PSM News

Apr 21,2024 With a view to widen the market and foster adequate protection from healthcare expenses, insurance regulator IRDAI has removed the age limit of 65 years for individuals buying health insurance policies. This marks a significant departure from the conventional constraints that limited individuals in securing comprehensive coverage. By abolishing the maximum age restriction on purchasing health insurance plans, the Insurance Regulatory and Development Authority of India (IRDAI) aims to foster a more inclusive and accessible healthcare ecosystem, ensuring adequate protection against unforeseen medical expenses. As per the earlier guidelines, individuals were allowed to purchase a new insurance policy only till the age of 65. However, with the recent amendment, which has been effective from April 1, anyone, regardless of age, is eligible to buy a new health insurance policy. In a recent gazette notification, IRDAI said, “insurers shall ensure that they offer health insurance products to cater to all age groups. Insurers may design products specifically for senior citizens, students, children, maternity, and any other group as specified by the Competent Authority.” Besides, insurers have been mandated to offer health policies to individuals with pre-existing medical conditions of any kind. Consequently, insurers are prohibited from refusing to issue policies to individuals with severe medical conditions like cancer, heart or renal failure, and AIDS. According to the notification, insurers are allowed to offer premium payment in instalments for the convenience of policyholders. Travel policies can only be offered by general and health insurers, it said. There is no limit on AYUSH treatment coverage. Treatments under systems like Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy will receive coverage up to the sum insured without any cap, it said. Policyholders with benefit-based policies can file multiple claims with various insurers, enhancing flexibility and options, it said. The proposed regulation seeks to handle the complaints and claims of senior citizens via a specialised channel, ensuring a more tailored and responsive approach to their requirements, it added. Source: Business Standard

Apr 21,2024 Vaccines mark one of the most significant milestones in public health, having prevented morbidity and mortality for millions yearly. Traditionally, vaccine technology has focussed on live attenuated or inactivated, but nanotechnology has revolutionised the development in this field. In this, lipid nanoparticle (LNP) technology has emerged as highly promising. Progress in medical science has facilitated the seamless integration of lipid nanotechnology into standard therapy, including developing several vaccines, which have yielded notable outcomes. The recent COVID-19 vaccines based on mRNA-contained LNPs have propelled this ground-breaking technology from being seen as speculative research to transformative in genetic medicines and vaccines. The inception of lipid nanotechnology dates back to 1965, when liposomes were first discovered. These closed lipid bilayer vesicles self-assemble in water, forming fatty capsules. Their potential for drug delivery was immediately recognised due to their ability to encapsulate small-molecule drugs and enhance their aqueous solubilities—a critical advantage since over 40% of these agents have low solubility in water. From this initial discovery, the technology has evolved, with continuous tweaks and refinements optimising the functionality of lipid nanoparticles, leading to the creation of highly versatile drug delivery platforms and liposomal drugs. In general, nanomedicine involves applying nanoparticles and the utilisation of lipids from natural or synthetic sources in disease diagnosis, monitoring, control, and treatment. A significant advantage of this technology is the ability to customise lipid-based nanoparticles to surpass the constraints imposed by the human body’s natural biological barriers, systemic or cellular. Introducing vaccines that utilise lipid nanotechnology has created a remarkably effective and innovative vaccine platform. LNPs are currently considered the most sophisticated non-viral gene delivery system in clinical use. They are a secure and highly efficient method of transporting nucleic acids, successfully overcoming a significant challenge in developing and applying genetic medicines and vaccines. Source: Healthworld

Apr 24,2024 Mumbai: Lupin Limited announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Aurangabad manufacturing facility. The inspection was conducted from March 6–15, 2024. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). “We are pleased to receive the EIR with VAI status from the US FDA as an outcome of the recent inspection of our Aurangabad facility. It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide,” said Nilesh Gupta, Managing Director, Lupin. Source: Pharma

Apr 18,2024 The Drugs Controller General (India) (DCGI) has informed all state drug regulators that the Central regulatory authority has not approved manufacturing and marketing of antibiotic combination of meropenem 1 mg and EDTA for injection and it is against the rules to produce and sell the drug without its approval. The drug regulator said that it has come to its notice that some manufacturers are involved in manufacturing and marketing the combination, which is not yet approved by the Central Drugs Standard Control Organisation (CDSCO) for manufacturing or marketing in the country and falls under the category of new drug. DCGI Dr Rajeev Singh Raghuvanshi in a notice to all the concerned stakeholders said, “No new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined in Rule 3 of New Drugs and Clinical Trial Rules, 2019”. Further, as per Rule 80 of New Drugs and Clinical Trial Rules, 2019, a person who intends to manufacture new drug in the form of active pharmaceutical ingredient (API) or Pharmaceutical formulation, as the case may be for sale or distribution, shall make an application for grant of permission to the Central Licensing Authority in Form CT-21 along with a fee as specified in Sixth Schedule. It may be noted that last month, the DCGI has directed the state drug regulators in the country to cancel the product permission granted by them for manufacturing and marketing of certain antibiotic drug combination meropenem and disodium EDTA for injection since it is a new drug and needs approval from the Centre also. The DCGI during the time said that it has come to the notice of the CDSCO that some manufacturers are involved in manufacturing and marketing of unapproved drugs which is not yet approved by his office for manufacturing or marketing in the country and falls under the category of new drug. “…you are hereby directed to convey the matter to all the manufacturers under your jurisdiction and cancel the product permission granted by you of the subject drug,” said the DCGI. The necessary information about the status and action taken in the matter may be intimated to the CDSCO at the earliest, he added. According to the online trading portals, the drug combination meropenem and disodium EDTA for injection is sold by a manufacturer as an ultra broad spectrum antibiotic and claimed as effective and well-tolerated for the treatment of infections including bacterial meningitis, lower respiratory tract infections and used in treatment of certain types of cancer.  Source: Pharmabiz

Apr 25,2024 Venezuela: Some of the 10 women and teenage girls who recently came to a medical clinic in eastern Venezuela for free contraceptives fidgeted a bit when a community health worker taught them how to use an IUD, condoms and birth control pills correctly. The health worker also asked what they knew about HPV, the most common sexually transmitted infection in the world and the cause of nearly all cervical cancer. Of the 10, ages 16 to 33 – two of whom had traveled to Putucual by boat and bus – only one had learned about human papillomavirus in middle school. The rest had talked about it with friends or cousins, but never their parents. None knew HPV vaccines exist, even though Venezuelan pediatricians have long recommended giving all children the vaccine starting at age 9. Venezuela’s government has repeatedly broken its promise to provide the shots for free, and many public-school teachers have failed to implement the requirement to teach sex ed. President Nicolas Maduro ‘s administration claims the well-being of youth and women is a priority, but the onus is on parents to talk to their kids about HPV and pay for the vaccines at private clinics. That’s out of reach for most in a country where private-sector workers earn $202 a month on average, and public employees’ monthly minimum wage is $3.60 plus $100 in bonuses. Most HPV infections are asymptomatic and go away without treatment. But some can lead to genital warts and cancers, primarily of the cervix, but also of the anus, penis and throat. Official health care statistics are elusive in Venezuela, making it virtually impossible to know the rate of HPV infection or how many people have been vaccinated either privately or by nongovernmental organizations. HPV vaccine coverage estimates from the World Health Organization show a blank space for Venezuela. In 2022, Maduro’s administration estimated 30% of Venezuelan women are affected by cancer-causing strains of HPV. But the Ministry of Popular Power for Health did not publicly provide the data nor historical figures to show how the rate may have changed. Health care professionals in the South American country told The Associated Press that the government’s figure is an undercount. “With HPV, all governments have a social and moral debt to the female population,” said Dr. Carlos Cabrera, an OB-GYN in private practice and director of the maternal fetal medicine program at the Central University of Venezuela. “But people don’t like to talk about sexual and reproductive health.” When HPV shots first hit the market in the mid-2000s, the oil-dependent state’s coffers were flush. The price of oil – Venezuela’s most valuable resource – was steadily climbing and the country produced more than a million barrels a day. In 2009, doctors urged the government of President Hugo Chavez to introduce the HPV vaccine into the country, but they were ignored. In 2015, Ministry of Health officials appeared ready to start offering HPV shots, mentioning in the agency’s annual performance report that the country’s vaccine schedule would include them and they “would be administered starting in 2016.” By this time, Venezuela’s budget holes due to financial mismanagement were apparent, but U.S. economic sanctions had not yet crippled the oil industry. Venezuela’s last vaccine promise came in late 2022 after it reached an agreement with GAVI, a public-private global alliance that helps poor countries procure vaccinations. Government officials said shipments were expected for 2023, but no shots were distributed then, and they are also not listed among those being offered during national vaccination week. The Ministry of Popular Power for Communication and Information did not respond to questions from the AP about the status of the vaccines, including reasons for the delay. Source: Healthworld

Apr 25,2024 New Delhi: A group of genes could be common to both depression and heart disease, a finding that researchers said could explain why having one of them increases risk of developing the other. The “puzzling” link between the diseases has been known to exist since the 1990s, they said. Studies have found that people with depression run a greater risk of cardiovascular disease, with early and effective treatment of the mental illness lowering the risk of developing heart-related conditions. Conversely, studies have also shown that people having cardiovascular disease tend to have depression as well. The researchers, including those from the Tampere University, Finland, said that the link between the two conditions could be partly explained by lifestyle commonly observed in depression patients such as poor diet and lack of exercise. However, they said, it is also possible that the two diseases could be related on a “deeper level” by sharing biological processes such as inflammation, which are important to developing these conditions. The findings are published in the journal Frontiers in Psychiatry. The researchers collected blood samples from close to 900 men and women aged between 34 and 49 years, who were participants in the Young Finns study. The study, examining cardiovascular risk factors in children and adolescents as they grow into adults, started in 1980. The participants were followed-up since then. The blood samples were analysed for gene expression, which is the process by which information in a gene eventually translates into observable traits in an individual. The researchers identified a specific group of genes that expressed themselves in a similar manner across both the conditions — depression and cardiovascular health. This group of genes, or gene module, was found to be associated with a high score for depressive symptoms as well as a low score for cardiovascular health. “We looked at gene expression profile in the blood of people with depression and CVD and found 256 genes in a single gene module (group of genes) whose expression at levels higher or lower than average puts people at greater risk of both diseases,” first author Binisha H. Mishra, a postdoctoral researcher at Tampere University, said. The genes forming the module are involved in biological processes such as inflammation known to play a role in the development of both depression and cardiovascular disease, the researchers said. Source: Healthworld

Apr 26,2024 Serving as a valuable opportunity to acknowledge the indispensable role of Intellectual Property (IP) in driving innovation and a spirit of scientific enquiry in the pharmaceutical sector, the World Intellectual Property Day is an occasion to commemorate the crucial role of intellectual property protection in advancing scientific frontiers, catalysing medical breakthroughs and nurturing ideas aimed at enhancing human well-being. In the pharmaceutical realm, IP ensures patient access to novel medicines while facilitating the research and development of future treatments and cures. Moreover, it serves as a catalyst for collaboration among industry players, academic institutions and small biotech firms, leveraging scientific expertise and capabilities to enhance healthcare outcomes and introduce approaches that benefit economies and strengthen the industry while improving the overall quality of life of the masses. A recent report of a study conducted by the Organisation of Pharmaceutical Producers of India (OPPI) and EY Parthenon has underscored the immense potential of the Indian pharmaceutical industry to not only meet but surpass expectations. This potential hinges on strategic investments and a commitment towards transformative innovation driven by value. The report is based on the feedback of 40 Chief Experience Officers (CXOs) from leading Indian and global pharmaceutical companies, where 30 per cent of the respondents highlighted the need for putting a robust research and innovation system in place. India is more inclined towards its generic manufacturers than innovators, which is evident from its stance against the inclusion of data exclusivity provisions, especially in Free Trade Agreements (FTAs), with the aim of safeguarding the interests of the domestic generic drug industry. Data exclusivity protects technical data or clinical trials data generated by innovator companies to prevent competitors from producing cheaper versions of medications unless they collect their own clinical trials data or wait for the exclusivity rights of innovators to lapse. This can compel generic manufacturers to either wait out the exclusivity period or undergo costly clinical trials afresh. Data exclusivity can also impede the process of issuing compulsory licences to generic manufacturers, limiting access to lower-priced medicines. The scope and terms of data exclusivity are, therefore, highly relevant to the pharmaceutical industry as well as the public, particularly with regard to the supply of new medicines and access to existing ones. Moreover, the vast financial resources and extended time required for gathering and generating pharmaceutical registration data for a new drug can create a market barrier that is too high for generic manufacturers. There is a pressing need for the government to enhance support for disruptive innovation, particularly through the enactment of more stringent IP laws, especially in cases involving rare diseases and diseases of critical nature. Currently, rare diseases pose a less attractive investment proposition for the industry due to a disproportionate investment-to-return ratio. The government should incentivise research in such areas so that the innovation ecosystem is not guided by profit considerations alone. By enforcing regulations for IP pertaining to medical solutions in critical care segments, India can leverage its research potential and demographic diversity to emerge as a global hub of research in this field. IP laws have historically catalysed diverse treatment options, addressing global health challenges effectively. Extending IP protection can empower more pharmaceutical and research firms to invest in the demanding process of innovation. Yet, it’s imperative that such laws are crafted and implemented in a way that continues to facilitate access to affordable medications, especially in low and middle-income regions. Striking the right balance will be crucial for India as it seeks to enhance its role as a global leader in pharmaceuticals and uphold its commitment to public health. The article is written by Saransh Chaudhary, President, Global Critical Care, Venus Remedies Ltd and CEO, Venus Medicine Research Centre (VMRC) Source: Pharma

Apr 26,2024 Geneva: Global immunisation efforts have saved at least 154 million lives in the past 50 years, the World Health Organization said Wednesday, adding that most of those to benefit were infants. That is the equivalent of six lives saved every minute of every year of the half century, the UN health agency said. In a study published in the Lancet, WHO gave a comprehensive analysis of the impact of 14 vaccines used under the Expanded Programme on Immunisation (EPI), which celebrates its 50th anniversary next month. Thanks to these vaccines, “a child born today is 40 percent more likely to see their fifth birthday than a child born 50 years ago”, WHO chief Tedros Adhanom Ghebreyesus told reporters. “Vaccines are among the most powerful inventions in history, making once-feared diseases preventable,” he said. “Smallpox has been eradicated, polio is on the brink, and with the more recent development of vaccines against diseases like malaria and cervical cancer, we are pushing back the frontiers of disease.” Infants accounted for 101 million of the lives saved through immunisation over the five decades, said the study. “Immunisation was the single greatest contribution of any health intervention to ensuring babies not only see their first birthdays but continue leading healthy lives into adulthood,” WHO said. Over 50 years, vaccines against 14 diseases — diphtheria, Haemophilus influenza type B, hepatitis B, Japanese encephalitis, measles, meningitis A, pertussis, invasive pneumococcal disease, polio, rotavirus, rubella, tetanus, tuberculosis, and yellow fever — had directly contributed to reducing infant deaths by 40 percent, the study found. For Africa, the reduction in infant mortality was more than 50 percent, it said. The vaccine against measles — a highly contagious disease by a virus that attacks mainly children — had the most significant impact. That jab accounted for 60 percent of the lives saved due to immunisation, according to the study. The polio vaccine means that more than 20 million people are able to walk today who would otherwise have been paralysed. The study also showed that when a vaccine saves a child’s life, that person goes on to live an average of 66 years of full health on average — with a total of 10.2 billion full health years gained over the five decades. WHO stressed that the gains in childhood survival showed the importance of protecting progress on immunisation. It highlighted accelerating efforts to reach 67 million children who missed at least one vaccination during the COVID pandemic. Source: Healthworld

Apr 25,2024 New Delhi: Humanity’s oldest and deadliest vector-borne disease, malaria has continued to be a silent killer. Although there has been continuous impressive gains in reduction of the disease burden in the country, the emerging and re-emerging diseases transmitted by mosquitoes pose a growing threat. India being the most populous country in the world and having numerous unplanned urban centers influenced by factors such as temperature, rainfall along with other ecological components, drone technology is said to be one of the cost-effective solutions to control mosquito breeding. India account’s to 66 per cent of the total cases in the South Asian continent which is considered as the malaria hotspot in the world after Africa. As per the World Health Organisation (WHO) World Malaria Report 2023 more than six lakh people lost their lives due to the seasonal disease making the number to cross pre-pandemic level. As per experts, the aspiration goal to make India Malaria free by 2027 and eliminate the problem by 2030, needs AI-based platforms and contemporary technologies like AI with Drones and other aerial tools have been able to provide a more effective and efficient solution. The drone technology is being used in two ways first as a means to spray the infectisides over water bodies like ponds, lakes which serve as the breeding ground for malarial mosquitoes. And second as to monitor and mapping a particular region to effectively meet the local requirements. Talking to ETHealthworld, Prem Kumar Vislawath a Hyderabad based entrepreneur of a startup Marut Drones said, “AI-backed disease prediction systems empower local authorities with timely insights, sparing workers from hazardous chemicals and fostering safer environments. Through real-time mosquito mapping, strategic alerts, deploying customized drones and GPS-tagged fogging systems to target breeding grounds precisely.” Regarding how profitable and scalable this profession is, Kumar said “Funding to fight malaria alone has reached US$3 billion globally in 2023. The future holds many new avenues for the use of UAVs (Unmanned Ariel Vehicles) as much of the operations are going to be replaced by UAVs.” He also added, “Indian government prohibited the import of drones into the country, the Ministry of Civil Aviation has now made it easier for people to legally fly small drones for non-commercial purposes.” Progressing in this direction several municipal authorities have adopted this technology in recent years, One instance is the Greater Hyderabad Municipal Corporation (GHMC) who has partnered with Kumar’s Marut Drones. Elaborating on the efficacy of the technology Hari Chandana, Zonal Officer, GHMC said, “We have seen a minimum 60 per cent reduction in mosquito breeding after each spray. We used to spend about Rs four to five lakh per lake before, now we spend about Rs. 25000 and with increased efficiency.” Chandra also informed that the drone technology covers a larger area in less time and it is of great help to municipal workers, who often had to get into deep lakes to spray repellents and were exposed to diseases and skin infection. Medical professionals and experts have also acknowledged the potential of the innovation and are advocating to various authorities to use the technology in their planning and response mechanism. Evocating his stance Dr Preetham Kumar Reddy, Pediatrician and Pediatric Intensivists, Rainbow Children’s Hospital, Secunderabad said, “Climate change can create a significant rise in vector activities. Hotter temperatures and wetter weather make mosquito larvae to multiply.” “Harnessing drone sensors to produce predictive analysis and data regarding vector activity, can help give critical alerts on outbreaks which can help healthcare professionals maintain a quick response time. Also, it prevents manual workers from being exposed to diseases and skin infection due to the water pollution as they have to go knee deep inside dirty lakes to clean it.” Reddy added. Sharing his opinion over the subject another expert Dr Kaushik Sarkar, Director, Institute for Health Modeling and Climate Solutions (IMACS) said, “Drones are used to help in mapping and analysing water bodies that are potential breeding grounds for mosquitoes with unprecedented accuracy. Additionally, IoT-enabled traps provide real-time entomological data, optimising vector control interventions. While traditional tools steadily aid in reducing the global malaria footprint”. “With India’s emphasis on the digital revolution and its burgeoning startup ecosystem, the country is setting global trends in pioneering innovations in the health sector to combat diseases like malaria.” Kaushik added. Source: Healthworld

Apr 19,2024 New Delhi: The country’s drug regulator has released draft guidelines on good distribution practices to curb the introduction of spurious, adulterated and sub-standard pharmaceutical products in the market. The draft guidance document issued by the Central Drugs Standard Control Organisation (CDSCO) is in line with the WHO Technical Report Series (TRS) on good storage and distribution practices for such products. The guidelines will be applicable to all persons and outlets involved in any aspect of storage and distribution of pharmaceutical products from the premises of the manufacturer to the person dispensing the products to a patient or his or her agent. “Not of standard quality and spurious products are a significant threat to public health and safety. Consequently, it is essential to protect the supply chain against the penetration of such products,” reads the draft ‘Guidelines on Good Distribution Practices for Pharmaceutical Products’. It sets out steps to assist stakeholders in fulfilling their responsibilities in different stages within the supply chain to avoid the introduction of sub-standard products in market. The draft has recommended the inclusion of self-inspections by a designated, competent person in an independent and detailed way in the ‘quality system’. All pharmaceutical product distributors shall establish and maintain ‘quality system’, it said, adding a responsible person shall be appointed by the management for each distribution site with defined authority and responsibility to ensuring the ‘quality system’ is implemented and maintained. The guidelines said deviations from the established procedures shall be documented and investigated. Appropriate corrective and preventive action (CAPA) shall be taken to correct deviations and prevent them, the guidelines said. The document stated if a produced is needed to be recalled, it shall be segregated during transit and clearly labelled as recalled products. Where segregation in transit is not possible, such goods shall be securely packaged, clearly labelled and be accompanied by appropriate documentation. All customers and competent authorities of all countries to which a given pharmaceutical product may have been distributed shall be informed promptly of any intention to recall the product, the draft document stated. The returned products shall be destroyed in accordance with international, national and local requirements and with due consideration to protection of the environment unless it is certain that their quality is satisfactory, after they have been critically assessed in accordance with a written and authorised procedure, the document said. Records for the dispatch of products should include a description of the products including name, dosage form and strength (if applicable), quantity, assigned batch number and expiry date, among other details. It shall be ensured that records of dispatch contain enough information to enable traceability of the pharmaceutical product, the draft guidelines said. Source: Pharma