April 2024

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

Apr 20,2024 New Delhi: The conflict in the Middle East could dent India’s pharma exports if it escalates, industry experts say. While exports have not been affected so far, the next few days are crucial because, if there is serious escalation in the conflict, it could impact the whole Middle East and North Africa (MENA) region. Many Indian pharma companies have a significant presence in the region. “Companies like Sun Pharma, Dr Reddy’s, Lupin, Torrent, and Divi’s Labs are likely to suffer the most due to their significant presence in the MENA region,” said Dinesh Dua, a former chairman of the Pharmaceutical Export Promotion Council (Pharmexcil). “In fact, Sun Pharmaceutical has a fully-owned subsidiary, Taro Pharmaceutical, based out of Israel which can have supply chain issues. India supplies bulk drugs and intermediaries, drug formulations and biologicals to countries in the MENA region and over the years there has been a surge of Indian pharma imports there. The UAE, Qatar, Saudi Arabia, Egypt and Bahrain are major destinations for Indian pharma products . “The imports by these countries amount to a billion dollars per year,” Dua said. In the first 11 months of the last fiscal year starting April 1, 2023, India’s pharma trade with the MENA region. “The region is dependent on India for a wide range of products like anti-infectives, injectables and therapies which India supplies in bulk. As of now no major news of disruptions has come but coming days are crucial,” an expert said. Another industry expert said the operations and supply chain issues in these countries may get affected if the tension escalates and continues. While pharma companies in the region tend to maintain buffer stocks, with many having stock at least for the next few days, any blockage of air and sea trade routes could deplete the stocks, resulting in shortages of essential drugs, experts say. “Iran’s unprecedented attack on Israel can have a spill-over effect on the pharma sector. We are keeping a vigil on the situation as there is fear of disruptions, as several airlines are changing routes and many shipping companies have stopped their operations due to the volatile situation. The delivery time will rise due to these issues and can disrupt the supply chain,” added another expert. The situation in the Middle East is tense as the Israeli military has pledged response to Iran’s attack. Since the war in Gaza began in October, clashes have erupted between Israel and Iran-aligned groups in places like Lebanon, Syria, Yemen and Iraq. Source: Pharma

Apr 18,2024 New Delhi: Should commonly used drugs such as cough and cold medicines, antacids, and antipyretics (fever-reducing drugs) be made available at general stores in India, like in many countries abroad? A govt appointed committee tasked with creating India’s OTC or over-the-counter drug policy is learnt to be considering this suggestion seriously and discussed it in a meeting held here on Monday. “Many countries, like the US, allow sale of commonly used medicines in grocery stores also. A suggestion was made by some of the experts looking into India’s OTC drug policy to allow the same here also for improved accessibility, especially in the rural areas. However, no decision has been taken yet,” said a source. Over-the-counter medicines refers to drugs that are allowed to be sold without a doctor’s prescription. Countries like the USA, UK and Australia have clear cut guidelines regarding their classification, uses and regulation. In Feb, Director General of Health Services, Atul Goel, formed an expert committee to formulate India’s OTC drug policy. The committee has submitted the first list of drugs that could be sold over the counter recently after which a meeting was called on Monday to discuss any potential addition or subtraction. “India has a rule for prescription drugs but there is no guideline or list of drugs that should be sold over the counter. A drug is considered an OTC unless it is specifically stated as a prescription only drug. This is the first time such an exercise is being undertaken,” said a source. Source: Healthworld

Apr 23,2024 New Delhi: Zydus Lifesciences Ltd on Tuesday said its new drug application of Desidustat tablets, indicated for treating anaemia in chronic kidney disease patients, has been accepted by the National Medical Products Administration of China. Discovered and developed by Zydus, Desidustat is being marketed by the group in India under the brand name Oxemia. CMS International Development and Management Ltd, a wholly-owned subsidiary of China Medical System Holdings Ltd (CMS) obtained an exclusive license for the product from Zydus in 2020, Zydus Lifesciences said in a regulatory filing. CMS had filed a New Drug Application (NDA) for the drug in China. “China Phase III trial of the product has demonstrated positive results. The primary endpoint has indicated that Desidustat is more effective than the Placebo in increasing Hb (hemoglobin) level,” the company said. Commenting on the NDA acceptance of Desidustat in China by National Medical Products Administration (NMPA), Zydus Lifesciences Managing Director, Sharvil Patel said, “We believe this collaboration with CMS will accelerate the development and commercialisation process of Desidustat in Greater China.” CMS holds the license to develop, register, manufacture, use and commercialise the Desidustat in Greater China, including mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan, the company said. Source: Pharma

Apr 23,2024 London: Pfizer and BioNTech asked a London court to revoke rival Moderna’s patents over technology key to the development of vaccines for COVID-19, as the latest leg of a global legal battle began on Tuesday. Pfizer and its German partner BioNTech sued Moderna at London’s High Court in September 2022, seeking to revoke patents held by Moderna, which hit back days later alleging its patents had been infringed. The competing lawsuits over the companies’ two vaccines, which helped save millions of lives and made the companies billions of dollars, are just one strand of ongoing litigation around the world which focuses on messenger RNA (mRNA) technology. Moderna says Pfizer and BioNTech copied mRNA advances it had pioneered and patented well before the COVID-19 pandemic began in late 2019. U.S.-based Moderna is seeking damages for alleged infringement of its patents by Pfizer and BioNTech’s Comirnaty shot on sales since March 2022. Pfizer made $11.2 billion in sales from Comirnaty last year, while Moderna earned $6.7 billion from its vaccine Spikevax, illustrating the potentially huge sums at stake. Pfizer and BioNTech, however, are asking the High Court to revoke Moderna’s patents, arguing that Moderna’s developments of mRNA technology were obvious improvements on previous work. The London lawsuits have been split into three separate trials, with one due to consider Moderna’s 2020 pledge not to enforce its vaccine-related patents during the pandemic starting next. Pfizer, BioNTech and Moderna are also involved in parallel proceedings in Germany, the Netherlands, Belgium and the United States, much of which has been put on hold, as well as at the European Patent Office. Source: Pharma

Apr 24,2024 New Delhi: The government has broadened the committee which will look into the reforms in pricing for drugs and medical devices so as to have better representation from the industry. The committee now includes special invitees from the industry including director general of Organisation of Pharmaceutical Producers of India (OPPI), managing director, US-India Strategic Partnership Forum (USISPF), industry representatives like Medical Technology Association of India (MTal), Confederation of Indian Industry (CII), forum coordinator of Association of Indian Medical Device Industry (AiMed), Federation of Pharma Entrepreneurs (FOPE), among others. The committee will evaluate the availability of medicines and medical devices, the pricing of essential medicines while providing incentives to the industry to maintain growth and build sustainability in exports. The committee will soon start consultations with the industry experts and associations of both medicines and medical devices, people in the know told ET. The final decision will, however, rest with the government. The committee will consist of three core members including the secretary, department of pharmaceuticals, chairman, National Pharmaceutical Pricing Authority and senior economic adviser, department of pharmaceuticals. The committee will see how to balance price and availability of essential medicines, while providing incentives to the industry to sustain growth and exports. It will also look into institutional reforms within the NPPA. It will also look into designing a price moderation framework for medical devices, while providing incentives to the industry to sustain growth and minimise imports. Source: Healthworld

Apr 24,2024 New Delhi: The Centre is planning to revamp key health schemes targeted at children, focusing on improving nutrition as well as strengthening mental health, said people familiar with the matter. “The idea is to come up with a comprehensive physical and mental development programme for schoolchildren, with a focus on nutrition to minimise cases of anaemia and to strengthen their mental health to reduce increasing incidence of anxiety, depression and suicides,” said a senior government official, who did not wish to be identified. The government could make changes to the School Health Programme under Ayushman Bharat, the National Mental Health Programme and Anaemia Mukt Bharat as part of this drive or subsume them under a single initiative to strengthen their overall focus, according to people in the know. The health and family welfare ministry, in consultation with the education, women and child development ministry and NITI Aayog, has kick-started discussions on the changes needed in these programmes to address the mental and physical health related challenges being faced by schoolchildren. “We are firming up the changes to these programmes to make them more effective and will notify them with the approval of the new government,” the official said. The interventions could include targeted preventive and remedial measures in the three schemes to help schoolchildren, with a greater role of the private sector to expand outreach of these programmes. As per the National Family Health Survey 5 (2019-21), 31.1 per cent adolescent boys (15-19 years), 59.1 per cent adolescent girls and 67.1 per cent children (6-59 months) are anaemic in the country. Source: Healthworld

Apr 24,2024 New Delhi: President Droupadi Murmu on Tuesday said the role of Artificial Intelligence and Robotics will continue to increase in diagnostics and treatment. Addressing the 4th convocation of AIIMS Rishikesh, Uttarakhand, Murmu hoped that these changes will be increasingly put to efficient use by AIIMS Rishikesh. The President said, “In Uttarakhand, due to lack of sunlight and local food habits, people, especially women, are affected by diseases like osteoporosis and anaemia.” The President said that using the latest technology in the interest of society should be the priority of institutions like AIIMS Rishikesh. She expressed happiness over AIIMS Rishikesh striving to move forward in the field of CAR T-cell therapy and Stem Cell Research. Murmu further said that providing world-class education and service in the field of medicine is a great national achievement of all AIIMS, including AIIMS Rishikesh. “All the AIIMS are recognised for providing the best and most affordable treatment. Many AIIMS are being established in different parts of the country with the objective that more and more people can benefit and more meritorious students can get an education in AIIMS,” she said. She stated that even in this era of global medicine, researching and solving national, regional and local problems related to medicine should be the priority of institutions like AIIMS Rishikesh. She urged AIIMS Rishikesh to pay maximum attention to public health and community engagement. She said that by doing this, the institute will be able to contribute towards building a ‘Healthy India’ and a ‘Developed India’. Noting that more than 60 per cent of students at AIIMS Rishikesh are female students, the President said that the increasing participation of women in areas ranging from policy making to tertiary healthcare presents a picture of a huge and positive social change. Source: Healthworld