October 2024

Oct 6, 2024 New Delhi: India’s apex health research body, ICMR, will undertake a study to evaluate the efficacy of two Polycystic Ovarian Syndrome (PCOS) drugs in improving fertility and bilth outcomes among women suffering from the ovarian condition. The drugs that have been recommended by experts for this purpose are Metformin and Inositol which are used in the treatment of the condition. The ICMR has recently invited expression of interest (EOI): “To undeltake a multi-centric randomised controlled trial for evaluating the efficacy of Metformin vs Inositol to improve fertility and bilth outcomes among PCOS women”. Polycystic Ovarian Syndrome (PCOS) is a complex disorder ranging from mild to severe clismptions in reproductive, endocrine and metabolic functions, with key features including irregular menstrual periods (anovulation), hyperandrogenism, insulin resistance and abnormal gonadotropin secretion. The prevalence of infertility in women with PCOS is high, varying between 70 and SO per cent, the ICMR said in the Eol document. Moreover, PCOS women have been found to have increased prevalence of pregnancy complications and less favourable pregnancy outcomes (live births, miscarriage, pregnancy rate) compared with women without PCOS, it stated. In contemporary practice, the use of Metformin and Inositol for the treatment of PCOS is widespread. ‘However, present evidence on the efficacy of these two drugs in terms of improvement in fertility and other related outcomes is insufficient,” the ICMR said in a document. A Finnish study suggested that, as compared to placebo, metformin improved the pregnancy rate, live birth rate and ovulation rate in the studied population, the document said. However, a Cochrane review with meta-analysis including three other smaller studies repoltecl that as compared with placebo, metformin may have only marginal benefit for live birth rate outcome. Additionally, there is very limited data available globally on the effectiveness of Inositol for PCOS women, especially for birth outcome and cycle regulation. “Evidence on the efficacy of both metformin and inositol in the Indian context is almost non-existent. To address the knowledge gap and to generate evidence on the management of PCOS for improving bilth outcomes in the Indian context, the current ICMR call is being proposed,” the document said. The ICMR is looking to partner with interested researchers for the development of a multicentre randomised controlled trial for the management of PCOS in Indian women. The selected researchers shall be invited to join the research team and shall collaborate to develop a full research proposal and roll out the multi-centre research project which will be coordinated by ICMR, the document said. The research question is “Among women with Polycystic Ovary Syndrome (PCOS), how does inositol in comparison to metformin work in terms of efficacy and safety on outcomes including pregnancy conception, menstrual cycle regularisation, and improvement in endocrinological and metabolic parameters?” Source: Economic Times

Oct 6, 2024 New Delhi: The word ‘psychedelic’ evokes images ofwild, mind-bending trips straight out of the 1960s. But what if the same ‘trippy’ substances used in drugs like LSD and magic mushrooms could be harnessed to treat mental health issues? A new study may have unlocked the way. A team at the Tata Institute of Fundamental Research (TIFR) in Mumbai have steered a first-of-its-kind study to come out of India, using a psychedelic to identify a neuron that can activate the ventral hippocampus in the brain—which processes emotional information and regulates stress—in a manner that could alleviate anxiety. “People’s first reaction to psychedelics is often alarmist. But substances like LSD, a synthetic psychedelic, psilocybin, found in magic mushrooms, and mescaline, derived from cacti, have been used extensively by traditional healers for thousands of years—by ancient tribes from the Amazonians to the Incas in Central and South America long before they became symbols of rebellion,” says Vidita Vaidya, a neuroscientist and professor of biological sciences at TIFR who led the project. Targeting the ventral hippocampus could help reduce anxiety at both cellular and neural levels, she says. “And using a psychedelic climg as a tool to achieve this opens the door to more targeted treatments for anxiety disorders, as well as the development of psychedelic-inspired medications for treatment-resistant mental health conditions like PTSD and depression without triggering hallucinations,” she adds. The drug used in their study is a synthetic one called DOI, designed by Alexander Shulgin in 1984. “Because of regulat01Y hurdles in India, we can’t import LSD or psilocybin to work with. That’s why we worked with DOI, which is potent but isn’t a common street drug and hasn’t been abused like LSD or psilocybin. However, it belongs to the same umbrella of psychedelics which alter states of reality,” says Vaidya, whose journey with DOI dates back to her days as a PhD student. “I’ve looked at it from multiple angles. It has profound, diverse effects — as an antidepressant, it produces hallucinations, reduces anxiety. We’ve also studied its ability to change mitochondria (the energy that cells need to function). Our main question was, how does DOI reduce anxiety?” To confirm that it actually does, the team used an ‘elevated plus maze’ an apparatus with open and closed arms used to measure anxiety in rodents. “We observed whether after being injected with DOI, they’d explore more open and risky areas. And they did. This was the first step, it confirmed that DOI reduces anxiety in rats and mice.” But there were still gaps in understanding “where in the brain” this was happening. “When my student Prachi Tiwari expressed her desire to delve deeper into this for her PhD thesis, I told her, ‘this is a meaty problem that’ll need multiple approaches,’ but she was determined,” says Vaidya. What staltecl five years ago as a challenge, grew into a collaborative effort that extended far beyond their TIFR lab as a multi-institutional study with researchers from Cornell, Yale, and Columbia universities, all working together. “So, it became an international eff01T as we brought in peers from all these universities to conduct experiments that our collaborators could help us answer faster,” says Vaidya. After several trials on rodents, the ventral hippocampus was identified as a key target for DOI in reducing anxiety. But they still faced a challenge. “It’s a part of the brain with millions of different cell types. We suspected it might be a specific group of neurons but weren’t sure,” says Vaidya. That’s when Cornell helped identify a “PV-positive neuron” that was hyperactive when the drug was present. Vaidya broke it down with a simple analogy: “Think of the brain as a map of Mumbai. We knew that DOI worked, kind of like knowing something is happening in a busy city like Mumbai. But we didn’t know exactly where. So, we had to search neighbourhood by neighbourhood—until we found Marine Drive, which represents the ventral hippocampus. Even then, it wasn’t just any building, but the specific AIT Deco ones. That’s our PV-positive neurons. Once we knew that, we could target just those neurons, to get the anxiety-reducing effect without needing the whole drug.” The discovery was significant, given that these neurons reduce anxiety without triggering hallucinations. “By understanding how these psychedelics work at a deeper level, we can design drugs that target those parts of the brain responsible for reducing anxiety without unwanted effects like hallucinations. Some colleagues are already designing psychedelic-inspired drugs that don’t produce hallucinations or motor effects.” Vaidya, whose scientific career has centred on the ‘neurobiology of emotion’ has been discussing her findings with experts at NIMHANS, to move the research from lab to clinical trials. “But India currently lacks clinical trials for psychedelic-assisted therapy…Australia, Europe and the US are moving fcnward with major, carefully controlled trials,” says Vaidya. Biju Viswanath, additional professor of psychiatry at NIMHANS, specialising in the effects of psychotropics on neural stem cell lines, said current medications for anxiety and depression take weeks to be effective and leave patients at risk during that waiting period. “Especially since around 50% of patients don’t respond to existing pharmacological treatments,” he said. “Exploring a new class of agents using animal models is a promising approach.” But he cautions that clinical trials in India may still be far off due to their high abuse potential. Vaidya shares his frustration. “Our regulatory knots make it hard to conduct this kind of research in India,” she says, as she prepares to present this research at the 2025 Gordon Research Conference on Neurobiology of Psychedelics at Rhode Island. “We need to stop playing catch-up…Right now, we have too few psychedelic researchers. That’s not good for a nation facing a growing mental health crisis. Source: Economic Times

Oct 5, 2024 Hyderabad: The fast-selling iron tablets have been found to be the most abused by illegal manufacturers, followed by vitamin D, zinc, and folic acid tablets as per the raid data for Sept with the Drugs Control Administration. Iron tablets are widely used in post-surgical cases, anaemia and pregnancy, making the circulation of illegally manufactured medicines highly dangerous, DCA officials said. “Suppose a patient requires iron in their body due to surgery, pregnancy or any other reason. Having such drugs could mean not getting the required iron. In such cases, the generalised weakness in the body will increase and can also result in malnutrition, neuropathy and healt failure. This can be life-threatening. In the case of pregnant women, it can lead to growth retardation of the baby,” said Dr Prabhu Kumar Challagali, general physician and anti-quackely chairman for Telangana, Indian Medical Association (IMA). Among the 14 medicines seized in Sept, eight were of different combinations of iron — primarily ferrous ascorbate, zinc, and folic acid. The seized drugs were manufactured in Telangana as well in other states. For instance, Ferrorus-XT tablets (ferrous ascorbate, folic acid & zinc tablets) found in Bhupalpally were manufactured in Kavadiguda. Ferin- XT tablets (ferrous ascorbate, folic acid & zinc tablets) found in Malkajgiri were manufactured at a unit in Mallapur, while Ferisyn-XT tablets (ferrous ascorbate & folic acid tablets) found in Pedapalli were manufactured in Haryana. Medicines manufactured and sold under a food licence are not produced in accordance with good manufacturing practices and often fail to meet quality standards, DCA officials said. “We have previous samples that have zero active ingredients in several cases. Such products pose serious risks to patients’ health and may have severe implications,” said VB Kamalasan Reddy, director general of DCA Telangana. Source: Economic Times

Oct 11, 2024 New Delhi: An analysis of calls received on Tele- Manas – India’s toll-free mental health helpline – has revealed that most people call for complaints related to disturbed sleep cycle. Since its launch in October 2022, Tele-Manas has attended to over 3.5 lakh calls from citizens across the countlY. According to the assessment report on Tele-Manas that was released by the govt on Thursday, an overview of the type of complaints shows that the top four complaints relate to sleep disturbances (14 per cent), sadness of mood (14 per cent), stress-related (11 per cent) and anxiety (9 per cent). Overall, less than 3 per cent of total complaints have been identified as suicide-related cases, the report suggests. Majority of the callers on Tele- Manas helpline are male (56 per cent) and aged 18-45 years (72 per cent), it adds. A 20-year-old young female student turned to Tele-Manas for help when sleep disturbances began to disrupt her life. According to the government report, it emerged that living in a hostel with some friends, her sleep cycle had fallen into disarray due to excessive use of cell phone and laptop. Officials said that the overall profile of usage suggests that the majority of the complaints received on Tele-Manas are for common mental disorders. Source: Economic Times

Sep 18, 2024 Lucknow: A recent study conducted by faculty at Indian Institute of Management Lucknow tackles the critical issue of low menstrual cup adoption rates in developing countries, particularly in India, despite their numerous benefits. The findings of this research have been published in the Journal of Social Marketing, in a paper co-authored by Prof Priyanka Sharma, Department of Marketing, 11M Lucknow, alongside Dr Rinku Sanjeev and Smriti Shukla from the Symbiosis Centre for Management Studies, Noida, and Symbiosis International (Deemed University), Pune, India. Titled ‘What Drives Women to Adopt Menstrual Cups? The Integration of Consumer Values and Theory of Planned Behaviour’, the study investigates the various factors influencing women’s intentions to adopt menstrual cups, focussing on how perceived values—functional, emotional, conditional, epistemic, and environmental—impact these adoption decisions. The findings reveal that emotional values play a significant role in shaping women’s attitudes towards menstrual cup adoption. Additionally, factors such as the desire for knowledge, price sensitivity, quality considerations, and environmental awareness greatly influence adoption intentions. Highlighting the impoltance of this research, Prof Sharma said, “Adopting menstrual cups in India can revolutionise feminine hygiene by promoting health, comfort, and environmental sustainability, reducing waste and infection risks for millions of women. It is a vital step toward empowering women with safer, eco-friendly choices. Prioritising menstrual health is key to fostering well-being and dignity for women across the nation.” One of the major challenges of this study was addressing a topic that is often considered taboo in Indian society. Women are generally uncomfortable discussing menstrual health, making data collection difficult. However, as the research underscores, menstntal health is clitical not just for individual well-being, but for larger societal development. It also aligns with the UN Sustainable Development Goals Goal 3 (Good Health and Well-being) and Goal 6 (Clean Water and Sanitation). The study contributes to these global objectives by paving the way for both theoretical and practical advancements in menstmal health. The insights gained from this research can be instrumental for social marketers and policymakers aiming to promote menstrual cup usage. By emphasising the emotional value of menstrual cups and showcasing their sustainable benefits, such as reducing environmental waste, marketing campaigns can be designed to encourage more women to make the switch. What sets this research apart is its application of the value-attitude- behaviour framework, an area that has seen limited exploration concerning menstlual cup adoption in developing countries. This innovative approach not only enhances understanding of the barriers and motivators associated with menstrual cup use but also provides a solid foundation for future studies in this critical field. This study represents a significant step towards increasing awareness and acceptance of menstrual cups among women in India, ultimately promoting better health and environmental sustainability. Source: Economic Times

Oct 9, 2024 Disruptive technologies such as AI, digital diagnostics and therapeutics, and machine learning (ML) are revolutionising healthcare by enabling unprecedented growth and innovation. 79per cent of the healthcare organisations are utilising generative AI and indust1Y is transforming at a rapid pace. AI is enhancing patient care and management, through telemedicine, drug discovery, imaging analysis, monitoring, and predictive analytics, while raising challenging questions of law relating to professional malpractice, privacy and product liability claims. Key legal risks One of the key issues facing AI arises from the limitations of uploading data into its algorithm for ML. As the quality of AI depends upon the quality of data used to train, the risk of data inputs being incomplete, selective, or manifesting a narrow understanding or unrepresentative of the total population and potential bias cannot be underestimated in healthcare. Extensive monitoring of information used for algorithm, assessment of benefit-risk profile for intended use and evaluation for potential bias is therefore pertinent to avoid legal consequences for stakeholders. AI misinformation or inaccuracy poses a considerable risk in healthcare, where precision is paramount. While AI fosters innovation, it also amplifies the risks of wrongful diagnosis or treatment, generating plausible but incorrect or misleading information, making it crucial for healthcare professionals to critically evaluate and validate outputs. AI’s inaccurate diagnosis may have multiple liability and costs ramifications. AI’s data intensive nature exposes patients’ personal and sensitive health records vulnerable to cybersecurity and privacy breaches. Healthcare organisations must implement robust security protocols to prevent data breach. Recent data breaches in India include the ransomware attack on the All India Institute of Medical Sciences and data leak from the Indian Council of Medical Research, highlight existing vulnerabilities of the Indian healthcare system. Statutory and common law compliance impacts all stakeholders. While India is yet to implement a comprehensive legislation regulating the use of AI in healthcare, experience from other matured jurisdictions may help in developing a robust and efficient legal framework. The World Health Organisation (WHO) mandates the regulation of digital and public health, the United Nations Charter and European Union’s international health regulations also require harmonisation of regulations governing AI use in healthcare. However, operators currently need to navigate complex regulatory landscapes to avoid liability based on local requirements. Most AI tools leverage preliminmy open-source content and is amenable to greater infringement claims. Understanding the ownership and licensing of AI technology is crucial to prevent infringement claims. Determining liability attributed to AI related inaccuracies, across multiple stakeholders (hospital, developer, licensor, and physicians) is challenging. Transparency in AI’s decision-making processes is vital to ensure accountability. For example, ethical issues may arise in AI driven diagnosis, which often lacks transparency, making it difficult for physicians to explain the reasoning behind a decision, and allocate responsibility for any liability particularly when disclosing the underlying AI bias to the patients. AI also raises antitrust concerns as its’ use can lead to algorithmic collusion among competitors, inadvertently fixing prices, which is closely scmtinisecl by competition law authorities. While attribution of liability in cases involving ‘algorithmic collusion’ is evolving, it is impoltant to assess this risk and consider monitoring algorithmic pricing tools to detect and prevent such situations. Medical liability Medical negligence under torts would typically consider severity of the injmy, expected standard of care and the AI tools’ causal relationship to the injmy to allocate liability. Under vicarious liability, operators may be held liable for the acts or omissions of the doctors or employees. An AI tool construed as a product, may entail strict or product liability (depending upon severity) or design defect claims against the developers, manufacturers or licensors, while wrongful operation of AI, may trigger professional malpractice claims. An AI tool deployed may be considered as an agent of the organisation or physicians using it, capable of holding the principal liable for breach. Jurispmclence is rapidly evolving with application of AI in healthcare becoming an integral part of patient care. The Texas Coult of Appeals (June 2024) held an AI based medical device manufacturer liable for a defective product, for providing an erroneous guidance to a surgeon. The U.S. Comt of Appeals (November 2022) held the developer and seller of a drug-management software liable for a product liability and negligence claim due to a defective AI user interface, leading physicians to mistakenly believe they had scheduled medication, which had not been scheduled. The Supreme Coult of Alabama (May 2023) held a physician liable for relying upon an erroneous AI software recommendation for cardiac health screening that wrongly classified a young adult with a family history of congenital healt defects as normal. Risk mitigation strategies To mitigate risks associated with AI in healthcare, stakeholders must upskill their workforce with comprehensive manuals, trainings on safe usage and troubleshooting errors. Developers must transparently disclose information around existing biases, providing mechanisms to explain decision making and develop processes for data security. Operators should also inform patients on AI usage and its role in their diagnostic or treatment decisions, obtain informed consent from patients’, providing an oppoltunity to withdraw consent, anonymise sensitive information and establish multiple layers of encryption. Appropriate risk allocation methods and strategies should be adopted by operators specifically identifying the obligations for cultailing liability, indemnification and insurance coverage in case of erroneous output or misuse. Conclusion Despite the foreseen risks, diverse benefits of using AI in healthcare, make its adoption an imperative for continued relevance and maintaining a competitive edge, unveiling a landscape brimming with potential and complexity. AI adds efficiency and innovation to the forefront, subject to its actors understanding and mitigating the risks and associated liability, to foster a transparent and ethical environment of trust. This article has been written by Aditya Patni, Paltner and Achint Kaur, Counsel at Khaitan & Co. Source: Economic Times

Oct 11, 2024 New Delhi: The Insurance Regulat01Y and Development Authority (Irdai) is intensifying scrutiny of cyber security lapses in the insurance sector after Star Health Insurance, one of the country’s largest health insurers, suffered a major data breach. Over 31 million customers’ sensitive personal information was allegedly sold to hackers, seen as one of the most severe breaches in the insurance industry. “Irdai sees this data leak as a very serious issue,” a person said, adding that other insurers would also need to review their data security policies. “As more sensitive data flows into insurance firms, there is a need for stronger cybersecurity. The regulator wants to ensure that every insurer applies the best possible security measures, including regular audits and updates to safeguard data.” Irdai will wait for an audit report to identify the gaps and issue instiuctions. The regulator has asked Star Health to extensively audit the company’s cybersecurity framework. The audit, led by an external firm, is expected to identify control gaps and recommend compliance measures to prevent future data thefts. The breach, linked to the company’s chief information security officer (CISO) Amarjeet Khanuja, surfaced after a hacker going by the alias “xenZen” claimed Khanuja had sold the data and later tried to renegotiate for more money in exchange for continued backdoor access. Source: Economic Times

Oct 8, 2024 The Union Ayush Ministry on Tuesday (October 08, 2024) said it was illegal to advertise Ayurveda, Siddha, Unani, and Homeopathy drugs claiming “miraculous or supernatural effects” for the treatment of diseases, stating such advertisements can “mislead and endanger” public health. In a public notice, the Ministry clarified it neither certifies or approves any Ayurvedic, Siddha, Unani and Homeopathic (ASU&H) company or its medicine nor grants license to manufacture for sale to any ASU&H manufacturer or company. Further, as the extant provisions of the Drugs and Cosmetics Act, 1940 and the rules thereunder, the license of manufacture for sale of any ASU&H drugs is granted by the state and Union Territory Licensing Authority of the concerned State and Union Territory. “It is illegal to advertise ASU&H drugs claiming miraculous or supernatural effects for the treatment of diseases. Such advertisements can mislead and endanger public health by promoting unverified or false claims,” the Ministry said. The Ministry further stated that The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, strictly prohibits the advertisement of drugs and magic remedies for the treatment of certain diseases and conditions. Any person found guilty of contravening this Act shall be liable for penalties as prescribed under the law. The Ayurvedic, Siddha and Unani (ASU) drugs containing Schedule El drugs are mandated to be consumed under the supervision and guidance of a registered medical practitioner of the concerned system of Ayush medicine, the public notice said. The container of such medicines will have instructions on its label — “Caution to be taken under medical supervision” — in both Hindi and English languages, it said. “General public are advised to use such medications only after consultations with registered medical practitioners/doctors of concerned Ayush systems,” the Ministry said. It further warned that self-diagnosis or self-medication with Ayurveda, Siddha, Unani & Homeopathy (ASU&H) drugs/medicines should be avoided. “Public is also encouraged to report any such objectionable advertisements, false claims, fake medicines etc to the concerned State Licensing Authority or the Ministry of Ayush for an appropriate action,” the notice stated. Source: The Hindu

Oct 5, 2024 New Delhi: While disposing of a batch of more than 100 petitions moved on behalf of patients suffering from Rare diseases, the Delhi High Coult said that the Right to health is an integral part of the right to life. Justice Prathiba M Singh on Friday directed the Central Government to set up the National Rare Disease Fund (NRDF) for which Rs. 974 Crores will be allocated. The bench said that this fund should be utilised for the treatment of persons suffering from rare diseases. It is also directed that the disbursement of funds will be monitored by a mandat01Y monthly and to identify delays if any. The first meeting should be scheduled within 30 days. A detailed copy ofthe judgement is yet to be uploaded. The High Court has passed a number of directions. The High Court directed that the National Rare Disease Committee formed on May 25, 2023, shall continue to work for the next five years. “The Union government shall create a national fund for rare diseases and a fund of Rs. 974 Crore as per the recommendation of NRDC and pending approval of the Minist1Y of Health shall be allocated for the year 2024-25 and 2025-26,” the High Court ordered on Friday. While pronouncing the judgement on 105 petitions, the High Court said Treatment and medicine should be provided to all patients suffering from rare diseases. The fund shall not be lapse or refunded on the grounds of non-utilisation. The High Court was dealing with petitions seeking free treatment to patients suffering from Rare Diseases. (ANI) Source: Economic Times