PSM News

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

Apr 25,2024 New Delhi: On the eve of the World Malaria Day, the World Health Organisation (WHO) emphasised on the need for heightened focus on addressing the obstacles to health equity, gender equality and human rights in malaria responses. Saima Wazed, WHO Regional Director for South-East Asia, stressed on redoubling efforts to overcome challenges posed by malaria and ensure all individuals, irrespective of their socio-economic status or geographical location, have access to prevention, diagnosis and treatment services for the disease. “Moreover, by leveraging digital technology, we can better understand the diverse health needs of populations, collect and analyse data and monitor progress in real-time, enabling us to identify and address health inequities through both proven interventions and innovation in service delivery,” Wazed said. “On World Malaria Day 2024, we unite under the theme ‘Accelerating the fight against malaria for a more equitable world’,” she said. This theme, which is in sync with this year’s World Health Day theme — “My Health, My Right” — underscores the urgent need to address the stark inequities that persist in access to malaria prevention, detection and treatment services. Wazed said in recent years, global efforts to reduce malaria have stagnated, posing a significant threat to public health and exacerbating inequalities within communities. Everyone has the right to quality, timely and affordable malaria services, yet this remains elusive for many, perpetuating a cycle of inequity that disproportionately affects the most vulnerable among us, she stated. Infants and young children, especially those under five, are particularly affected, with disparities in access to education and financial resources compounding their risk, Wazed said, adding that pregnant women also face heightened risks as pregnancy reduces immunity to malaria, making them more susceptible to infection and severe disease. She added that refugees, migrants, internally displaced people and indigenous people are also at heightened risk of malaria. “Malaria remains a significant public health challenge in our region, affecting nine out of eleven countries and accounting for a third of the global burden outside Africa,” the WHO regional director for South-East Asia said. “Despite the formidable obstacles we face, I am heartened by the progress we have made in recent years. In recent years, our region witnessed a substantial decline in malaria cases and deaths, marking the most significant reduction among all WHO regions,” she added. Wazed said their journey towards malaria elimination is still far from over. “While several countries are on track to meet the Global Technical Strategy (GTS) targets, challenges persist, particularly, in countries like Indonesia and Myanmar, where case incidence has seen an increase,” she said. Accelerate the fight against malaria for a more equitable world by ending discrimination and stigma, engaging communities in health decision-making and bringing healthcare close to where people live and work through primary health care, Wazed said. Source: Healthworld

Apr 21,2024 New Delhi: The Union health ministry has asked all states and UTs to investigate any violations and take appropriate action, including suspension of registration, against hospitals performing illegal organ transplants, officials said on Sunday. In a letter to all states and UTs, Dr Atul Goel, Director General of Health Services (DGHS), Government of India, urged all states and Union Territories to ensure regular collection and sharing of data of all transplant cases, including those of foreigners, with the National Organ and Tissue Transplant Organisation (NOTTO) on a monthly basis. The ministry’s direction comes over two weeks after an organ trafficking racket, involving Bangladeshi nationals, being run in Haryana and Rajasthan was busted. Referring to media reports mentioning commercial dealings in organs involving foreign citizens, Dr Goel stated, “It has also been noted from the registry of NOTTO that there has been a surge in the number of organ transplants of foreigners in the country, which calls for monitoring of such transplants by the state or UT government authority concerned.” Goel, in the letter issued on April 10, directed that appropriate authority of the state appointed as per the Transplantation of Human Organs and Tissues Act (THOTA), 1994, should investigate the transplant cases of foreign nationals in their respective states. He also asked the officials to take appropriate actions whenever a breach of any provision of the Act or any of the rules made thereunder are noted. “Investigate any violation of the THOTA, 1994 and rules thereunder and take appropriate action including suspension of registration for performing Organ Transplant, of the hospitals involved in illegal activities,” the letter said. “It should be ensured that a unique NOTTO-ID for both donor and recipient is generated by the hospital from NOTTO website (www.notto.mohfw.gov.in), in all cases of organ transplant, whether from a living donor or deceased donor,” the letter said. Besides NOTTO-ID being mandatory for considering allocation of organ in case of deceased donor transplant, this ID in case of a living donor transplant, shall also be generated at the earliest, at least within 48 hours of the transplant surgery, the minsitry said, it added. The letter called for devising a system of regular inspection of the registered transplant or retrieval hospitals by the state appropriate authority, so as to maintain on-site monitoring of their activities, quality of transplantation, post operative follow-up of donor and recipient and outcome of the transplantation. “Time and again, letters have been written to states for sharing of data related to organ donation and transplantation with NOTTO. However, complete data is still not being received. It is again requested to ensure regular collection and sharing of data of all transplant cases, including those of foreigners, with NOTTO on monthly basis,” the ministry said. The healthy ministry also asked all states and UTs to submit an action-taken report on the instructions within 15 days. Source: Healthworld

Apr 21,2024 New Delhi: Recently, a report published on the official website of Hong Kong’s food regulatory authority– Centre for Food Safety (CFS) on April 5th mentioned that three spice products in India have cancer-causing chemicals that contain a pesticide known as ethylene oxide. Here’s all you need to know about this shocking report. Food regulators in Hong Kong and Singapore released a report in the first week of April and warned the masses to avoid adding spices products from India as they were tested with cancer causing substances Ethylene oxide. The list of spices include three spice products from two big Indian companies MDH and one from Everest that have exceeded the permissible limit of chemicals. However, the companies haven’t responded to the report of levels exceeding the permissible limit. The International Agency for Research on Cancer has classified ethylene oxide as a ‘Group 1 carcinogen’. Hong Kong’s food regulatory authority, said that three spice products of MDH — Madras Curry Powder (spice blend for Madras Curry), Sambhar Masala (Mixed Masala Powder), and Curry Powder (Mixed Masala Powder) — along with Everest’s Fish Curry Masala contains a pesticide, ethylene oxide. This study was conducted under its routine food surveillance programme, the CFS took the products from three retail outlets in Hong Kong. “The test results showed that the samples contained a pesticide, ethylene oxide,” said to a CFS spokesperson. As per a report by IANS, it was mentioned that the regulator instructed the vendors “to stop the sale and remove from shelves the affected products”. “According to the Pesticide Residues in Food Regulation (Cap. 132CM), food for human consumption containing pesticide residue may only be sold if consumption of the food is not dangerous or prejudicial to health. An offender is liable to a maximum fine of $50,000 and imprisonment for six months upon conviction,” the CFS spokesperson said. AS per CFS noted that “investigations are ongoing” and “appropriate action” may be initiated in the matter. Meanwhile, the Singapore Food Agency (SFA) also ordered a recall of Everest’s Fish Curry Masala due to the presence of ethylene oxide at levels “exceeding the permissible limit”. The SFA posted a release on its website on April 18 that said it “has directed the importer, Sp Muthiah & Sons Pte. Ltd., to recall the products. The recall is ongoing.” The SFA mentioned in the report that ethylene oxide is not fit for consumption, but is “used to fumigate agricultural products to prevent microbial contamination”. However, under Singapore’s food regulations, ethylene oxide can be “used in the sterilization of spices”. It was also mentioned that there is no immediate risk to consuming foods with low levels of ethylene oxide, but the carcinogenic properties of this pesticide may trigger cancer cells on prolonged consumption and may lead to health hazards in the long run. As per the SFA, noting that exposure to the “substance should be minimized as much as possible”. Source: Healthworld