PSM News

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

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

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

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

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

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

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

Apr 12,2024 New Delhi: In the battle against drug-resistant tuberculosis (TB), young children have faced a particularly challenging hurdle: the painful injectables in treatment regimens. These medications, notorious for their severe side effects, added an extra layer of distress to an already daunting ordeal for infants and children. Now, with approval of Delamanid for children under 5 in India in March, doctors anticipate a significant shift in paediatric TB treatment. In an important update to its treatment guidelines in March, Central TB Division announced an expansion in use of Delamanid for younger paediatric patients. Previously restricted to children above the age of six years, Delamanid is now endorsed for use in children, including infants, as part of the initial oral regimen for treating multi-drug resistant (MDR-TB) and extensively drug-resistant TB (XDR-TB), it said. The department said Delamanid can be administered according to recommendations for children weighing at least 10kg. Centres have been told to use 50mg dispersible tablets till 25mg tablets are available under the national programme. This approval, albeit coming two years after global go ahead for young kids, signifies a major leap in paediatric TB treatment because doctors can finally offer young patients an all-oral regimen, free from the discomfort and potential harm associated with injectables. Before this permission, treatment regimens for younger babies suffering from XDR-TB included injectables such as amikacin, a drug known for its potential to cause mild to severe hearing loss in children and adults alike. Dr Sushant Mane, national expert in National TB Elimination Programme (NTEP) from JJ Hospital, called it a “transformational” development that will bring relief not just to children but also to their families. In drug-resistant TB, children go through a daunting 18-month treatment regimen, where they have to take daily injections for six months. “But it’s not just about the pain of each needle prick; it’s the constant fear of abscesses and secondary infections at the injection site,” the doctor said. The news has special implications for Mumbai, said chest physician and TB specialist Dr Vikas Oswal, where 51 per cent cases are pre-XDR and XDR. Source: Healthworld

Apr 14,2024 The government has told ecommerce websites that Bournvita and other beverages should not be called health drinks because the category isn’t defined in the country’s food laws. “All ecommerce companies/portals are hereby advised to remove drink/beverages including Bournvita from the category of ‘health drinks’ from their sites/portals,” the commerce and industry ministry said in a notification. Cadbury Bournvita, the country’s most popular malted drink, had found itself in a controversy last year after a social media influencer alleged that the drink has high sugar content. Mondelez India, which owns Bournvita, sent a legal notice to the influencer, forcing him to take down the video. But the issue snowballed into a controversy, and the National Commission for Protection of Child Rights (NCPCR) asked the brand to withdraw all misleading packaging, advertising, and labels. Earlier this month, the Food Safety and Standards Authority of India (FSSAI) instructed ecommerce portals against labelling dairy-based or malt-based beverages as ‘health drinks’. The latest directive from the commerce and industry ministry has come after an inquiry by NCPCR — a statutory body constituted under the Commission for Protection of Child Rights Act, 2005. It “concluded that there is no ‘health drink’ defined under FSS Act 2006, rules and regulations as submitted by FSSAI and Mondelez India Food Pvt Ltd”, as per the notification dated April 10. “This might be the effect of the (Baba) Ramdev judgment where Patanjali was named by the court for misleading consumers,” said Santosh Desai, managing director of brand consulting firm Futurebrands Consulting. There could be an effort to widen the net and try and take action against anything that the government thinks misleading,” he said. In the latter half of the past decade there has been a clear shift towards natural, chemical free food in the market, according to a report by Wazir Advisors. “Consumers, owing to their demanding lifestyles have also gravitated towards functional foods to supplement their normal nutrition intake,” the report said. As a result, the packaged health and wellness food and beverage market in India is expected to touch Rs 2,50,000 crore by 2026, it added. The demand for these products, which was earlier largely concentrated in the metros and big cities, is expected to penetrate down deeper into tier II cities as well, the report said. Source: Economic Times

Mar 27,2024 London: Gene therapy maker bluebird bio said on Tuesday it plans to revise its financial statements for 2022 and the first three quarters of last year due to accounting errors related to some contract manufacturing agreements. The company said it has identified “material weakness in its internal control over financial reporting”, and will take time till April 16 to file its 2023 annual report that was expected this month. The restatement will have no impact on its revenue or current cash position, said a spokesperson for the company, which has contract manufacturing agreements with Thermo Fisher Scientific and Lonza, among others, according to bluebird’s annual report released last year. Shares of bluebird were down 17 per cent at $1.12 in morning trading. The company said it incorrectly separated the lease and non-lease components of some of the contracts in its reporting, resulting in an estimated understatement of lease assets and liabilities between $100 million and $200 million in 2022. For the first three quarters of 2022 and 2023, the understatement was between $30 million and $125 million each. The restatements come at a time when bluebird is focused on commercialising its three gene therapies, including its recently approved sickle cell disease treatment, Lyfgenia, which is expected to generate revenue from the third quarter. Source: Healthworld