Latest news with #westernIndia
Reuters
21-07-2025
- Business
- Reuters
India's HPCL seeks 10 LNG cargoes for March 2026-December 2027 delivery, sources say
SINGAPORE, July 21 (Reuters) - India's Hindustan Petroleum Corp (HPCL) has issued a tender seeking 10 cargoes of liquefied natural gas (LNG) for delivery from March 2026 to December 2027 to its Chhara import terminal in western India, two industry sources said on Monday. HPCL is seeking one cargo per month for delivery in March, April, October and November in 2026, and in February, April, June, August, October and December in 2027, added one of the sources. The tender closes on July 21.
CNN
20-06-2025
- Health
- CNN
Threat in your medicine cabinet: The FDA's gamble on America's drugs
Federal agencies Prescription drugs Astronomy IndiaFacebookTweetLink Follow This story was originally published by ProPublica, is a nonprofit newsroom that investigates abuses of power. Sign up to receive its biggest stories as soon as they're published. On a sweltering morning in western India in 2022, three U.S. inspectors showed up unannounced at a massive pharmaceutical plant surrounded by barricades and barbed wire and demanded to be let inside. For two weeks, they scrutinized humming production lines and laboratories spread across the dense industrial campus, peering over the shoulders of workers at the tablet presses, mixers and filling machines that produce dozens of generic drugs for Americans. Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records that showed vials of medication that were 'blackish' from contamination had been sent to the United States. Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown 'extraneous matter' were used anyway, mixed into batches of drugs. Sun Pharma's transgressions were so egregious that the Food and Drug Administration imposed one of the government's harshest penalties: banning the factory from exporting drugs to the United States. But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America's drug supply. A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. Pills and injectable medications that otherwise would have been banned went to unsuspecting patients across the country, including those with cancer and epilepsy. The FDA didn't routinely test the medications for quality problems or use its vast repository of drug-related complaints to proactively track whether they were harming the people who relied on them. And the agency kept the exemptions largely hidden from the public and from Congress. Even others inside the FDA were unaware of the details. In the hands of consumers, according to the FDA's longtime head of drug safety, the information would have caused 'some kind of frenzy.' 'We felt we didn't have to make it a public thing,' said Janet Woodcock, who spent nearly four decades at the agency. The exemptions for Sun weren't a one-time concession. A ProPublica investigation found that over a dozen years, the same small cadre at the FDA granted similar exemptions to more than 20 other factories that had violated critical standards in drugmaking, nearly all in India. All told, the group allowed into the United States at least 150 medications or their ingredients from factories with mold, foul water, dirty labs or fraudulent testing protocols. Some of the drugs were recalled — just before or just after they were exempted — because of contaminants or other defects that could cause health problems, government records show. And a ProPublica analysis identified more than 600 complaints in the FDA's files about exempted drugs at three of those factories alone, each flagging concerns in the months or years after they were excluded from import bans in 2022 and 2023. The 'adverse event' reports about drugs from the Sun plant and two others run by Indian drugmaker Intas Pharmaceuticals described medication with an abnormal taste, odor or residue or patients who had experienced sudden or unexplained health problems. The reports cite about 70 hospitalizations and nine deaths. And those numbers are conservative. ProPublica limited its count to reports that linked problems to a single drug. However, the total number of complaints to the FDA that mention exempted drugs is in the thousands. 'Abdominal pain … stomach was acting very crazy,' one report said about a woman using a seizure drug from Sun Pharma. The FDA received the complaint in 2023, nine months after it excluded the medication from the import ban. 'Feeling really hot, breaking out with hives, hard to breathe, had confusion, glucose level was high, heart rate went up and head, arms and hands got numb,' noted another report about a patient taking a sedative from Intas. The complaint was sent to the FDA in June 2023, the same month the agency exempted the medication. The outcomes described in the complaints may have no connection to the drug or could be unexpected side effects. In some cases, the FDA received complaints about the same drugs made by other manufacturers. Still, the seriousness of the reports involving exempted drugs did not galvanize the agency to investigate, leaving the public and the government with no way of knowing whether people were being harmed and, if so, how many. Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a 'cascade of failure' at one of the Intas plants, finding workers had destroyed testing records, in one case pouring acid on some that had been stuffed in a trash bag. At the second Intas factory, inspectors said in their report that records were 'routinely manipulated' to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company's drugs. The FDA barred both plants in 2023 from shipping drugs to the U.S. Then the agency simultaneously granted more than 50 exemptions to those banned factories — the broadest use of exclusions in ProPublica's analysis. Intas, whose U.S. subsidiary is Accord Healthcare, said in a statement that the company has invested millions of dollars in upgrades and new hires and launched a companywide program focused on quality. Exempted drugs were sent to the United States in a 'phased manner,' the company said, with third-party oversight and safety testing. Intas also said that some exempted drugs were never shipped to the United States because the FDA found other suppliers. The company would not provide details. 'Intas is well on its way towards full remediation of all manufacturing sites,' the company said. Sun did not respond to multiple requests for comment. When the FDA imposed the ban, the company said it would 'undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company's remedial action. Sun Pharma remains committed to being … compliant and in supplying high-quality products to its customers and patients globally.' Both companies' factories are still under import bans. 'We're supposed to have the best medicine in the world,' said Joe DeMayo, a kidney transplant patient in Philadelphia who took an immunosuppression medication made by Intas until December 2023, unaware that a month earlier the FDA had excused the drug from an import ban. 'Why are we buying from people who aren't making it right?' Game of chance How the United States wound up here — playing a game of chance with risky drugs made thousands of miles away — is the story of an agency that has relentlessly pressed to keep the supply of low-cost generics flowing even as its own inspectors warned that some of those drugs posed a potentially lethal threat to the American public. The vast majority of the prescriptions filled in the country are for generic drugs, from penicillin to blood thinners to emergency contraception, and many of those come from overseas, including India and China. For years, the FDA has vouched for the quality of generics, assuring the public in press releases, speeches and social media campaigns that they are just as safe and effective as brand-name drugs. That guarantee came under serious question in 2019 when journalist Katherine Eban published a breakthrough book, 'Bottle of Lies,' that exposed rampant fraud and manufacturing violations in Indian factories and the FDA's reluctance to aggressively investigate. ProPublica identified another alarming level of entrenched failure: Even when the agency did investigate and single out factories that were among the worst in India, it still gave them access to American consumers. All the while, patients took their medicine without question, trusting an agency that has long been considered the gold standard in drug regulation. While specialized business publications have sometimes reported on exemptions when they happen, they've offered little context and few specifics. The FDA in many ways put itself in this untenable position, forced to decide between not having enough drugs or accepting potentially dangerous ones, interviews and government records show. For years, the agency gave companies with a history of manufacturing breakdowns approval to produce an increasingly larger share of generic drugs, allowing them to become a dominant force in American medicine with the power to disrupt lives if production lines were shuttered. 'It's our own fault,' said former FDA inspector Peter Baker, who reported a litany of failures during inspections in India and China from 2012 to 2018. 'We allowed all these players into the market who never should have been there in the first place. They grew to be monsters and now we can't go back.' In a series of interviews with ProPublica, Woodcock said she supported the use of exemptions 'as a practical approach.' 'We had to kind of deal with the hand we were dealt,' she said. Woodcock said she didn't see a need to inform the public because the agency believed the drugs were safe. She said she mentioned the practice periodically in closed-door meetings with congressional staffers, but she did not provide specifics about those conversations. After Woodcock left her post in 2020 to help lead the agency's response to the COVID-19 pandemic, the exemptions — including those for Sun and Intas — continued under her successor, Patrizia Cavazzoni. Cavazzoni, who left the agency earlier this year and rejoined Pfizer, declined to comment. Former FDA Commissioner Robert Califf, who led the agency when Sun and Intas received exemptions, told ProPublica that tough calls had to be made and the practice did not worry him. The FDA did not respond to questions about who made those decisions or how the drugs were evaluated, and it declined requests for interviews with officials who currently oversee drug regulation. In an email, the agency said the exemptions are 'thoroughly evaluated through a multi-disciplinary approach.' Years after the FDA started granting exemptions, some current and former officials say they wrestle with a lingering fear that bad drugs are circulating in the United States. 'It's not even a hypothetical,' said one senior FDA employee familiar with the exemptions, who, like others, spoke on the condition of anonymity because they were not authorized to speak publicly. 'It's not a question of if — it's a question of how much.' 'It was rotten eggs' Although the FDA has been giving companies a way around import bans since at least 2013, the internal process was so secretive that many current and former FDA officials said they have no idea how many exemptions have been granted or for what drugs. In an email, the agency said it did not maintain a comprehensive list. Even two high-level FDA staff members who worked on drug shortage challenges for the agency said in interviews they had never heard of the exemptions. Congress required the FDA in 2012 to provide specific information every year about how and when the agency relaxed its rules for errant drugmakers to prevent shortages. But the FDA did not mention exemptions to import bans until 2024 — and only then in a single footnote of its 25-page report to Congress. ProPublica uncovered the frequent use of exemptions by searching for the 'import alert' list published on the FDA's website that names factories banned from the U.S. marketplace. Because the agency publishes only a current list and doesn't make the old ones public, the news organization used internet archives and FDA documents maintained by the data analytics company Redica Systems, ultimately compiling import alerts dating back more than a decade. The lists identify the drugs exempted from bans but provide few other details. ProPublica reviewed scores of inspection reports and corporate documents for overseas factories and interviewed more than 200 people, including current and former officials of the FDA, to understand the little-known practice and the ongoing threat posed by the agency's decisions. The investigation revealed not only how many drugs received exemptions from import bans, but also how long the FDA allowed those exemptions to stay in place — in some cases for years. The agency has removed exemptions when there is no longer a shortage concern. In those cases, the drugs are then banned along with the others at the factory. Both Sun and Intas have had drugs that lost their exemptions. Two and a half years after the Sun factory was banned, five drugs are still exempted. Intas, whose factories were banned in 2023, currently has 24 drugs on the list. The bans themselves are removed only after companies fix the problems. Earlier this month, the FDA went back to the Sun Pharma factory for a surprise inspection and found ongoing problems, according to a Sun filing with the Indian stock exchange and Indian media reports. The concerns focused on the way sterile drugs were made, including some of the exempted drugs still being sent to the United States, according to a person familiar with the situation who did not want to be named because they were not authorized to speak publicly. The FDA said it put protections in place for exempted drugs: Manufacturers are required to conduct additional quality checks before they are sent to the United States. That has included extra drug-safety testing, in some cases at an independent lab, and bringing on third-party consultants to verify the results. The agency did not provide ProPublica with the names of the third-party consultants hired by Sun and Intas. Intas declined to name its consultants. 'The odds of these drugs actually not being safe or effective is tiny because of the safeguards,' said one former FDA official involved in the exemptions who declined to be named because he still works in the industry and fears professional retribution. 'Even though the facility sucks, it's getting tested more often and it's having independent eyes on it.' But current and former FDA inspectors said those safety measures require trusting the vigilance of companies that were banned, at least in part, for providing unreliable or deceptive test results to the government or failing to investigate reports about drugs with contaminants or other quality concerns. The FDA could have done its own routine testing of the exempted drugs but chose not to. The agency said in an email that it tests the drugs using a 'risk-based approach' but would not provide ProPublica with any information about which drugs have been tested and what the results were. Woodcock said testing was expensive and budgets were tight. She acknowledged that regularly assessing the exempted drugs for quality or safety concerns 'would have enhanced our confidence … and made everyone more comfortable.' The European Union, by contrast, requires drugs made in India and China to be checked for quality on EU soil. And the U.S. Department of Defense is conducting its own testing of more than three dozen generic medications and has already identified potency and other quality issues. 'If you don't know about the quality of the product, why are you letting it in?' said Murray Lumpkin, the FDA's former deputy commissioner for international programs, who left the agency in 2014 before most of the exemptions were granted. Beyond the lack of testing, the FDA didn't actively look for patterns of harm among the exempted drugs in its adverse event database, Woodcock and others said. ProPublica's analysis of that data found thousands of reports both before and after the factories were given a pass to sidestep import bans. The reports described unexpected cases of cardiac arrest, blurred vision, choking, vertigo and kidney injuries, among other issues — and in some instances identified specific concerns about how the drugs were made. One person who took Intas' clonazepam, a sedative and epilepsy drug, reported getting 'brain zaps' and bright blue teeth from the coating of dye on the drug. The FDA received the complaint the same month the agency exempted the drug from the import ban. Even before the FDA exempted Intas' antidepressant bupropion, consumers reported that it made them sick, wasn't always effective and had an abnormal odor, which pharmacists and others say can happen when an inactive ingredient breaks down. 'It was rotten eggs,' Nari Miller, a geologist in California who took the pills in 2022 and had severe stomach pain, told ProPublica. 'I opened it and smelled it when I got home and it was awful.' Intas said it could not respond to specific complaints and that all drugs have side effects. 'Intas and Accord pay attention to each and every adverse event report,' the company said, adding, 'Accord and Intas are committed to continuing to bring safe and effective medicines to patients.' In its statement, the FDA said the database is monitored weekly for new reports in general. Woodcock, however, acknowledged the reports about exempted drugs, ideally, 'would be under much more scrutiny.' Too big to fail Decisions made by the FDA decades ago gave rise to the use of exemptions and the risks that now confront the American public. When new brand-name drugs come to market, they are protected by patents and exclusive sales rights that make them generally expensive. When patents expire, generic drug companies rush in to make their own versions, which are supposed to be equivalent to the brand. Generics are often far cheaper, and insurance companies typically insist that patients use them. In the 2000s, as the cost of brand-name drugs soared, the FDA began to approve large numbers of generics. The agency, however, gave hundreds of those approvals to foreign manufacturers that had been in trouble before, companies well known to the inspectors working to stamp out safety and quality breakdowns at overseas factories, ProPublica found. The FDA granted Sun Pharma alone more than 250 approvals for generic drugs since the late 2000s, when the company started amassing violations, records show. The agency's decisions helped to transform the company from a local provider in India to one of the leading exporters of medications to the United States, with nearly $2 billion in annual U.S. sales. The approvals kept coming as inspectors continued to raise concerns about manufacturing practices at the company's factories in India, government records show. More problems were found at a factory that Sun had acquired in Detroit, where the diabetes drug metformin was contaminated with metal scrapings. The violations were so significant that federal marshals in 2009 raided the plant and seized drugs. The company eventually shuttered the factory. The rapid expansion of Sun and other foreign drugmakers set off new alarms among inspectors, their supervisors and advisers to Woodcock. 'In a rational system, you would have said, 'This company is not producing properly, so let's not approve any more of their drugs,' said William Hubbard, former FDA deputy commissioner for policy, planning and legislation. 'The agency in a sense kind of let this happen.' Ajaz Hussain, the former deputy director of an FDA office that oversaw pharmaceutical science, said that after leaving the agency and becoming a consultant, he made his concerns known in meetings with Woodcock and others. 'They can't manufacture it. Why do you keep approving it?' Hussain recalled in an interview with ProPublica. 'I said, 'Wake up.' … But they didn't listen.' Hussain in 2012 went to work for Wockhardt, one of the largest pharmaceutical companies in India, but quit eight months later after he said he told his superiors about manufacturing failures in the company's factories. Although FDA inspectors had reported lapses after multiple visits to Wockhardt plants between 2004 and 2012, the agency cleared the way for the company to export sedatives, antibiotics, beta blockers, painkillers and other generics to the United States, records show. Wockhardt received exemptions from import bans in 2013. The company did not respond to repeated requests for comment, but at the time, the company said it was going to quickly address the FDA's concerns. The FDA could have denied generic drug applications — nothing in the law prohibits the agency from saying no to companies with spotty track records. In an email, the FDA said it considers a company's history and conducts inspections in some cases before issuing approvals. Woodcock said the agency knew which factories were poor performers but feared being sued by companies blocked from introducing new drugs based on past behavior. Instead, she said that she tried to convince drugmakers to invest in equipment and practices that would turn out higher-quality drugs. 'We had many meetings about this, and we agonized about all these problems,' she said. But little changed. Shortages vs. quality In 2008, dozens of Americans were killed by contaminated blood thinner from China. So when Margaret Hamburg was appointed commissioner of the FDA in the aftermath of the crisis, she pressed the agency to crack down on overseas drugmakers. Her efforts ran headlong into what would become the worst drug shortage in modern history. By 2010, cancer drugs were scarce. So were the drugs on hospital crash carts. In all, more than 200 critical medications were in short supply. Razor-thin profit margins had limited the number of companies that were willing to make generic drugs. And the FDA's enforcement overseas had forced some manufacturing lines to temporarily shut down, which exacerbated the problem. Congress lambasted the FDA for the shortages and started requiring the agency to prove every year how it was combatting the problem. At the time, the FDA had a small team focused on shortages that operated on the edges of Woodcock's 4,000-person Center for Drug Evaluation and Research. With the pressure on, Woodcock elevated the team in 2010 to report directly to her deputy, a move that gave those staff members a commanding voice at the highest levels of the agency, several former staffers told ProPublica. After 16 years in top leadership roles, Woodcock was formidable enough to force a culture change. Standing 5'2' in FDA conference rooms where she had often been disregarded as the lone woman, Woodcock had fought for her status — sometimes, she said, pushed nearly to tears with frustration. The board-certified internist asserted her authority by wielding data, what she called 'brute force' and the soft persuasion of an occasional gift of an orchid, picked from her garden in suburban Maryland. By 2010, Woodcock had marshalled the center into a powerhouse with great independence — in many ways, outside the reach of the political whims of the commissioners who came and went. Those who worked with her over the years said despite her approachable manner, she fiercely guarded her territory. In the conference room next to Woodcock's office, the drug shortage staff began to weigh in whenever the FDA's compliance team moved to penalize wayward drugmakers because of bad inspections, according to several former FDA officials involved in the deliberations. Sometimes the small group would decide that a factory could no longer ship drugs to the United States and would try to get other manufacturers to make more. And other times, the group determined that exemptions from import bans were the only course. Discussions could be tense and often lasted for weeks. A former employee on the compliance team told ProPublica that they repeatedly argued to impose a total import ban on a foreign factory because they feared the drugs couldn't be trusted. They were left feeling uncomfortable about an exemption granted anyway — for a product that they would not use themselves. Without exemptions, Woodcock told ProPublica, the FDA might have been forced to source the drugs from a 'totally unknown manufacturer, say, from China or somewhere.' Current and former FDA officials said the concessions became a yearslong practice rather than a stopgap measure and that the protections put in place by the agency were not sufficient. They question why Woodcock and her successor didn't do more to raise alarms with Congress or the public about the decision to rely on inadequate factories for critical drugs. Woodcock said she thought the exemptions were a symptom of larger issues involving the drug supply that the FDA had no control over — the agency, for example, can't force companies concerned about slim profit margins to produce generic drugs. Two former FDA commissioners told ProPublica they knew about the practice but were not included in the decision-making. Hamburg, who spent six years at the agency under the Obama administration, said the extent of the practice surprised her. 'Had I known that it was sort of an open-ended policy, I would have been disturbed,' she said. One of her successors, Stephen Hahn, appointed during President Donald Trump's first term, said more people should have been involved in the decisions. 'You're talking about a drug of questionable quality being brought into the country,' he said. Woodcock said she did not believe she needed their input. 'I didn't think in the individual circumstances it was necessary to elevate,' she said, 'because what could they do?' 'We know what was found' In 2020, the billionaire founder of Sun Pharma joined a pivotal conference call with FDA compliance and investigative staff. Dilip Shanghvi, whose father had run a wholesale drug business in Kolkata, India, started the company in the 1980s and ultimately turned Sun Pharma into one of the largest suppliers of generic drugs in the United States. On the call, Shanghvi spoke about improvements at Sun's enormous plant in the Indian city of Halol, according to an FDA official who attended the meeting. Among other drugs, the plant produced at least 16 sterile injectables for the U.S. market, according to a Sun email to the FDA obtained by ProPublica. Injectables are particularly dangerous if contaminated because the medication is injected directly into the body, unlike a pill that goes through the filtering of the digestive tract. In 2018 and 2019, inspectors had reported a series of violations at the factory, and Sun had received more than 700 complaints about what appeared to be crystals or spider webs forming in one of its injectable medications, records show. The company also had to recall more than 135,000 vials of vecuronium bromide, a muscle relaxer used during surgery, after reports that the medication contained glass particles. Sun said the defect could cause life-threatening blood clots. On the call with the FDA, according to the agency official, Shanghvi assured the government that the Halol plant was turning out high-quality products. Yet, when the three investigators went back to the factory that scorching morning in 2022 for the surprise inspection, it was clear within days that the FDA would have to take swift action. Splitting up to check different parts of the plant, the inspectors quizzed workers about cleaning procedures and looked at disassembled equipment to see if it was contaminated with residue from old drugs. At one point, they spotted water leaking near areas where sterile drugs were made, an alarming observation because water can introduce contaminants capable of causing infections or even death. Digging through company records and test results, they found more evidence of quality problems, including how managers hadn't properly investigated a series of complaints about foreign material, specks, spots and stains in tablets. Several FDA employees familiar with the inspection report — 23 pages of detailed violations — said they had no idea why the agency went on to exclude so many of Sun's drugs from the subsequent import ban. 'We know what was found,' said the FDA official who attended the meeting with Shanghvi. 'How could you trust [those] drugs?' Sun did not respond to questions about the recalls or its regulatory history with the FDA. In its 2023-24 annual report, the company said, 'We have a relentless focus on 24x7 compliance to ensure continuity of supplies to our customers and patients worldwide.' The specific findings of the FDA's latest inspection of the Sun plant conducted this month have not yet been made public, and the company did not respond to a request for comment. To some current and former FDA officials and other experts, plugging a supply shortage with drugs that may be contaminated or ineffective is no solution at all. 'That might be helping a shortage but might be creating a new problem,' said Lumpkin, the former deputy commissioner. Last summer, a pair of FDA investigators arrived at another manufacturing plant in India that had a bustling production line. After more than a week at the Viatris factory, they left with a familiar list of safety and quality violations. The inspectors found that equipment wasn't clean and managers failed to thoroughly investigate unexplained discrepancies in test results. In a statement to ProPublica, Viatris said it immediately worked to resolve the FDA's concerns. 'Patient safety remains our primary and unwavering focus,' the company said. Just before Christmas, the FDA banned the facility from exporting drugs. Then the agency gave the factory a pass, and four of its drugs are still bound for the United States. Patricia Callahan and Vidya Krishnan contributed reporting, and Alice Crites contributed research. Medill Investigative Lab students Haajrah Gilani, Emma McNamee, Julian Andreone, Isabela Lisco, Aidan Johnstone, Megija Medne, Yiqing Wang, Phillip Powell, Gideon Pardo, Casey He, Lindsey Byman, Josh Sukoff, Kunjal Bastola, Shae Lake, Alyce Brown, Zhiyu Solstice Luo, Jessie Nguyen, Sinyi Au, Kate McQuarrie and Katherine Dailey contributed reporting.
CNN
20-06-2025
- Health
- CNN
Threat in your medicine cabinet: The FDA's gamble on America's drugs
Federal agencies Prescription drugs Astronomy IndiaFacebookTweetLink Follow This story was originally published by ProPublica, is a nonprofit newsroom that investigates abuses of power. Sign up to receive its biggest stories as soon as they're published. On a sweltering morning in western India in 2022, three U.S. inspectors showed up unannounced at a massive pharmaceutical plant surrounded by barricades and barbed wire and demanded to be let inside. For two weeks, they scrutinized humming production lines and laboratories spread across the dense industrial campus, peering over the shoulders of workers at the tablet presses, mixers and filling machines that produce dozens of generic drugs for Americans. Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records that showed vials of medication that were 'blackish' from contamination had been sent to the United States. Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown 'extraneous matter' were used anyway, mixed into batches of drugs. Sun Pharma's transgressions were so egregious that the Food and Drug Administration imposed one of the government's harshest penalties: banning the factory from exporting drugs to the United States. But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America's drug supply. A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. Pills and injectable medications that otherwise would have been banned went to unsuspecting patients across the country, including those with cancer and epilepsy. The FDA didn't routinely test the medications for quality problems or use its vast repository of drug-related complaints to proactively track whether they were harming the people who relied on them. And the agency kept the exemptions largely hidden from the public and from Congress. Even others inside the FDA were unaware of the details. In the hands of consumers, according to the FDA's longtime head of drug safety, the information would have caused 'some kind of frenzy.' 'We felt we didn't have to make it a public thing,' said Janet Woodcock, who spent nearly four decades at the agency. The exemptions for Sun weren't a one-time concession. A ProPublica investigation found that over a dozen years, the same small cadre at the FDA granted similar exemptions to more than 20 other factories that had violated critical standards in drugmaking, nearly all in India. All told, the group allowed into the United States at least 150 medications or their ingredients from factories with mold, foul water, dirty labs or fraudulent testing protocols. Some of the drugs were recalled — just before or just after they were exempted — because of contaminants or other defects that could cause health problems, government records show. And a ProPublica analysis identified more than 600 complaints in the FDA's files about exempted drugs at three of those factories alone, each flagging concerns in the months or years after they were excluded from import bans in 2022 and 2023. The 'adverse event' reports about drugs from the Sun plant and two others run by Indian drugmaker Intas Pharmaceuticals described medication with an abnormal taste, odor or residue or patients who had experienced sudden or unexplained health problems. The reports cite about 70 hospitalizations and nine deaths. And those numbers are conservative. ProPublica limited its count to reports that linked problems to a single drug. However, the total number of complaints to the FDA that mention exempted drugs is in the thousands. 'Abdominal pain … stomach was acting very crazy,' one report said about a woman using a seizure drug from Sun Pharma. The FDA received the complaint in 2023, nine months after it excluded the medication from the import ban. 'Feeling really hot, breaking out with hives, hard to breathe, had confusion, glucose level was high, heart rate went up and head, arms and hands got numb,' noted another report about a patient taking a sedative from Intas. The complaint was sent to the FDA in June 2023, the same month the agency exempted the medication. The outcomes described in the complaints may have no connection to the drug or could be unexpected side effects. In some cases, the FDA received complaints about the same drugs made by other manufacturers. Still, the seriousness of the reports involving exempted drugs did not galvanize the agency to investigate, leaving the public and the government with no way of knowing whether people were being harmed and, if so, how many. Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a 'cascade of failure' at one of the Intas plants, finding workers had destroyed testing records, in one case pouring acid on some that had been stuffed in a trash bag. At the second Intas factory, inspectors said in their report that records were 'routinely manipulated' to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company's drugs. The FDA barred both plants in 2023 from shipping drugs to the U.S. Then the agency simultaneously granted more than 50 exemptions to those banned factories — the broadest use of exclusions in ProPublica's analysis. Intas, whose U.S. subsidiary is Accord Healthcare, said in a statement that the company has invested millions of dollars in upgrades and new hires and launched a companywide program focused on quality. Exempted drugs were sent to the United States in a 'phased manner,' the company said, with third-party oversight and safety testing. Intas also said that some exempted drugs were never shipped to the United States because the FDA found other suppliers. The company would not provide details. 'Intas is well on its way towards full remediation of all manufacturing sites,' the company said. Sun did not respond to multiple requests for comment. When the FDA imposed the ban, the company said it would 'undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company's remedial action. Sun Pharma remains committed to being … compliant and in supplying high-quality products to its customers and patients globally.' Both companies' factories are still under import bans. 'We're supposed to have the best medicine in the world,' said Joe DeMayo, a kidney transplant patient in Philadelphia who took an immunosuppression medication made by Intas until December 2023, unaware that a month earlier the FDA had excused the drug from an import ban. 'Why are we buying from people who aren't making it right?' Game of chance How the United States wound up here — playing a game of chance with risky drugs made thousands of miles away — is the story of an agency that has relentlessly pressed to keep the supply of low-cost generics flowing even as its own inspectors warned that some of those drugs posed a potentially lethal threat to the American public. The vast majority of the prescriptions filled in the country are for generic drugs, from penicillin to blood thinners to emergency contraception, and many of those come from overseas, including India and China. For years, the FDA has vouched for the quality of generics, assuring the public in press releases, speeches and social media campaigns that they are just as safe and effective as brand-name drugs. That guarantee came under serious question in 2019 when journalist Katherine Eban published a breakthrough book, 'Bottle of Lies,' that exposed rampant fraud and manufacturing violations in Indian factories and the FDA's reluctance to aggressively investigate. ProPublica identified another alarming level of entrenched failure: Even when the agency did investigate and single out factories that were among the worst in India, it still gave them access to American consumers. All the while, patients took their medicine without question, trusting an agency that has long been considered the gold standard in drug regulation. While specialized business publications have sometimes reported on exemptions when they happen, they've offered little context and few specifics. The FDA in many ways put itself in this untenable position, forced to decide between not having enough drugs or accepting potentially dangerous ones, interviews and government records show. For years, the agency gave companies with a history of manufacturing breakdowns approval to produce an increasingly larger share of generic drugs, allowing them to become a dominant force in American medicine with the power to disrupt lives if production lines were shuttered. 'It's our own fault,' said former FDA inspector Peter Baker, who reported a litany of failures during inspections in India and China from 2012 to 2018. 'We allowed all these players into the market who never should have been there in the first place. They grew to be monsters and now we can't go back.' In a series of interviews with ProPublica, Woodcock said she supported the use of exemptions 'as a practical approach.' 'We had to kind of deal with the hand we were dealt,' she said. Woodcock said she didn't see a need to inform the public because the agency believed the drugs were safe. She said she mentioned the practice periodically in closed-door meetings with congressional staffers, but she did not provide specifics about those conversations. After Woodcock left her post in 2020 to help lead the agency's response to the COVID-19 pandemic, the exemptions — including those for Sun and Intas — continued under her successor, Patrizia Cavazzoni. Cavazzoni, who left the agency earlier this year and rejoined Pfizer, declined to comment. Former FDA Commissioner Robert Califf, who led the agency when Sun and Intas received exemptions, told ProPublica that tough calls had to be made and the practice did not worry him. The FDA did not respond to questions about who made those decisions or how the drugs were evaluated, and it declined requests for interviews with officials who currently oversee drug regulation. In an email, the agency said the exemptions are 'thoroughly evaluated through a multi-disciplinary approach.' Years after the FDA started granting exemptions, some current and former officials say they wrestle with a lingering fear that bad drugs are circulating in the United States. 'It's not even a hypothetical,' said one senior FDA employee familiar with the exemptions, who, like others, spoke on the condition of anonymity because they were not authorized to speak publicly. 'It's not a question of if — it's a question of how much.' 'It was rotten eggs' Although the FDA has been giving companies a way around import bans since at least 2013, the internal process was so secretive that many current and former FDA officials said they have no idea how many exemptions have been granted or for what drugs. In an email, the agency said it did not maintain a comprehensive list. Even two high-level FDA staff members who worked on drug shortage challenges for the agency said in interviews they had never heard of the exemptions. Congress required the FDA in 2012 to provide specific information every year about how and when the agency relaxed its rules for errant drugmakers to prevent shortages. But the FDA did not mention exemptions to import bans until 2024 — and only then in a single footnote of its 25-page report to Congress. ProPublica uncovered the frequent use of exemptions by searching for the 'import alert' list published on the FDA's website that names factories banned from the U.S. marketplace. Because the agency publishes only a current list and doesn't make the old ones public, the news organization used internet archives and FDA documents maintained by the data analytics company Redica Systems, ultimately compiling import alerts dating back more than a decade. The lists identify the drugs exempted from bans but provide few other details. ProPublica reviewed scores of inspection reports and corporate documents for overseas factories and interviewed more than 200 people, including current and former officials of the FDA, to understand the little-known practice and the ongoing threat posed by the agency's decisions. The investigation revealed not only how many drugs received exemptions from import bans, but also how long the FDA allowed those exemptions to stay in place — in some cases for years. The agency has removed exemptions when there is no longer a shortage concern. In those cases, the drugs are then banned along with the others at the factory. Both Sun and Intas have had drugs that lost their exemptions. Two and a half years after the Sun factory was banned, five drugs are still exempted. Intas, whose factories were banned in 2023, currently has 24 drugs on the list. The bans themselves are removed only after companies fix the problems. Earlier this month, the FDA went back to the Sun Pharma factory for a surprise inspection and found ongoing problems, according to a Sun filing with the Indian stock exchange and Indian media reports. The concerns focused on the way sterile drugs were made, including some of the exempted drugs still being sent to the United States, according to a person familiar with the situation who did not want to be named because they were not authorized to speak publicly. The FDA said it put protections in place for exempted drugs: Manufacturers are required to conduct additional quality checks before they are sent to the United States. That has included extra drug-safety testing, in some cases at an independent lab, and bringing on third-party consultants to verify the results. The agency did not provide ProPublica with the names of the third-party consultants hired by Sun and Intas. Intas declined to name its consultants. 'The odds of these drugs actually not being safe or effective is tiny because of the safeguards,' said one former FDA official involved in the exemptions who declined to be named because he still works in the industry and fears professional retribution. 'Even though the facility sucks, it's getting tested more often and it's having independent eyes on it.' But current and former FDA inspectors said those safety measures require trusting the vigilance of companies that were banned, at least in part, for providing unreliable or deceptive test results to the government or failing to investigate reports about drugs with contaminants or other quality concerns. The FDA could have done its own routine testing of the exempted drugs but chose not to. The agency said in an email that it tests the drugs using a 'risk-based approach' but would not provide ProPublica with any information about which drugs have been tested and what the results were. Woodcock said testing was expensive and budgets were tight. She acknowledged that regularly assessing the exempted drugs for quality or safety concerns 'would have enhanced our confidence … and made everyone more comfortable.' The European Union, by contrast, requires drugs made in India and China to be checked for quality on EU soil. And the U.S. Department of Defense is conducting its own testing of more than three dozen generic medications and has already identified potency and other quality issues. 'If you don't know about the quality of the product, why are you letting it in?' said Murray Lumpkin, the FDA's former deputy commissioner for international programs, who left the agency in 2014 before most of the exemptions were granted. Beyond the lack of testing, the FDA didn't actively look for patterns of harm among the exempted drugs in its adverse event database, Woodcock and others said. ProPublica's analysis of that data found thousands of reports both before and after the factories were given a pass to sidestep import bans. The reports described unexpected cases of cardiac arrest, blurred vision, choking, vertigo and kidney injuries, among other issues — and in some instances identified specific concerns about how the drugs were made. One person who took Intas' clonazepam, a sedative and epilepsy drug, reported getting 'brain zaps' and bright blue teeth from the coating of dye on the drug. The FDA received the complaint the same month the agency exempted the drug from the import ban. Even before the FDA exempted Intas' antidepressant bupropion, consumers reported that it made them sick, wasn't always effective and had an abnormal odor, which pharmacists and others say can happen when an inactive ingredient breaks down. 'It was rotten eggs,' Nari Miller, a geologist in California who took the pills in 2022 and had severe stomach pain, told ProPublica. 'I opened it and smelled it when I got home and it was awful.' Intas said it could not respond to specific complaints and that all drugs have side effects. 'Intas and Accord pay attention to each and every adverse event report,' the company said, adding, 'Accord and Intas are committed to continuing to bring safe and effective medicines to patients.' In its statement, the FDA said the database is monitored weekly for new reports in general. Woodcock, however, acknowledged the reports about exempted drugs, ideally, 'would be under much more scrutiny.' Too big to fail Decisions made by the FDA decades ago gave rise to the use of exemptions and the risks that now confront the American public. When new brand-name drugs come to market, they are protected by patents and exclusive sales rights that make them generally expensive. When patents expire, generic drug companies rush in to make their own versions, which are supposed to be equivalent to the brand. Generics are often far cheaper, and insurance companies typically insist that patients use them. In the 2000s, as the cost of brand-name drugs soared, the FDA began to approve large numbers of generics. The agency, however, gave hundreds of those approvals to foreign manufacturers that had been in trouble before, companies well known to the inspectors working to stamp out safety and quality breakdowns at overseas factories, ProPublica found. The FDA granted Sun Pharma alone more than 250 approvals for generic drugs since the late 2000s, when the company started amassing violations, records show. The agency's decisions helped to transform the company from a local provider in India to one of the leading exporters of medications to the United States, with nearly $2 billion in annual U.S. sales. The approvals kept coming as inspectors continued to raise concerns about manufacturing practices at the company's factories in India, government records show. More problems were found at a factory that Sun had acquired in Detroit, where the diabetes drug metformin was contaminated with metal scrapings. The violations were so significant that federal marshals in 2009 raided the plant and seized drugs. The company eventually shuttered the factory. The rapid expansion of Sun and other foreign drugmakers set off new alarms among inspectors, their supervisors and advisers to Woodcock. 'In a rational system, you would have said, 'This company is not producing properly, so let's not approve any more of their drugs,' said William Hubbard, former FDA deputy commissioner for policy, planning and legislation. 'The agency in a sense kind of let this happen.' Ajaz Hussain, the former deputy director of an FDA office that oversaw pharmaceutical science, said that after leaving the agency and becoming a consultant, he made his concerns known in meetings with Woodcock and others. 'They can't manufacture it. Why do you keep approving it?' Hussain recalled in an interview with ProPublica. 'I said, 'Wake up.' … But they didn't listen.' Hussain in 2012 went to work for Wockhardt, one of the largest pharmaceutical companies in India, but quit eight months later after he said he told his superiors about manufacturing failures in the company's factories. Although FDA inspectors had reported lapses after multiple visits to Wockhardt plants between 2004 and 2012, the agency cleared the way for the company to export sedatives, antibiotics, beta blockers, painkillers and other generics to the United States, records show. Wockhardt received exemptions from import bans in 2013. The company did not respond to repeated requests for comment, but at the time, the company said it was going to quickly address the FDA's concerns. The FDA could have denied generic drug applications — nothing in the law prohibits the agency from saying no to companies with spotty track records. In an email, the FDA said it considers a company's history and conducts inspections in some cases before issuing approvals. Woodcock said the agency knew which factories were poor performers but feared being sued by companies blocked from introducing new drugs based on past behavior. Instead, she said that she tried to convince drugmakers to invest in equipment and practices that would turn out higher-quality drugs. 'We had many meetings about this, and we agonized about all these problems,' she said. But little changed. Shortages vs. quality In 2008, dozens of Americans were killed by contaminated blood thinner from China. So when Margaret Hamburg was appointed commissioner of the FDA in the aftermath of the crisis, she pressed the agency to crack down on overseas drugmakers. Her efforts ran headlong into what would become the worst drug shortage in modern history. By 2010, cancer drugs were scarce. So were the drugs on hospital crash carts. In all, more than 200 critical medications were in short supply. Razor-thin profit margins had limited the number of companies that were willing to make generic drugs. And the FDA's enforcement overseas had forced some manufacturing lines to temporarily shut down, which exacerbated the problem. Congress lambasted the FDA for the shortages and started requiring the agency to prove every year how it was combatting the problem. At the time, the FDA had a small team focused on shortages that operated on the edges of Woodcock's 4,000-person Center for Drug Evaluation and Research. With the pressure on, Woodcock elevated the team in 2010 to report directly to her deputy, a move that gave those staff members a commanding voice at the highest levels of the agency, several former staffers told ProPublica. After 16 years in top leadership roles, Woodcock was formidable enough to force a culture change. Standing 5'2' in FDA conference rooms where she had often been disregarded as the lone woman, Woodcock had fought for her status — sometimes, she said, pushed nearly to tears with frustration. The board-certified internist asserted her authority by wielding data, what she called 'brute force' and the soft persuasion of an occasional gift of an orchid, picked from her garden in suburban Maryland. By 2010, Woodcock had marshalled the center into a powerhouse with great independence — in many ways, outside the reach of the political whims of the commissioners who came and went. Those who worked with her over the years said despite her approachable manner, she fiercely guarded her territory. In the conference room next to Woodcock's office, the drug shortage staff began to weigh in whenever the FDA's compliance team moved to penalize wayward drugmakers because of bad inspections, according to several former FDA officials involved in the deliberations. Sometimes the small group would decide that a factory could no longer ship drugs to the United States and would try to get other manufacturers to make more. And other times, the group determined that exemptions from import bans were the only course. Discussions could be tense and often lasted for weeks. A former employee on the compliance team told ProPublica that they repeatedly argued to impose a total import ban on a foreign factory because they feared the drugs couldn't be trusted. They were left feeling uncomfortable about an exemption granted anyway — for a product that they would not use themselves. Without exemptions, Woodcock told ProPublica, the FDA might have been forced to source the drugs from a 'totally unknown manufacturer, say, from China or somewhere.' Current and former FDA officials said the concessions became a yearslong practice rather than a stopgap measure and that the protections put in place by the agency were not sufficient. They question why Woodcock and her successor didn't do more to raise alarms with Congress or the public about the decision to rely on inadequate factories for critical drugs. Woodcock said she thought the exemptions were a symptom of larger issues involving the drug supply that the FDA had no control over — the agency, for example, can't force companies concerned about slim profit margins to produce generic drugs. Two former FDA commissioners told ProPublica they knew about the practice but were not included in the decision-making. Hamburg, who spent six years at the agency under the Obama administration, said the extent of the practice surprised her. 'Had I known that it was sort of an open-ended policy, I would have been disturbed,' she said. One of her successors, Stephen Hahn, appointed during President Donald Trump's first term, said more people should have been involved in the decisions. 'You're talking about a drug of questionable quality being brought into the country,' he said. Woodcock said she did not believe she needed their input. 'I didn't think in the individual circumstances it was necessary to elevate,' she said, 'because what could they do?' 'We know what was found' In 2020, the billionaire founder of Sun Pharma joined a pivotal conference call with FDA compliance and investigative staff. Dilip Shanghvi, whose father had run a wholesale drug business in Kolkata, India, started the company in the 1980s and ultimately turned Sun Pharma into one of the largest suppliers of generic drugs in the United States. On the call, Shanghvi spoke about improvements at Sun's enormous plant in the Indian city of Halol, according to an FDA official who attended the meeting. Among other drugs, the plant produced at least 16 sterile injectables for the U.S. market, according to a Sun email to the FDA obtained by ProPublica. Injectables are particularly dangerous if contaminated because the medication is injected directly into the body, unlike a pill that goes through the filtering of the digestive tract. In 2018 and 2019, inspectors had reported a series of violations at the factory, and Sun had received more than 700 complaints about what appeared to be crystals or spider webs forming in one of its injectable medications, records show. The company also had to recall more than 135,000 vials of vecuronium bromide, a muscle relaxer used during surgery, after reports that the medication contained glass particles. Sun said the defect could cause life-threatening blood clots. On the call with the FDA, according to the agency official, Shanghvi assured the government that the Halol plant was turning out high-quality products. Yet, when the three investigators went back to the factory that scorching morning in 2022 for the surprise inspection, it was clear within days that the FDA would have to take swift action. Splitting up to check different parts of the plant, the inspectors quizzed workers about cleaning procedures and looked at disassembled equipment to see if it was contaminated with residue from old drugs. At one point, they spotted water leaking near areas where sterile drugs were made, an alarming observation because water can introduce contaminants capable of causing infections or even death. Digging through company records and test results, they found more evidence of quality problems, including how managers hadn't properly investigated a series of complaints about foreign material, specks, spots and stains in tablets. Several FDA employees familiar with the inspection report — 23 pages of detailed violations — said they had no idea why the agency went on to exclude so many of Sun's drugs from the subsequent import ban. 'We know what was found,' said the FDA official who attended the meeting with Shanghvi. 'How could you trust [those] drugs?' Sun did not respond to questions about the recalls or its regulatory history with the FDA. In its 2023-24 annual report, the company said, 'We have a relentless focus on 24x7 compliance to ensure continuity of supplies to our customers and patients worldwide.' The specific findings of the FDA's latest inspection of the Sun plant conducted this month have not yet been made public, and the company did not respond to a request for comment. To some current and former FDA officials and other experts, plugging a supply shortage with drugs that may be contaminated or ineffective is no solution at all. 'That might be helping a shortage but might be creating a new problem,' said Lumpkin, the former deputy commissioner. Last summer, a pair of FDA investigators arrived at another manufacturing plant in India that had a bustling production line. After more than a week at the Viatris factory, they left with a familiar list of safety and quality violations. The inspectors found that equipment wasn't clean and managers failed to thoroughly investigate unexplained discrepancies in test results. In a statement to ProPublica, Viatris said it immediately worked to resolve the FDA's concerns. 'Patient safety remains our primary and unwavering focus,' the company said. Just before Christmas, the FDA banned the facility from exporting drugs. Then the agency gave the factory a pass, and four of its drugs are still bound for the United States. Patricia Callahan and Vidya Krishnan contributed reporting, and Alice Crites contributed research. Medill Investigative Lab students Haajrah Gilani, Emma McNamee, Julian Andreone, Isabela Lisco, Aidan Johnstone, Megija Medne, Yiqing Wang, Phillip Powell, Gideon Pardo, Casey He, Lindsey Byman, Josh Sukoff, Kunjal Bastola, Shae Lake, Alyce Brown, Zhiyu Solstice Luo, Jessie Nguyen, Sinyi Au, Kate McQuarrie and Katherine Dailey contributed reporting.
Malay Mail
09-06-2025
- Business
- Malay Mail
India's US$80b coal-power push is running dry
CHANDRAPUR (India), June 9 — April marks the start of the cruelest months for residents of Solapur, a hot and dry district in western India. As temperatures soar, water availability dwindles. In peak summer, the wait for taps to flow can stretch to a week or more. Just a decade ago, water flowed every other day, according to the local government and residents of Solapur, some 400km inland from Mumbai. Then in 2017, a 1,320-megawatt coal-fired power plant run by state-controlled NTPC began operations. It provided the district with energy — and competed with residents and businesses for water from a reservoir that serves the area. Solapur illustrates the Catch-22 facing India, which has 17 per cent of the planet's population but access to only 4 per cent of its water resources. The world's most populous country plans to spend nearly US$80 billion (RM339 billion) on water-hungry coal plants by 2031 to power growing industries like data centre operations. The vast majority of these new projects are planned for India's driest areas, according to a power ministry document reviewed by Reuters, which is not public and was created for officials to track progress. Many of the 20 people interviewed by Reuters for this story, which included power company executives, energy officials and industry analysts, said the thermal expansion likely portended future conflict between industry and residents over limited water resources. Thirty-seven of the 44 new projects named in the undated power ministry shortlist of future operations are located in areas that the government classifies as either suffering from water scarcity or stress. NTPC, which says it draws 98.5 per cent of its water from water-stressed areas, is involved in nine of them. NTPC said in response to Reuters' questions that it is 'continuously striving towards conservation of water with best of our efforts in Solapur,' including using methods like treating and reusing water. It did not answer queries about potential expansion plans. India's power ministry has told lawmakers in parliament, most recently in 2017, that the locations of coal-fired power plants are determined by factors including access to land and water and that state governments are responsible for allocating water to them. Access to land is the dominant consideration, two federal groundwater board officials and two water researchers told Reuters. A boy fills a bottle with water from a water ATM machine in Solapur, India, March 3, 2025. — Reuters pic India's complex and arcane land laws have delayed many commercial and infrastructure projects for years, so power operators under pressure to meet burgeoning demand pick areas where they are likely to face little resistance, said Rudrodip Majumdar, an energy and environment professor at the National Institute of Advanced Studies in Bengaluru. 'They look for areas with easy land availability — minimum resistance for maximum land — even if water is available only far away,' he said. The federal power ministry, as well as energy and water authorities in Maharashtra state, where Solapur is located, did not respond to queries. Delhi attempted to reduce its reliance on coal before reversing track after the Covid pandemic. It has invested heavily in renewable energy sources like solar and hydro, but thirsty thermal power will still be dominant for the coming decades. India's former top energy bureaucrat Ram Vinay Shahi said ready access to power was strategically important for the country, whose per-capita power consumption is far lower than its regional rival China. 'The only energy resource we have in the country is coal,' he said. 'Between water and coal, preference is given to coal.' 'Nothing' in Solapur? Solapur resident Rajani Thoke plans her life around water in high summer. On days with supply, 'I do not focus on anything other than storing water, washing clothes and such work,' said the mother of two, who strictly polices her family's water use. Sushilkumar Shinde, the federal power minister who approved the Solapur plant in 2008, when the area had already been classified 'water scarce,' told Reuters he helped NTPC procure the land by negotiating payments to locals. The member of the opposition Congress party, who won election to retain Solapur's parliamentary seat a year after the plant's approval, defended the operation on grounds of NTPC's sizable investment. The US$1.34 billion plant generated thousands of jobs during its construction and now provides part-time employment to about 2,500 locals. 'I made sure farmers got good money for the land NTPC acquired,' he said, adding that mismanagement by local authorities was to blame for water shortages. Solapur municipal official Sachin Ombase acknowledged that water distribution infrastructure had not kept up with population growth, but said that authorities were trying to address the problem. Women work in sugarcane fields next to the NTPC (National Thermal Power Corporation) power plant in Solapur, India, March 3, 2025. — Reuters pic Shinde said 'there was nothing' in Solapur in 2008 and that residents who received land payments had no reason to oppose the plant. Researcher Shripad Dharmadhikary, who founded environment advocacy group Manthan Adhyayan Kendra, said local politicians often supported splashy infrastructure projects to boost their popularity. Any 'problems come up much later,' he said. Even before the Solapur plant started operating, there were signs of the trouble to come. The first of its two units was supposed to start generating power by the middle of 2016, but it was delayed by more than 12 months because of years of severe water shortages, according to a 2020 regulatory filing. The absence of nearby water resources meant the station ended up drawing on water from a reservoir about 120 km away. Such distances can sharply increase costs and the risk of water theft, said Dharmadhikary and two plant sources. As of May 2023, the station is among India's least water-efficient, according to the latest available federal records. It also has among the lowest capacity utilisation rates of coal-fired plants, according to data from government think-tank NITI Aayog. NTPC said its data indicates the Solapur plant has an efficiency ratio in line with the country's norms. Indian stations typically consume twice as much water as their global counterparts, according to the Delhi-based Centre for Science and Environment think-tank. Solapur plant officials told reporters in March that capacity utilisation will improve with increasing demand, indicating that water consumption could surge in the future. A forthcoming survey on water use in Solapur led by state groundwater authorities and reviewed by Reuters showed that irrigation demand in the district outstrips supply by a third. Dharmes Waghmore owns farmland a few miles from the plant and said that developing it would provide more financial security than his current casual work. But he said borrowing money to develop the land by drilling a bore well is too risky: 'What if there's no water?' Kuladeep Jangam, a top local official, said authorities were struggling to draw businesses to Solapur. The lack of 'water neutralises all other pull factors,' he said. A general view of the Ujani Dam, on the outskirts of Solapur, India, March 1, 2025. — Reuters pic Thirst for water Since 2014, India has lost 60.33 billion units of coal-power generation across the country — equivalent to 19 days of coal-power supply at June 2025 levels — because water shortages force plants to suspend generation, according to federal data. Among the facilities that have struggled with shortages is the 2,920 MW Chandrapur Super Thermal Power Station, one of India's largest. Located about 500 km north-east of Solapur but also in a water-stressed area, the plant shuts several of its units for months at a time when the monsoon delivers less rain than usual, according to NITI Aayog data. Despite the challenges, the plant is considering adding 800 MW of new capacity, according to the power ministry list seen by Reuters and half a dozen sources at Mahagenco, which operates the station. The document indicates the plant hasn't identified a water source for the expansion, though it has already sourced its coal. State-owned Mahagenco did not respond to Reuters' questions. The plant's thirst for water has previously led to tensions with residents of nearby Chandrapur city. Locals protested the station during a 2017 drought, prompting officials such as local lawmaker Sudhir Mungantiwar to order it to divert water to homes. Mungantiwar, however, says he supports the expansion of the plant, which he hopes will lead to it retiring water-inefficient older units. But the station has already delayed a plan to decommission two polluting and water-guzzling power units with a capacity of 420 MW by about seven years, citing instructions from the federal government, the company sources said. The Indian government asked power companies not to retire old thermal plants until the end of the decade due to a surge in demand following the pandemic, Reuters has reported. Chandrapur resident Anjali, who goes by one name, said she is resigned to visiting a tap installed by the station near one of its gates for drinking water. 'We're poor, we make do with whatever we can get,' she said. — Reuters
