the nerves .
Women’s health disorders with the liver
A healthy liver means more energy, regulated periods, and less PMS symptoms. You are ready to face more adventures.
Western perspective: As a part of the endocrine system, liver dysfunction can impact hormonal balance. In women, chronic liver disease may cause amenorrhea (missing periods) and infertility. This can be triggered by low testosterone along with high estrogen and prolactin levels.
TCM perspective: An unbalanced liver can cause irregular periods, premenstrual syndrome (PMS), mood disorders, fatigue, fever and/or chills, abdominal pain, growth of benign masses in the uterus called fibroids, and early menopause..
Another important role of the liver is the storing of blood as well as regulate blood volume in the body. During rest, blood requirement in organs and structures is less and excess blood is channeled to the liver for storage. When there is activity, demand for blood increases and the liver transports blood to the respective organs to meet these needs. In the case of liver blood deficiency, organs fail to receive adequate nourishment which can result in symptoms such as giddiness, weakness in limbs, insomnia, and scanty periods in women or even amenorrhea. When blood cannot be stored in the liver effectively, the circulation of blood becomes unpredictable, leading to either bleeding from the orifices or heavy menstruation in females.
Visual disorders
Western perspective: Eye and visual issues can also be connected to liver disorders. Conditions such as Xanthelasma signified by a yellowish bubble on the eyelid, jaundice, cataracts, or Wilson’s disease may suggest a disrupted liver function.
The liver is also responsible for the production and storage of vitamin A. Because of this, problems in the liver can cause nyctalopia — an inability to see clearly in dim light or at night — and dry eye disease.
TCM perspective: Every organ has an association with a sense organ. The liver is most closely linked to the health of our eyes. Any unpleasant signs of the eyes can therefore be used to assess the health status of the liver. TCM believes that liver blood can travel upwards to nourish eye structures and gives the eyes capacity to see. A deficiency in liver blood may lead to eye issues such as blurred vision, myopia and eye floaters. On the other hand, excess liver heat can manifest in symptoms like red and bloodshot eyes, painful eyes which may be accompanied by a burning sensation.
A herbal tonic prepared using goji berries can nourish the liver, thus help improve your vision. It also improves circulation and strengthens your immune system.
How to Maintain a Healthy Liver
Several cubes of dried poria mushrooms on a copper plate
Poria mushroom is one of the many TCM ingredients that can boost liver health.
A healthy liver function is essential for your overall well-being. Maintaining a healthy lifestyle is important for the body as well as the liver. This includes regular exercise, moderate-to-no drinking or drug use, practicing safe sex, and eating healthy foods. A diet rich in green tea, vegetables, legumes, whole grains, nuts, oats, fatty fish, and limited salt, sugar, saturated fats, and refined carbs is important for liver health.
A classic formula called ‘Free and Easy Wanderer (Xiao Yao San)‘ contains eight ingredients. They are bupleurum, peppermint, Chinese Angelica, ginger root, licorice root, Poria mushrooms, white atractylode, and white peony roots. Xiao Yao San is a classical TCM formula that soothes the liver, strengthens the spleen and nourishes blood. It clears “liver stagnation” which contribute to stress, mood swings, pain, irritability, constipation, abdominal upset, premenstrual syndrome (PMS), and irregular periods.
Supplementation can help to enhance the healthy liver, such as Wild Yunzhi Powder and LLiva Max, containing medicinal fungus, stout camphor fungus (niu chang chih). These formulations can also improve the body’s resistance to disease, promote vitality, and enhance the respiratory system. According to studies conducted on mice, antrodia cinnamomea, has been widely to treat diseases such as liver disease, drug and food intoxication, diarrhea, and certain cancers.
Many issues that arise with the liver are preventable or reversible. However, if you are experiencing any symptoms related to imbalances in the liver, you should seek the advice of a doctor or TCM practitioner. These professionals can assess your situation and prescribe remedies for your specific issues.
Why Healthy Liver Function is Essential to Maintain a Balanced Life https://www.allthingshealth.com/en-us/general-health/digestive-health/healthy-liver-function/
Inactivated COVID-19 vaccine CoronaVac produced by Chinese vaccine developer Sinovac Photo: Courtesy of Sinovac
https://youtu.be/mm4hBBeOsVo
https://youtu.be/FsTAF7ppG6s
Chinese vice premier Sun Chunlan stressed a scientific and rigorous preparation is required for the mass production of Chinese-developed COVID-19 vaccines during an inspection tour of vaccine production lines of some leading manufacturers in Beijing on Wednesday, the same day the UK became the first Western country to approve a coronavirus vaccine for widespread use.
Sun and State Councilor Wang Yong visited the National Institute for Food and Drug Control, and two leading vaccine producers Sinovac, National Vaccine & Serum Institute under Sinopharm in Beijing, the Xinhua News Agency reported late Wednesday.
The visit was seen as a prelude for the vaccine coming to market in a rigorous and scientific manner. Russia and the UK announced on Wednesday they will start mass vaccinations against the coronavirus next week.
Sun and Wang learned about COVID-19 vaccine research, visited production plants and checked preparation work, and fully affirmed the achievements of the vaccine developers.
Fourteen vaccines using five technology methods are in clinical trials and five vaccines are undergoing phase Ⅲ clinical trials. Emergency use, production preparation and other work are proceeding in an orderly manner.
Sun called for scientific and rigorous phase Ⅲ clinical trials to carry out review and approval work in strict accordance with laws, regulations and internationally recognized technical standards to ensure the safety and effectiveness.
She required Chinese companies prepare for mass production, strictly comply with laws, regulations, procedures and requirements on quality supervision and biosafety, improve the traceability system for vaccines, punish illegal activities for creating a favorable market environment.
Sun said it's necessary to formulate a vaccination distribution plan before the vaccines are made available to the public. The emergency use of the vaccine in high-risk groups, such as port workers and front-line supervisors, will be completed by the end of 2020, she said.
The UK's approval of Pfizer's coronavirus vaccine on Wednesday paved the way for widespread uses of the vaccine. The first doses are already on their way to the UK, with 800,000 due to arrive in the coming days, Pfizer said.
Analysts said the UK and Russia's quick approval for widespread use of vaccine is mainly in response to new outbreaks that may get worse during the coming winter.
China is very likely to introduce its first officially approved vaccine for mass use in December, but whether it would be approved only for limited use is still under discussion, a Beijing-based immunological professor who asks not to be named told the Global Times.
The first vaccines to get approval are likely the inactivated vaccine candidates from either Sinovac or state-owned Sinopharm, said the professor, noting that other frontrunner candidates such as recombinant adenovirus vector vaccine would be slightly behind or approved for emergency use first.
The Global Times learned from the Sinovac's Brazilian partner Butantan Institute which is carrying out the phase Ⅲ clinical trials of the inactivated vaccine CoronaVac that the data from the trials have been sent to the Brazilian National Health Surveillance Agency. Sinovac told the Global Times that analysis of the clinical data will take some time.
Compared to China, vaccines are more urgently needed in the West, said a Shanghai-based vaccine expert. "The epidemic battle left many Americans desperate, let's hope President-elect Joe Biden will take human rights seriously and not follow in Trump's footsteps."
If the US is afraid of losing its stature, nothing is
stopping it from following in China's lead. America is more than welcome
to use vaccines as a way to help some of the poorest countries in the
world – not for isolationist purposes.
Pharmaceutical firms Pfizer and BioNTech, as well as
their competitor Moderna, have filed applications for approval of their
COVID-19 vaccines, the European Medicines Agency (EMA) said on Tuesday.
No matter how successfully China has contained the spread
of the coronavirus with all-out efforts and how the country has passed
on its experiences of handling the pandemic to the world in a timely
manner, some Western media has not given up its longstanding prejudices
and ideological biases when looking back at the past year, after
American broadcaster CNN came up with a so-called classified file on
Tuesday in an attempt to sensationalize obsolete issues and mislead the
world again.
African and some Latin American countries would prefer
Chinese-developed inactivated vaccines, due to their competitive costs
and easier logistics, to stop their pandemic crisis, said analysts in
both the vaccine and drug transportation services.
China will make its Covid-19 vaccine a global public good when it is
ready for application after successful research and clinical trials, a
senior Chinese official said.
