April 2024

Apr 05,2024 New Delhi: Pune-based Serum Institute of India (SII) is ready to ramp up capacity of injectable poliomyelitis vaccine (IPV) to fill up the vacuum caused by France’s Sanofi’s shuttering of manufacturing plants in India. In an interview to Vikas Dandekar and Teena Thacker, SII CEO Adar Poonawalla said the company gives half of the total 20 million doses of IPV to the government’s immunisation programme. With SII currently being the sole supplier for IPV, he said it will take 3-4 months notice to provide additional doses of the vaccine. Edited excerpts: Sanofi has already closed its manufacturing sites in India. Have you got any heads up from the government yet to fill in the gap? Typically, for these vaccines they have a tendering process. When the next tendering process starts, we will certainly supply and we have done this in the past when other manufacturers have stopped supplies or shut down facilities. We can supply any quantities of the vaccine that they may be in shortage of. We have ample supply coming from Dutch facility-Bilthoven Biologicals (BBio) where we import the bulk and we fill it in India. Yes, this is absolutely right and I agree with Sanofi that it is not viable because the price is so low. It just doesn’t make sense for most companies to make vaccines and supply at the current prices.SII has chosen to do it only as a service to the nation and this is very important to note. If we were only looking at it commercially, we would have stopped making this product a long time back. This is very important and we’re selling it at cost. In fact, at the moment, we are selling IPV below our cost. If there was another alternative, I would happily not make it. We’ve been supplying around 50 per cent and Sanofi has been doing around 50 per cent. And now with them shutting down, we will pretty much be the only supplier for injectable polio vaccine till some other Indian companies also make it after a few years. In light of that, and with this in mind, we have made sure that we have enough stock for the Indian population as and when the health ministry floats new tenders or asks us for any extra vaccine, we can give it with 3 months’ notice. Sanofi is under the obligation and commitment to fulfil their orders. They have made a statement that they will fulfil their commitments and if they can’t, then we are always there to support the health ministry and give them additional vaccines. But the ministry has to tell us. It’s not fair for me to say what they should do. Or what Sanofi should do. So let’s wait for a few months and see. But the main thing I wanted to clarify is that there is no shortage for the country of this vaccine because Serum can make it and it’s available. It will take at least 3-4 months from the time I receive a phone call or a written order. We have been making this product for the last 10 years since we acquired the company in the Netherlands. India started procuring IPV only a few years ago. Since then, we have been the 50 per cent supplier, and the quantity is not very large. Around 20-25 million doses a year is what the government takes. So we were supplying 10 -12 million doses, and now our production is much higher, so if the government needs 20-25 million doses from us, we can easily give it. Source: Healthworld

Apr 04,2024 Chennai : Apollo Hospitals unveiled the fourth edition of its flagship annual report, “Health of Nation”. The report deep dives into the prevalence and growth of Non-Communicable Diseases (NCDs) in India, and highlights the importance of preventive health measures. The report highlighted the concerning rise of NCDs in India, including cancer, diabetes, hypertension, cardiovascular diseases, and mental health issues, all of which significantly impact the nation’s overall health. Particularly the escalating incidence of cancer in India compared to global rates, making India the “cancer capital of the world”. The report further predicts a potential surge in healthcare burdens due to conditions such as pre-diabetes, prehypertension, and mental health disorders manifesting at increasingly younger ages. Highlighting the importance of regular health screenings, the report underscores their role in reducing Blood Pressure (BP) and body mass index (BMI) levels, thereby lowering the risk of cardiac-related ailments. Apollo’s data further finds that while there continues to be a need to increase the penetration of health checks in India, people are increasingly choosing more comprehensive health checks today than before, a positive step towards safeguarding one’s health and wellness. Indicating that the report demonstrated a significant need for immediate interventions to fight, prevent and reverse the growing epidemic of cancer, diabetes, hypertension and obesity among others, Dr Preetha Reddy, Vice Chairperson, Apollo Hospitals, said, “The importance of health in our nation’s development cannot be overstated. With our Health of Nation report, we hope to draw attention and awareness to the ever-increasing burden of non-communicable diseases and strongly believe that the entire healthcare ecosystem and the nation needs to come together and have a unified outlook so that we can combat NCDs in the truest sense. The need to educate the public and create individualised preventive healthcare solutions has never been greater. By prioritizing investments in health infrastructure, promoting preventive healthcare measures, and addressing health inequities, we will be able to unlock the full potential of our nation and pave the way for inclusive and sustainable development.” Sharing the deep insights of the report, Dr Madhu Sasidhar , President and CEO, Apollo Hospitals, said, “The significant rise of NCDs, especially over the past few decades, represents a profound shift in the global health landscape, posing formidable challenges to individuals, communities, and nations. Innovation in preventive healthcare and boosting accessibility must become a priority for the entire healthcare industry. At Apollo Hospitals, we are actively integrating technology to break healthcare delivery barriers to offer highly personalized and effective services. From our AI-backed preventive healthcare program to a vast screening footprint, we are committed to leveraging the power of technology to improve disease prevention, increase the accuracy of diagnoses, and create world-class patient-centric treatment methodologies that shape the future of healthcare. As we navigate the complex challenges of the 21st century, let us recognize that health remains our most valuable asset and a healthy population serves as the bedrock of a prosperous and resilient society.” In an effort to empower Indians with an accurate and unbiased understanding of their health, Apollo has launched a digital health risk assessment called ‘ProHealth Score ’. This free risk score evaluates factors such as family history, lifestyle, and current symptoms, it generates a personalized numeric indicator of your health status. Additionally, it provides simple corrective measures to guide you toward better health. Elucidating about how ProHealth risk score, which aims to raise awareness about the contributing factors to this health crisis and advocate for proactive measures to address the growing impact of NCDs on the population, Dr Sathya Sriram, Chief Executive Officer, Apollo Preventive Health, said, “The tool is designed to assist people in making informed decisions. A QR code which can be scanned will have a questionnaire on family history, lifestyle generates a personalized numeric indicator of your health status helps to understand their current health status and enables them to make informed lifestyle shifts.” Source: Healthworld

Mar 29,2024 New Delhi: Researchers from the Indian Institute of Technology- Guwahati in collaboration with the University of Animal and Fishery Sciences, Kolkata have formulated three ingenious treatment solutions for a certain type of knee injury that has historically proven difficult to treat. By developing these key regenerative therapies, the researchers have provided possible alternative solutions to manage the problem of a knee meniscus tear , an injury to tissue in one’s knee joints. Trauma to the knee meniscus, a cushioning tissue in the knee joint, is a commonly occurring yet complex problem. It can be caused during day-to-day activities by sudden accidents, mishaps while playing sports, or simply aging. A tear in this crucial tissue can make it difficult for an individual to walk, run or participate in daily activities. However, these new developments signal a significant advancement in treating knee injuries, providing a solution that is custom-made for each patient and could also potentially prevent future complications such as osteoarthritis. The three different approaches have been published in three manuscripts across two International journals, Applied Materials Today and Advanced Biology, co-authored by Prof. Biman B. Mandal, Department of Biosciences and Bioengineering, along with his research scholars, Ashutosh Bandyopadhyay, Baishali Ghibhela, and Sayanti Shome, from IIT Guwahati, and collaborators Dr Debajyoti Pal, Dr Samsamul Hoque and Prof. Samit K. Nandi from the University of Animal and Fishery Sciences, Kolkata. Speaking about the research, Prof. Biman B. Mandal, Department of Biosciences and Bioengineering, IIT Guwahati, said, “We have developed regenerative treatment approaches that would be tailored for the patient and help in rapid healing meniscus tears or replacing parts of the damaged tissue. Our problem statement also accounts for the shape and size variability of the meniscus in patients of different age groups and is a source of growth factors for better healing.” Healing the knee meniscus naturally is a slow and difficult process because of its restricted blood supply. Surgically removing the injured tissue may cause joint discomfort and osteoarthritis in the long run. This causes movement constraints, pain, and livelihood issues for millions in India and across the globe. The team from IIT Guwahati has created three hydrogel formulations that are blends of silk fibroin and other polymers, which they envision can be used by doctors in clinics, to treat the meniscus injury. These components, especially silk, are well known for their strength, bioactivity and flexibility. They are also cost-effective compared to other materials such as commercially available polyurethane and collagen meniscus implants. Out of the three, one is an injectable hydrogel, which can be injected in a minimally invasive manner directly into the meniscus site to expedite the healing of smaller injuries. When it comes to treating larger full thickness complex meniscus tissue injuries, the researchers have additionally created two 3D bio-printable inks that can be 3D printed into implants. Source: Healthworld

Mar 29,2024 Mumbai: Incinerators and treatment units at Maharashtra’s around thirty common bio-medical waste treatment facilities (CBWTF) spread across the state are contributing to the pollution, due to carelessness on the part of hospitals in segregating medical waste eventually harming the environment and the health of the people living around them, a latest audit has revealed. The latest Maharashtra Pollution Control Board (MPCB) survey, with the help of IIT Mumbai, has found that several health care facilities (HCF) or hospitals are not following proper bio-waste segregation rules while collecting Biomedical waste a result of their treatment and incineration eventually pose serious health risks to citizens. “There is a specific method for each category of biowaste for its disposal or incineration at the CBWTFs. In the absence of segregation, the treatment process for disposal goes wrong eventually leading to polluted air or landfill. The board has therefore issued a warning saying that regular inspections will follow and bank guarantees will be forefitted as a penalty if any health facilities are found breaching segregation rules,” said MPCB sources. The survey was conducted at common bio-medical waste treatment facilities (CBWTF) such as Deonar, Taloja, Nashik, Chandrapur, Pimpri Chinchwad, Talegaon, Satara, Baramati, Pune, Solapur, Kudal, Lote, Kolhapur, Sangli, Ichalkaranji, Dhule, Nandurbar, Jalgaon, Ahmednagar, Palghar, Kalyan, Jalna, Latur and Sambhaji Nagar. In the audit by the IIT Mumbai, the CBWTF authorities cited the fact that HCFs such as Hospitals, Nursing Homes, and Clinics, were not adhering to the Bio-Medical Waste Management Rules of 2016. A major concern highlighted by the audit is the acceptance of non-segregated biomedical waste by CBWTFs, which poses serious risks to public health and environmental safety, an MPCB release stated. “It is mandatory for HCFs to register with an MPCB’s authorized CBWTF operating in the vicinity. Also, it is mandatory to segregate the Biomedical waste at source as per the category mentioned in schedule I of Bio medical waste management rules 2016. HCFs shall hand over the segregated waste through barcoding bags for efficient tracking and management. The MPCB has given strict instructions to all HCFs to follow the rule as per the guidelines from 1st April 2024. Non-compliance with the prescribed rules and guidelines will result in immediate legal action against the HCFs. This collective effort is crucial to safeguarding public health and preserving our environment for future generations,” the MPCB letter to HCFs stated. Source: Healthworld

Mar 29,2024 New Delhi: Prices of essential medicines, including painkillers, antibiotics and anti-infectives, are set to see a minuscule increase from April 1. Drug pricing regulator announced an annual change of 0.0055% increase in prices of drugs under the National List of Essential Medicines (NLEM), in line with the annual change in the wholesale price index. “Based on the WPI data provided by the office of the Economic Advisor, Department of Industry and Internal trade Ministry of Commerce and Industry, the annual change in WPI works out as (+) 0.00551% during the calendar year 2023 over the corresponding period in 2022,” said the notice by the National Pharmaceutical Pricing Authority (NPPA). An industry insider said this is hardly anything to cheer the pharma industry, especially after two massive hikes of 12% and 10% in prices last year and 2022. However, an executive associated with an NGO said that this will be a good move in the interest of maintaining the affordability of these drugs. Source: Pharma

Apr 10,2024 Mumbai: On the eve of World Parkinson’s Day, Jaslok Hospital and Research Centre unveiled findings from a comprehensive clinical trial aimed at slowing the progression of Parkinson’s disease. Led by principal investigator Prof (Dr) Paresh Doshi, Director of Neurosurgery and Stereotactic and Functional Neurosurgical programme at Jaslok Hospital and Research Centre. The trial marks a significant milestone in Parkinson’s care, potentially revolutionising management approaches and enhancing the quality of life for patients and caregivers worldwide. Parkinson’s Disease (PD) affects over 10 million people globally, with a particularly high prevalence in Asia, notably in India. The disease significantly impairs motor functions and quality of life due to the degeneration of dopaminergic neurons. Current treatments focus primarily on symptom management, leaving a critical gap in altering the disease’s progression. This trial explores the potential of transformative approaches such as dance and music therapy, along with mindfulness meditation, in managing PD symptoms and improving overall well-being. The study, conducted at Jaslok Hospital and Research Centre, engaged 28 individuals diagnosed with mild to moderate PD over six months. After obtaining informed consent from the patient, patients were randomly assigned by a computer-generated algorithm either to a therapy or a control group. The group chosen for therapy was offered either dance or music as their preferred form of therapy. The philosophy is that people who love music may not like dance, and people who like to dance may prefer dance over music. Both groups of therapy were also given guided meditation by an expert trainer in the field of meditation. Several Parkinson’s disease-related scorings were performed to evaluate the motor function, behaviour, mood, and cognitive functions of these patients before the trial and on the completion of the trial. The control group was also evaluated in the same manner. Both groups continued their usual medical management. A patient diary was maintained to ensure adequate compliance, and patients who could not follow the required schedule were excluded from the trial. The assessments were made on two main areas of primary results. The first was the quality of life (measured by the Parkinson’s Disease Questionnaire-PDQ39), and the second was the gold standard used to determine the impact of any treatment on the progression of Parkinson’s disease (Unified Parkinson’s Disease Rating Scale-UPDRS), including two other data points to evaluate the impact of this treatment on the caregivers: PDQ-Carer Change and Zarit Burden Interview Change. All four endpoints showed significant improvement, which was statistically significant, as seen in the below graph. The results confirm that any therapy that the patient prefers, ie dance or music; along with meditation, has a definitive impact on the progress of Parkinson’s disease and also on the quality of life of the patient. This also translates into better well-being and an improved quality of life for the caretakers. Notably, the benefits observed in this trial extend beyond the intervention period, indicating the potential for long-lasting effects. The results underscore the importance of exploring alternative therapies for managing PD comprehensively. Future directions include longer-term studies and investigations into diverse populations. Besides the above results, there was improvement in other areas like mood (Beck depression scale), memory function (MMSE), balance (TUG and Berg balance test), and anxiety (Anxiety scale). Commenting on this Prof (Dr) Doshi said, “These results mark a significant leap forward in Parkinson’s care. Our trial demonstrates the potential of alternative therapies in not just managing symptoms, but in potentially slowing the progression of this debilitating disease. Through innovative approaches like dance and music therapy, we are paving the way for a brighter future for Parkinson’s patients and caregivers worldwide.” Dr Doshi also highlighted that this is the first trial to have a blinded randomised evaluation of patients undergoing treatment and not undergoing therapy ever presented or studied in the world. This is the first-ever trial in the world that has evaluated not only Parkinson’s disease but also the caregivers’ burden in the management of Parkinson’s disease through dance and music therapy. Laying a lot of emphasis on the quality of life, which was one of the principal trial endpoints which again has been very rarely evaluated for this form of treatment. The level of detailed evaluation of motor disability, mood, behaviour, and cognition has always been performed in surgical interventional trials or medical interventional trials but never in any trials where no intervention accept therapy like dance and music were offered. “By harnessing the power of alternative therapies, we are not just treating Parkinson’s disease, but transforming lives,” said Dr Milind Khadke, Director Medical Services, Jaslok Hospital. Source: Healthworld

Apr 12,2024 The Supreme Court has issued strong remarks against the Uttarakhand authorities for their failure to take action against Patanjali Ayurved, founded by Yoga guru Ramdev and Balkrishna. The court’s comments came as it rejected apologies from the duo, with Justice Hima Kohli and Justice A Amanullah stating that they will pass an order on April 16. “What about all the faceless people who have consumed these Patanjali medicines stated to cure diseases which cannot be cured?” the court questioned, highlighting the seriousness of the issue. The Beginning: Coronil’s Launch In February 2021, Ramdev launched Coronil, just before the Delta wave of Covid wave struck. Coronil was touted as the “first evidence-based medicine for COVID-19”. The launch, attended by then Union Health Minister Harsh Vardhan, claimed WHO’s Good Manufacturing Practices recognition, a statement later clarified by WHO as false. Initially the event poster claimed that Coronil was a pharmaceutical product which was also recognised by the WHO’s Good Manufacturing Practices. Later, however, WHO clarified that it had not reviewed or certified any traditional medicine to treat or prevent COVID-19. The Indian Medical Association stated that it was shocked by the ‘blatant lie’ of WHO certification for the reportedly ‘secret medicine’ which was launched in the presence of the Health Minister, Harsh Vardhan. The country “needs an explanation” from the minister, it said. Months later, a video of Ramdev went viral, in which he was heard saying that allopathy was a “stupid and bankrupt science” that is “responsible for the deaths of lakhs of people”. He claimed that no modern medicine was curing Covid. In response, the IMA sent a legal notice to Ramdev, seeking an apology and withdrawal of statements. It appealed to then Health Minister Dr. Harsh Vardhan to take action against the Yoga guru under the Epidemic Diseases Act. Patanjali Yogpeeth responded by stating that Ramdev was only reading out from a forwarded WhatsApp message and has no ill-will against modern science. According to a BBC report, in December 2020, Patanjali urged state authorities to change Coronil’s license from an “immunity booster” to one for “medicine for Covid-19”. The following month, the company claimed that the product had received approval as a “supporting measure” against Covid-19. The AYUSH Ministry and Uttarakhand state authorities confirmed to the BBC that a new license had been issued, but emphasized that Coronil was “not a cure” for Covid-19. Dr. YS Rawat, then director of Uttarakhand traditional medicine department and state licensing authority , explained that the upgraded license meant Coronil could be sold like zinc, vitamin C, multi-vitamins, or any other supplemental medicines, but it was not a cure. In its reply to the Supreme Court, the Centre stated that Patanjali had been instructed not to publish misleading advertisements until the Ayush Ministry had reviewed the matter. It further stated that after a detailed interdisciplinary process, the State Licensing Authority was informed that the Coronil tablet “may only be considered as a supporting measure in Covid-19”. The Centre also mentioned that it had taken proactive steps regarding false claims related to Covid cure. In August 2022, the Indian Medical Association (IMA) filed a petition against Patanjali after it published an advertisement in newspapers titled ‘Misconceptions Spread By Allopathy: Save Yourself And The Country From The Misconceptions Spread By Pharma And Medical Industry’. The ad claimed that Patanjali drugs had cured people of diabetes, high blood pressure, thyroid, liver cirrhosis, arthritis, and asthma. The IMA highlighted the “continuous, systematic, and unabated spread of misinformation” by Patanjali, along with Ramdev’s earlier remarks on modern medicine. The doctors’ body criticized Patanjali’s efforts to make false and unfounded claims about curing certain diseases through the use of Patanjali products. The Drugs and Other Magical Remedies Act, which regulates magic pill claims, stipulates a jail term and fine for misleading advertisements. On November 21, 2023, the Supreme Court warned Patanjali against claims that its products can completely cure ailments such as diabetes and high blood pressure, threatening heavy fines. Patanjali’s counsel assured the court that there would be no further violations of laws, especially regarding advertisement and branding of products. He also assured that “no casual statements of claiming medicinal efficacy of any system of medicine will be released to the media in any form”. On January 15 of this year, the Supreme Court received an anonymous letter addressed to Chief Justice of India DY Chandrachud with copies marked to Justice Kohli and Amanullah. The letter highlighted misleading advertisements being continued by Patanjali. The IMA’s counsel, Senior Advocate PS Patwalia, also presented newspaper advertisements after the November 21, 2023 warning and transcripts of a press conference by Ramdev and Balkrishna following the court’s hearing. Source: Healthworld

Apr 12,2024 New Delhi: The US health regulator has pulled up Kilitch Healthcare India for manufacturing lapses, including packing drugs in insanitary conditions at its Maharashtra-based plant. In a warning letter to the company’s Managing Director Paresh Mehta, the US Food and Drug Administration (USFDA) pointed out various lapses at the Navi-Mumbai plant, which produces finished pharmaceuticals. The warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, the US health regulator said. “Because your drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health,” it stated. “FDA investigators observed your facility to be in a state of disrepair, poorly cleaned and maintained.” A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. It usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for its plans for correction. The regulator then checks to ensure that the company’s corrections are adequate. The USFDA inspected Kilitch Healthcare’s Navi-Mumbai-based plant on October 12-20, 2023. Elaborating on the CGMP violations at the facility, the USFDA stated that the company failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilisation processes. “Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards,” it added. The USFDA also said the plant administration to collect the required amount of environmental and personnel monitoring samples required to support the manufacture of sterile drug products. “Your environmental monitoring (EM) program is deficient,” it added. The regulator also asked the company to have a comprehensive investigation into the extent of the inaccuracies in data records and reporting. “We acknowledge your commitment to suspend production of all drugs for the US market. In response to this letter, clarify whether you intend to resume manufacturing drugs for the US market at this facility in the future,” the USFDA said. Source: Pharma

Apr 12,2024 New Delhi: Prime Minister Narendra Modi led a meeting on Thursday to assess the nation’s readiness for potential heatwave conditions in the upcoming summer months. The meeting focused on coordinated efforts among central, state, and district-level government bodies. During the meeting, attendees discussed the forecast of above-normal maximum temperatures across most regions of the country from April to June, particularly focusing on central western peninsular India. The discussion encompassed various aspects of preparedness in the health sector, including the availability of essential medical supplies such as medicines, intravenous fluids, ice packs, Oral Rehydration Solution (ORS), and drinking water. Additionally, there was an emphasis on the timely dissemination of essential information, education, and communication (IEC) materials in regional languages through television, radio and social media platforms. Given the anticipation of a hotter-than-normal summer in 2024, coinciding with the general elections, it was proposed to translate advisories issued by the health ministry and the National Disaster Management Authority (NDMA) into regional languages for wider dissemination. PM Modi underscored the importance of a comprehensive government approach, urging all levels of government and ministries to collaborate effectively. He highlighted the necessity for raising awareness and ensuring preparedness in hospitals, with specific attention to early detection and containment of forest fires. The meeting was attended by senior officials including the principal secretary to the prime minister, the home secretary, representatives from the Indian Meteorological Department (IMD), and the National Disaster Management Authority. As India braces for extreme heat during the April to June period, with central and western peninsular regions expected to be most affected, preparations are underway amidst the backdrop of the forthcoming seven-phase general elections commencing on April 19. Source: Healthworld

Apr 12,2024 New Delhi: Next time you pop a nimesulide, a commonly used painkiller, be watchful. Pharma standards body Indian-Pharmacopoeia-Commission (IPC) has issued a drug safety alert over nimesulide, saying the pill can trigger rashes on the skin (fixed drug eruption). It asked consumers and healthcare professionals to closely monitor the use of the drug and report any adverse reaction to the National Coordination Centre-Pharmacovigilance Programme of India of the IPC. According to the IPC, the drug is used in inflammatory conditions including joint disorders like rheumatoid arthritis, post-traumatic and post-operative painful conditions and fever, as well as in acute pain in orthopaedic, ENT and dental conditions. Sandeep Budhiraja, group medical director at Max Healthcare, said a fixed drug eruption is a drug rash on the skin and it happens only in specific locations on the body. The only treatment for this, he says, is that “you have to remove the culprit drug”. The adverse reaction is not contagious. “Companies manufacturing nimesulide may be asked to insert warnings in their package insert so that patients and doctors know about the adverse event,” a government official said on the condition of anonymity. A safety alert has also been issued over cefuroxime, an antibiotic drug used for lower and upper respiratory tract infection, gynaecological infection and skin or soft tissue infection. A safety alert has also been issued for dutasteride+tamsulosin. The drug can trigger palpitation, the IPC said. The IPC has warned that beta blockers (metoprolol, propranolol and atenolol) used for various cardiac events can trigger temporary erectile dysfunction. Source: Healthworld