Category: Medical

  • The Coordination Division is set up by CDSCO & has six major priority areas

    The Coordination Division is set up by CDSCO & has six major priority areas

    The Central Drugs Standard Control Organization (CDSCO) has established a new unit — the “Coordination Division” — as India broadens the mandate of its drug regulatory authority beyond just quality testing.

    The division is responsible for several functions, ranging from preparing monthly reports for the Cabinet to managing special assignments from senior leadership. It has been entrusted with six key priority areas.

    According to the document, “A new Division titled ‘Co-ordination Division’ is hereby created within CDSCO (HQ) with immediate effect.”

    With multiple tasks at hand ranging from approval and regulation of drugs, vaccines, cosmetics and medical devices, CDSCO is running risk-based inspections and audits across the country at pharmaceutical firms, medical device-making units, contract research organisations and private and public laboratories.

    The health ministry has also asked CDSCO to wipe out the concerns of counterfeit medicines from the Indian market while pushing small and micro pharmaceutical manufacturers to upgrade their units on par with global standards.

    “Amid the ongoing changes at the CDSCO, the industry is experiencing delays of at least one to two months in the processing of requests and applications. Given the limited manpower and an expanding list of responsibilities, this new arm has been introduced to free up key personnel, allowing them to focus on handling priority areas,” a senior government official said, requesting anonymity.

    List of tasks
    The document further details the work responsibilities shifting from other departments to the new coordination division, with the first being “submission of monthly summary to Cabinet”.

    Currently, the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC) division were responsible for the task.

    Also, the new division will be responsible for “monitoring coordination requirements in CDSCO that are not specifically allocated to other sections”.

    It will not only collate the “achievement of CDSCO objectives as directed by the ministry from time to time”, but also monitor the “circulation of general circulars, training circulars or vacancy circulars among other tasks, which till now was being done by the administration division”.

    The charge of collecting and collating sample data related to the strengthening of states’ drug regulatory system (SSDRS) scheme has also been given to the new division, transferring it from the GCT & Ethics Committee.

    “Any other work as assigned by the competent authority from time to time,” the order issued by the drug regulatory agency said. News18

  • India’s healthcare system grows significantly, with 23 AIIMS

    India’s healthcare system grows significantly, with 23 AIIMS

    Union minister J P Nadda on Tuesday said the country’s healthcare sector has taken a monumental leap under the Narendra Modi government with the number of AIIMS rising to 23 and medical colleges being set up in rural areas.

    Addressing the 5th convocation ceremony of the All India Institute of Medical Sciences (AIIMS), Rishikesh, the health minister said AIIMS that have come up in different parts of the country are all equipped with state-of-the-art facilities.

    “For half a century, the AIIMS in Delhi was the only institute of its kind in the country. After Atal Bihari Vajpayee became the prime minister, six more were set up of which AIIMS-Rishikesh is one.

    “But in the last 10 years of Narendra Modi’s prime ministership, 16 more AIIMS have been added, taking the total number to 23,” Nadda, the Union Minister of Health and Family Welfare, said.

    He praised the premier institute in Rishikesh for the “great work” it was doing in the field of telemedicine promotion alongside AIIMS, Delhi and PGI, Chandigarh by providing quality healthcare services to remote and under-served areas.

    The air ambulance service launched by Prime Minister Modi at AIIMS-Rishikesh in October last year has in a short span of time saved the lives of 309 critical patients by airlifting them from their homes in difficult terrain to the premier health facility, Nadda said.

    The number of medical colleges in the country has risen from 387 to 780 over the last 10 years which indicates that medical colleges are being opened in rural areas as well.

    “Medical colleges have been opened in non-descript remote places where one could not imagine them at one time,” he said.

    He attributed the reformative changes to the approach of today’s policymakers.

    “Today, you have world-class facilities right here. You do not need to go anywhere else,” he said.

    He spoke at length about how the shift in focus from curative health to preventive and promotive health in the new health policy was proving beneficial to the country.

    Nadda said education is a birthright but not professional education which he described as a privilege given by society.

    “On each student in a professional course, the government is spending Rs 35 lakh per annum. So, your responsibility towards the society is immense,” he told the gathering.

    He said students who were conferred with their degrees on Tuesday should look upon the day as just the beginning of a long journey and use the skills learnt at the institute to the service of the society. PTI

  • Gujarat advocates for the use of AI in healthcare

    Gujarat advocates for the use of AI in healthcare

    Gujarat Chief Minister Bhupendra Patel on Sunday said that the state government has always supported emerging technologies in the medical sector and added that the time has now come to integrate artificial intelligence into healthcare.

    “Chief Minister Bhupendra Patel stated that Gujarat has consistently supported emerging technologies in the medical sector. Prime Minister Narendra Modi introduced robotic surgery in Gujarat as early as 2013. Now is the time to integrate artificial intelligence into the healthcare sector. The state government has paved the way for the integration of artificial intelligence at various stages within Gujarat’s healthcare sector,” as per a Gujarat Chief Minister’s office release.

    Narendra Modi has made efforts to ensure excellent and affordable healthcare for every citizen of the country through futuristic technology while simultaneously strengthening advanced infrastructure and the essential manpower for modern medical science. As a result, technologies such as AI and robotics have gained significant momentum in the country’s healthcare sector.

    “Chief Minister Bhupendra Patel virtually inaugurated the ‘Center of Excellence in Robotic Gastrointestinal Surgery’ at Kaizen Hospital in Ahmedabad. Marking a significant milestone, Kaizen Hospital becoming the first in the country to perform 100 robotic gastrointestinal (GI) surgeries, the Chief Minister delivered an inspiring address to commemorate the achievement,” the release read.

    In this context, Chief Minister Patel noted that building on the foundation laid by Prime Minister Narendra Modi, the state government has installed the CyberKnife – a Robotic Linear Accelerator Machine – for advanced radiotherapy treatment at the cancer hospital, at an investment of Rs95 crore. Robotic surgery has also been initiated at U.N. Mehta Hospital since 2022. Over the past decade, under the Prime Minister’s leadership, sustained efforts have been made to develop a highly skilled workforce in the medical sector.

    “Chief Minister highlighted the rapidly growing use of Artificial Intelligence in healthcare. With the advent of AI and telemedicine, quality medical services are now reaching even the most remote regions. AI has made it easier to access patients’ medical histories and provides clinical decision support to doctors, significantly reducing treatment time. In emergency situations, it also enables swift and effective care,” the release read.

    Chief Minister Patel added that the state government has launched such an AI-based digital ICU at UN Mehta Hospital. Whenever the Prime Minister engages in dialogue with AI leaders, he places special emphasis on the use of AI in the health sector. When he meets startup innovators, he inspires them to bring practical solutions to challenges in the healthcare sector. An AI Center of Excellence has been set up at GIFT City, where we also encourage health-sector startups.

    “Chief Minister Patel stated that the number of medical colleges in the country has increased from 319 to 703. The number of medical seats in MBBS and post-graduate courses has grown from 85,000 to 1.68 lakh. There are currently 22 AIIMS functioning in the country,” the release read.

    Explaining the importance of a healthy lifestyle, Chief Minister Bhupendra Patel said, “Prevention is better than cure.” We should live in such a way that we do not fall ill, going back to basics–back to nature. He also explained to everyone the nine resolutions given by Prime Minister Narendra Modi for the well-being of the human body, the environment, and the Earth: Save Water, Ek Ped Maa Ke Naam, Cleanliness, Vocal for Local, Desh Darshan, Natural Farming, Healthy Lifestyle, Yoga and Sports, and Support for the Poor.”

    “Chief Minister Patel congratulated Dr Sanjiv Haribhakti and the entire team of Kaizen Hospital for becoming the first hospital in India to perform over 100 GI robotic surgeries,” the release read.

    On this occasion, Amit Thakar, MLA; Harit Shukla, Principal Secretary of the Administrative Reforms and Training Division; Dr Sanjiv, senior doctor at Kaizen Hospital; Dr Mahesh Desai, renowned medical expert; and several citizens associated with the medical field were present. ANI

  • Funding cuts by the Trump admin chill the biotech sector

    Funding cuts by the Trump admin chill the biotech sector

    Trump administration cuts across federal health agencies have sent shivers through a biotech industry already struggling through a prolonged downturn, increasing concerns they will have a harder time getting products approved, investors, company executives and analysts said.

    Mass firings at the US Food and Drug Administration are particularly risky for small- and mid-cap biotech companies that have innovative treatments in clinical trials but no products on the market to keep them afloat, these sources told Reuters.

    Directives from President Donald Trump’s administration to freeze grant funding from the National Institutes of Health may also discourage future talent and resources from flowing into the biotech sector, some of them said.

    The S&P Biotech ETF index hit an 18-month low last week and is trading at less than half its 2021 peak. It is down about 20% this year.

    A record nearly 30% of US-listed small- and mid-cap biotech companies are trading at or below cash, suggesting the market does not ascribe any value to their existing business or drug development pipeline, according to Jefferies analysts.

    “The sector needs a predictable, science-led regulator to function,” said Linden Thomson, senior fund manager at asset manager Candriam, whose biotech fund holds shares in Vertex and Ascendis Pharma.

    “The future cash flows of the businesses that are used to value stocks are, in biotechnology, in large part based on US commercial sales. If you don’t have US approvals you don’t have future value,” Thomson added.

    US Health Secretary Robert F. Kennedy Jr. says the layoffs that began last week are needed to streamline the nation’s health bureaucracy and will improve agencies’ work. But the ouster of top scientists at FDA and other institutions has raised questions over how they will fulfill their missions.

    Biotechs have faced delays in scheduling meetings and receiving feedback from the FDA that guides drug development, according to a letter from company executives and investors to Congress this week. “Many have concerns that approval decision deadlines will be missed,” the letter said.

    “The overwhelming view is that the regulatory agency is impaired, although we have not seen the consequences of it yet since the layoffs and firings have only recently occurred,” said Paul Ariano, associate portfolio manager at Thornburg Investment Management, whose fund holds shares in Sarepta Therapeutics and Cytokinetics.

    “Sentiment is bad and there is little clarity on the factors that could provide more optimism,” he said.

    ‘Perilous time’
    Multiple Trump executive orders are blocking funding from the NIH. Funds for early-stage research that NIH has traditionally provided help drive the formation of biotech startups, some of which go on to develop important medicines on their own or in conjunction with large pharmaceutical companies.

    “It’s a perilous time for small- and mid-cap biotech companies and this will have knock-on effects for the development of new medicines and treatments in years to come,” said Tim Opler, managing director in Stifel Investment Bank’s Global Healthcare Group.

    Shares in biotech firms have been under pressure since a peak of investment during the Covid-19 pandemic, hampered by high interest rates.

    They declined further after Trump took office in January and the selloff deepened following the resignation of senior FDA scientist Peter Marks, who led the FDA center that regulates vaccines and biological treatments.

    “Everyone is wondering what it will mean with the FDA losing this champion for accelerated regulatory approvals for innovative treatments,” said Nawal Ouzren, CEO of French company Sensorion, which has hearing loss treatments in mid-stage clinical trials.

    The market is viewing each FDA decision on new drug products as a barometer of whether it is functioning normally, investors said. The agency recently missed a decision deadline on a Covid vaccine from Novavax, but gave a green light to a pre-filled syringe version of Argenx’s already-approved immune disorder drug.

    The climate of uncertainty has left biotechs largely unable to access public capital. Biotech companies have raised $4.2 billion this year compared to $11.1 billion in the same period last year, according to LSEG data.

    Christian Koch, head of the biotech fund at Bellevue Asset Management in Zurich, said his fund had recently exited from some companies that could not access capital, while others were trying to find alternative ways to extend their cash runways. He did not name them.

    Arbutus Biopharma, which is testing a hepatitis B drug in mid-stage trials, announced layoffs in March, adding to a growing list of biotech firms who have collectively announced hundreds of staff cuts this year.

    Biotech firms unable to raise fresh funds may increasingly see a benefit in being acquired, said Jefferies analyst Michael Yee. But large deals involving pharma and biotech companies have stalled as executives grapple with mercurial White House economic policies and a global trade war, Reuters reported last month.

    “The vast majority of biotech companies in our coverage are now trading below their fundamental fair value in a near worst case scenario,” said RBC Capital Markets global healthcare analyst Brian Abrahams. Reuters

  • BMC will turn six hospitals up to investors

    BMC will turn six hospitals up to investors

    For seven months last year, Aktari Mohammed Khan had to make frequent visits to Lokmanya Tilak Municipal hospital, 10 km from her home in Mumbai.

    Khan had splitting headaches due to a neurological condition called occipital neuralgia. With no money to afford private treatment, she had to travel in crowded buses till the hospital in Sion, where a government neurologist treated her for free.

    The 38-year-old lives in a tiny hutment in a slum in Mankhurd, where a large number of people displaced by various development projects in Mumbai have been settled over the years. Most of the slum’s residents live in cramped, poorly ventilated spaces and have little access to healthcare.

    For years, they have demanded a government hospital for their needs.

    In 2013, the Mumbai Metropolitan Region Development Authority decided to construct a hospital for the rehabilitated people of Mankhurd. The hospital was supposed to have a high-tech operation theatre, a maternity wing and was to have been finished by 2015.

    After a delay of 10 years, the hospital is nearly ready and has been handed over to the municipal corporation.

    Domestic worker Sunita Gazdhane said they have waited for the hospital to open up for years. The 50-year-old lives in a hutment across the new hospital building. “It will be a huge relief for slum dwellers,” said Gazdhane, who visits a private clinic whenever she is ill. “I spend between Rs 100 and Rs 200 there.”

    But there is a catch.

    The Brihanmumbai Municipal Corporation, short on staff and funds, is in process of handing the hospital over to a private organisation to run.

    Khan, whose four sons work in a landfill not far from their home, said she was disappointed with the news. “How will we ever pay for private treatment?” she asked.

    Ateeque Ahmed Khan, a leader of the All India Majlis-e-Ittehadul Muslimeen, who contested for the Mankhurd Shivaji Nagar Assembly seat in 2024, asked what “purpose a government hospital will serve in a poor locality if it is privatised”.

    For Mankhurd’s residents, it is vital for the entire hospital to be run at government rates, he said.

    Besides the Mankhurd hospital, the municipal corporation has announced plans to give away five major hospitals in Borivali, Bandra, Vikhroli, Govandi and Mulund to private players under the public-private partnership model, said Ashok Jadhav, chairman of the Municipal Mazdoor Union.

    Each of these hospitals currently serves a significant slum population, who stand to lose out because of the decision.

    Municipal workers protest
    The municipal corporation has so far floated tenders for two hospitals to be handed over to private players – one in Borivali and the second in Mankhurd.

    In Borivali, a newly redeveloped Shri Harilal Bhagwati hospital with 490 beds will be given out to a private player for 30 years.

    According to the tender, accessed by Scroll, the private organisation will have to reserve 147 beds for poor patients, according to rates fixed by the civic body, and can charge private rates on the remaining 343 beds.

    In the Mankhurd hospital, which has 410 beds, only 150 beds will be reserved for free for patients like Khan. The private partner can profit from the remaining 260 beds.

    Four other hospitals that the corporation plans to give away are the KB Bhabha hospital in Bandra, the MT Agrawal hospital in Mulund, the Madan Mohan Malviya Shatabdi hospital in Govandi and Krantiveer Mahatma Jyotiba Phule Hospital in Vikhroli.

    All the hospitals have either undergone a recent expansion funded by the municipal corporation or were in the process of completing it. In its 2020-’21 budget, the civic body had estimated the revamp of Bhagwati hospital in Borivali to cost Rs 592 crore, that of MT Agrawal hospital to cost
    Rs 457 crore, the Shatabdi hospital in Govandi to cost Rs 500 crore and the redevelopment of the Bandra Bhabha to cost Rs 287 crore. It has allocated Rs 1,849 crore for the hospitals in the last four years.

    A former additional municipal commissioner at the Brihanmumbai Municipal Corporation said the hospitals’ capacity was expanded to meet the growing patient load.

    Bhabha hospital’s bed strength grew to 497 beds, MT Agrawal hospital now can accommodate 470 beds, and the Shatabdi hospital’s bed strength was increased to 580. The Mahatma Jyotiba Phule is still undergoing an expansion.

    The redeveloped hospitals have departments like cardiology, plastic surgery, urology, and gastroenterology, making it easier for people to access free treatment closer to their homes.

    But a health department official said the civic body is fund-strapped as well as short on staff, making it difficult to handle the 17 hospitals under it. This finally led to the decision to hand over the five hospitals, with nearly 2,500 beds, to private partners.

    The move has run into opposition from municipal employees, who will be removed from the hospitals.

    Pradeep Narkar, from the Municipal Mazdoor Union, said their union has begun to approach MLAs and MPs to gather support against the decision. “At least 2,000 nurses, staffers and doctors will be relieved from these hospitals once they get handed over,” Narkar said. Their union has already held a protest outside Bhagwati hospital.

    The Brihanmumbai Municipal Corporation has promised that the staff will be absorbed in other hospitals with vacancies. For example, there are about 2,230 vacant posts in the KEM, Sion and Nair hospitals.

    “But our opposition is also to the idea of PPP,” Narkar said. “These hospitals are meant for the public who depend on the government to provide affordable treatment.”

    Past experience
    The municipal corporation’s former executive health officer Dr Mangala Gomare said the public-private partnership model is a good option if the civic body has no manpower to manage hospitals or maternity homes.

    “But the challenge is monitoring the private partner and whether they are following all the terms of the contract,” Gomare said, adding that they need a separate cell to monitor such projects.

    For instance, the corporation handed over three maternity hospitals in Goregaon, Mulund and Deonar to private players in 2019. Gomare said monitoring had posed a problem when she was in charge.

    Dr Abhijeet More, from Jan Swasthya Abhiyaan, an organisation that works on public health, said the lack of supervision allows the private partner to profit disproportionately. “This finally affects the health services a poor person receives,” he said. “We have seen in the past that this model has failed in the BMC hospitals.”

    In 2018, the Brihanmumbai Municipal Corporation handed over the administration of intensive care units of six hospitals to Jeevan Jyot Charitable Trusts.

    Five years later, a first information report was filed against the trust for recruiting doctors with Bachelor of Ayurvedic Medicine and Surgery and Bachelor of Homeopathic Medicine and Surgery degrees, instead of trained intensivists, to treat patients in intensive care units. The municipal corporation had to terminate the contract.

    After the Jeevan Jyot incident, similar contract with Criticare and Associates to run intensive care units of two hospitals was terminated.

    The civic body had also handed over the Seven Hills hospital in Marol to a private player in 2005. The contract had to be terminated in 2018 after numerous lapses were found in the implementation of the contract.

    In Govandi, activist Jameela Shaikh helps local residents avail Ayushman Bharat cards to get free treatment under the Pradhan Mantri Jan Arogya Yojana. “People in this area are very poor,” she said. “They earn Rs 20,000 per month. With that earning they buy rations, pay children’s school fees and rent. There is hardly any money left for healthcare.”

    She added: “If the Shatabdi hospital is privatised, many poor people will have nowhere to go. Instead of expanding services, the BMC is stripping them of their health rights.” Scroll.in

  • Charitable hospitals in Pune spent ₹95.2cr on patient care

    Charitable hospitals in Pune spent ₹95.2cr on patient care

    Last year, charitable hospitals in Pune districts spent ₹ 95.2 crore on treating patients free or at discounted rates under the Indigent Patients Fund (IPF) scheme. However, many such hospitals couldn’t utilise all their funds due to patients’ preferences, said the officials.

    Dr H K Sale, chairman of the Association of Hospitals in Pune, claims that the IPF scheme at Charitable Hospital is benefiting the rich instead of the needy and eligible patients.

    “Several hospitals have noticed a new trend in which ineligible patients are getting admitted to Charitable hospitals as paying patients for treatment. While receiving treatment, they present documents claiming to be eligible for the scheme and free treatment. With the help of politicians and officials, they pressure the hospitals to provide free treatment and even demand a refund for the money they had initially paid despite being ineligible,” he said.

    District collector Jitendra Dudi, who is also head of the district monitoring committee for Charitable Hospitals, said that there is a preference amongst the patients who want specific hospitals due to which funds of some hospitals get exhausted and their IPF account goes into negative balance. However, even if they are in negative balance, they cannot refuse treatment to needy patients,” he said.

    As per the officials, there are 58 charitable hospitals in Pune, 74 in Mumbai and 468 across the rest of the state.

    In the Pune district last year, as many as 86,826 patients were provided free and discounted treatment under the IPF scheme by Charitable Hospitals. Between 1 January and 31 December 2024, as many as ₹ 81.8 crore were deposited in the IPF account by all 58 charitable hospitals. However, the hospitals together provided treatment worth ₹ 95.2 crore, i.e., ₹ 13.4 crore more than they were supposed to spend, said the officials.

    The Indigent Patients Fund (IPF) scheme, framed by the Bombay High Court (HC) and rolled out in September 2006, all charitable hospitals in the state allocate two per cent of their gross billing to help indigent or economically weak patients. This aid has to be in the form of free treatment to those with an annual income below ₹ 1.8 lakh and at 50 per cent discounted billing for patients whose family’s annual income does not exceed ₹ ₹ 3.6 lakh. Charitable hospitals get FSI, concessions in water, power, customs, sales and income taxes, amongst other benefits.

    Dudi further informed that last year, 34 complaints were received against the charitable hospitals, and all have been resolved.

    “Patients and kin in case of any complaints regarding the charitable Hospitals, can approach the Joint Charity commissioner Pune or district collector office with their complaints,” he said.

    The State government last year (April) established a Special Help Cell and district-level committees (November) to monitor the reserved beds and implementation of the IPF scheme at charitable hospitals in the state. These changes were made to monitor the successful implementation of the IPF scheme to increase transparency and ensure that poor patients receive free and subsidized treatment under the system.

    According to government data, after the system was made online, in 2024, 10,040 patients were allotted beds online, with ₹9.40 crore spent on their treatment in the state. Officials report no formal complaints this year, except for one against Aditya Birla Memorial Hospital, Pune, during which a notice was issued to the hospital, said officials.

    Rameshwar Naik, head of the Special Help Cell, Maharashtra, said some hospitals reportedly fail to even display their charitable status or inform patients of their entitlements. Due to this, we have established a district-level committee to monitor the IPF scheme. “There are preferences due to which there is a load on some hospitals and their funds get exhausted. We don’t want injustice either to the hospital or the patients. Soon we will make mode changes in the scheme for better implementation,” he said. Hindustan Times

  • FDA approves supervisors and review staff to return to telework

    FDA approves supervisors and review staff to return to telework

    Weeks after ordering all Food and Drug Administration employees back into the office, the agency is reversing course, allowing some of its most prized staffers to work remotely amid worries that recent layoffs and resignations could jeopardize basic functions, like approving new medicines.

    An internal email obtained by The Associated Press states that FDA leadership are “allowing review staff and supervisors to resume telework” at least two days a week. The policy shift was confirmed by three FDA staffers who spoke to the AP on the condition of anonymity to discuss internal agency matters.

    The message was sent Tuesday to some of FDA’s hundreds of drug reviewers. Staffers said a similar policy was communicated to reviewers who handle vaccines, biotech drugs, medical devices and tobacco products although not necessarily in writing.

    It’s the latest example of the Trump administration’s chaotic approach to overhauling the federal health workforce, which has included firings, a scramble to rehire some employees, and then additional layoffs last week of an estimated 3,400 staffers, or more than 15 percent of the agency’s workforce. When FDA employees were called back to the agency’s headquarters last month they confronted overflowing parking lots, crowded offices and broken or missing supplies.

    A spokeswoman for Health Secretary Robert F. Kennedy Jr. said the administration is returning to “pre-Covid telework arrangements for reviewers, whose read and write work output is tracked in 15-minute increments to ensure productivity and accountability.”

    While many agencies switched to telework during the pandemic, the FDA began embracing the practice a decade earlier. The flexibility was seen as a competitive perk for recruiting employees who can often earn more working in industry.

    Last week’s cuts included entire offices focusing on FDA policy and regulations, most of the agency’s communication staff and teams that support food inspectors and investigators. Senior officials overseeing tobacco, new drugs, vaccines and other products have also been dismissed or forced to resign. Staffers have described rank-and-file employees “pouring” out of the agency.

    Former FDA Commissioner Dr David Kessler called the cuts “devastating, haphazard, thoughtless and chaotic” during a House hearing on Wednesday.

    When Kennedy announced plans to eliminate 10,000 staffers across the federal health workforce, he noted out that FDA medical reviewers and safety inspectors wouldn’t be impacted.

    In February, HHS was forced to recall some probationary employees who were fired, including hundreds of medical reviewers at FDA, who are largely funded by industry fees, not federal dollars.

    But last week’s cuts combined with resignations and retirements have raised a new threat: that FDA funding could fall so low that it short circuits a long-standing system in which companies help fund much of the agency’s operations.

    Nearly half the FDA’s $7 billion budget comes from fees collected from drug, device and tobacco companies. The agency uses the money to hire thousands of staffers to quickly and efficiently review new products. For example, about 70 percent of the FDA’s drug program is financed by user-fee agreements, which must be reauthorized by Congress every five years.

    But the agreements stipulate that if FDA’s federal funding falls below set levels, companies are no longer required to pay and, in some cases, can claw back their money. The threshold requirements are designed to ensure Congress continues funding FDA, rather than relying entirely on the private sector.

    FDA and industry groups are supposed to begin negotiations later this year to renew several user-fee agreements, including those for drugs and devices.

    “I don’t think the agency nor regulated industry can afford for ‘user fees’ not to be reauthorized,” said Michael Gaba, an attorney who advises FDA-regulated companies.

    Whatever the reasoning behind the telework shift, former federal officials say it’s a sign that recently confirmed FDA Commissioner Marty Makary is trying to retain and rebuild agency staffing. Makary made his first appearance at FDA’s headquarters last Wednesday, one day after the mass layoffs. According to the memo obtained by the AP, Makary signed off on the return to telework for some employees.

    “Dr Makary needs to rebuild teams and restart the engine of productivity lost to weeks of job insecurity, uncertainty and shortages of team members,” said Steven Grossman, a former HHS official. “Turning commuting time back into work time is a great first step in achieving both.” PBS

  • The World Bank praises India’s proficiency in medical tourism

    The World Bank praises India’s proficiency in medical tourism

    India’s focus on complex surgeries, including cardiac procedures, organ transplants, and orthopaedics, has boosted its medical tourism sector, according to the January 2025 Tourism Watch Quarterly Report published by the World Bank Group. The report notes that initiatives like the e-Medical Visa and marketing campaigns like ‘Heal in India’ have further bolstered the industry. In 2023, the country attracted 476,000 foreign patients, which is among the highest in the world.

    To secure a share in this growing industry, the World Bank Jobs Accelerator technical assistance is working with the Tamil Nadu government on both the tourism and health sectors to establish an institution to promote medical tourism, facilitate public-private dialogue, support marketing efforts and facilitate access to international health insurance markets.

    The report notes that medical tourism presents a significant opportunity for middle-income countries to generate jobs and foreign exchange. Medical tourism is characterised by high expenditures per visitor, and patients are often accompanied by one or more family members, multiplying the economic impact. By nurturing medical tourism, the host countries get to enjoy spillover benefits like enhancing the quality of domestic healthcare services and strengthening competitiveness in the sector.

    The report notes that the demand for medical tourism has more than doubled in the ten years between 2013 and 2023, while global health-related travel exports have grown by 70%. India, alongside Thailand, Turkey and Mexico, were some of the countries that have successfully tapped into this growing market by offering specialised treatments in various fields, the report notes. Asian Medical Tourism

  • Delhi govt will turn the nation’s capital into a medical tourism destination

    Delhi govt will turn the nation’s capital into a medical tourism destination

    Chief Minister Rekha Gupta on Sunday said the government will strengthen health facilities to attract patients from across the globe and develop the city into a medical tourism hub.

    “We aim to make Delhi a global destination for medical treatment. Promoting health tourism will not only enhance medical services but will also strengthen the economic ecosystem. The Delhi government is continuously working to reform and expand the healthcare sector,” Gupta said at the 70th foundation day celebrations of Sir Ganga Ram Hospital.

    The CM said that the government understands the ground reality and is working for betterment of the health sector in the Capital.

    ‘New mission’
    “Institutions that treat health care as a mission, not just as a service, are crucial and the government is committed to providing all possible support to such institutions at the level of policy, resources and structure,” she added.

    Gupta stated that a “healthy Delhi is the foundation of a self-reliant India”. “In this year’s budget, we [BJP govt.] have allocated ₹12,893 crore to improve health services, of which ₹2,144 crore has been allocatedfor the implementation of Ayushman Bharat Yojana,” she said. The Hindu

  • A bill to fund medical AI was filed in the US Senate

    A bill to fund medical AI was filed in the US Senate

    US Senators Mike Rounds (R-S.D.) and Martin Heinrich (D-N.M.), co-chairs of the Senate Artificial Intelligence Caucus, today introduced legislation aimed at improving health outcomes for Medicare patients by encouraging the use of cutting-edge, artificial intelligence (AI)-enabled medical devices. The Health Tech Investment Act establishes a consistent and predictable Medicare payment pathway for these technologies, providing patients with earlier and more accurate diagnoses.

    “Medicare patients deserve access to the life-changing care that artificial intelligence-enabled devices can offer,” said Rounds. “There is currently no clear Medicare payment system for these devices, meaning that it can take years to be approved and paid out by Medicare accurately. This legislation would create that system, improving diagnoses and encouraging the adoption of AI devices in clinical settings.”

    “I’m proud to cosponsor legislation that expands Medicare coverage of new technologies and helps New Mexicans get the best, most affordable high-quality care they need when they need it,” said Heinrich.

    “Too often the prolonged pathway to coverage for medical devices and technology delays patient access to the critical care they need,” said Randall Rutta, CEO of the National Health Council. “This issue has intensified as the pace of innovation has increased. The National Health Council is pleased to support the Health Tech Investment Act to help patients gain timely access innovative health solutions.”

    “Senator Rounds’ legislation to create a Medicare coverage pathway for AI-enabled medical devices will be an important development for cancer patients in South Dakota,” said Jane Veerman, an oncology clinical research nurse at Sanford Health. “Patients in rural regions of the country are too often the last to be able to access medical innovation since too many rural providers lack the resources to invest in innovative technologies. Senator Rounds’ bill would give Medicare patients certainty that their hospitals and physician offices would be reimbursed for investing in AI-enabled technologies and bringing them to patient care.” Senator Mike Rounds