Team JGJ

Dec 13,2024 Washington: Some early breast cancer patients can safely avoid specific surgeries, according to two studies exploring ways to lessen treatment burdens. One new study, published in the New England Journal of Medicine, examines whether removing lymph nodes is always necessary in early breast cancer. Another in the Journal of the American Medical Association suggests a new approach to a type of breast cancer called ductal carcinoma in situ, or DCIS. The research was discussed Thursday at the San Antonio Breast Cancer Symposium. DCIS and active monitoring Every year, about 50,000 women in the US are diagnosed with ductal carcinoma in situ, or DCIS, where the cells that line milk ducts become cancerous, but the nearby breast tissue remains healthy. Many choose to have surgery, although it’s unclear whether they could instead take a “wait-and-see” approach with more frequent monitoring. The new study, based on two years of data, suggests that such active monitoring is a safe alternative to surgery for many of these women, though some doctors will want to see if the results hold up over time. “This is an option that patients should consider for their DCIS,” said Dr Virginia Kaklamani of the University of Texas Health Science Center San Antonio, who was not involved in the research. “For a long time, we’ve had the feeling that we’re overtreating some patients with DCIS. This is a confirmation of what we suspected is happening.” Taking a more cautious view, Dr Monica Morrow of Memorial Sloan Kettering Cancer Center, who was not involved in the study, said a two-year study isn’t long enough to draw conclusions. The finding is based on following more than 950 U.S. patients randomly assigned to surgery or active monitoring. All had low-risk DCIS with no sign of invasive cancer. They had the type of DCIS that responds to hormone-blocking drugs and many in the study took those drugs as part of their treatment. After two years, the rates of invasive cancer were low and did not differ significantly between the groups, with about 6% in the surgery group and about 4% in the monitoring group diagnosed with invasive cancer. Among patients in the monitoring group, changes spotted on a mammogram would prompt a biopsy. They also could opt for surgery at any time for any reason. Some study participants didn’t stick with the treatment they were randomly assigned. So in a separate analysis looking at those who actually had surgery or not, the rates of invasive cancer were about 9% for the surgery group and 3% for the monitoring group. Tina Clark, 63, of Buxton, Maine, joined the study after being diagnosed with DCIS in 2019. Randomly assigned to the monitoring-only group, she was able to avoid surgery and radiation during a time when she was raising a teenage nephew and going through the illness and death of her husband. “I feel just so grateful and fortunate that I found this study when I did,” Clark said. She has mammograms every six months to keep watch on the DCIS in her right breast, which has not advanced. The mammograms spotted a small cancer in her other breast in 2023, unrelated to the DCIS. She had a lumpectomy to remove it. “If you’re diagnosed with low-risk DCIS, you have time to understand more about your disease and understand what your options are,” said study author Dr Shelley Hwang of Duke University School of Medicine. Lymph nodes and early breast cancer Women having surgery for breast cancer often also have what’s called a sentinel lymph node biopsy where a few lymph nodes in the armpit are removed to check for spreading cancer. But removing lymph nodes can cause lasting pain and arm swelling, so research is underway to determine when it can be avoided. A study in Europe last year showed that older women with small tumours could safely avoid the added surgery. In the new study, researchers in Germany looked at whether women with early breast cancer who were planning to have breast-conserving surgery could safely skip having lymph nodes removed. They followed 4,858 women who were randomly assigned to have lymph nodes removed or not. After five years, about 92% of women in both groups were still alive and free of cancer. “Removing lymph nodes does not improve survival, and the risk of cancer coming back in the armpit is quite low when lymph nodes are not removed,” said Morrow, who added that some women will still need the lymph node procedure to help determine which treatment drugs they should take after surgery. Source: Healthworld

Dec 14,2024 New Delhi: The Supreme Court on Friday sought responses from the Centre and others on a plea seeking directions to make available anti-venom and snakebite treatment at health centres, hospitals and medical colleges to save lives of victims. A bench of Justices B R Gavai and K V Viswanathan agreed to hear the petition and issued notices to the Centre, states and union territories seeking their responses. “Issue notice, returnable in four weeks,” the bench said. The plea filed by Shailendra Mani Tripathi, an advocate, said the country faced a significant public health crisis due to the scarcity of anti-venom which was crucial for treating snakebites. “India has the highest rate of snakebite deaths globally, with approximately 58,000 fatalities each year. Despite this much of high mortality rate there is scarcity of anti-venom (polyvenom),” the plea, filed through advocate Chand Qureshi, said. It said many rural areas in the country lacked adequate stocks of anti-venom, leading to delays in treatment for snakebite victims. The plea has sought directions to conduct snakebite prevention health mission and snakebite public awareness campaigns to reduce mortality, especially in rural India. It also sought directions to establish snakebite treatment and care units along with special trained doctors as per standard medical norms in government district hospitals and government medical colleges. Source: Healthworld

Dec 13,2024 Dehradun: The 10th World Ayurveda Congress and AROGYA Expo began here on Thursday with Prime Minister Narendra Modi asserting that the ancient Indian system of medicine has the potential to strengthen the global healthcare systems . In a message read out at the inaugural function of the event, Modi also reiterated the government’s commitment to promote Ayurveda. Ayurveda has the potential to strengthen the global healthcare systems as it focuses on providing “comprehensive remedies” to various health problems and lays equal emphasis on prevention, nutrition and mental health, the prime minister said. Modi expressed confidence that the four-day meet will expedite the promotion of Ayurveda at the global level and asked the delegates to come out with a new “blueprint” for the purpose. The event is being attended by over 5,500 delegates, including about 350 overseas delegates from 54 countries. Addressing the event, Uttarakhand Chief Minister Pushkar Singh Dhami said the state government is working towards implementing the country’s “first” yoga policy. It will play an important role in bringing about a new revolution in the field of health by bringing Ayurveda and yoga together on a big scale, he said. Dhami described Uttarakhand as the land of Ayurveda and AYUSH since ancient times because of its herbal wealth. Uttarakhand is the first Himalayan state where the event is being held. Dhami thanked Prime Minister Modi for the event being organised in Dehradun. He said the presence of representatives from more than 50 countries and nearly 6,000 experts in the program and more than 250 stalls set up in the expo are giving evidence of the global acceptance of Ayurveda. He expressed hope that the conference will create new opportunities for cooperation and business along with mutual knowledge sharing and promotion of various research works in the field of Ayurveda. The state government has requested the Union Ministry of AYUSH to establish an All India Institute of Ayurveda in the state, which will prove to be a milestone in the field of Ayurveda education and research, Dhami said. He also spoke about steps being taken by the state government to continuously promote Ayurveda. Dhami said 300 AYUSH-based ‘Ayushman Arogya Kendras’ are being operated in the state, while AYUSH consultation is being given by more than 70 experts through the e-Sanjeevani portal. He further said that 50-bed AYUSH hospitals are being set up in each district, while one village in each district is being established as a model AYUSH village to promote the production of Ayurvedic herbs. The chief minister said the state government has implemented the ‘Ayush Policy’ to accelerate the production of AYUSH manufacturing, wellness, education, research and medicinal plants. Along with this, the state government will start AYUSH tele-consultation in the coming years and set up 50 new yoga and wellness centres. The chief minister requested the experts to promote the English names of herbs along with their Hindi names, which will facilitate the access of local herbs to the global market. Union Minister of State for AYUSH (Independent Charge) Prataprao Jadhav said the initiatives taken in the field of AYUSH during the last 10 years have led to an eight-fold increase in the production of AYUSH products. Now, AYUSH and herbal products are being exported to more than 150 countries of the world, he said. The Union minister said that Ayurveda is also now moving forward by adopting the technology of Artificial Intelligence and Machine Learning tools. Jadhav said the central government is trying to establish AYUSH medicine centres at district, tehsil and village level to make all the medicines of Ayurveda available under one roof. The first such centre has been started in All India Institute of Ayurveda, Delhi. He said that with the opening of such centres across the country, AYUSH doctors will be able to easily prescribe Ayurvedic medicines to patients. He said that the World Ayurveda Congress will prove to be a confluence of new ideas, ancient culture and innovations. Source: Healthworld

Dec 13,2024 New Delhi: The incidence rate of tuberculosis (TB) in India has shown a 17.7 per cent decline from 237 per 1,00,000 population in 2015 to 195 per 1,00,000 population in 2023, Union Health Minister J P Nadda told Lok Sabha on Friday. The TB deaths has reduced by 21.4 per cent from 28 per lakh population in 2015 to 22 per lakh population in 2023, he said while responding to a question. Shorter oral regimen for drug resistant TB was introduced in 2021. This intervention has improved treatment success rates of drug resistant TB patients from 68 per cent in 2020 to 75 per cent in 2022, he said. The government of India has implemented a National Strategic Plan (2017-2025) with a view to eliminating TB by 2025, five years ahead of the United Nation’s Sustainable Development Goal (SDG) target of 2030. The ministry implements the National Tuberculosis Elimination Programme (NTEP) under the aegis of the National Health Mission (NHM). “The NTEP has made significant efforts to make India TB free. The incidence rate of TB in India has shown a 17.7 per cent decline from 237 per 100,000 population in 2015 to 195 per 100,000 population in 2023. TB deaths has reduced by 21.4 per cent from 28 per lakh population in 2015 to 22 per lakh population in 2023,” the minister said. The steps taken by the government in all states and Union Territories (UTs) to achieve the mentioned goals include targeted interventions in high TB burden areas through state and district specific strategic plans, provision of free drugs and diagnostics to TB patients and active TB case-finding through campaigns in key vulnerable and co-morbid populations. The government has also initiated integration of Ayushman Arogya Mandir with TB screening and treatment services, private sector engagement with incentives for notification and management of TB cases, scaling up of molecular diagnostic laboratories to sub-district levels and expansion of coverage under Ni-kshay Poshan Yojana for nutritional support to TB patients, Nadda stated. The initiatives also include intensified Information, Education and Communication (IEC) interventions to reduce stigma, enhance community awareness and improve health seeking behaviour, convergence of efforts and resources of line ministries for TB elimination, provision of TB preventive treatment to contacts of TB patients and vulnerable population, tracking of notified TB cases through Ni-kshay portal and providing additional nutritional, diagnostic and vocational support to TB patients and household contacts under Ni-kshay Mitra initiative, the minister said. Source: Healthworld

Dec 13,2024 Geneva: After making a temporary effort to support their public healthcare spending during the peak pandemic phase, the World Health Organisation has reported that the governments across the world have cut down their average per capita spending on health in 2022 from 2021. Released on the Universal Healthcare Coverage Day, the 2024 Global Heath Expenditure Report by the World Health Organization (WHO) states, “that the average per capita government spending on health in all country income groups fell in 2022 from 2021 after a surge in the early pandemic years.” It also alarms that, “government spending on health is crucial to delivering UHC (Universal Healthcare Coverage) and its deprioritisation can have dire consequences in a context where 4.5 billion people worldwide lack access to basic health services and 2 billion people face financial hardship due to health costs. Speaking over the development Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said, “while access to health services has been improving globally, using those services is driving more and more people into financial hardship or poverty. Universal Health Coverage Day is a reminder that health for all means everyone can access the health services they need, without financial hardship.” As per the global healthcare advocacy body, during the COVID-19 pandemic in 2020–2022, public spending on health – mainly via government health budgets –enabled health systems to respond quickly to the emergency. Government funding ensured that more people were protected and more lives were saved, in particular population-based public health interventions, versus other health financing schemes, during times of health emergencies. “Public funding needs to budget for an affordable package of essential health services – from health promotion to prevention, treatment, rehabilitation and palliative care – using a primary health care approach”, the report added. WHO’s report also flags that, “protecting people from the financial burden caused by out-of-pocket expenditure is fundamental but on the contrary out-of-pocket spending remained the main source of health financing in 30 low- and lower-middle-income countries.” In 20 of these countries, more than half of total health spending in the country was paid for by patients out of their pocket, which contributes to the cycle of poverty and vulnerability. The World Health Organisation has been tracking the healthcare expenditure of countries for the last 25 years and has established a Global Health Expenditure Database which consists of health expenditure data of more than 190 countries since 2000–and the Global Health Expenditure Report, which has been published annually since 2017. Source: Healthworld

August 29,2024 New Delhi: The government will shortly notify a revised version of good manufacturing practices (GMP), at par with the World Health Organization (WHO) standards, for small pharmaceutical companies with an annual turnover of less than ₹250 crore. Companies with an annual revenue of up to ₹250 crore fall under the micro, small, and medium enterprises (MSMEs) category. As part of the government’s guidelines, which were announced in July 2023 and notified in December, drugmakers with an annual turnover of more than ₹250 crore were to compulsorily follow GMP within six months, while those with a turnover of less than ₹250 crore were supposed to do so over a 12-month period. “Already GMP is applicable for bigger companies that have annual turnover of ₹250 crore or above. The government notified the GMP guidelines last year on 28 December. However, smaller firms were given time for one year to create an enabling environment to comply with GMP rules. A revised version of the GMP at par with WHO standards is in the works and will shortly be notified to be effective from December onwards,” a government official aware of the matter said. The government is also doing risk-based assessment of these bigger companies to check whether GMP is being followed, and suitable action is being taken against errant companies, the official said on the condition of anonymity. Queries sent to a health ministry spokesperson remained unanswered till press time. Earlier this month, Union health minister J.P. Nadda said in parliament that more than 300 measures, including show-cause notices, production-halt order, suspension, cancellation of licences /product licences etc., were ordered based on the risk-based assessment of the drug firms by the state licensing authorities and Central Drugs Standard Control Organisation (CDSCO) under the provisions of the Drugs Rules 1945. Last year, the Centre revised Schedule M of the Drugs and Cosmetics Rules, 1945, which prescribes good manufacturing practices, or GMP standards for drug firms. GMP is a set of mandatory guidelines for pharmaceutical companies to maintain the quality of products by way of controlling the quality of raw materials, methods, machines, processes, personnel, facility and environment, among other things, used in the manufacture of pharmaceutical items. This revision of Schedule M was done in view of allegations of contaminated cough syrups manufactured by Indian firms that were allegedly linked to deaths of children in developing countries, including 66 in Gambia and 68 in Uzbekistan in 2022. The GMP compliance would secure India’s image as the pharmacy of the world and bring the country’s drug manufacturing capability at par with global standards, especially those issued by the WHO. Moreover, this would ensure the production of globally-acceptable quality of drugs. Mint recently reported about the Drugs Controller General of India (DCGI) considering issuing and renewing licences only to those pharmaceutical firms that can prove they follow GMP. There are around 10,500 drug manufacturing units in India, of which around 8,500 fall under the MSME category. “We are educating our member companies on the GMP guidelines and how to work on it. Workshops are being created on the same. However, one year’s time was a very a little period to do such a mammoth task. It is easier to start a new factory than to upgrade the existing one and this activity consumes a lot of time. We have submitted our request to the Union health minister and Drugs Controller General of India to extend our deadline,” said Harish Jain, president, Federation of Organizations of Pharmaceutical Entrepreneurs (FOPE), an association of MSME drug firms. Source: Livemint

August 27,2024 New Delhi: Union Minister Prataprao Jadhav on Monday said special medical stores will be opened in every tehsil of the country to ensure adequate availability of AYUSH medicines. The Union AYUSH Minister also said the government is mulling on ways to ensure Ayurvedic medicines based on traditional knowledge get due recognition. “Only a few AYUSH medicines are available in common medical stores, due to which patients and doctors prescribing these medicines face problems. The government wants to ensure AYUSH drugs come into the market in abundance after research. These medicines should be available everywhere. For this, we are trying to open at least one special medical store of AYUSH medicines in every tehsil of the country,” he said. AYUSH hospitals are also being opened at the tehsil level, said the minister, who also visited medical institutes in Indore, Dewas and Ujjain and reviewed facilities there. Source: Healthworld

August 26,2024 As the globe faces a rise in antibiotic-resistant bacteria – making traditional antibiotics ineffective – specific viruses could offer a solution. Viruses called bacterio phages, or phages, target bacteria but can’t infect humans or other higher organisms. Phages inject their DNA into the bacterial cell, multiply to large numbers using the resources of the host, and then burst out to infect more bacteria in the vicinity. Essentially, they are a naturally occurring, self-replicating and specific antibiotic. Discovered more than 100 years ago, their use against bacteria was largely sidelined in favour of antibiotics. Our new research looked at one particular protein used by phages to bypass the natural defences of bacteria. We found this protein has an essential control function by binding to DNA and RNA. This increased understanding is an important step towards using phages against bacterial pathogens in human health or agriculture. Bacterial defence systems There are hurdles to using phages to target bacteria. Much like our bodies have immune mechanisms to fight off viruses, bacteria have also evolved defences against phage infections. One such defence are “clustered regularly interspaced short palindromic repeats”, or CRISPR, now better known for its applications in medicine and biotechnology. CRISPR systems in general act as “molecular scissors” by cutting DNA into pieces, be it in a lab-based setting or, in nature, inside a bacterium to destroy a phage. Imagine wanting to use a phage against an antibiotic-resistant bacterial infection. The only thing standing in the way of that phage killing the bacteria and eradicating the infection might be the bacterium’s CRISPR defence which renders the phages useless as an antimicrobial. That’s where knowing as much as possible about phage counter-defences becomes important. We are investigating so-called anti-CRISPRs: proteins or other molecules that phages use to inhibit CRISPR. A bacterium that has CRISPR might be able to stop a phage from infecting. But if the phage has the right anti-CRISPR, it can neutralise this defence and kill the bacterium regardless. The importance of anti-CRISPRs Our recent research focused on how an anti-CRISPR response is controlled. When faced with a powerful CRISPR defence, phages want to automatically produce large amounts of anti-CRISPR to increase the chance of inhibiting CRISPR immunity. But excessive production of anti-CRISPR prevents the replication of the phage and is ultimately toxic. This is why control is important. To achieve this control, phages have another protein in their toolbox: an anti-CRISPR-associated (or Aca) protein that frequently occurs alongside the anti-CRISPRs themselves. Aca proteins act as regulators of the phage’s counter-defence. They make sure the initial burst of anti-CRISPR production that inactivates CRISPR is then rapidly dampened to low levels. That way, the phage can allocate energy to where it is most needed: its replication and, eventually, release from the cell. We found this regulation occurs at multiple levels. For any protein to be produced, the gene sequence in the DNA first needs to be transcribed into a messenger-RNA. This is then decoded, or translated, into a protein. Many regulatory proteins function by inhibiting the first step (transcription into messenger-RNA), some others inhibit the second (translation into protein). Either way, the regulator often acts as a “road block” of sorts, binding to DNA or RNA. Intriguingly and unexpectedly, the Aca protein we investigated does both – even though its structure would suggest it is merely a transcriptional regulator (a protein that regulates the conversion of DNA to RNA), very similar to ones that have been investigated for decades. We also examined why this extra-tight control at two levels is necessary. Again, it seems to be all about the dosage of the anti-CRISPRs, especially as the phage replicates its DNA in the bacterial cell. This replication will invariably lead to the production of messenger-RNAs even in the presence of transcriptional control. Source: Healthworld

August 26,2024 New Delhi: An affordable tuberculosis testing technology that can detect the disease using a patient’s sputum for just Rs 35 has been developed by apex medical research body ICMR’s regional centre in Assam’s Dibrugarh. The ‘A CRISPR case-based TB detection system ‘ is light, portable and involves three steps of testing. Over 1,500 samples can be tested in one single run in around two-and-half hours, ICMR sources said. Conventional diagnostic techniques for TB commonly rely on culture, which requires 42 days to confirm as TB negative, microscopy, and nucleic acid-based methods. These are also time-consuming and may require sophisticated equipment. An official said, “Tuberculosis (TB) remains a global health challenge, necessitating the development of accurate and rapid diagnostic tools for effective disease management. Current diagnostic methods often exhibit limitations in terms of sensitivity, specificity, speed and cost, emphasising the need for innovative approaches”. Additionally, some molecular diagnostic methods, while offering improved sensitivity, may lack the desired specificity or face challenges associated with cost and ease of handling. “Considering these problems, the CRISPR-Cas12a-based molecular diagnostic system ‘GlowTBPCRKit’ coupled with an amplification step (using thermal cycler) and the ‘ RapidGlow device ‘ provides a promising solution,” the official said. The Indian Council of Medical Research (ICMR) has now invited Expression of Interest (EoI) from eligible organisations, companies, manufacturers for undertaking ‘Transfer of Technology’ for commercialisation of the ‘A CRISPR case-based TB detection system’ for the detection of Mycobacterium tuberculosis. The ICMR-RMRCNE institute will provide expert guidance and technical support for the production of ‘A CRISPR Cas based TB detection system’ in all phases. Such technical oversight by the institute would accelerate the development of the product and its commercialisation. The ICMR would also provide technical support through its team of experienced scientists in study, planning, product development, development of study protocol, results or data analysis, outcome assessment, safety and efficacy assessment, product improvement, etc., if deemed fit upon the mutual understanding between ICMR and collaborative company. The apex health research body through its institutes would provide support and facilitation to conduct the research and development or clinical study of new technology or product in India through its affiliates or institutes, in collaboration with the company and institutions in a professional and mutually agreed upon manner and timelines. Source: Healthworld

August 24,2024 The Central Drugs Standard Control Organisation (CDSCO) has released a list of 70 drug samples declared as Not of Standard Quality (NSQ), with samples of drugs labelled as manufactured by some of the major companies failing the quality test. The State drug regulators have reported 13 NSQs to the CDSCO in the prescribed format, while CDSCO released the list of 57 NSQs during the month. During July also a large number of States and Union Territories did not submit any data related to NSQ alert to the CDSCO, it reported. The list of drugs failed the quality test by the CDSCO and Central Laboratories during the month of July include samples of budesonide nebuliser suspension BP (Budecort Respules) and tamsulosin and dutasteride tablets (Urimax-D) labelled as manufactured by Cipla Ltd, amoxycillin and potassium clavulanate tablets IP (Pressclav625) labelled as manufactured by Aurobindo Pharma, and carboplatin USP labelled as manufactured by Hetero Labs. Samples of compound sodium lactate injection (Ringers Lactate Solution for Injection) labelled as manufactured by public sector enterprise Hindustan Antibiotics Ltd, and ofloxacin and ornidazole tablets and paracetamol tablets IP 650 mg labelled as manufactured by Karnataka Antibiotics and Pharmaceuticals Ltd were also declared as NSQs by the CDSCO. Even though the labels claim major companies as manufacturers of these failed products, in the past some of these companies have informed the regulator that the samples were not manufactured by them and are spurious drugs. The list of drug samples declared as NSQ by the state laboratories include new improved gentle daily care natural protein shampoo labelled as manufactured by Himalaya Wellness Company, and several drugs supplied by Kerala Medical Services Corporation, among others. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Telangana, Uttarakhand, West Bengal have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of July, 2024 as per DCG(I) Circular dated February 9, 2024, said the CDSCO. The Union Territories which failed to submit the data include Delhi, Pondicherry, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep. Besides, NSQ data was not received as per the format in Excel sheet prescribed by the DCGI’s circular from the State Drugs Licensing Authorities of Karnataka and Jharkhand for the month of July, 2024. It may be noted that the CDSCO has changed its data releasing format related to NSQs for the public, from the month of May, and started publishing the names of States and Union Territories which are not submitting the monthly data on NSQ to the Central drug regulator in the stipulated format within the time limit. Interestingly, the CDSCO also stopped publishing the drugs which are suspected or reported as spurious, while the data was part of its earlier data format. The 63rd Drugs Consultative Committee (DCC) meeting held at the end of January sought the State drug regulators to submit data related to NSQs and spurious drugs on a monthly basis. The committee also mooted preparing a list of manufacturers who repeatedly produce NSQ drugs and black list them. The Committee also noted that only a few states are sharing the NSQ data with the central authority on a monthly basis and called for all the States to share the data periodically and in a timed manner for publication on the website. During the meeting, the Central drug regulator sensitised all the States to look into the matter regarding any difficulties and to send the NSQ data periodically and in a timely manner, so that the information can be compiled and published on the website for the attention of all the stakeholders. Source: Pharmabiz