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July 2024

Drug regulator to crack down on pharma companies not using barcodes

July 10,2024 New Delhi: India’s drug regulatory authority will take action against pharma companies that have failed to implement barcodes or QR codes on top 300 medicine brands. The drug regulator is also considering setting up a joint task force for fighting the menace of spurious and adulterated drugs in the country, people in the know told ET. In a recent meeting the drug regulator has asked states for “strict implementation” of barcodes. In a bid to weed out spurious drugs, the regulator had made it mandatory for the companies to have a barcode on its label so that information such as manufacturing licence and batch number can be accessed upon scanning. The top 300 brands of drugs included widely used analgesics, pain relievers, anti-platelet, vitamin supplements, blood-sugar lowering medicines and contraceptive tablets. “The move was to ensure authenticity of drugs and enable tracing,” added the person. The brands identified by the National Pharmaceutical Pricing Authority (NPPA) include Dolo, Saridon Fabiflu, Ecosprin, Limcee, Sumo, Calpol, Corex syrup, Unwanted 72 and Thyronorm. They were shortlisted on the basis of their moving annual turnover value as per data from market research firm Pharmatrac. Prior to this, the health ministry had asked the department of pharmaceuticals (DoP) to shortlist top 300 drugs so that necessary amendments can be made in the drug rules for its implementation. Source: Pharma

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Nearly 50% of government doctor prescriptions deviate from guidelines, finds study

July 10,2024 New Delhi: Nearly one in every two prescriptions issued by doctors from top govt hospitals, including AIIMS and Safdarjung, have been found to deviate from standard treatment guidelines in a study published in the Indian Journal of Medical Research. While most deviations are ‘acceptable’ as they don’t pose any threat to patient’s life, the study showed that at least 10 per cent of prescriptions had deviations that were ‘unacceptable’ as they could result in a drug interaction, lack of response, increased cost, preventable adverse drug reaction and/or antimicrobial resistance. Sample this: A patient suffering from anal fissure or tear in the inner lining of anus was prescribed two antibiotics when standard treatment guidelines suggest treatment of anal fissure in topical therapy unless it is secondary to other systemic diseases. The IJMR study said unnecessary prescription of antibiotics in such a case increases the risk of antibiotic resistance, adverse drug reactions and the cost of treatment; thus, putting the prescription in the category of unacceptable deviation. An acceptable deviation would include incomplete prescriptions with respect to formulation, dose, duration and frequency. In the study, researchers analysed 4,838 prescriptions issued by doctors posted at the outpatient departments of tertiary care hospitals across the country where the 13 Indian Council of Medical Research Rational Use of Medicine Centres are located. All prescribers were post-graduates in their respective disciplines & on average were in practice for four to 18 years. Researchers found OPDs having maximum deviations was community medicine, followed by ENT & paediatrics. “It’s possible that deviations in community medicine were more as such OPDs are run by junior docs,” the study stated. Source: Healthworld

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Private hospitals in Haryana refuse to admit patients under Ayushman scheme, leaving patients harried

July 04,2024 Jind: In an ongoing deadlock over pending payments, private hospitals in Haryana have stopped admitting patients under the Ayushman Bharat and Chirayu Haryana schemes. The Indian Medical Association (IMA) has called for the protest, affecting nearly 700 private hospitals across the state which refused treatment of patients. Notably, private doctors claimed that several private hospitals are empanelled under the central government’s Ayushman Bharat and state government’s Chirayu Haryana schemes. The schemes provide cashless treatment to beneficiaries, with the government clearing the dues of private hospitals. However, the state government has not released payments worth over ₹225 crore, prompting the protest statewide, said doctors. The move has left several patients in need of treatment under the schemes in a difficult situation. Gauri, Rampal, Vicky and many other patients who reached private hospitals in Jind district were forced to return as doctors refused to treat them. Shamser Singh, a native of Chhatar village of Uchana Kalan town said that “my treatment was going on in a private hospital in the city. Doctors have fixed my appointment today for conducting back bones’ operation but they refused citing payment issues. It’s up to government and private hospitals to settle down the issue but patients should not be harassed. We don’t know where to go now,” he said while expressing his Reportedly, nearly 74.33 lakh beneficiaries are covered under the Chirayu scheme in Haryana and 28.89 lakh beneficiaries are covered under the Ayushman scheme in the state. Each family gets health coverage of up to ₹5 lakh per year for secondary and tertiary care hospitalisation under the schemes. Talking to TOI, Dr Gopal Goyal said that patients who are being denied for treatment in private hospitals are being looked after in government hospitals. “We have asked our teams to speed up the process to treat such patients as per requirements,” he added. On being contacted Dr Ajay Mahajan, IMA state president, said that “today we held a meeting with Sudhir Rajpal, ACS health who assured us to clear our pending payment till July 15. We will wait as per the assurance given by him and action would be taken accordingly. We would start treatment once we get minutes of a meeting held with ACS, said IMA state president. Source: Healthworld

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Wockhardt Hospitals, Mumbai Central successfully completes 200 robotic minimally invasive joint replacement surgeries

July 03,2024 Mumbai: Wockhardt Hospitals, Mumbai Central, has successfully completed 200 minimally invasive joint replacement surgeries utilising cutting-edge Makoplasty robotic techniques from its launch in October 2024. A substantial contribution to this milestone has been made by Dr Mudit Khanna, Senior Orthopaedic Consultant & Joint Replacement Surgeon, Wockhardt Hospitals, Mumbai Central, who has individually completed 100 of these procedures within a span of few months since its launch. The integration of the Mako Smart Robotic system has revolutionised the way complex joint replacement procedures are performed. The system is capable of performing hip replacements, partial knee replacements, and total knee replacements. The robotic system uses CT-guided pre-planning for accurate assessments and haptic technology to ensure safety, allowing for surgeries with unparalleled accuracy. This results in reduced operative time, minimised tissue damage, and faster recovery for patients. Dr Virendra Chauhan, Centre Head, Wockhardt Hospitals, Mumbai Central, stated, “A team of orthopaedicians trained in Mako robotic knee and hip replacement surgery has contributed to achieve the milestone of 200 plus robotic surgeries. We are immensely proud of Dr Khanna’s contributions and our team’s collective efforts in reaching this achievement.” Dr Khanna, sharing his thoughts on the accomplishment, said, “Reaching the milestone of 100 surgeries is just the first step in utilising the transformative power of technology in modern healthcare. Makoplasty has allowed us to redefine what’s possible in orthopaedics, enabling us to deliver better outcomes and improve the quality of life for our patients.” The hospital looks forward to the continued impact of its ground-breaking work in orthopaedic surgery. Source: Healthworld

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Kerala’s first paediatric liver transplantation done in govt hospital

July 06,2024 Thiruvananthapuram: Kerala’s first paediatric liver transplantation was done in Government Medical College Hospital in Kottayam district. The surgery was performed on a five-year-old child suffering from liver-related ailments, Health Minister Veena George said here in a statement on Saturday. “The child’s 25-year-old mother donated her liver. It is the first paediatric liver transplantation in the state,” she said. Paediatric liver transplantations are very rare in government hospitals, she said, adding that live surgery is a very complicated procedure. An expert tream, led by Dr R S Sindhu, head of the surgical gastro department of the hospital, carried out the complicated operation, she said. George also congratulated the doctor and her team for conducting the rare surgery. Kottayam Medical College has begun liver transplantation in the government sector for the first time in the southern state in February 2022, the statement added. Source: Healthworld

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Drugs body flags side effects of heart, Glaucoma medications

July 06,2024 New Delhi: Drug standards body Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert on commonly used drugs amlodipine and acetazolamide, saying both these medicines cause adverse reactions. Amlodipine – used for treatment of fatal coronary heart disease and non-fatal myocardial infarction and to reduce the risk of stroke – causes lichenoid keratosis, an inflammatory reaction, IPC said. According to IPC, amlodipine is also used to reduce the risk of coronary revascularisation procedures and need for hospitalisation due to angina in patients with coronary artery disease. The medicine is used alone or in combination with other medications. The lesions generally appear on the forearms, hands, chests of middle-aged women, or areas exposed to the sun, it said. Acetazolamide – a carbonic anhydrase inhibitor used to treat glaucoma- may lead to choroidal effusion or choroidal detachment, which is fluid buildup in the choroid layer of the eye. IPC, which comes under the health and family welfare ministry, has cautioned healthcare professionals to “diligently monitor” the potential occurrence of adverse drug reactions (ADRs) when administering these drugs. It has also advised patients and consumers to closely monitor the possibility of the above ADRs when using the suspected drugs. “Companies manufacturing these drugs may be asked to insert warnings in their package so that patients and doctors know about the adverse event,” a government official said on the condition of anonymity. The IPC warning is based on preliminary analysis of adverse drug reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database. Source: Pharma

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Diabetes patients on GLP-1s instead of insulin have lower cancer risk, study shows

July 06,2024 London: Patients with type 2 diabetes taking GLP-1 treatments, which include Ozempic, have a lower chance of developing 10 types of obesity-related cancers than those taking insulin and other diabetes drugs, according to a study published on Friday. GLP-1 treatments for type 2 diabetes have been on the market for nearly 20 years. The newer generation – such as Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro – are far more effective at controlling blood sugar levels and inducing weight loss. Ozempic was the first of the newer generation in the class to be approved, in 2017. In the study published on Friday in medical journal JAMA Network Open, researchers examined the medical records of 1.6 million patients with type 2 diabetes who had no prior history of 13 types of obesity-related cancers including gallbladder cancer and kidney cancer. The study did not specify which GLP-1 medicines the patients took, but the records were for patients on these medicines or insulin or the diabetes drug metformin between March 2005 and November 2018. Ozempic was only approved by the U.S. Food and Drug Administration in December 2017. The study found that the patients treated with a GLP-1 therapy instead of insulin “had a significant risk reduction” in 10 of those cancers. The findings are “preliminary evidence of the potential benefit” of GLP-1 drugs for cancer prevention in high-risk population, the researchers concluded. They also said that studies of the newer generation of these medicines for their cancer preventative effects are warranted. The authors of the study did not report having received funds from drugmakers who market these medicines. The versions of these medicines that are approved to treat obesity, and have been shown to help patients lose as much as 20% of their weight on average, have exploded in popularity, leading to record profits for Novo and Lilly. Lilly’s Mounjaro and weight-loss therapy Zepbound, as well as Novo’s rival medicines Ozempic and Wegovy are already being studied to see whether they can improve health in many other ways, ranging from alcohol addiction to sleep apnea. In March, the U.S. Food and Drug Administration approved Wegovy for lowering the risk of stroke and heart attack in overweight or obese adults who do not have diabetes. (Reporting by Maggie Fick; Editing by Susan Fenton) Source: Healthworld

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Kerala CM holds meeting on preventing amoebic meningoencephalitis infections

July 06,2024 Thiruvananthapuram: A day after a 14-year-old boy died due to amoebic meningoencephalitis, Kerala Chief Minister Pinarayi Vijayan held a meeting in which several suggestions, including not to bathe in unclean water bodies, were given to prevent further infections. Amoebic meningoencephalitis is a rare brain infection caused by a free-living amoeba found in contaminated waters and the suggestions to tackle it came during the meeting chaired by the CM, a statement issued by his office said. In the meeting, also attended by state Health Minister Veena George and various senior government officials including Chief Secretary Dr Venu V, it was also suggested that there should be proper chlorination of swimming pools and children should be careful when entering water bodies as they are mostly affected by this disease, the statement said. Using swimming nose clips to prevent infection by the free-living amoeba was also suggested in the meeting. The Chief Minister also said that everyone should take care to keep the water bodies clean. Besides the death of the 14-year-old boy on Wednesday night, two others — a five-year-old girl from Malappuram and a 13-year-old girl from Kannur died on May 21 and June 25, respectively, due to the rare brain infection. Medical experts said the infection occurs when free-living, non-parasitic amoebae bacteria enter the body through the nose from contaminated water. The health authorities have advised people to exercise caution against amoebic meningoencephalitis. The disease was earlier reported in coastal Alappuzha district in the state in 2023 and 2017. Source: Healthworld

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Doctors on alert as typhoid cases rise in Pune; PMC blames uncleaned water tanks

July 07,2024 Pune: The city is witnessing a sudden spike in typhoid cases, putting local medical professionals on alert. Adults as well as children have been affected by this recent outbreak, Pune Municipal Corporation Pune Municipal Corporation (PMC) health department officials said, and added that the situation is under control. PMC assistant health officer Dr Rajesh Dighe said there was an outbreak recently in a society in Sadanandnagar, where the water tanks had not been cleaned for some time. “Once typhoid patients started being reported from the society, we took water samples from the tanks as well as the civic body water supply taps in the area and sent them for testing,” Dighe said. “We found that the water in the tanks was contaminated, and the society was intimated about it and asked to clean the tanks or face action,” Dighe said. As many as 21 people had tested positive from the society, he said, and added that they have all now recovered. “We had found two more patients from other areas such as Kondhwa,” he said, and emphasised that hospitals should immediately notify the civic administration of any cases. He warned that they could face action for failing to do so. Dr Amita Kaul, head of the department and senior paediatrics consultant at Surya Mother and Child Super Speciality Hospital, told TOI, “We’ve seen a marked increase in enteric fever cases over the past month. Our institute is admitting two to three children daily with high fever, vomiting, and in some instances, severe abdominal pain and dehydration.” The bacterial infection, caused by Salmonella typhi and Salmonella paratyphi A, enters the body through contaminated food and water. Kaul said that many patients’ blood cultures have tested positive for Salmonella typhi, with some children presenting low blood counts and platelet levels. “We suspect the surge may be linked to sewage contamination in water lines or increased coliform content in rivers. This systemic infection in most cases is not responding to oral antibiotics and needs hospitalisation and IV antibiotics,” Dr Kaul said. Typhoid is a vaccine-preventable disease. “However, this year has seen a rise in cases caused by the paratyphoid strain, which is not covered by the current vaccine,” she added. Dr Ameet Dravid, an infectious diseases specialist from Noble Hospital, agreed that there has been a significant surge in typhoid cases. Dravid added that the majority of patients presented with prolonged fever and tested positive for Salmonella in blood cultures. Doctors have noticed that it is taking longer for the fever to subside, typically seven to 10 days, indicating a prolonged fever feature in the current cases. “In some cases, diagnosis was initially challenging as patients had taken over-the-counter antibiotics. This can prevent Salmonella from growing in blood cultures, obscuring the diagnosis. As a result, some patients had a history of fever for a month but weren’t diagnosed with typhoid initially,” he said. Source: Healthworld

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IMA urges government to enhance health allocation in budget to minimum 2.5% of GDP

July 07,2024 New Delhi: The Indian Medical Association has demanded increased allocation of financial resources in the budget, advocating a tax-based system of health financing, the medical body said in a letter written to Finance Minister Nirmala Sitharaman on Saturday. Indicating that government spending on health was low, the medical body said that allocations varying from 1.1 to 1.6 per cent of GDP by the various governments are among the lowest in the world. The body demanded an increased allocation of financial resources for the health sector. Urging the Finance Ministry for this year’s union budget, it further demanded that the expenditure incurred on health determinants like drinking water and sanitation should be provided separately. “A minimum allocation for health alone should be around 2.5 per cent of the GDP, the medical body demanded. India’s overall health spending (public and private) is currently estimated to be 3.8 per cent of its GDP, lower than the low- or middle-income country’s (LMIC) average health spending share of GDP of around 5.2 per cent, as per the IMA. Among the major demands, the body urged for tax-funded universal healthcare with a basic package for all citizens. It demanded investments in public sector hospitals, an allocation of 5 per cent of GDP for health, a re-envision of PMJAY to cover outpatient care and the cost of drugs, and facilities for direct patient transfer, copayment, and reimbursement models, among others. IMA suggested that to achieve the goals of Viksit Bharat 2047, “the health sector has to be promoted judiciously and made a priority sector, like industries, education, and agriculture.” “New hospital projects capital equity financing support through SIDBI/NationalInfrastructure fund/infrastructure grants/state infrastructure,” it suggested. The IMA also suggested working capital loan subsidies as a supply-side financing mechanism to help with cash flow issues in PMJAY. Highlighting the complexities of the third-party payer system under PMJAY, it said that the system is creating serious fault lines in India.medical care system. Third-party payor system making medical care complex and creating serious fault lines in Indian medical care system (like US Healthcare), distorting its Indian values and USPs and leading to Burocratisation of medical care: “Third-party payors are bringing indirect price control, and their predatory suboptimal pricing is killing the quality of medical care and creating moral and ethical distortions in medical care, illegalOOPE and undermining the trust relationships between patient-providers and payor-providers, the IMA said. The body also emphasised the need to review the health insurance regulations and GST. Source: Healthworld

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