PSM News

May 24,2024 New Delhi: About 7.5 lakh deaths associated with antimicrobial resistance (AMR) could be prevented every year in low-and middle-income countries (LMICs) by improving measures that prevent infections, according to an analysis, part of a four-paper series published in The Lancet journal. These measures included hand hygiene, regular cleaning and sterilisation of equipment in healthcare facilities, along with providing access to safe drinking water, effective sanitation and paediatric vaccines, researchers said. The international team of researchers estimated that each year, one in every eight deaths globally is caused by bacterial infections- about 77 lakh deaths in total, of which 50 lakh are associated with bacteria that have become resistant to antibiotics. The authors called for support in providing sustainable access to antibiotics to be central to ambitious and actionable targets for tackling AMR. “Access to effective antibiotics is essential to patients worldwide. A failure to provide these antibiotics puts us at risk for not meeting the UN sustainable development goals on child survival and health ageing,” said series co-author, Iruka Okeke of the University of Ibadan, Nigeria. Okeke said that effective antibiotics prolong lives, reduce disabilities, limit healthcare costs and enable other life-saving medical actions such as surgery. “However, antimicrobial resistance is on the rise – accelerated by inappropriate use of antibiotics during the COVID-19 pandemic – threatening the backbone of modern medicine and already leading to deaths and disease which would have once been prevented,” said Okeke. Existing infection prevention methods can prevent AMR-associated deaths, according to modelling analysis undertaken for putting together the series of papers. Up to 3.37 lakh deaths a year could be saved by improving infection prevention and control in healthcare facilities including better hand hygiene and regular cleaning and sterilisation of equipment, the authors found. Around 2.5 lakh deaths could be avoided yearly by providing universal access to safe drinking water and effective sanitation in community settings, they found. Further, 1.82 lakh deaths a year could be saved by expanding the rollout of some paediatric vaccines, such as pneumococcal vaccines which help protect against pneumonia and meningitis, along with introducing new ones, such as RSV vaccines for pregnant women, the researchers found. “Our findings highlight how public health actions to prevent infections in the first place should be prioritised as a strategy to tackle AMR as these methods have the potential to drastically reduce the number of deaths from AMR-associated infections,” said co-author Yewande Alimi of Africa Centres for Disease Control and Prevention (CDC). Source: Healthworld

May 23,2024 New Delhi: India will highlight its universal coverage through Ayushman Bharat, public health emergency preparedness and digital health transformations in the country at the World Health Assembly to be held in Geneva from May 27, official sources said on Wednesday. It will also showcase the Arogya Maitri Disaster Management Cube — an indigenous portable hospital — equipped with several innovative tools designed to enhance disaster response and medical support at the annual event organised by the World Health Organisation (WHO). The 77th session of the World Health Assembly (WHA) will be held in Geneva from May 27 to June 1. Indian delegation from the Ministry of Health and Family Welfare is being led by Union Health Secretary Apurva Chandra. Representatives from 194 countries will participate in the event to structure the global health ecosystem. The theme for this year’s WHA is “All for Health, Health for All”. The WHA comprises sessions in three main committees — Plenary, Committee A and Committee B. The plenary session will open the Health Assembly and will be attended by health ministers/heads of delegation of 194 nations, sources said. Committee A will be chaired by India and facilitate discussion on topics covering universal health coverage, public health emergency preparedness and response, anti-microbial resistance, climate change, sustainable financing for WHO etc, an official source said. Committee B mainly focuses on internal and external audit, budget and financing matters and the WHO secretariat. At least 14 side events and multiple strategic roundtables are being organised on the sidelines of WHA focusing on diverse health topics where the participant will share their thoughts on the way forward for the global health architecture. India is leading and supporting the Regional One Voice for the Southeast Asia region, advocating for well-being and health promotion, social determinants of health, maternal, infant and young child nutrition and economics and health for all. Source: Healthworld

May 22,2024 New Delhi: With the Indian Council for Medical Research (ICMR) and the National Institute of Nutrition (NIN) releasing new Dietary Guidelines for Indians, FSSAI’s plea that it is hampered in regulating ultra-processed food (UPF) and foods high in fat, sugars and salt (HFSS) because the terms “have not been defined” may no longer be valid. The guidelines released last week have detailed definitions of UPF and HFSS foods put together by a scientific body. The guidelines also spell out the harm caused by consumption of UPF. “Lack of fibre and poor micronutrients makes them unhealthy. Also, UPFs contribute to high calorie (energy) intake as they are often high in fat. UPFs are consumed in larger quantities by a large population since these have unique taste, high palatability and low cost as well as are easily available even in remote areas. …UPF consumption is associated with overweight/obesity and higher risks of coronary heart disease (heart attack), cerebrovascular diseases (stroke) and diabetes. UPFs also hasten the process of ageing,” stated the guidelines. On February 5, Nutrition Advocacy in Public Interest-India (NAPi), a national think tank on nutrition consisting of independent experts in epidemiology, nutrition, and paediatrics, wrote to the health ministry seeking regulations for labelling and marketing of UPF and HFSS foods “to halt their rising consumption”. Responding to the letter on April 15, FSSAI stated that “it is informed that the terms ultra-processed food and junk foods have not been defined in any of the Food Safety and Standards Regulations” and that comments and suggestions received from stakeholders on the Food Safety and Standards (Labelling & Display) Amendment Regulations , 2022 notified by the FSSAI “are under examination”. It included a list of initiatives taken by FSSAI to reduce consumption of UPFs such as Eat Right India, the social media campaign “Aaj se thoda kam” urging dietary modifications to reduce diet-related non-communicable diseases and a ban on sale/marketing of HFSS foods in schools or in areas within 50 metres from the school gate in any direction. “Why does it take FSSAI so long to examine the comments given in 2022? It has been working on regulation of front-of-pack labeling for a decade now,” said Dr Arun Gupta of NAPi. Front-of-pack labelling was proposed in 2014 by an expert committee constituted by the FSSAI on the order of the Delhi High Court on a public interest petition seeking labelling and a ban on sale of junk food in schools. On May 10, NAPi wrote to the health ministry urging the use of the NIN dietary guidelines, which are “science-based practicable guidelines”, “for developing regulations that could meaningfully prohibit advertising of HFSS and UPFs”. The guidelines also provide guidance on which food products could be regulated for front-of-pack labelling and prohibition of advertisements, stated the letter. Source: Healthworld

May 23,2024 New Delhi: The Delhi High Court on Tuesday reserved its order on a plea by several doctors’ associations against yoga exponent Ramdev over his alleged “unsubstantiated” claim about ‘Coronil’ being a “cure” for COVID-19 and not just an immunity booster. The plea forms part of a 2021 lawsuit by doctors’ associations against the yoga guru, his aide Acharya Balkrishna as well as Patanjali Ayurveda founded by Ramdev, and seeks an interim relief of removal of statements from various media platforms with respect to the claim. According to the lawsuit, Ramdev made unsubstantiated claims about ‘Coronil’ being a cure for COVID-19, contrary to the licence granted to the drug for merely being an “immuno-booster”. The senior counsel appearing for the plaintiffs also sought a direction to restrain the defendants from making further similar statements. Ramdev’s senior lawyer said he was bound by the undertaking given in the Supreme Court in the case concerning advertisements of Patanjali products, adding that he was willing to make a similar statement in the high court as well. The plaintiffs’ senior lawyer, however, urged the court to pass an order on the interim application stating that the undertaking before the apex court was with regard to not making “causal statements” that are not in compliance with the law. Justice Anup Jairam Bhambhani said the matter before him concerned “specific instances” and reserved the order. Three Resident Doctors’ Association of the All India Institute of Medical Sciences at Rishikesh, Patna and Bhubaneswar as well as Association of Resident Doctors, Post Graduate Institute of Medical Education & Research, Chandigarh; Union of Resident Doctors of Punjab (URDP); Resident Doctors’ Association, Lala Lajpat Rai Memorial Medical College, Meerut, and Telangana Junior Doctors’ Association, Hyderabad had moved the high court in 2021 against Ramdev and others. In their lawsuit filed through advocate Harshavardhan Kotla, the associations have submitted that the yoga guru, who is a highly influential person, was sowing doubts in the minds of the general public about the safety and efficacy of not only allopathic treatments but also COVID-19 vaccines. They alleged that the “misinformation” campaign was nothing but an advertisement and marketing strategy to further the sales of the product sold by Ramdev, including ‘Coronil’, which he claimed to be an alternative treatment for COVID-19. On October 27, 2021, the high court had issued summons to Ramdev and others on the lawsuit, saying it was not a frivolous matter and a case was “definitely” made out for its institution. Source: Healthworld

May 23,2024 New Delhi: Spices play a key role in making the Indian culinary experiences a worthy one. But, the recent buzz about contamination of spice mixes by MDH and Everest with cancer-causing chemical called Ethylene oxide has raised eyebrows and concerns in the national and international market. Keeping the same in view, the Food Safety and Standards Authority of India (FSSAI) recently collected samples from across India and released the report. FSSAI recently announced that it did not find ethylene oxide (ETO), a food contaminant flagged by foreign countries, in MDH and Everest product samples. As per a report by ANI, FSSAI made the announcement after testing of the samples of spices sold by the two companies. It is reported that FSSAI collected 34 samples of Everest and MDH spices for testing, 9 from Everest’s facilities in Maharashtra and Gujarat, and 25 from those of MDH’s in Delhi, Haryana and Rajasthan. According to the same ANI report, the tests also included several parameters including moisture content, insect and rodent contamination, heavy metals, aflatoxins, and pesticide residues. The samples were tested for ethylene oxide at NABL-accredited laboratories as well. The FSSAI received around 28 lab reports so far and the chemical was found absent in them. However, the body awaits the results from 6 more samples. If reports are to be believed, the Food Standards Agency (FSA) said that it had already been issuing early warning alerts for ETO in various spices from India since before January 2023. Source: Healthworld

May 23,2024 NEW DELHI: Healthcare emerged as the most violative sector in India with respect to advertising rules in 2023-24, with majority of violations took place due to misleading claims, an annual analysis of Advertising Standards Council of India (ASCI) showed. Among the violators, healthcare ads contribute 19% of cases, followed by illegal offshore betting (17%), personal care (13%), conventional education (12%), food and beverage (10%), and realty (7%). Babycare emerged as a new contender in the top violators category, with influencer promotions (by celebrities without proper disclosure) contributing to 81% of cases. In 2023-24, the analysis studied 10,093 complaints and 8,299 advertising campaigns. Nearly half of the advertisements picked up by ASCI were not contested by the advertisers. The majority of violations were on account of misleading claims at 81%, followed by ads that promoted harmful situations or products at 34% (the same ad can be processed for multiple objections). Manisha Kapoor, CEO & secretary general of ASCI, said, “2023-24 has been a truly challenging year and ASCI stepped up to this by focusing on digital. About 3,200 advertisements were shared with various regulators, such as MIB, Ayush, and MahaRera, for direct violations of the law. We see this as a continuing area of focus. With the highest number of violative ads seen online, advertisers and platforms must work more closely with regulators and self-regulators to keep consumers protected.” Further, digital media remained the primary source of violations, accounting for 85% of ads processed and had a lower compliance rate of 75%, compared to 97% for print and TV. This raises serious questions about the online safety of consumers, a point highlighted last year as well, ASCI said. In 2023-24, the number of complaints regarding misleading and violative ads was 12.8% higher over 2022-23. Saugata Gupta, ASCI chairman said, “As digital emerges as a dominant media in which advertisements thrive, ASCI has geared up to challenges through constant investment in technology’. And, celebrities continued to appear in ads that were in violation of ASCI code. ASCI processed complaints against 101 ads featuring celebrities, 91% of which required modification, the analysis said. About 104 celebrities appearing in these 101 ads were found to be in violation of guidelines as they could not provide any evidence of due diligence. The analysis pointed to lack of due diligence of marketing and advertising campaigns by social media influencers. Due diligence is a requirement under the Consumer Protection Act, 2019. Source: TOI

May 20,2024 Indian Council of Medical Research (ICMR) has castigated Banaras Hindu University (BHU) researchers for “incorrectly” associating it with an observational study on the side effects of the Covid-19 vaccine Covaxin, and asked why it should not take legal and administrative action for it. The premier research body has also directed BHU to immediately remove the “acknowledgement to ICMR” for the study and publish an erratum. According to a recent research by a team of researchers at BHU, nearly a third of the 926 participants of an observational study on the side effects of Bharat Biotech’s Covid-19 vaccine, Covaxin, reported adverse events of special interest (AESI). The study covered a one-year period after the vaccine was administered. In its letter to the researchers, ICMR said the research body is not associated with this “poorly designed” study and has not provided any financial or technical support for the research. “You have acknowledged ICMR for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable,” ICMR’s director general said in the letter. “ICMR cannot be associated with this poorly designed study, which purports to present a safety analysis of Covaxin.” The director general said the study has flaws like it has no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups. “Hence, the reported events in the study cannot be Iinked or attributed to Covid-19 vaccination,” the letter said. The director general said the study does not provide background rates of observed events in the population, making it impossible to assess the change in incidence of observed events in the post-vaccination period. “Baseline information of study participants is missing”, the letter said. According to ICMR, the study tool used is inconsistent with “adverse events of special interest” as defined in the reference provided in the paper for AESI. “The method of data collection has a high risk of bias. Study participants were contacted telephonically one year after vaccination and their responses recorded without any confirmation with clinical records or by physician examination,” the letter said. “We have also noticed that you have similarly acknowledged ICMR in similar previous papers without permission. Please explain why ICMR should not seek Iegal and administrative action against you,” the letter said. Source: Economic Times

May 21,2024 New Delhi: Centre has asked drug controllers of all states and UTs to share a list of antibiotic combinations licensed by them for manufacturing and marketing in their respective jurisdictions. It has also asked states/UTs to monitor the availability of unapproved antibiotic combinations, if any, present in markets under their jurisdiction and take action, reported. In 2018, Central Drugs Standard Control Organisation (CDSCO) had banned 26 antibiotic combinations. However, a follow-up study published in the Journal of Pharmaceutical Policy and Practice in 2022 showed that a significant number of such antibiotics remained available in the market. Also, the study found, sales of antibiotic combinations containing chemical compounds belonging to the same drug classes as the banned drugs increased after the ban. Sales of similar non-banned formulations also went up. Some pharma companies promoted products containing new non-antimicrobial components to the banned combination to dodge the govt order, therefore nullifying any attempts to reduce antibiotic resistance caused by the consumption of such drugs. An antibiotic combination refers to fixed dose combination medicine comprising two or more antibiotics in a fixed ratio of doses and available in a single dosage form. “Although antimicrobial FDCs (fixed-dose combinations) have been critical in improving clinical outcomes among patients with certain infections such as tuberculosis and HIV, use of such FDCs for routine bacterial infections is inappropriate as it drives AMR (antimicrobial resistance) by selecting co-resistant microorganisms. Thus, their indiscriminate use is widely discouraged, including in World Health Organisation’s AWaRe framework of antimicrobial prescribing,” the study said. It added that many FDCs marketed in India were never approved by CDSCO, their approval comes from state-level regulatory bodies that, at times, lacked sufficient technical expertise to make such decisions. Source: Healthworld

May 19,2024 New Delhi: The Food Safety and Standards Authority of India (FSSAI) has alerted traders, fruits handlers and Food Business Operators (FBOs) who are operating ripening chambers to strictly ensure compliance with the prohibition on Calcium Carbide for artificial ripening of fruits, particularly during the mango season. FSSAI is also advising Food Safety Departments of States/UTs to remain vigilant and take serious action and deal stringently against person(s) indulging in such unlawful practices as per the provisions of FSS Act, 2006 and Rules/Regulations made thereunder, the Ministry of Family and Health Welfare informed in a press release. Calcium carbide, commonly used for ripening fruits like mangoes, releases acetylene gas which contains harmful traces of arsenic and phosphorus. These substances, also known as ‘Masala’, can cause serious health issues such as dizziness, frequent thirst, irritation, weakness, difficulty in swallowing, vomiting and skin ulcers, etc. Additionally, acetylene gas is equally hazardous to those handling it. There are chances that calcium carbide may come in direct contact with fruits during application and leave residues of arsenic and phosphorus on fruits, the release stated. Due to these dangers, the use of calcium carbide for ripening fruits has been banned under Regulation 2.3.5 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011. This regulation explicitly states, “No person shall sell or offer or expose for sale or have in his premises for the purpose of sale under any description, fruits which have been artificially ripened by use of acetylene gas, commonly known as carbide gas.” Considering the issue of rampant use of banned calcium carbide, FSSAI has permitted the use of ethylene gas as a safer alternative for fruit ripening in India. Ethylene gas can be used at concentrations up to 100 ppm (100 ml/L), depending upon the crop, variety and maturity. Ethylene, a naturally occurring hormone in fruits, regulates the ripening process by initiating and controlling a series of chemical and biochemical activities. The treatment of unripe fruits with ethylene gas triggers the natural ripening process until the fruit itself starts producing ethylene in substantial quantities. Further, the Central Insecticides Board and Registration Committee (CIB & RC) has approved Ethephon 39 per cent SL for the uniform ripening of mangoes and other fruits. The Ministry emphasised that FSSAI has published a comprehensive guidance document titled “Artificial Ripening of Fruits – Ethylene gas a safe fruit ripener” suggesting the Food Business Operators to follow the procedure for artificial ripening of fruits. This document outlines a Standard Operating Procedure (SOP) incorporating all aspects of artificial ripening of fruits by ethylene gas viz. Restrictions, Requirements for Ethylene Ripening System/Chamber, handling conditions, Sources of Ethylene Gas, Protocol for application of Ethylene gas from various sources, post treatment operations, safety guidelines etc. “In case any use of Calcium Carbide or any wrong practice of using ripening agents for artificial ripening of fruits is noticed by the consumers, the same may be brought to the notice of concerned State Commissioners of Food Safety for taking action against such violators,” the release added. Source: Healthworld

May 19,2024 Drug makers Dr Reddy’s Laboratories, Sun Pharma, and Aurobindo Pharma are recalling products from the US market due to manufacturing issues, according to the latest Enforcement Report by the US Food and Drug Administration (USFDA). Dr Reddy’s Laboratories is recalling nearly 20,000 cartons of a medication used to control blood phenylalanine levels in adults and children. Dr Reddy’s Laboratories, Inc, based in Princeton, New Jersey, is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) because it is sub-potent, according to the USFDA. The company is also recalling another lot of sapropterin dihydrochloride for the same reason. Sapropterin dihydrochloride is used to treat hyperphenylalaninemia (HPA), a condition characterized by high levels of phenylalanine in the blood. It is specifically indicated for individuals with phenylketonuria (PKU), a genetic disorder in which the body cannot break down the amino acid phenylalanine, leading to its accumulation in the blood. High levels of phenylalanine can cause various health problems, including intellectual disabilities, developmental delays, and other neurological issues. The USFDA stated that the company initiated the Class I recall on April 8 this year. A Class I recall, as defined by the US health regulator, pertains to defective products that can cause serious health problems. The USFDA also reported that Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal infections, from the US market. Sun Pharma’s US-based arm initiated the Class II recall on April 19 this year due to being “Out of specification for assay,” according to the USFDA. Similarly, Aurobindo Pharma is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg), used to treat anxiety, from the US market. The recall is due to “Discoloration: Dotted and yellow spots on tablets,” as stated by the USFDA. Aurobindo Pharma’s US-based arm initiated the Class II recall on April 24 this year. Additionally, the USFDA reported that FDC Ltd is recalling 382,104 units of Timolol Maleate Ophthalmic Solution, used to treat glaucoma, from the US market. The Aurangabad, Maharashtra-based drug firm is recalling the affected lot due to a “Defective Container.” According to the USFDA, a Class II recall is initiated when the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. The US generic drug market, valued at approximately $115.2 billion in 2019, is the largest market for pharmaceutical products. Source: CNBCTV18