A deadly hospital fire claiming 91 patients' lives in India last week is raising serious concerns about the safety of foreigners being wooed by the nation's growing medical tourism industry.
The fire swept through AMRI, a 180-bed, state-of-the-art facility regarded as one of the best hospitals in India. There were no exit doors or evacuation plan, the windows were sealed, and the local fire department took more than 90 minutes to arrive. Trapped, many of the patients died from smoke inhalation, according to a report in Christian Science Monitor. Most died in their beds, unable to escape the inferno that raged for hours. Residents living in the neighborhood accused the hospital guards of not taking any measures to control the fire and of even preventing others from rushing to the rescue of the victims who were abandoned by the hospital staff. The hospital is known to attract many foreign patients. However, it's too early to tell if any foreigners died in the blaze because most of the charred remains have yet to be identified.
“Large numbers of hospitals are coming up in a big way across India. What we need to look into when issuing the licenses for running the hospitals is that building construction has complied to safety building codes and a safety plan is in place in case of fire,” said Dr. Muzzafer Ahmed, a member of the country's National Disaster Management Authority, speaking to the media.
Though Indians remain among the most under-served in the world in terms of health care, growing for-profit Indian hospital industry has been promoting itself as an inexpensive alternative to high-cost surgery in the United States and Europe. There are a large number of foreign-trained highly-skilled physicians and surgeons in India. And the heart bypass surgery that costs $6,000 in India costs more than $20,000 in the US, according to Yaleglobal. There are similar deep discounts available for joint replacement, in vitro fertilization (IVF), and surrogate mothers' womb rental services.
Many Indians are expecting exponential growth in foreign demand to take advantage of the opportunity to combine medical treatment with vacations at significantly lower costs. "With health care costs going north," says Dr Alok Roy of Fortis Hospital, one of the leading service providers in the medical tourism sector, "patients are compelled to look at cost-effective destinations for medical treatments. And what could be better if they can combine that with sightseeing at scenic locations?"
The safety concerns about India go beyond the fear of being burned in a fire. Other major concerns include:
1. Fake pharmaceuticals are a big worry. In fact, 75 percent of counterfeit drugs supplied world over have origins in India, according to a report released by the Organization for Economic Co-operation and Development (OECD).
2. Lack of proper hygiene contributes to a large number of infections in hospital settings. A recent investigation into the death of 13 women in a Rajasthan hospital found that the poor hygiene standard in the hospital were flagrantly overlooked, according to Times of India.
Will the latest incident at AMRI in Kolkatta, combined with general concerns about unhygienic practices and widespread use of fake pharmaceuticals, hurt India's efforts at growing its medical tourism industry? The short answer is yes. However, the growth prospects could improve in the future when the Indian government and the hospital industry begin to improve the safety situation to regain the trust of prospective foreign customers.
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WHO Report on Medical Tourism in India
33 comments:
Loss of life is a very sad event. Watch out soon they will blame Pakistan for this disaster.
@khalid
Not a bad idea to raise a report to state that it is subotage of pakistan and divert the attention toward the enemy. Generally that is the style of pakistan and not india.
@riaz
NO medical tourist comes to the government hospital. They go to private sector hospital which has five star comfort with seven star bills. But from their perspective it is still cheaper. You could read here and there even Pakistani coming over to India for treatment.
http://sociologyindex.com/medical_tourism_in_india.htm
Nothing will happen after this fire as government hospital are place for the mp / mla to loot the fund by supplying substandard equipments and infrastructure.
http://www.economist.com/blogs/freeexchange/2011/12/india%E2%80%99s-economy
India’s economy
Slip-sliding away
EXPECTATIONS for India’s economic growth rate have been sliding inexorably. In the early spring there was still heady talk about 9-10% being the new natural rate of expansion, a trajectory which if maintained would make the country an economic superpower in a couple of decades. Now things look very different. The latest GDP growth figure slipped to 6.9% and industrial production numbers just released, on December 12th, showed a decline of 5.1% compared with the previous period, a miserable state of affairs. The slump looks broadly based, from mining to capital goods, and in severity compares with that experienced at the height of the financial crisis, in February 2009, when a drop of 7.2% took place. Bombast is turning to panic.
A Bangladeshi is among the dead at Kolkatta's AMRI hospital, according The Independent of Bangladesh:
DHAKA: Bangladeshi patient is among the 73 killed so far in the massive fire at AMRI private hospital in Kolkata, the foreign ministry says.
However, a number of foreign and Indian media put the death toll at 90 in the hospital inferno, saying nearby hospitals were providing emergency treatment to the seriously wounded AMRI hospital victims.
The process to bring back the body of Gauranga Mandal through the Bangladesh Deputy High Commission in Kolkata is underway, the South Asia Department director general Mashfi Binte Shams told the reporters.
Family members had identified the body, Shams said.
She, however, did not have Gauranga's address or other information about him immediately.
Nearly 160 patients were admitted in the facility, The Times Of India said quoting hospital sources.
Additional director general, Fire Services, D Biswas was quoted as saying that patients who died were admitted in the critical care and orthopaedic units and were unable to move.
Only 85 patients were rescued and removed to two other units of the same hospital located at Mukundapur and Saltlake, they told the Indian daily. It said the hospital authority could not confirm the condition of remaining 75 patients....
http://www.theindependentbd.com/international/asia/83826-20-killed-in-kolkata-hospital-fire.html
Here's an excerpt of Businessweek story on medical tourism:
Convincing Americans to jet off to third-world India is a bit of a harder sell, though. By buying a 23.9% stake in Parkway from U.S. private equity firm TPG for $687 million, Fortis has now positioned itself to become the regional leader in medical tourism, with a strong presence in India (where it has 46 hospitals) for the most price-sensitive patients and a new base in Singapore for higher-end customers aiming for more luxury. Investors are pretty upbeat about the deal: Fortis shares today hit a twelve-month high of 187.4 rupees and are up 35% so far this year. Parkway investors are happy, too. The Singapore company hit a 52-week high of 3.3 Singapore dollars today.
http://www.businessweek.com/blogs/eyeonasia/archives/2010/03/india_hospital.html
Here's an APP report on the use of technology by US to teach and treat in Pakistan:
U.S. Ambassador to Pakistan Cameron Munter Thursday highlighting Pak-US cooperation in science and technology said that it has trained more than 100 doctors nationwide, and treated more than 2,000 patients remotely through the use of cutting-edge technology. During his visit here Thursday the Ambassador and his wife Marilyn Wyatt met with the faculty and students of the Rawalpindi Medical College at Holy Family Hospital’s telemedicine facility, working together with U.S. hospitals.
He said Pak-US cooperation in science and technology focused on many elements, including innovations in Pakistan’s public health sector. During a tour of the hospital with the hospital’s Telemedicine E-Health Training Center Project Director Dr. Asif Zafar, Ambassador Munter stated, “Holy Family’s partnership with American hospitals is an example of the true spirit of our people, who work together, across oceans, to improve access to healthcare in remote areas of Pakistan and treat the sick.” He said, “We commend Dr. Asif Zafar and the Holy Family Hospital team for its efforts to strengthen the health sector in Pakistan, and look forward to more shared successes that bring Pakistanis and Americans closer together.”
http://pakobserver.net/detailnews.asp?id=134092
Here's a Businessweek story on fake medicines in Pakistan:
In Pakistan’s biggest market for wholesale medicines, it pays to be observant.
More than 2,500 stalls wedged along dirt lanes in Karachi’s busiest trading district offer everything from Pfizer Inc. (PFE) (PFE)’s cholesterol pill Lipitor to GlaxoSmithKline Plc (GSK)’s painkiller Panadol. Closer study of the remedies lining rickety shelves reveals the source of an unfolding medical crisis: Lipitor sold in obsolete packaging, Panadol packets missing tell-tale ribbing, and allergy medicine Zyrtec mislabeled as Zytrec.
Now, the free flow of fake medications channeled through the market for decades may soon be slowed. Lawmakers are poised to pass legislation in June creating an agency to quash the trade after 107 heart patients were killed this year by pills tainted with lethal amounts of an anti-malarial agent. That may help break the ring of counterfeiters in Pakistan, part of a wider network supplying what the World Health Organization estimates is a $431 billion global market for spurious drugs.
“The issue is serious, demanding serious steps,” said Salman Burney, chief executive of GlaxoSmithKline Pakistan Ltd. (GLAXO) in Karachi. “Better regulation will generate more investment in the pharmaceutical industry, which will mean better quality medicines.”
The problem spans national borders. Pakistan was one of the 10 largest sources of counterfeit goods seized in the U.S. last year, U.S. Customs and Border Protection said in January. Medicines accounted for 85 percent of the value of the Pakistani items obtained.
At least 30 percent of medicines bought in the country are either counterfeits or substandard, said Kulsoom Parveen, a lawmaker who chairs a Senate health committee. Pharmacies nationwide sell drugs without a doctor’s prescription, enabling the treatments to be taken without medical supervision.
’Exploiting Weaknesses’
Pakistan has 4,000 registered pharmacists and 25 times more merchants dispensing medicines illegally, the Pakistan Pharmacists Association said.
It’s no coincidence that fake and substandard drugs are flourishing in Pakistan, said Laurie Garrett, senior fellow for global health at the Council on Foreign Relations. The New York- based think-tank prepared six recommendations to fight the drug- safety crisis for consideration by the Group of Eight summit at Camp David, Maryland, today and tomorrow.
“Individuals that are exploiting weaknesses in global drug safety and regulation will base themselves in places where they know the system is fragile or nonexistent,” Garrett said in a telephone interview. “Pakistan is really struggling to keep its entire public health infrastructure alive.”
Damaging Brands
Protecting product integrity would also benefit makers of brand-name medicines. Pharmaceutical sales in Pakistan, with a population of 196 million, total $2 billion annually, compared with $12.4 billion in neighboring India, with 1.2 billion people.
GlaxoSmithKline Pakistan, based in Karachi, made 1.14 billion Pakistani rupees ($12 million) in profit on sales of 21.75 billion rupees last year. In India, Mumbai-based GlaxoSmithKline Pharmaceuticals Ltd. (GLXO) had net income of 6.3 billion Indian rupees ($118 million) and revenue of 23.9 billion rupees.
Prime Minister Syed Yousuf Raza Gilani’s government hasn’t had a federal health minister or a central drug regulatory agency since powers were handed to the country’s four provinces last year. A new bill, to be voted on by Pakistan’s senate next month, will strive to fill the void....
http://www.businessweek.com/news/2012-05-17/stopping-fake-drugs-from-pakistan-is-too-late-for-victims#p1
Here's a Reuters' piece on absence of hygiene in India:
My Indian friends and I joke around a lot about me as the typical white American guy visiting India. Cows! Con men! Colors! Most people I’ve met in India have restricted their reactions to my westerner-in-the-east experiences to gentle teasing. When I stuck a picture of a man urinating in public on my Facebook page, calling it one more picture of what you see everywhere you go in India, people weren’t as patient. What was I doing? Insulting the nation? Focusing on the ugly because it’s what all the westerners do when they visit India? Why does India provoke such visceral reactions in visitors?
Public urination, public defecation, dirt, garbage, filth, the poor living on the street — talking about these things, even acknowledging that they’re in front of your face, risks making your hosts unhappy, and possibly angry. It’s the third rail of India, and the voltage can be lethal. That’s why I was surprised when B.S. Raghavan decided to touch it with all 10 fingers.
Raghavan’s column in The Hindu Business Line newspaper begins with this headline: Are Indians by nature unhygienic?
Consider these excerpts:
From time to time, in their unguarded moments, highly placed persons in advanced industrial countries have burst out against Indians for being filthy and dirty in their ways of life. A majority of visitors to India from those countries complain of “Delhi belly” within a few hours of arrival, and some fall seriously ill.
There is no point in getting infuriated or defensive about this. The general lack of cleanliness and hygiene hits the eye wherever one goes in India — hotels, hospitals, households, work places, railway trains, airplanes and, yes, temples. Indians think nothing of spitting whenever they like and wherever they choose, and living in surroundings which they themselves make unliveable by their dirty habits. …
Open defecation has become so rooted in India that even when toilet facilities are provided, the spaces round temple complexes, temple tanks, beaches, parks, pavements, and indeed, any open area are covered with faecal matter. …
Even as Indians, we are forced to recoil with horror at the infinite tolerance of fellow Indians to pile-ups of garbage, overflowing sewage, open drains and generally foul-smelling environs.
There’s plenty more that you can read in that story, but I’ll direct you to the article. I’ll also ask you some questions:
Some people say you shouldn’t point out these problems, and that every country has problems. Do you agree with this statement? Why?
Does anyone disagree with Raghavan’s descriptions of these sights and smells?
Is this even a problem? Or should people get used to it?
Should visitors, especially ones from countries where people are generally wealthier, say nothing, and pretend that they don’t see unpleasant things?
As for me, I can say this: I got used to it, but I would be lying if I said I didn’t notice it. Indians notice it too. Otherwise, people wouldn’t suggest public shaming campaigns against people urinating in public, they wouldn’t threaten fines for doing it, and they wouldn’t respond with relief to plans to finally make sure that toilets on India’s trains don’t open directly onto the tracks. Of course, these are people in India. It’s a family, taking care of business the family way.
As for me, the message usually seems to be: “If you don’t love it, leave it.” It would be nice if there were some other answer. Acknowledging problems, even ones that are almost impossible to solve, makes them easier to confront.
http://blogs.reuters.com/india/2012/11/17/indians-inherently-unhygienic-indian-writer-touches-third-rail/
Here's a Pulitzer winning piece on the dangers of India's medical tourism for the unsuspecting foreigners:
NDM-1 bacteria are propagating most lushly in India. The NDM-1 gene circulates in a family of bacteria called “Gram-negative” (after the Gram test used to identify them) whose unique cell envelopes make them both more toxic and harder to treat than “Gram-positive” bacteria. Many Gram-negative bacteria colonise the human gut and thrive in places with poor sanitation, where gut bacteria can pass from host to host through food and water contaminated with faecal matter. Basic sanitation remains rudimentary in many places in India. Only 65% of Delhi’s sewage is adequately treated and 20% of the population live in overcrowded slums highly exposed to contaminated water and food (9). Uncollected trash and teeming crowds abound just outside Medanta’s gates. Hawkers sell freshly squeezed fruit juice and vegetables from carts and, in a dusty lot next to the hospital, men sit on overturned buckets, eating rice and curry. A narrow stream emerges from near the hospital gates; its weedy banks are lined with trash. In a nearby slum, barefoot children play in narrow alleyways lined by open gutters carrying waste water and excrement.
In April 2011 researchers found NDM-1 bacteria in samples of Delhi’s drinking water and in puddles around the city. University of Cardiff microbiologist Tim Walsh suspects that between 100 million and 200 million Indians now carry NDM-1 bacteria in their guts. NDM-1 bacteria flourish at tropical temperatures, so the warm weather and floods of the monsoon season expose even more people.
Better healthcare for the poor, improved hospital hygiene and more judicious use of antibiotics could help contain NDM-1. But the politics of national pride may make such measures impossible. Indian medical authorities and politicians have both denied the public health relevance of NDM-1, and accused scientists working on the issue of a “conspiracy to hurt Indian medical tourism”, as The Indian Express put it. After initial reports on the bacteria appeared, Indian government authorities sent threatening letters to Indian researchers who had collaborated with British scientists on NDM-1 studies, according to the UK’s Channel 4 News (10). Walsh, who led many of the studies, said that his Indian collaborators were pressured to disavow their research and he became persona non grata in India: “I’m the devil incarnate and eat babies for breakfast according to the Indian government. It’s a witch hunt.”
The Indian government first complained that the bacteria gene was named after their capital city. Then, as the controversy grew, it convened an advisory committee on antibiotic resistance, and floated an ambitious proposal to ban the sale of antibiotics without a physician’s prescription, and restrict the use of last-resort intravenous antibiotics to tertiary hospitals. But after pharmacists went on strike in August 2011, the proposal was withdrawn (11). “The committee was a knee-jerk response,” said Ramanan Laxminarayan, of the Public Health Foundation of India. Wattal, Laxminarayan and others agree that the proposed restrictions would have affected a wide range of drugs besides antibiotics, and would have impeded access to life-saving antibiotics for the rural poor. In fact, the policy had little chance of being enforced: health policy is implemented at state level in India, not federal level.
http://pulitzercenter.org/reporting/india-global-health-crisis-super-antibiotic-resistant-bacteria-ndm-1-medical-tourism-poverty
Here's a Bloomberg story on a tourist's experience with Indian medical system:
Lill-Karin Skaret, a 67-year-old grandmother from Namsos, Norway, was traveling to a lakeside vacation villa near India’s port city of Kochi in March 2010 when her car collided with a truck. She was rushed to the Amrita Institute of Medical Sciences, her right leg broken and her artificial hip so damaged that replacing it required 12 hours of surgery.
Three weeks later and walking with the aid of crutches, Skaret was relieved to be home. Then her doctor gave her upsetting news. Mutant germs that most antibiotics can’t kill had entered her bladder, probably from a contaminated hospital catheter in India. She risked a life-threatening infection if the bacteria invaded her bloodstream -- a waiting game over which she had limited control, Bloomberg Markets magazine reports in its June issue.
“I got a call from my doctor who told me they found this bug in me and I had to take precautions,” Skaret remembers. “I was very afraid.”
Skaret was lucky. Eventually, her body rid itself of the bacteria, and she escaped harm from a new type of superbug that scientists warn is spreading faster, further and in more alarming ways than any they’ve encountered. Researchers say the epicenter is India, where drugs created to fight disease have taken a perverse turn by making many ailments harder to treat.
India’s $12.4 billion pharmaceutical industry manufactures almost a third of the world’s antibiotics, and people use them so liberally that relatively benign and beneficial bacteria are becoming drug immune in a pool of resistance that thwarts even high-powered antibiotics, the so-called remedies of last resort.
Medical Tourism
Poor hygiene has spread resistant germs into India’s drains, sewers and drinking water, putting millions at risk of drug-defying infections. Antibiotic residues from drug manufacturing, livestock treatment and medical waste have entered water and sanitation systems, exacerbating the problem.
As the superbacteria take up residence in hospitals, they’re compromising patient care and tarnishing India’s image as a medical tourism destination.
“There isn’t anything you could take with you traveling that would be useful against these superbugs,” says Robert Moellering Jr., a professor of medical research at Harvard Medical School in Boston.
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India is susceptible because it has many sick people to begin with. The country accounts for more than a quarter of the world’s pneumonia cases. It has the most tuberculosis patients globally and Asia’s highest incidence of cholera.
Most of India’s 5,000-plus drugmakers produce low-cost generic antibiotics, letting users and doctors switch around to find ones that work. While that’s happening, the germs the antibiotics are targeting accumulate genes for evading each drug. That enables the bugs to survive and proliferate whenever they encounter an antibiotic they’ve already adapted to.
India’s inadequate sanitation increases the scope of antibacterial resistance. More than half of the nation’s 1.2 billion residents defecate in the open, and 23 percent of city dwellers have no toilets, according to a 2012 report by the WHO and Unicef.
Uncovered sewers and overflowing drains in even such modern cities as New Delhi spread resistant germs through feces, tainting food and water and covering surfaces in what Dartmouth Medical School researcher Elmer Pfefferkorn describes as a fecal veneer..
http://www.bloomberg.com/news/2012-05-07/drug-defying-germs-from-india-speed-post-antibiotic-era.html
Michaela Cross, an American student at the University of Chicago, on her stay in India:
Do I describe the lovely hotel in Goa when my strongest memory of it was lying hunched in a fetal position, holding a pair of scissors with the door bolted shut, while the staff member of the hotel who had tried to rape my roommate called me over and over, and breathing into the phone?
How, I ask, was I supposed to tell these stories at a Christmas party? But how could I talk about anything else when the image of the smiling man who masturbated at me on a bus was more real to me than my friends, my family, or our Christmas tree? All those nice people were asking the questions that demanded answers for which they just weren't prepared.
When I went to India, nearly a year ago, I thought I was prepared. I had been to India before; I was a South Asian Studies major; I spoke some Hindi. I knew that as a white woman I would be seen as a promiscuous being and a sexual prize. I was prepared to follow the University of Chicago’s advice to women, to dress conservatively, to not smile in the streets. And I was prepared for the curiosity my red hair, fair skin and blue eyes would arouse.
But I wasn't prepared.
There was no way to prepare for the eyes, the eyes that every day stared with such entitlement at my body, with no change of expression whether I met their gaze or not. Walking to the fruit seller's or the tailer's I got stares so sharp that they sliced away bits of me piece by piece. I was prepared for my actions to be taken as sex signals; I was not prepared to understand that there were no sex signals, only women's bodies to be taken, or hidden away.
I covered up, but I did not hide. And so I was taken, by eye after eye, picture after picture. Who knows how many photos there are of me in India, or on the internet: photos of me walking, cursing, flipping people off. Who knows how many strangers have used my image as pornography, and those of my friends. I deleted my fair share, but it was a drop in the ocean-- I had no chance of taking back everything they took
For three months I lived this way, in a traveler's heaven and a woman's hell. I was stalked, groped, masturbated at; and yet I had adventures beyond my imagination. I hoped that my nightmare would end at the tarmac, but that was just the beginning. Back home Christmas red seemed faded after vermillion, and food tasted spiceless and bland. Friends, and family, and classes, and therapy, and everything at all was so much less real than the pain, the rage that was coursing through my blood, screaming so loud it deafened me to all other sounds. And after months of elation at living in freedom, months of running from the memories breathing down my neck, I woke up on April Fool's Day and found I wanted to be dead.
http://ireport.cnn.com/docs/DOC-1023053
Here's a NY Times story on drug safety concerns about India:
India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines.
Dr. Margaret A. Hamburg, the commissioner of the United States Food and Drug Administration, arrived in India this week to express her growing unease with the safety of Indian medicines because of “recent lapses in quality at a handful of pharmaceutical firms.”
India’s pharmaceutical industry supplies 40 percent of over-the-counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for American consumers.
F.D.A. investigators are blitzing Indian drug plants, financing the inspections with some of the roughly $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants. The agency inspected 160 Indian drug plants last year, three times as many as in 2009. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers.
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Enforcement of regulations over all is very weak, analysts say, and India’s government does a poor job policing many of its industries. Last month, the United States Federal Aviation Administration downgraded India’s aviation safety ranking because the country’s air safety regulator is understaffed, and a global safety group found that many of India’s best-selling small cars are unsafe.
India’s Central Drugs Standard Control Organization, the country’s drug regulator, has a staff of 323, about 2 percent the size of the F.D.A.'s, and its authority is limited to new drugs. The making of medicines that have been on the market at least four years is overseen by state health departments, many of which are corrupt or lack the expertise to oversee a sophisticated industry. Despite the flood of counterfeit drugs, Mr. Singh, India’s top drug regulator, warned in meetings with the F.D.A. of the risk of overregulation.
This absence of oversight, however, is a central reason India’s pharmaceutical industry has been so profitable. Drug manufacturers estimate that routine F.D.A. inspections add about 25 percent to overall costs. In the wake of the 2012 law that requires the F.D.A. for the first time to equalize oversight of domestic and foreign plants, India’s cost advantage could shrink significantly....
http://www.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html?hpw&rref=world&_r=0
NEW DELHI: India has become heavily import dependent on China when it comes to many essential and large volume drugs making it vulnerable to sudden disruption of supplies, according to a study by Assocham.
The study released today cites the gradual erosion of domestic manufacturing capacity for certain key Active Pharmaceutical Ingredients ( APIsBSE 0.00 %) and steady migration of Indian pharma players to value-added formulations with higher margins as the primary reasons behind th ..
Read more at:
http://economictimes.indiatimes.com/articleshow/37787639.cms
Before #Nestle #Maggi Noodles Scare: Look at What the U.S. #FDA Found in #India made Snacks #Haldiram http://on.wsj.com/1GuQfQr via @WSJIndia
Indian regulators’ findings that samples of Nestlé SANESN.VX +0.24% Maggi instant noodles contained impermissibly high levels of lead stunned middle-class consumers this month. But long before India yanked the product off store shelves, U.S. food-safety inspectors had deemed hundreds of made-in-India snacks unfit for sale in America.
Data on the website of the U.S. Food and Drug Administration show that it rejected more snack imports from India than from any other country in the first five months of 2015. In fact, more than half of all the snack products that were tested and then blocked from sale in the U.S. this year were from India. Indian products led the world in snack rejects last year as well.
Mexico, a much larger trading partner of the U.S., was second in terms of rejections this year, followed by South Korea. China — whose exports to the U.S. are worth ten times as much as India’s — was a distant eighth.
And it’s not just snack foods. The U.S. FDA has rejected all sorts of imports from India, including everything from cosmetics to drugs to ceramics.
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Most Indian snacks rejected by the FDA this year were from the Nagpur-based food company Haldiram’s. Among the rejected Haldiram’s products were some sugar candies and salty Indian snack mixes. The FDA said on its website that it rejected the Haldiram’s products because it found pesticides in them.
A.K. Tyagi, a senior-vice president at Haldiram’s, said its food “is 100% safe and complies with the law of the land.” Discrepancies, he said, arise because food-safety standards differ in India and the U.S. “A pesticide that is permitted in India may not be allowed there. And even if it is, they may not allow it in the same concentration as it is here,” he said.
Indian baked snacks also had troubles getting into the States. Out of 217 imported baked products rejected by the U.S. FDA so far this year, more than half were made in India. One of them was a biscuit pack manufactured by India’s largest biscuit-maker, Britannia Industries Ltd.
Reddy- one of #India's largest drugmakers is crashing after the #US #FDA warning on quality http://read.bi/1Prz0Ua via @bi_contributors
Dr Reddy's Laboratories Ltd, India's second-largest drugmaker, has received a "warning letter" from US regulators over inadequate quality controls at three manufacturing plants producing drugs for cancer and other diseases.
The warning is the latest in a string of incidents that have hurt the industry's reputation and slowed its growth in the world's largest drug market, where India supplies more than 40% of the generic and over-the-counter medicines.
Dr Reddy's said the FDA warning meant it would not receive US approvals for drugs made at the plants until it fixed the problems, a blow for business at a company that relies on the US for a majority of its sales.
The affected plants account for more than 10% of the company's sales.
Dr Reddy's said a production halt may not be required, but the news caught investors by surprise, sending shares to their lowest level in four months.
"We are probably looking at flat to declining earnings in FY 2017, while earlier we were expecting growth," said analyst Nimish Mehta, founder of Research Delta Advisors.
Analysts warned the move by the US Food and Drug Administration would hit US sales for at least the next two years, as the launch of key products may be delayed.
"There is no indication in the warning letter that we need to stop manufacturing, but we will be examining the contents and deciding our strategy," Dr Reddy's CFO Saumen Chakraborty told the Indian television news channel ET Now.
The FDA inspected the company's Srikakulam, Miryalaguda, and Duvvada drug-manufacturing sites in November, January, and February, and it almost immediately issued initial notices asking the group to rectify some problems.
But the company was unable to fix the issues to the satisfaction of the FDA, and it was hit with a warning letter. Such letters are issued by the agency when it finds a manufacturer has "significantly violated" its regulations.
"We had absolutely no idea it could escalate to this level," Siddhanth Khandekar of ICICI Securities said.
Dr Reddy's said the agency's concerns with the plants related to quality-control procedures and how data was recorded. It did not provide details.
The FDA has already banned plants of other Indian firms, such as Wockhardt Ltd and Ranbaxy Laboratories Ltd, a unit of the country's largest drugmaker Sun Pharmaceutical Industries Ltd, after finding faulty, fudged, or incomplete data records in recent years.
Both companies have been unable to get their plants cleared by the agency, more than two years after the bans.
But analysts say the FDA considers data integrity issues to be the most serious, typically requiring at least two years to be remedied to its satisfaction.
Dr Reddy's CEO G V Prasad said the group was revamping its quality systems as a result.
The FDA has increased the number of inspections of foreign plants supplying to the US over the past year, exposing quality-control issues at several Indian drugmakers. India plants of multinational drugmakers, such as Novartis and Mylan, have also come under fire.
Industry executives say they have been improving their manufacturing and systems, but sanctions continue.
Dr Reddy's makes drug ingredients at the Srikakulam and Miryalaguda plants, and cancer medicines at the Duvvada plant.
#India's Sun Pharmaceutical’s factory in #Gujarat gets #FDA warning for quality issues. #Pharma http://on.wsj.com/1OevB6S via @WSJ
Sun Pharmaceutical Industries Ltd., India’s largest drugmaker by sales, said Saturday that one of its factories is under increased scrutiny from U.S. regulators.
The generic-drug maker’s factory in Halol, in the western Indian state of Gujarat, received a warning letter from the U.S. Food and Drug Administration. Warning letters are issued when the FDA isn't satisfied with a drugmaker’s plan to fix quality issues spotted by the regulator.
This is the latest setback for India’s pharmaceutical companies, which have struggled with quality issues under the increased scrutiny from the FDA. Indian companies account for around 40% of generic drug sales in the U.S.
U.S. inspectors in September last year said they were concerned with how Sun Pharma workers at its plant handled quality-test data and the plant’s “sterile environment,” said Dilip Shanghvi, Sun Pharma’s managing director.
If Sun Pharma is unable to assure the FDA that it can fix the problems, the regulator will issue an import alert, barring that factory from producing medicines for the U.S.
Sun Pharma makes some of its most profitable products at the Halol factory, including pre-filled syringes that need to manufactured in a sterile environment.
The Halol factory is continuing to produce drugs as it tries to fix quality issues, better train its staff and automate more of the manufacturing process, Mr. Shanghvi said.
The company has already moved production of some of the drugs produced at Halol to mitigate any impact on sales should the Halol plant be unable to export to the U.S., he said.
A deadly epidemic that could have global implications is quietly sweeping India, and among its many victims are tens of thousands of newborns dying because once-miraculous cures no longer work.
These infants are born with bacterial infections that are resistant to most known antibiotics, and more than 58,000 died last year as a result, a recent study found. While that is still a fraction of the nearly 800,000 newborns who die annually in India, Indian pediatricians say that the rising toll of resistant infections could soon swamp efforts to improve India’s abysmal infant death rate. Nearly a third of the world’s newborn deaths occur in India.
“Reducing newborn deaths in India is one of the most important public health priorities in the world, and this will require treating an increasing number of neonates who have sepsis and pneumonia,” said Dr. Vinod Paul, chief of pediatrics at the All India Institute of Medical Sciences and the leader of the study. “But if resistant infections keep growing, that progress could slow, stop or even reverse itself. And that would be a disaster for not only India but the entire world.”
In visits to neonatal intensive care wards in five Indian states, doctors reported being overwhelmed by such cases.
“Five years ago, we almost never saw these kinds of infections,” said Dr. Neelam Kler, chairwoman of the department of neonatology at New Delhi’s Sir Ganga Ram Hospital, one of India’s most prestigious private hospitals. “Now, close to 100 percent of the babies referred to us have multidrug resistant infections. It’s scary.”
These babies are part of a disquieting outbreak. A growing chorus of researchers say the evidence is now overwhelming that a significant share of the bacteria present in India — in its water, sewage, animals, soil and even its mothers — are immune to nearly all antibiotics.
Newborns are particularly vulnerable because their immune systems are fragile, leaving little time for doctors to find a drug that works. But everyone is at risk. Uppalapu Shrinivas, one of India’s most famous musicians, died Sept. 19 at age 45 because of an infection that doctors could not cure.
While far from alone in creating antibiotic resistance, India’s resistant infections have already begun to migrate elsewhere.
“India’s dreadful sanitation, uncontrolled use of antibiotics and overcrowding coupled with a complete lack of monitoring the problem has created a tsunami of antibiotic resistance that is reaching just about every country in the world,” said Dr. Timothy R. Walsh, a professor of microbiology at Cardiff University.
Indeed, researchers have already found “superbugs” carrying a genetic code first identified in India — NDM1 (or New Delhi metallo-beta lactamase 1) —around the world, including in France, Japan, Oman and the United States.
Anju Thakur’s daughter, born prematurely a year ago, was one of the epidemic’s victims in Amravati, a city in central India. Doctors assured Ms. Thakur that her daughter, despite weighing just four pounds, would be fine. Her husband gave sweets to neighbors in celebration.
Three days later, Ms. Thakur knew something was wrong. Her daughter’s stomach swelled, her limbs stiffened and her skin thickened — classic signs of a blood infection. As a precaution, doctors had given the baby two powerful antibiotics soon after birth. Doctors switched to other antibiotics and switched again. Nothing worked. Ms. Thakur gave a puja, or prayer, to the goddess Durga, but the baby’s condition worsened. She died, just seven days old.
“We tried everything we could,” said Dr. Swapnil Talvekar, the pediatrician who treated her. Ms. Thakur was inconsolable. “I never thought I’d stop crying,” she said.
A test later revealed that the infection was immune to almost every antibiotic. The child’s rapid death meant the bacteria probably came from her mother, doctors said.
http://www.nytimes.com/2014/12/04/world/asia/superbugs-kill-indias-babies-and-pose-an-overseas-threat.html?_r=0
India man carries wife's body home from hospital after vehicle refused. 12-year-old weeping daughter in tow. @CNN
http://www.cnn.com/2016/08/26/asia/india-man-carries-wifes-body/index.html
A grieving man in India carried his wife's body for miles after the hospital where she died allegedly failed to provide a way to transport her body back to their village.
Without the money to hire a vehicle, Dana Manjhi walked for 6.2 miles (10 kilometers) by foot Wednesday.
In the humid and sweltering summer temperatures, he hoisted his wife's body, wrapped in a blue sheet, over his shoulder. He was accompanied by his weeping 12-year-old daughter.
His wife, Amang Dei, 42, died of tuberculosis Tuesday night at a hospital in the eastern state of Odisha.
On-lookers intervene
Manjhi and his daughter had about 50 kilometers (31 miles) to go before reaching their village when passersby called a local journalist.
Odisha TV journalist Ajit Singh found them and recorded video of the pair that has been widely-shared across the nation.
"I am carrying the dead body of my wife as I am poor and cannot afford a vehicle. I told the same to the hospital authorities. They said they could not offer any help," Manjhi said in the video.
Singh described the story to CNN.
"Some locals ... spotted Mr. Manjhi carrying the dead body of his wife accompanied by his 12-year-old daughter, Sanadei Manjhi, and called me," he said. "We filmed him carrying the dead body and asked him what happened.
A car was eventually organized for Manjhi.
A government-provided transport van should have been available to Manjhi, affiliate CNN News 18 reported. However, he said he was refused help and told by the hospital to take the body and leave.
The hospital denied reports it withheld a car from him. A hospital official told CNN they did not even know when Manjhi took his wife's body.
"No one knows when her husband carried her out of the hospital," said Dr. Jaghu Lal Agarwal, assistant district medical officer at the Kalahandi hospital.
"Her death was not confirmed by the on-duty doctor and no discharge slip was issued. The hospital staffs on duty were not informed by Mr. Manjhi."
A government inquiry had been launched into the incident, said Brundha D, a district official.
"We have ordered a probe and due actions will be taken if any wrongdoing has been done," she said.
Odisha is one of the remotest states in India. A 2011 UN report that examined 19 Indian states gave it the lowest ranking on the Human Development Index.
India ranks 106 out of 140 countries for health care, according to the World Economic Forum Global Competitiveness Index.
#American woman US dies from antibiotic resistant superbug after #surgery in #India #MedicalTourism
http://www.mirror.co.uk/news/world-news/woman-who-returned-surgery-india-9619602
An American woman who travelled to India died after contracting a superbug resistant to all forms of antibiotic, doctors have said.
The victim, aged in her 70s, died in Nevada after medics in the US were unable to find any drug that could treat her.
A report into the incident says it is believed she contracted the superbug NDM-1.
"The patient developed septic shock and died in early September," it read.
"During the two years preceding this US hospitalization, the patient had multiple hospitalizations in India related to a right femur fracture and subsequent osteomyelitis of the right femur and hip; the most recent hospitalization in India had been in June 2016,"
The lethal bug NDM-1 first came to the attention of doctors in Britain around 2010.
Scientists writing in the journal Lancet Infectious Diseases said there had been 37 cases in the UK of a bug resistant to all antibiotics.
All patients had travelled from Asia after cosmetic surgery, cancer treatment and transplants.
New Delhi-Metallo-1 (NDM-1) also has an "alarming potential to spread and diversify."
Experts said there are currently no drugs in development to counter NDM-1 meaning it was likely to spread.
Randall Todd of the Washoe County, Nevada health department, said: "We have a shrinking world.
"Hospitals should be reminded that they have got to take a travel history and be open to the possibility that an uncommon infection might be responsible."
BBC News - Video of #India doctors fighting in operation theater during C-section goes viral.
http://www.bbc.com/news/world-asia-india-41092466#
Two doctors in India were temporarily released from their duties after a video surfaced of them arguing while standing over a pregnant patient during an operation, their hospital says.
Footage of the incident, at the Umaid hospital in north Rajasthan, has been widely circulated, causing outrage.
A senior hospital official told the BBC that the woman and her baby are fine.
The source of the leaked video is unclear, but the official confirmed that it came from within the hospital.
Trading insults
After the video emerged online, many media reports claimed the woman pictured on the operating table gave birth to a baby who did not survive.
But Dr Ranjana Desai, the superintendent of Umaid Hospital in Jodhpur, said this was inaccurate. "By the time I saw the video and conducted an internal inquiry, the media had already reported that this baby had died," she told the BBC.
A baby did die, but not the one the media reported, she said. A few feet away, on another operating table within the same room, a different woman gave birth to a stillborn baby. "These two incidents are not linked," Dr Desai told the BBC.
In the video, which has been shared widely across media and online, the two doctors can be heard slinging insults at each other in Hindi before arguing over whether the patient had eaten before surgery.
Dr Desai identified the two doctors as Dr Ashok Nanival and Dr Mathura Lal Tak.
She said that the two doctors were not formally suspended, but had been released from their duties at the hospital while they proceed with an internal inquiry. Additionally, the hospital is in the process of collecting statements from staff to find out who shot the video and how it came to be leaked.
The Rajasthan High Court has ordered the hospital to submit a report, while they proceed with a separate state level investigation into the incident.
Visa hurdle stops #Pakistani patients, hurts medical tourism in #India http://toi.in/hJPrAb via @TOIDelhi
When countries go to war, even diplomatically, it's always the people who suffer. This is exactly what's been happening to the people as Indo-Pak ties have become frosty. India's imposition of restrictions on the issue of medical visas to Pakistanis has not just affected hundreds of patients from across the border but also dealt a body blow to medical tourism in India.
It's hard to find out precisely how many people travelled to India from Pakistan for treatment, but several laboratories TOI spoke to in Islamabad revealed that before visa restrictions were imposed, over 600 Pakistani patients used to visit India.
Most of them suffering from liver and heart ailments would go to major hospitals in Delhi, Mumbai, Chennai and other cities. But in February, there was a sharp drop in the numbers. And in the last two months, not a single Pakistani was granted a medical visa.
India took this decision after a Pakistani court sentenced Indian national and retired naval officer Kulbhushan Jadhav to death on the charge of espionage. Islamabad has reacted strongly to this, while Pakistani civil society has appealed to human rights organisations to take it up with India and international bodies.
On this side of the border, business has been affected a bit. Even though more people come from Bangladesh, Iraq and Maldives for treatment, Pakistanis spend the most in India. A recent report by ministry of commerce and industry says an average Pakistani spends Rs 1.87 lakh on treatment in India. Those from Bangladesh spend Rs 1.34 lakh on an average, followed by those from Commonwealth countries (Rs 1.25 lakh), Russia (Rs 1.04 lakh) and Iraq (Rs 98,554).
"This is because Pakistani patients mostly come for organ transplants and heart surgeries for children that are costly," said Manish Chandra, co-founder of Vaidam medical travel assistance company.
In 2015-16, he added, nearly 166 Pakistanis received treatment in India every month. Top Delhi hospitals, which are frequented by foreign nationals, confirmed this.
"We have observed a decrease in the number of patients coming from Pakistan. Patients have also informed us that visas have become hard to get. Issuing of visas is in the domain of the two governments and we would not like to comment on the policy of the central government on this," said a spokesperson of Max healthcare.
Dr Subhash Gupta, senior liver transplant surgeon at the hospital, added that there hasn't been a single patient from Pakistan for a month as against up to 30 earlier.
At Fortis, sources said, at least 20 patients who had contacted the hospital for various procedures have failed to come due to visa issues.
Officials at Apollo hospital said they used to get 30 Pakistani patients each month till last year, but not a single one has come in the last month.
Swiss tourist couple badly injured in youth assault at #Agra #India. #Tourism #TajMahal
https://www.nytimes.com/2017/11/06/world/asia/taj-mahal-assault-tourism.html
Youths would later tell the police that the couple, both 24, had offended them by ignoring their greetings and kissing in front of them. Not so, Ms. Droz told The Times of India. They were trying to force her to take selfies with them, Mr. Clerc added. Eventually, they began beating the couple with sticks and rocks.
By the time a crowd had gathered and the youths had run away, he had a fractured skull and possibly permanent hearing damage and she had a fractured left arm. “The blood was flowing,” said Ram Kishor, a police constable in the area.
The assault late last month made headlines for several days in India. It was a fresh setback for tourism in this part of the country, which is home to some of the world’s most famous monuments but finds its status threatened by disputes about its Muslim heritage, amid reports of declining visitor numbers and of harassment of tourists.
Stops at Fatehpur Sikri and in the nearby city of Agra to see the Taj Mahal, all of which are in Uttar Pradesh State, are at the top of many itineraries for tourists in India. Built in the 17th century by the Muslim emperor Shah Jahan as a tomb for his wife, Mumtaz Mahal, the Taj Mahal attracts millions of visitors every year. Tour operators call it India’s monument to eternal love.
But Hindu nationalists, some of them aligned with the governing Bharatiya Janata Party, have taken aim at the Taj Mahal and its ties to a Muslim ruler.
During a trip to Agra in June, Yogi Adityanath, the chief minister of Uttar Pradesh, said at a rally that small replicas of the monument given to foreign dignitaries “did not reflect Indian culture.” Other far-right leaders went further, describing it as having been built by “traitors” who “wanted to wipe out Hindus.”
But Mr. Adityanath seems to be softening his stance, at least in public. When he visited Agra in late October, he called the Taj Mahal a “unique gem.” A tourism brochure published by the state government that initially omitted the Taj Mahal has been updated to include it.
Tour guides said the controversy had hurt their business.
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On a recent day, a throng of tourists formed a line at the mouth of the Taj Mahal complex, pressing their bodies forward. Among them was Vital Labonte, 66, a French Canadian visitor in hiking boots, who said the occasional jostle or appeal for money did not bother him.
“The kids run at you, they want money to better their life,” he said. “Just say no. I’m not worried with it.”
Viktoria Simeoni, 23, an Austrian visitor who had booked a trip to India on a whim, said she sometimes felt unsafe when men stared at her or asked for pictures, a request often made to foreign tourists in India.
“One lady gave me her baby,” she said. “I was just holding the baby, and then she took pictures of me. I didn’t feel so comfortable.”
The police found it necessary to crack down. In the days after the attack, they arrested over 50 people they accused of being touts with reputations for hounding tourists.
In Fatehpur Sikri, officials emphasized that the severity of the attack against the Swiss couple was rare. The crime that tourists report most often is theft.
BBC News - Anger as #India doctor mistakenly declares newborn dead. #Health #MedicalTourism
http://www.bbc.com/news/world-asia-india-42194192#
A newborn baby, declared dead by a hospital in the Indian capital Delhi, was found to be alive while they were on their way to his funeral.
Doctors at the privately run Max Hospital had pronounced the baby dead hours after his twin who was stillborn.
The parents said they noticed one of the babies squirming inside the plastic bag that doctors placed the infants in.
The incident has sparked outrage and a debate over the quality of private healthcare which is often costly.
Delhi Chief Minister Arvind Kejriwal tweeted that he had ordered an inquiry into the matter. The state health minister has also described the incident as "shocking criminal negligence".
According to the twins' grandfather, the stunned family rushed the newborn to a nearby hospital where they were told that their baby was still alive, local media reported.
In a statement to reporters, Max hospital said they were "shaken" and "concerned" over the incident, and added that the doctor has been asked to go on leave, pending an inquiry.
According to ANI news agency, Delhi police have begun to investigate the case and have consulted legal experts.
This is the second instance in recent months where a private hospital in India has been called out for negligent care. Last month, a girl died of dengue fever in another hospital and the parents allege they were overcharged for her treatment.
NDM-1 in India: Drug Resistance, Political Resistance
https://www.wired.com/2011/10/ndm1-india-politics/
It's been more than a year since the "Indian superbug" NDM-1 – not actually a bacterium, but a gene that directs production of an enzyme – hit the news. The enzyme, whose acronym is short for New Delhi metallo-beta-lactamase-1, disables almost all antibiotics directed against it, leaving the bacteria in which the gene appears vulnerable to only two imperfect and sometimes toxic drugs.
The enzyme and its gene, blaNDM-1, were first identified in 2008 in people who had traveled in India or sought medical care in South Asia. Hence its name: Many beta-lactamases, enzymes that denature the very large class of everyday antibiotics known as beta-lactams, are named for countries and cities where they were first identified. Since its identification, NDM-1 has been discovered in patients in more than a dozen countries and has also been found to be widely harboured outside hospitals in India, and in surface waters and sewage there.
The unveiling of NDM-1 clearly caused embarrassment for India, and media and lawmakers there struck back, throwing around intemperate language and claiming the naming of the enzyme was a plot to derail the subcontinent's medical-tourism industry — even though the Indian doctors hadattempted to raise the alarm earlierand had been ignored.
So it seemed like a promising signal of openness when an international conference on antibiotic resistance opened in New Delhi a week ago. But in its wake, just what is going on in India – and whether its government is willing to face up to what might be an international crisis – is less clear than ever.
------------------
If India is moving to contain NDM-1, it is doing so barely in time. Dr. Timothy Walsh, who first isolated the gene and enzyme in a resident of Sweden who had been hospitalized in India, told the Times of India:
We estimate that the carriage rate of NDM-1 in India is between 100 and 200 million, which means that NDM-1 has become a very serious public health issue... With globalization, NDM-1 will continue to spread unchecked around the world and once established in higher enough numbers in a particular country, will further disseminate.
We are desperate to help in any way we can to initiate studies to realize the full impact of NDM-1 on Indian society... I cannot say whether the Indian government is finally taking the issue seriously – only they can answer that charge. However, what is clear is that we have lost a year fighting amongst ourselves when our energies and resources should have been focused elsewhere – on NDM-1.
The growing peril of drug-resistant superbugs
Many in India face a similar fate – they get admitted to hospitals with seemingly treatable illnesses, only to contract HAIs caused by superbugs.
https://www.hindustantimes.com/india-news/the-growing-peril-of-drug...
Manoj Ghamandayan, 21, has little memory of the month he was hospitalised and nearly died.
It started out as a fever in the first week of October 2019. Then he began to have trouble breathing. Soon, Ghamandayan, an undergraduate Arts student from Haryana’s Jhajjar district, was admitted to Sunflag Global Hospital in Rohtak. He was diagnosed with dengue, a viral infection spread by the Aedes mosquito and scrub typhus, a bacterial infection. To help him recover, the hospital hooked him to multiple devices: a mechanical ventilator to aid breathing, a catheter for draining urine, and a central line to pump medicines into his body.
But Ghamandayan got sicker. During his two-week stay at the hospital, he caught three healthcare-associated infections (HAIs) or infections that patients catch at hospital. Invasive devices like ventilators, central lines and catheters pose the risk of HAIs because they breach the body’s protective barriers.
For example, a ventilator’s breathing tube could easily transfer bacteria from a nurse’s hands to the patient’s lungs, triggering pneumonia.
Ghamandayan came down with two bacterial infections, Escherichia coli and Acinetobacter baumanii, and a fungal species called Candida.
These pathogens were superbugs — i.e, resistant to multiple antimicrobial drugs — which make them hard to treat. His family moved him to New Delhi’s Sir Gangaram Hospital, where his doctor, Atul Gogia, deployed two last-line antibiotics called colistin and meropenem —both expensive, with toxic side effects. Yet these drugs are the only hope for patients when all else fails.
Ghamandayan eventually got better and was discharged nearly a month after he was first hospitalised. In all, he had spent Rs 6 lakh on his treatment.
Many in India face a similar fate – they get admitted to hospitals with seemingly treatable illnesses, only to contract HAIs caused by superbugs.
Few Indian hospitals track their HAI rates, which is why it is hard to get a countrywide picture of this problem.
But several stand-alone studies show that India has higher rates compared to richer countries like the US. For example, a study by the International Nosocomial Infection Control Consortium, which surveyed data from 40 hospitals in 20 cities in India, between 2004 and 2013, found that for every 1,000 days that patients were hooked to ventilators in Indian cardiac Intensive Care Units, there were around 11 times as many pneumonia cases as in American hospitals. “The rates of infections in Indian hospitals are just unacceptably high,” says Ramanan Laxminarayan, a public-health expert at Washington DC’s Center for Disease Dynamics, Economics & Policy (CDDEP).
But that’s just part of the problem. Many of the bugs that cause these infections have learnt to tolerate powerful antimicrobial drugs. Unpublished 2019 data from a 20-hospital surveillance network run by the Indian Council for Medical Research (ICMR) shows that key hospital bugs, like Acinetobacter baumanii and Klebsiella pneumoniae, have grown widely drug-resistant.
Patients infected with any of these bugs often have to be treated with last line drugs, which are both expensive and toxic. Many of them succumb: A 2018 study, carried out in 10 Fortis Group hospitals found that patients with multidrug resistant infections were almost thrice as likely to die as those with susceptible ones.
Ten newborn babies have died in a fire at a #hospital in #India's #Maharashtra state. The fire was caused by a short circuit in the SNCU (Sick Newborn Care Unit). #MedicalTourism #Health #Modi https://www.cnn.com/2021/01/09/india/india-hospital-fire-babies-intl-hnk/
Ten newborn babies died in a hospital fire in the western Indian state of Maharashtra on Friday, according to the country's state-run broadcaster Doordarshan.
The fire broke out in a local hospital's Sick Newborn Care Unit (SNCU) in Maharashtra's Bhandara district, Doordarshan said in a tweet on its verified Twitter account. Firefighters rescued seven other babies from the unit.
The fire was caused by a short circuit in the SNCU, said CNN affiliate CNN-News18, citing Maharashtra Health Minister Rajesh Tope.
"The investigations are going on," Tope said, adding that $6,813 (5 lakh Indian rupees) would be paid in compensation to each of the families affected. The state will also bear funeral and counseling costs.
"Whosoever is guilty in this will not be spared at all," Tope said. "It should be ensured that such type of incidences do not occur henceforth."
Indian Prime Minister Narendra Modi mourned the incident on Saturday morning. "Heart-wrenching tragedy in Bhandara, Maharashtra, where we have lost precious young lives. My thoughts are with all the bereaved families. I hope the injured recover as early as possible," he wrote on Twitter
The office of Indian President Ram Nath Kovind also tweeted in Hindi, "I am deeply saddened by the untimely death of infants in a fire accident in Bhandara, Maharashtra. My heartfelt condolences to the families who lost their children in this heartbreaking event."
Home Minister Amit Shah said in a tweet that he was "pained beyond words" by the "irreparable loss."
The country's Health and Family Welfare Minister, Harsh Vardhan, said he was in touch with Tope about the incident.
#Fake #vaccines administered in #India. #Medical scams are nothing new in India, where, during the country’s mammoth outbreak this spring, profiteers targeted vulnerable #COVID19 patients with fake drugs and oxygen. #Modi #BJP #fraud #pandemic https://www.nytimes.com/2021/07/04/world/asia/india-covid-vaccine-scam.html
As India intensifies its vaccination effort amid fears of another wave of the coronavirus, officials are investigating allegations that perhaps thousands of people were injected with fake vaccines in the financial capital, Mumbai.
The police have arrested 14 people on suspicion of involvement in a scheme that administered injections of salt water instead of vaccine doses at nearly a dozen private vaccination sites in Mumbai over the past two months. The organizers, including medical professionals, allegedly charged between $10 and $17 per dose, according to the authorities, who said they had confiscated more than $20,000 from the suspects.
“Those arrested are charged under criminal conspiracy, cheating and forgery,” said Vishal Thakur, a police officer in Mumbai.
More than 2,600 people came to the camps to receive shots of the Oxford-AstraZeneca vaccine, manufactured and marketed in India as Covishield. Some said that they became suspicious when their shots did not show up in the Indian government’s online portal tracking vaccinations, and when the hospitals that the organizers had claimed to be affiliated with did not match the names on the vaccination certificates they received.
“There are doubts about whether we were actually given Covishield or was it just glucose or expired/waste vaccines,” Neha Alshi, who said she was a victim of the scam, wrote on Twitter.
Siddharth Chandrashekhar, a lawyer who has filed a public interest lawsuit in Mumbai’s high court, described the scenario as “heartbreaking.” The court said it was “really shocking that incidents of fake vaccination are on the rise.”
Medical scams are nothing new in India, where, during the country’s mammoth outbreak this spring, profiteers targeted vulnerable Covid patients with fake drugs and oxygen. The police in West Bengal state are also investigating whether hundreds of people, including a local lawmaker, received fake vaccines there.
India has administered more than 340 million vaccine doses, but less than 5 percent of the population is fully vaccinated, according to the Our World in Data project at the University of Oxford. The country is reporting nearly 50,000 new cases daily and nearly 1,000 Covid deaths, numbers that are far lower than two months ago, although experts have always believed India’s official tallies to be vastly undercounted.
On Saturday, the pharmaceutical company Bharat Biotech reported that its Covaxin shot — the other vaccine in wide use in India — was 77.8 percent effective in preventing symptomatic illness, according to the results of a late-stage trial. Those results were published online but have not been peer-reviewed.
India-made cough syrups may be tied to 66 deaths in Gambia: WHO | Business and Economy News | Al Jazeera
https://www.aljazeera.com/economy/2022/10/5/india-made-cough-syrups-may-be-tied-to-66-deaths-in-gambia-who
The WHO also issued a medical product alert asking regulators to remove Maiden Pharma goods from the market.
The deaths of dozens of children in The Gambia from kidney injuries may be linked to contaminated cough and cold syrups made by an Indian drug manufacturer, the World Health Organization said on Wednesday.
WHO Director-General Tedros Adhanom Ghebreyesus told reporters that the UN agency was conducting an investigation along with Indian regulators and the drugmaker, New Delhi-based Maiden Pharmaceuticals Ltd.
Maiden Pharma declined to comment on the alert, while calls and Reuters messages to the Drugs Controller General of India went unanswered. The Gambia and India’s health ministry also did not immediately respond to a request for comment.
The WHO also issued a medical product alert asking regulators to remove Maiden Pharma goods from the market.
The products may have been distributed elsewhere through informal markets, but had so far only been identified in The Gambia, the WHO said in its alert.
The alert covers four products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
Lab analysis confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic when consumed, the WHO said. The Gambia’s government said last month it has also been investigating the deaths, as a spike in cases of acute kidney injury among children under the age of five was detected in late July.
Medical officers in The Gambia raised the alarm in July, after several children began falling ill with kidney problems three to five days after taking a locally sold paracetamol syrup. By August, 28 had died, but health authorities said the toll would likely rise. Now 66 are dead, WHO said on Wednesday.
The deaths have shaken the tiny West African nation, which is already dealing with multiple health emergencies including measles and malaria.
Maiden Pharmaceuticals manufactures medicines at its facilities in India, which it then sells domestically, as well as exporting it to countries in Asia, Africa and Latin America, according to its website.
#India facing a #pandemic of #antibiotics-resistant superbugs. It is worst hit by what doctors call "antimicrobial resistance" - #antibiotic-resistant neonatal #infections alone are responsible for the deaths of nearly 60,000 newborns each year. #health https://www.bbc.com/news/world-asia-india-63059585
Things are so worrying that only 43% of the pneumonia infections caused by one pathogen in India could be treated with first line of antibiotics in 2021, down from 65% in 2016, the ICMR report says.
Saswati Sinha, a critical care specialist in AMRI Hospital in the eastern city of Kolkata, says things are so bad that "six out of 10" patients in her ICU have drug-resistant infections. "The situation is truly alarming. We have come to a stage where you are not left with too many options to treat some of these patients."
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At the 1,000-bed not-for-profit Kasturba Hospital in the western Indian state of Maharashtra, doctors are grappling with a rash of antibiotic-resistant "superbug infections".
This happens when bacteria change over time and become resistant to drugs that are supposed to defeat them and cure the infections they cause.
Such resistance directly caused 1.27 million deaths worldwide in 2019, according to the Lancet medical journal. Antibiotics - which are considered to be the first line of defence against severe infections - did not work on most of these cases.
Millions are dying from drug-resistant infections
India is one of the countries worst hit by what doctors call "antimicrobial resistance" - antibiotic-resistant neonatal infections alone are responsible for the deaths of nearly 60,000 newborns each year. A new government report paints a startling picture of how things are getting worse.
Tests carried out at Kasturba Hospital to find out which antibiotic would be be most effective in tackling five main bacterial pathogens have found that a number of key drugs were barely effective.
These pathogens include E.coli (Escherichia coli), commonly found in the intestines of humans and animals after consumption of contaminated food; Klebsiella pneumoniae, which can infect the lungs to cause pneumonia, and the blood, cuts in the skin and the lining of the brain to cause meningitis; and the deadly Staphylococcus aureus, a food-borne bacteria that can be transmitted through air droplets or aerosols.
Doctors found that some of the main antibiotics were less than 15% effective in treating infections caused by these pathogens. Most concerning was the emergence of the multidrug-resistant pathogen called Acinetobacter baumannii, which attacks the lungs of patients on life support in critical care units.
Hidden pandemic of antibiotic-resistant infections
"As almost all our patients cannot afford the higher antibiotics, they run the real risk of dying when they develop ventilator-associated pneumonia in the ICU," Dr SP Kalantri, medical superintendent of the hospital, says.
A new report by Indian Council of Medical Research (ICMR) says that resistance to a powerful class of antibiotics called carbapenems - it defeats a number of pathogens - had risen by up to 10% in just one year alone. The report collects data on antibiotic resistance from up to 30 public and private hospitals every year.
"The reason why this is alarming is that it is a great drug to treat sepsis [a life-threatening condition] and sometimes used as a first line of treatment in hospitals for very sick patients in ICUs," says Dr Kamini Walia, a scientist at Indian Council of Medical Research (ICMR) and lead author of the study.
Necessary #Indian Drugs Prove Deadly For Dozens of Children. Deaths believed to be linked to contaminated #cough syrups in #Gambia have brought attention to loose #regulations in #India and a lack of testing capacity in poor importing nations. #health https://www.nytimes.com/2022/11/03/world/asia/india-gambia-cough-syrup.html?smid=tw-share
“What happened in Gambia is happening in other African countries without us even knowing,” said Michel Sidibé, the African Union special envoy for the African Medicines Agency, a new body aimed at harmonizing drug regulation across the continent.
“Most African countries don’t have testing capacities nor well-trained regulatory bodies,” Mr. Sidibé said. “The African market is very fragmented, but because of poor regulations, drugs move from one country to another.”
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They had fevers, aches, runny noses, the normal stuff of childhood. The kind of illnesses for which a doctor would prescribe cough syrup.
But the children’s condition only worsened. They developed persistent diarrhea, then could no longer urinate, as their kidneys failed. The very medicines that were supposed to make them better, simple cough syrups imported from India, were instead killing them, because they turned out to be poison.
In all, 70 children in the tiny West African nation of Gambia are suspected to have died in recent months from contaminated Indian-made cough syrups. Among them was 2-year-old Muhammad Lamin Kijera, who died on Aug. 4.
“He was lively and likable — he was everybody’s friend,” said his father, Alieu Kijera, who works as a nurse at an eye clinic in Banjul, the Gambian capital. “How can they allow something like this into the country, destroying lives?”
India has taken to calling itself “the world’s pharmacy” as its drug industry has expanded rapidly, providing a lifeline to the developing world by selling medicines, many of them generics, for an array of illnesses like malaria and AIDS at prices lower than those of American or European drugs.
But the deaths in Gambia have raised alarm over what one expert called a “dangerous cocktail”: on one side, a $50 billion Indian pharmaceutical industry whose regulation has remained loose and chaotic despite repeated calamities, and on the other, poor nations with little or no way to test the quality of the medicines they import.
India’s drug industry, experts say, is rife with data fraud, inadequate testing and substandard manufacturing practices. While people around the world take Indian medicines every day without incident, the regulatory weaknesses give the country’s drug makers openings to cut corners and increase profits, experts say.
That has created a hazardous reality far more widespread than the occasional tragic cases of mass poisonings, and could shake faith in Indian medicines in the places that need them most.
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India is the world’s third-largest drug manufacturer by volume, producing 60 percent of global vaccines and 20 percent of generic medicines. In a sign of the world’s reliance on Indian drugs, the country’s pharmaceutical exports increased nearly 20 percent during the first year of the pandemic, reaching $24 billion, despite lockdowns that disrupted global supply chains.
As a stamp of approval for the quality of Indian medicines, officials point out that more than half of the drugs manufactured in India go to highly regulated markets — “every third pill in the U.S. and every fourth pill in Europe is sold from India,” according to the Indian Pharmaceutical Alliance.
As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. The shot engineered by Bharat Biotech was, in part, an important effort to create a home-grown product that could bolster the fortunes of the Indian pharmaceutical industry.
https://www.statnews.com/pharmalot/2022/11/15/vaccine-covid19-india-bharat-covaxin-transparency-protocols/
However, a STAT review of documents detailing the steps taken toward government approval found that regulators endorsed the vaccine, called Covaxin, despite discrepancies in the number of clinical trial participants. Moreover, questionable changes were made to the trial protocols — which are established procedures for testing a vaccine or medicine — to expedite the approval process.
For instance, the number of people enrolled in the Phase 1 portion of the trial differed from what was later published in a medical journal. There were also important changes made to the protocol for Phase 2 testing, when immunogenicity data from the previous Phase 1 stage were not yet available.
In addition, the protocol for Phase 3 was approved while Phase 2 was still underway and the final vaccine candidate was selected without Phase 2 data, according to protocol documents and minutes of meetings held by an expert committee that reported to India’s Central Drugs Standard Control Organization (CDSCO), the national regulator responsible for approving medicines. This was the agency that authorized the vaccine for emergency use in January 2021, two months before Phase 3 results were known.
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More controversy erupted last spring. Brazilian authorities raised concerns about Bharat Biotech manufacturing. Then, the WHO, which listed the vaccine for emergency use in November 2021, suspended supplies after an inspection of the facilities found unspecified problems. The decision meant United Nations procurement agencies, such as UNICEF, would no longer be able to supply the shot to other countries. A WHO spokesperson declined to offer an update on the findings.
For now, it remains unclear whether the newly disclosed issues surrounding the clinical trial will trigger still more questions about the willingness of the Indian government to boost its oversight. The CDSCO and the Drugs Controller General of India, which oversees the CDSCO, did not respond to emails seeking comment about the changes made to the Covaxin trial protocols and subsequent government approval.
In reviewing the documents, there was a clear discrepancy in the number of enrollees. In reporting the Phase 1/2 data, the protocol stated 402 participants were given the first dose and 394 got the second dose. But results published in Lancet Infectious Diseases in January 2021 stated 375 people were given a first dose and 368 received a second dose. (See Figure 1 on page 640.)
#India still uses #asbestos. Poor #Indians use it for roofing. WHO says all asbestos types cause “lung cancer, mesothelioma, cancer of the larynx and ovary, and asbestosis [fibrosis of the lungs]”. Exposure, handling or inhaling it results in death.
https://aje.io/6v4rpw
Asbestos – a cheap, heat-resistant mineral – was once used widely in building materials all around the world. Today, it is banned in 70 countries which have deemed that this construction material is a “silent killer” since its fibres are carcinogenic.
While there are six types of asbestos, chrysotile – white asbestos – is the most common form, used especially in roofing houses.
According to the World Health Organization, all types of asbestos cause “lung cancer, mesothelioma, cancer of the larynx and ovary, and asbestosis [fibrosis of the lungs]”.
Exposure to the fibres and handling or inhaling them could also result in death.
Yet some countries like India continue trading it.
In 2011, India banned asbestos mining and asbestos waste used in ships. But it continues to trade in raw asbestos and asbestos-based products, commonly found in the roofs of houses, especially in poorer regions of the country.
According to a November 2021 report by the Indian government, between 2019 and 2020, India imported 361,164 tonnes of asbestos, a 1 percent decrease compared with 364,105 tonnes in the previous year.
The report noted that almost the entire import was chrysotile asbestos, with 85 percent of these fibres coming from Russia. About 3 percent also came from Brazil, Kazakhstan and Hungary each, and 2 percent came from Poland and South Africa respectively.
Aaron Cosbey, a development economist and head of Small World Sustainability, a consultancy, told Al Jazeera that trade goes on because commercial interests have been prioritised over human welfare.
“India’s biggest source of chrysotile asbestos – Russia – has not banned it nationally. So there is no hypocrisy; it is just bad policy, given that the WHO and 70 states worldwide have agreed that there are no safe uses for the substance,” he said.
India also exports asbestos, but its sales have decreased substantially to 1,001 tonnes between 2019 and 2020, compared with 1,112 tonnes in the previous year.
The Indian government’s November 2021 report noted that most of the exports went to Bangladesh, and 7 percent to Sri Lanka.
Gopal Krishna, an environmental lawyer and co-founder of the Ban Asbestos Network of India, said despite countries like Brazil ruling that asbestos use was unconstitutional – and Hungary, Poland and South Africa banning asbestos – India continues with its import and export.
“The trade continues because nobody in India has time to deal with health complaints when money is involved and there is a lewd relationship between the Indian government and the asbestos manufacturers in the country,” he told Al Jazeera.
“A 2012 study (PDF) was conducted by the National Institute of Occupational Health in Ahmedabad, India, surveying 1,248 workers exposed to the substance. Noting that the fibres affected only three workers, the study concluded that asbestos and its derivatives are not harmful to human health. But this study by a government body was co-sponsored by the Asbestos Cement Products Manufacturers’ Association, which lobbies for the industry, making it a conflict of interest,” he added.
Krishna said the study contradicts the UN Rotterdam Convention, which was adopted in 2004 and reviews the harmful effects of a wide range of chemicals and pesticides.
#Indian #pharma company used toxic industrial-grade ingredient in #cough syrup – #Noida #UP-based Marion Biotech linked to the deaths of 19 children due to poisoning in Uzbekistan. Marion sold the syrups without testing the ingredient used in its syrups
https://www.independent.co.uk/asia/india/india-cough-syrup-marion-uzbekistan-gambia-b2365605.html
An Indian pharma company whose cough syrups were linked to the deaths of 19 children due to poisoning in Uzbekistan allegedly used industrial-grade ingredients, according to a report.
Reuters reported quoting sources that Marion Biotech, a company based in the township of Noida in the northern Indian state of Uttar Pradesh, bought the ingredient propylene glycol (PG) from trader Maya Chemtech India, which only sold industrial-grade materials and not pharmaceutical-grade ingredients.
Last year, India launched an investigation against Marian Biotech and suspended its license after WHO issued a global medical alert for two cough syrups produced by the company.
The firm’s Dok-1 Max and Ambronol cough syrups were linked to the deaths of 19 children in Uzbekistan last year.
A person who refused to be identified said Maya Chemtech did not have a licence to sell pharmaceutical-grade materials.
Two sources told Reuters that the syrup was made using PG which is a toxic material used in liquid detergents, antifreeze, paints or coatings, as well as pesticides.
"We did not know Marion was going to use it to make cough syrups," said the person, who declined to be identified while the case was being investigated. "We are not told where our material is used."
Another person, who is involved in the official investigation into the case, said Marion bought commercial-grade propylene glycol.
"They were supposed to take Indian Pharmacopoeia-grade," the person said referring to national standards for the composition of pharmaceutical products.
The source who is involved in the investigation told Reuters that Marion sold the syrups to a Uzbekistan company without testing the ingredient used in its syrups.
India, the world’s largest exporter of generic drugs, has come under scrutiny over the quality of the exported drugs that have been linked to deaths and hospitalisations in almost half a dozens countries.
Last week, the WHO flagged seven India-made syrups that were linked to over 300 deaths globally.
Around 20 syrups manufactured by companies in India and Indonesia were also flagged by the health agency, according to NDTV.
Marion Biotech denied allegations of wrong doing in previous statements. It previously said that it "did not agree" with the WHO’s findings and said the company was cooperating with investigation.
The WHO said that Uzbekistan’s health ministry found "unacceptable amounts" of diethylene glycol and ethylene glycol in the drugs.
Apart from Uzbekistan, at least 70 children were reported dead in Gambia after consuming cough syrups made by Maiden Pharmaceuticals.
Maiden Pharmaceuticals denied the allegations in previous comments.
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