PSM News

Mar 26,2024 New Delhi: It’s an almost entirely preventable disease but cervical cancer kills one woman in India every seven minutes. That represents 21 per cent of global cervical cancer deaths, and makes it the second most common cancer in Indian women with 1,25,000 women being diagnosed and over 75,000 dying from the disease in India each year. Vaccinating people against the human papillomavirus or HPV which causes the vast majority of cervical cancer cases is a highly effective way of preventing the disease. HPV vaccines were first introduced in 2006 in the United States, and Australia became the first country to roll out a national vaccination programme the following year. But until recently, the cost of the vaccines – as much as Rs 4,000 for a single dose with usually at least two doses required – has put preventing cervical cancer this way out of reach of most low- and middle-income countries across the world, including India. Launched in September 2022, India’s first indigenously developed quadrivalent HPV vaccine, Cervavac, has the potential to improve access to vaccines and revolutionise cervical cancer prevention in these countries. Developed by the Serum Institute of India, one of the largest vaccine producers in the world, it’s currently priced at half of the cost of its competitors Merck & Co’s Gardasil and GlaxoSmithKline ‘s Cervarix at Rs 2,000 per dose with plans announced to produce 200 million doses. But as production is scaled up, the Institute hopes to be able to make a dose of Cervavac available to the public at a price of between Rs 200-400 in the near future. The vaccine alliance Gavi signed a new three-year partnership with the Indian government in February 2023, with the aim to extend life-saving vaccines to millions of children nationwide, including helping the country introduce the HPV vaccine into India’s national immunisation regimen. And in February 2024, the government announced the vaccine would be part of the Universal Immunisation Programme, following endorsement from the National Technical Advisory Group on Immunisation. During her recent interim budget speech for 2024-25, Indian Finance Minister Nirmala Sitharaman emphasised the government’s commitment to actively “encourage” vaccination as a proactive measure against cervical cancer – a significant announcement for women’s health in India. It hasn’t only been affordability that has hindered the widespread adoption of HPV vaccines in India. Source: Healthworld

Mar 22,2024 London: The European Union’s medicines regulator did not mention Eisai and Biogen’s Alzheimer’s drug in its notes and recommendations on Friday. The European Medicines Agency had said it would hold a oral hearing to discuss the drug, lecanemab, this week. The drug, sold as Leqembi in the United States has been under review in Europe since January 2023. It gained traditional approval in the United States last year and is also approved in other countries, including China and Japan. The infusion given twice a month removes sticky clumps of a protein called amyloid beta, believed to be a hallmark of Alzheimer’s, from the brain. Source: Pharma

Mar 19,2024 New Delhi: ENTOD Pharmaceuticals on Tuesday announced the developement of human insulin eye drops designed to treat corneal eye conditions like neurotrophic corneal ulcers and dry eyes. Although Insulin has traditionally been administered through injections to manage blood sugar levels in diabetic patients globally, recent research from various global studies and literature searches has demonstrated its potential effectiveness when applied as eye drops. These findings suggest that insulin eye drops can aid in repairing corneal tissue and addressing ocular surface conditions. The company’s next step involves initiating the drug regulatory approval process in India. This will begin with an application to the CDSCO for approval to conduct clinical trials of these eye drops. Subsequently, the company will seek approval from the DCGI for commercialization. ENTOD Pharmaceuticals’ CEO, Nikkhil K Masurkar , said, “There is compelling and growing global evidence suggesting that insulin eye drops could revolutionize ophthalmic therapeutics. Our eye drop formulation, EyeSulin, would be the first of its kind in the world to treat eye conditions once approved. Upon regulatory clearance, we aim to produce these eye drops as part of the ‘Make in India’ initiative, making them accessible across India and globally at an affordable price. As far as our knowledge extends, no commercially viable insulin eye drops exist worldwide or are in development. Therefore, we are thrilled to lead the charge ahead of the US and other Western nations in pioneering this potentially groundbreaking eye medicine, poised to benefit millions.” Source: Pharma

Mar 27,2024 Mumbai, March 26, 2024. An exclusive distribution and marketing agreement was today announced between Sanofi India and Cipla for Sanofi’s Central Nervous System (CNS) product line in India. As part of this collaboration, Cipla will handle the distribution of Sanofi India’s six CNS brands, which include the industry-leading Frisium® brand of anti-epileptic drugs. Cipla will make use of its skills and strong India-wide network of distributors, institutions, and market outreach programmes to expand access to these treatments for patients who need them, while Sanofi India will continue to own, import, and manufacture its entire range of CNS products across plants in India and abroad. Rodolfo Hrosz, Managing Director, Sanofi India Limited, said “Sanofi India’s CNS products are leaders in their respective categories. These well-established brands already improve lives of many patients across urban centres in the country. Cipla’s wide presence will enable us to expand the reach of this portfolio to healthcare professionals and patients across all India.” Mr. Achin Gupta, Chief Executive Officer – One India Business, Cipla Limited, said “Enhancing access to high quality treatments is central to our purpose of ‘Caring for Life’. We are pleased to collaborate with Sanofi India to enhance accessibility to highly efficacious and quality therapeutic solutions in CNS and bring value to patients across the country. Central Nervous System is one of the most challenging areas in medicine, and we believe this partnership is a significant step forward to address unmet needs of patients.” Sanofi India continues to focus on accelerating its strong innovation pipeline into India, across multiple therapeutic areas including Diabetes, Transplants, Rare Diseases, Consumer Healthcare and Vaccines. Source: Pharma

Mar 25,2024 New Delhi: About 77% of the 56,000 IT sector corporate employees in the age group of 25-40 years suffers from deranged values in several health parameters and 61% have high cholesterol, a clinical study conducted by HCL Healthcare has revealed. The study was conducted on people working in the sector who underwent health checks and doctors’ consultations at its onsite clinics. The objective of this study was to underline the growing need for preventive care in the corporate spectrum of India. The clinical parameters studied included 8 key health conditions – obesity, prediabetes, diabetes, prehypertension, hypertension, anaemia, hypothyroidism and high cholesterol. The study has revealed that high cholesterol (61%) tops the chart with nearly two-thirds of corporate individuals showing deranged values. It is followed by obesity (around 22%), prediabetes (17%), hypothyroidism and anaemia (11% each), diabetes (7%), and then other health problems. The same individual can have more than one abnormal health condition. It was also observed that nearly 44% of the younger population below 25 years of age also suffered from deranged cholesterol followed by anaemia (14%), obesity (13%), hypothyroidism (8%), and prediabetes (7%). These chronic health conditions appear to be growing at a rapid pace and with a higher prevalence among those with advancing age. “We see a considerable rise in the prevalence of these health conditions in the above-40 age group, with high cholesterol, obesity, pre-diabetes, and diabetes topping the list,” quality data analysts said. Only 23% of these employees had their health parameters within range. About 37% of the individuals who were studied had a single chronic health condition while 26% suffered from two conditions followed by 11% having three (comorbidities). Doctors said that the above parameters make up a constellation of common lifestyle problems and noncommunicable diseases which mean that these conditions may have a common underlying cause and can co-exist in an individual. This is clinically called metabolic syndrome and requires timely intervention. Shikhar Malhotra, vice-chairman and CEO of HCL Healthcare, said: “The data clearly shows the incidence of diseases and health abnormalities starting at a much younger age. The health issues that used to begin in the 40s have now shifted base to early 30s. Some fluctuations in health and vitality are normal, attributed to hormonal and metabolic shifts but what is concerning is the amplified stress and lifestyle-induced ailments that are becoming synonymous with such health issues now seen in the 30s.” He added that employers need to give access to basic health check-ups because early intervention in these conditions can help people control symptoms and find timely treatments. “Today, we suffer not just from health problems, but we suffer from a lack of awareness,” he said. Source: Healthworld

Mar 24,2024 Hyderabad: MTBVAC, the Spanish tuberculosis vaccine, the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human reaches a new milestone by starting clinical trials in India, the most populated country in the world and the one with the highest number of cases of this infectious disease. The trials are carried out by Bharat Biotech in close collaboration with Biofabri. Trials to evaluate the safety and immunogenicity of MTBVAC have started with a pivotal safety, immunogenicity and efficacy trial planned to start in 2025. After more than three decades of research, Esteban Rodriguez, CEO, Biofabri said, “It is a giant step to test in adults and adolescents in the country where 28 per cent of the world’s TB cases accumulate and concludes that more effort and funding is needed to combat TB, which remains one of the world’s leading infectious causes of death, especially in India.” It should be remembered that the only vaccine in use today, BCG (Bacillus Calmette and Guérin), is an attenuated variant of the bovine TB pathogen. It is more than a hundred years old and has a very limited effect on pulmonary tuberculosis, which is responsible for the transmission of the disease, hence the need to make progress on this new vaccine, which will be a milestone in global vaccinology and is an example of public-private, national and international collaboration. Dr Krishna Ella, Executive Chairman, Bharat Biotech added, “Our quest for a more effective vaccine against tuberculosis received a big boost today, with clinical trials in India. Our goal to develop TB vaccines to prevent disease in adults and adolescents has taken a big step today. We are honoured to partner with BioFabri, Dr. Esteban Rodriguez and Dr. Carlos Martin in this noble effort to reinvent TB vaccines.” A long process, an example of public-private collaboration The MTBVAC vaccine has passed several milestones before entering clinical trials in India. The first is that after the recent completion of a Phase 2 dose-finding trial, a double-blind, controlled Phase 3 clinical trial in newborns started in 2023, comparing the vaccine with the current BCG vaccine. 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated. To date, more than 1,900 babies have been vaccinated. The aim is to assess the immunogenicity and efficacy of MTBVAC which is administered intradermally to infants on the first day of life. Vaccination began at a time of setbacks in the global fight against TB. Health restrictions imposed during the COVID-19 pandemic led to an increase in infections and a decrease in diagnosis and treatment. As a result, annual TB deaths have risen to over 1.6 million. This Phase 3 neonatal project, partially funded by the European Union through its EDCTP (European & Development Countries Clinical Trial Partnership) programme, is being coordinated by Biofabri, as part of a consortium that also includes the University of Zaragoza (Unizar), TuBerculosis Vaccine Initiative (TBVI), The University of Cape Town (UCT)/SATVI, Wits VIDA Health Consortium (WHC), Stellenbosch University (SUN-FAMCRU), Enhancing Care Foundation (ECF), Centre de Recherche Biomedicale Espoir Pour La Santé (CRB-EPLS, Senegal) and Institut Pasteur de Madagascar (IPM). Another important milestone is that after completing a dose escalation trial in HIV uninfected adults, a Phase 2 study in HIV-infected adults started in 2024 to determine whether MTBVAC is safe in this population. This ongoing trial at 16 sites in South Africa – involving the vaccination of 276 adults – is evaluating safety and immunogenicity in HIV-negative and HIV-positive adults and adolescents vaccinated with MTBVAC. A Phase 2b efficacy study in adolescents and adults is planned to start in the second half of 2024 in Sub-Saharan Africa. Source: Healthworld

Mar 26,2024 NAGPUR: Two govt doctors have been booked in Maharashtra’s Wardha district, where prohibition is in force, after they were found in an inebriated condition while examining a child at Pulgaon rural hospital, police said. Dr Pravesh Dhamane and Dr Maniklal Raut were found “reeking of alcohol” on duty and a bottle containing around 180ml leftover liquor was recovered from their car, police said. Various sections of Maharashtra Prohibition Act have been invoked against them. Their blood samples have been collected and sent for testing to Regional Forensic Science Laboratory in Nagpur. Sources said the incident occurred on Thursday. The child’s family and friends were furious on finding the doctors drunk. The family alerted Wardha police control room. A mob gathered at the hospital by the time police reached there, sources said, adding the offence was registered on Thursday night. A video of the incident also went viral on social media. Probationary IPS officer Rahul Chavan, holding charge as Pulgaon SDPO, said while offence has been registered, the state health department would be informed. Deputy director of health services Dr Kanchan Wanere said an inquiry has been initiated under assistant director of medical services Dr Pramod Gavai. “We are waiting for the report to initiate further action,” she said. Pulgaon rural hospital functions without doctors most of the times, said social worker Ankush Koche, who was approached by the aggrieved family. “When the family brought the child suffering from fever to the hospital, the nurse there refused to administer medicine citing absence of doctors,” he said. Seeing no option, he called up district civil surgeon Dr Sachin Tadas, who sent Dr Dhamane and Dr Raut to the hospital. Dr Tadas neither responded to TOI calls nor replied to text messages. Dr Gavai, who visited the hospital on Sunday, said he will inquire into allegations. “Let police find out whether the two were under the influence of alcohol,” he said. Source: Healthworld

Mar 26,2024 PUNE: Two patients, including a senior citizen, undergoing treatment on beds next to each other at Aundh Civil Hospital were transfused with the wrong blood group, in a major mix-up on Saturday, landing both the patients in ICU. Doctors said the patients did not show any major reaction and were under observation. The patients, one suffering from anaemia (70+) and another (54) admitted with swelling in the stomach and limbs, were advised blood transfusion. While one has B+ blood group, another is A+, the hospital said. Confirming the goof-up, civil surgeon at Aundh Civil Hospital Dr Nagnath Yempalle said, “The blood transfusion was stopped immediately after the patient aged above 70 complained of uneasiness. Preliminary report stated that the patient was recommended blood transfusion to boost immunity and increase haemoglobin count. The treating doctor checked both the patients thoroughly and mentioned their blood groups too before the transfusion. It has been brought to my notice that the nurse attending to the patients mistakenly switched the blood pouches at the time of transfusion.” The civil surgeon said the mix-up, however, did not lead to any major ‘reaction’ in the two patients. “But we do accept that this is a major mistake. We have launched an enquiry into the issue and sent the nurse responsible on a forced leave. A three-member committee has been formed to look into the incident, findings of which will be submitted to the deputy director of health for further action.” When contacted, deputy director of health services, Pune region, Dr Radhakishan Pawar said, “Strict action will be taken against those found guilty after the report is received from the hospital panel,” Dr Pawar said. The relatives of the two patients alleged that the nurse was busy on her phone during the blood transfusion. Son of the 54-year-old patient told TOI, “My dad was admitted to the hospital on Thursday for swelling in the stomach and limbs. We were told on Saturday that he would be discharged from the hospital the next day. However, while the blood transfusion was underway, the relative of the patient (70+) occupying bed next to my father’s happened to notice wrong name on the blood pouch and raised an alarm. My father and the other patient were then immediately shifted to the ICU.” He said the doctors told him that his father was stable and the other patient was passing blood in the urine. “The nurse was busy on her phone during the transfusion, resulting in the swapping of the blood pouches. My father will be under observation for 72 hours for any signs of reaction. So, it will be only by Tuesday evening that we will know the exact health status,” the son said. According to experts, if the recipient’s body is transfused with the wrong blood type reaction can occur in the recipient about 24 hours after receiving the blood or may occur during blood transfusion. Dr Ameet Dravid, infectious disease specialist at Noble Hospital, said, “The blood is grouped into A, B, O and AB types, which are either either RH negative or positive. While O+ is a universal donor, AB+ is a universal recipient irrespective of the RH type.” He said if an A+ person is given a B+ blood group, it can lead to haemolysis, a process wherein the body’s immune system begins to attack the red blood cells perceiving them as ‘foreign objects’. “This can further result in reactions as serious as kidney shutdown or liver shutdown or even death. The consequences can be serious, especially when the patient is already weak. In such a case, the first thing to do is to stop the transfusion immediately and shift the patient to the ICU. The patient can then be provided with steroids to calm down the immune system,” Dr Dravid said. On Saturday, MLA Ashwini Jagtap also visited the hospital and enquired about the health of the patients. She directed the administration to take strictest action against those found guilty. Source: Healthworld

Mar 24,2024 The 7th CII AYUSH Conclave, organised by the Confederation of Indian Industry was held on Friday on the theme “Emerging trends in AYUSH: Unleashing the market potential” at India Habitat Centre, New Delhi. The conclave has brought together opinion and thought leaders from AYUSH industry, Academicians, Practitioners, Central and State Government Stakeholders, Innovators/start-ups, Medical and Healthcare professionals of Ayurveda, Yoga, Unani, Siddha and Homoeopathy. The conclave highlighted measures for positioning AYUSH products in global marketplace, demand generation and future scope. It also witnessed discussions on the role of AYUSH in achieving universal health coverage, the entrepreneurship ecosystem of the sector and modern-day perspective on AYUSH. Padmashri Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH draw attention of the stakeholders towards how AYUSH sector has achieved a value of 24 billion in 10 years. Dr. Batra’s, Global Homoeopathic Federation (GHF) and The Homoeopathic Medical Association of India (HMAI) represented Homoeopathy in the Conclave by Dr.Tushar Mittal, Dr.Sreevals Menon, Dr.Praveen , Dr. Shivang Shrinivasan Mr. S.B.Dangayach and Dr.A.K.Gupta Secretary General HMAI respectively. Dr. Kanwal Sethi, Dr.Poonam Chablani, Dr.Nilanjana Basu and Dr.Rajender Singh were also present . Dr. Tushar Mittal , Mr. Dangayach and Dr.Sreevals were among the Panelists and share their views.Dr.A.K.Gupta, Dr. Shivang and Dr.Nilanjana too actively participated by putting questions and suggestions.Recommendations and a detail work on impact of UHC was sent and also sRecommendations from Homeopathy to CII Need of equal opportunities for public in a renewed Insurance ecosystem by inclusion of centuries old pluralistic healthcare heritage, and not leaving at odds on Homeopathy as second largest international healthcare option. Insurance sector to recognize choice of Homeopathy as a safe & economic healthcare solution used either in complementary mode of treatment used with standard medical practices or as Integrative or alternative treatment in place of conventional medicine. Deep, uniform presence and ever growing statistics of Homeopathy in public healthcare systems in many states and in central government healthcare facilities apart from collegiate and research facilities proves the growing demand. Coverage for Homeopathy can help access to much more beneficiaries in terms of insurance coverage. Adoption of digital technology promote more standardized treatment methods in Homoeopathy sector as seen making insurance engagement easier. Integration of Homeopathy to AYUSHMAN BHARAT DIGITAL MISSION shall streamline beneficiary data and data transfer across different treatment modalities and sectors enabling care, choice’s and coverages easier and free flowing. Homeopathy strength in Autoimmune Disorders, Pediatrics, Antenatal care, NCDs, Behavioural Disorders etc. shall make its insurance engagement open up more choice’s, satisfaction and appreciation. A decade and half long engagement of Homeopathy Hospital based care in quality accreditation/NABH-Ayush domain as a regulatable entity exercised across a fair fraction of collegiate hospitals effectively adds to enhanced accountability in insurance adaptation. Entry level accreditation of clinic’s launched as well. OPD Care predominance in Homeopathy, Drug Safety, Alternative & Complementary engagement possibility with conventional medicine, detoxification possibilities and capability to have Integrable models with Homeopathy in end of life care, all can extend safe choices making Healthcare & Insurance more complete. Progressive evidence of possibilities of Homeopathy in AMR, extensive solutions in viral diseases, in vitro studies establishing Homeopathy effective in M.D.R.T.B cases can all add value from Homeopathy systematic inclusion in the standard insurance palette.Mr. Dangayach advocated for the Homoeopathic Nosodes to be tried extensively and can be used akin to Vaccination . Source: Sarkaritel

Mar 23,2024 The International Diabetes Federation (IDF) based at Belgium is a federation of around 200 diabetes associations based in countries around the world. The IDF has released a Position Statement that presents the 1-hour post-load plasma glucose (1-h PG) test as a more sensitive and practical method to screen for intermediate hyperglycaemia (IH), (earlier known as Pre-Diabetes) and type 2 diabetes(T2D) in people at risk. The Statement was prepared by an international panel of 22 experts from 15 countries and presented recently at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy and was published online in the journal of Diabetes Research and Clinical Practice. Dr V. Mohan, Chairman, Madras Diabetes Research Foundation and Dr Mohan;s Diabetes Specialities Centre represented India on this panel. The Statement recommends the use of 1-h PG with the validated cut points of 155 mg/dL (8.6 mmol/L) for diagnosing IH and 209 mg/dL(11.6 mmol/L) for diagnosing T2D. IH, earlier referred to as “prediabetes,” is a state between normal glucose regulation (NGR) and T2D. It includes two types of IH or prediabetes namelyImpaired fasting glycaemia (IFG) and impaired glucose tolerance (IGT). Many individuals with IH as defined by current diagnostic criteria, will progress to T2D. Evidence shows that T2D can be prevented by lifestyle modification and/or medications in people with IGT diagnosed by 2-h PG during a 75-gram oral glucose tolerance test (OGTT). Given the continued rising prevalence of diabetes worldwide, a more sensitive and practical method is therefore needed to detect people with IH and T2D for early diagnosis and intervention. A wealth of epidemiological data has confirmed the superior value of 1-h PG over fasting PG (FPG), glycated haemoglobin (HbA 1c) and 2-h PG in populations of different ethnicity, sex and age. The IDF Position Statement reviews findings that the 1-h post-load PG> 155 mg/dL (8.6 mmol/L) in those with a normal FPG and 2hr PG during an OGTT which would have been labelled as ‘normal’ earlier is highly predictive for detecting people at risk of progression to T2D, micro- and macrovascular complications, obstructive sleep apnoea, cystic fibrosis-related diabetes, metabolic dysfunction-associated steatotic liver disease, and premature death. Importantly, by using the 1-h PG cut points of .155 mg/dL(8.6 mmol/L) for diagnosing IH and 209 mg/dL (11.6 mmol/L) for diagnosing T2D, people at risk can be detected earlier than with the currently recommended glycaemic thresholds. Therefore, the IDF Position Statement recommends the adoption of 1-h PG with the aforementioned cut points during routine OGTT measurements at all laboratories. Presenting the Position Statement at ATTD, Professor Michael Bergman, who co-chaired the Expert Panel with Professor Jaakko Tuomilehto, said that there are many people who would not be diagnosed through an HbA1c or FPG test but who would, if given an OGTT, be more likely to be detected as having IH or T2D. The 1-h PG has been found to be a more sensitive biomarker for the earlier identification of these high-risk individuals he added. The IDF Position Statement proposes the following pathway for detecting IH (Pre-diabetes) and T2D. People determined to be at high-risk for T2D through a validated screening tool (e.g. Indian Diabetes Risk Score (IDRS)Finnish FINDRISC, ADA risk score) should undergo a 75-gram 1-h OGTT after an overnight fast. People with a1-hPG value at or above 155 mg/dL(8.6mmol/L) are considered to have IH and should be prescribed lifestyle intervention and referred to a diabetes prevention programme. People with a1-hPG value at or above 209 mg/dL (11.6 mmol/L) are considered to have T2D. They should have a repeat test to confirm the diagnosis and then be referred for further evaluation and treatment of their diabetes. Years ago, the original OGTT test was a 5 sample test and comprised of fasting, 30, 60, 90 and 120 mins. Later, this was modified to just fasting and 2 hr sample. However, we have always advocated the continuation of the 1 hr test during the OGTT, as a raised 1 hr value in those with normal fasting and 2 hr glucose values is predictive of future diabetes. Our own published follow up studies have clearly shown this and I am very happy that all our Indian data was included in this IDF Position Statement. My recommendation to all labs and Diabetes and Endocrine centres in India is to include the 1 hr value along with the fasting and 2 hr value when doing an OGTT as it will identify an earlier stage, in the natural history of diabetes at which stage reversal or remission of diabetes is much easier. The expert IDF panel was co-chaired by Professor Michael Bergman, Professor of Medicine and Population Health at New York University Grossman School of Medicine, New York City and Professor Jaakko Tuomilehto, Professor Emeritus of Public Health, University of Helsinki, Finland, and Visiting Scientist, Finnish Institute for Health and Welfare, Helsinki, Finland. Leadership and support for this initiative was provided by Professor Akhtar Hussain, President of the International Diabetes Federation, Professor (Diabetes & Metabolic Disorder) NORD University, Boda, Norway and Professor Antonio Ceriello IRCCS MultiMedica, Milan, Italy. Source: Healthworld