PSM News

Nov 09, 2024 New Delhi: Many ethical concerns are raised when it comes to the In Vitro Fertilization (IVF). In vitro fertilization (IVF) is an innovative medical procedure that has transcended the boundaries of traditional conception methods, offering hope to countless couples who are battling infertility challenges. It is one of the common alternatives chosen by couples to conceive, especially in cases of blocked fallopian tubes in females, male factor infertility, recurrent miscarriages, endometriosis, or diminished ovarian resewe. During this procedure, the eggs and sperms are combined outside the body in a controlled laborat01Y environment, and the resulting embryo is transferred back into the uterus with the aim of fulfilling the dream of having a baby. When exploring the option of in vitro fertilization (IVF), one cannot overlook the ethical complexities that are linked to this popular technique and one such pertinent question which remains unanswered is— the optimum number of embryos to be transferred during IVF. More the number of embryos transferred, more are the chances of multiple pregnancies. This is done to maximize pregnancy rates in order to sustain the competition between IVF units, and making the treatment more cost- effective. The practice of multiple embryo transfer can pose serious risks to both the mother and the infants. Almost every obstetric complication happening in a singleton pregnancy is more common in multiple pregnancy and even routine life after delivery is more difficult for the parents with increased incidences of anxiety and depression. Risks to the children can be due to premature delivery, complications of intra- uterine growth retardation and all these can have short term and long term ill effects on the babies. Further, the health care costs related to the management of these complications increase and higher number of multiple pregnancies can be a public health issue. However simply stating that multiple pregnancy has potential risks to both the mother and child doesn’t mean that multiple embryo transfer should be prohibited. There is a need for proper legislation on the number of emblyos to be transferred to curtail both the parental and physician autonomy. The parents have the right to decide as to how many children they want in their family and the IVF specialist has a moral obligation towards both the parents and the future child. Hence a conscious decision regarding the number of embryos to be transferred has to be made considering many factors because any risk to either the parent or the child may be morally and ethically unacceptable. The key component of IVF treatment is informed consent. In order to make decisions that are consistent with their beliefs and goals, couples must have a thorough understanding of the physical, emotional, financial, medical and ethical components of the procedure. This covers the risks and benefits of single embryo transfer vs multiple embryo transfer and also their choices about cryopreservation, embryo selection and genetic testing. The decision regarding performance and possibility of multifetal reduction should also be discussed in length. The ethical dilemmas of reduction is perceived as a problem of abortion. Regardless of the education provided before treatment, people may still consider decision to reduce the number of emblyos as psychologically demanding and it is better not to go to that stage where couples have to take certain decisions which may jeopardize their present pursuit. Hence prevention of multiple pregnancies should be preferred to multifetal reduction of pregnancy. Age, parity, diagnostic criteria and co-existing medical conditions are examples of patient variables that affect the decision-making process. Couples should be informed about the potential dangers and how these factors may affect the treatment outcome, since they have an impact on the overall success of IVF. Technological advancement such as pre — implantation genetic testing (PGT-A) offers the parents an opportunity to screen for aneuploidy or genetic disorders and provide optimal pregnancy rates after elective transfer of a single normal embryo. Another factor to be considered is concerns of couples on cryopreservation of emblyos as many of them tend to experience emotional distress and this should be well addressed. Finally—the—prognosis – patients need to know about their chances of success depending on their particular medical/ obstetrical background, their profile as a patient — poor responders or poor implanters, their infertility treatment history, the quality of the embryos and the clinic’s experience. This aids them in reaching practical decisions. The treating physician and the couple reach an agreement on the modalities of treatment. Finally as adults, patients should have an ultimate say on the treatment that they would wish to receive within the framework of risks vs benefits and all the associated treatment alternatives prioritizing health outcomes. This article is written by Dr. Vandana Bhatia, Fertility Specialist , Nova Southend Fertility and IVF, Vasant Vihar. Source: Economic Times

Nov 11, 2024 The department conducts raids on pharmacies showing unusually high sales and inspects the outlets. So far, 470 pharmacies have been raided. While action has been taken against 73 of them, 10 have been shut down, and their permits have been revoked. Dr Umesh S, drugs controller of the Karnataka Drug Control Department, stated, “We received several complaints from the police department and have strictly instructed all pharmacies not to sell painkiller tablets without a prescription. We are closely monitoring their purchase and sale.” Ramesh, a retired officer from the drug control department, remarked, “Earlier, addicts preferred Tramadol tablets, followed by Diclofenac. Now, Tempetedol tablets are in high demand among addicts. When one tablet is controlled, they switch to similar tablets from other manufacturers. The Union government must implement stricter regulations.” Ravish R, a drug control officer, noted, “A patient might have purchased 100 painkiller tablets within a month. When sales increase, the department monitors the situation. By tracking sales details, locations, and outlets, more than 50% of the unauthorized use of painkillers has been curbed.” Karnataka has a total of 53,000 pharmacies, with a significant 25,600 located in Bengaluru. Source: Daiji World

Oct 18, 2024 In an insightful interview with ETPharma’s Rashmi Mabiyan Kaur, DrAshish Gawde, CountlY Medical Director, Pharmaceuticals, South Asia, Bayer, discusses the significant challenges faced by patients with retinal diseases, including financial burdens, geographical disparities, and lack of awareness. Dr Gawde emphasizes the transformative role of technology, from AI to telemedicine, in revolutionizing the diagnosis and management of eye diseases. Edited excerpts below: Q. In your experience, what are the biggest challenges patients with retinal diseases face in accessing eye treatments? The most pressing challenges include the financial and emotional burdens associated with frequent, long-term treatments for conditions such as Diabetic Macular Edema (DME) and Wet Age-related Macular Degeneration (AMD). These treatments often need to be sustained over the long term, and this can impact adherence, as patients may prioritize immediate concerns over regular care. Access to timely and effective treatment for retinal diseases remains a significant hurdle for many patients. Additionally, geographical disparities can affect treatment access. Individuals in rural or underserved areas may need to travel long distances to reach specialized care, which can impact adherence and lead to delays in treatment. Furthermore, a lack of awareness about retinal diseases contributes to late diagnoses, with many individuals seeking treatment only after experiencing considerable vision loss. This highlights the urgent need for comprehensive education on early warning signs and the importance of routine eye examinations. To address these challenges, Bayer has implemented innovative patient support initiatives like the “Eylea 4 U” program, which ensures timely access to treatment. Collaborations with organizations such as Arogya Finance enhance our capacity to reach patients effectively, ensuring they receive the care necessary for optimal outcomes. Q. How has EYLEA changed the landscape of treatment for patients with retinal diseases? The launch of Eylea (aflibercept solution) has marked a pivotal shift in the management of retinal diseases such as wet AMD and DME. Eylea is clinically proven to be superior in efficacy to other treatment options available for retinal diseases. Now, with the new dose regimen, Eylea offers similar efficacy but with fewer injections. The dosing regimen can be personalized based on each patient’s unique needs. This advancement not only enhances patient adherence but also improves overall quality of life, allowing individuals to maintain greater independence in their daily activities. Eylea’s development reflects a broader movement toward personalized treatment strategies. This individualized approach ensures optimal care and minimizes the burden often associated with frequent injections in previous treatment regimens. Q. How do you envision the role of technology evolving in the treatment and management of eye diseases? The future of ophthalmology is being redefined by the rapid integration of technology, presenting exciting prospects for the diagnosis and management of eye diseases. Innovations such as artificial intelligence (AI) are revolutionizing diagnostic accuracy, enabling healthcare providers to detect conditions like Diabetic Retinopathy and AMD at earlier stages. This technological advancement ensures that patients receive timely interventions, ultimately preserving vision. Telemedicine also plays a transformative role, allowing patients in remote areas to access specialized care without the logistical challenges of travel. This increased accessibility is crucial for populations that may otherwise delay necessary treatment. Q. How is Bayer working towards making eye disease treatment options more accessible in India? We are committed to enhancing the accessibility of treatments for eye diseases across India, particularly in areas where specialized care is less available. We support patients with initiatives like the Eylea Easy Pay program, offering flexible and affordable payment options to improve access to Eylea (aflibercept solution) in India. Such initiatives provide manageable payment solutions for patients undergoing treatment for retinal diseases, reducing the logistical burdens associated with ongoing care and promoting adherence to treatment regimens. In addition to financial support programs, Bayer has established outreach initiatives that emphasize the importance of regular eye examinations and early intervention. By engaging with communities, we aim to educate patients on the risks associated with untreated retinal diseases and empower them to seek timely care. Q. How do you see the future of ophthalmology and treatments in eye care? The future of ophthalmology is on the brink of remarkable advancements, driven by continuous innovation in treatments and preventive care strategies. There is a palpable sense of optimism surrounding the development of new therapies, including gene therapies, that promise to offer solutions for genetic retinal disorders. As research progresses, breakthroughs are anticipated that will address conditions previously deemed untreatable, significantly enhancing the quality of life for countless patients. Moreover, the integration of technology — particularly artificial  intelligence and telehealth solutions  is expected to improve  diagnostic accuracy and broaden access to care. With a growing  emphasis on preventive measures, the goal is to reduce the incidence of  vision loss caused by conditions like Wet AMD and DME through early  detection and timely intervention. We are committed to playing a pivotal role in this evolving landscape by investing in the research and development of innovative therapies and forging partnerships that advance eye care. Our overarching aspiration is to create a future where preventable blindness is significantly reduced, and every individual has access to the comprehensive eye care they deserve. Source: Economic Times

Oct 25, 2024 Mumbai: The National Tuberculosis (T B) Elimination Programme has started training sessions for doctors to introduce BPaL, the shortest treatment for drug-resistant TB to date. BPaL, a combination of bedaquiline, pretomanid and linezolid, can treat drug-resistant forms of TB in just six months compared with the present average of 18 months. The treatment is expected to be launched in early Jan, following the completion of trainer-doctor training in all states over the next two months. DrVikas Oswal, a Chembur-based pulmonologist and member of the NTEP technical expert team, said, “On Wednesday, we completed the first national three-day training module on the new TB treatment guidelines and BPaL for Delhi’s doctors.” The training for Maharashtra’s public health doctors is scheduled to take place in Pune during the second half of Nov. The training-of-trainers programme must be completed in all states before the BPaL treatment can be implemented. BPaL has been eagerly anticipated and has already been introduced in more than 40 countries. Indian authorities approved the combination a few months ago, following the results of a three-year trial that demonstrated a 90% cure rate. The Indian trial involved 403 patients with drug-resistant T B, of whom 352 were cured while one patient with COPD passed away. Eleven patients experienced a recurrence, and 19 others had severe adverse reactions during the 12-month followup. The trial also confirmed that a daily dosage of 600mg of the antibiotic linezolid is as effective as the originally prescribed 1,200mg. “The Indian study proved that 600mg to 300mg of linezolid is also as effective as 1,200mg,” said Dr Oswal. The most significant advantage of BPaL for patients, compared to older regimens, is that only three tablets need to be taken daily, and there are no daily injections. Public health experts expect the shorter and fewer-drug regimen will lead to a decrease in the drop-out rate associated with MDR-TB. Source: Economic Times

Oct 25, 2024 New Delhi: Medical device makers have raised concerns over the import of refurbished medical devices into India, highlighting potential risks to patient safety and violations of the medical regulat01Y framework. Lobby groups have asked the health minister JP Nadda to intervene and recall the policy that allows unregulated influx of second-hand medical equipment such as CT scanners, MRI machines, and surgical robots into the country. The ministry of environment, forest and climate change recently issued a memorandum stating a revised list of high end and high value used or refurbished medical equipment. According to Rajiv Nath, forum coordinator, AiMeD, the office memorandum is in violation ofthe National Medical Devices Policy 2023 launched by the PM as it permits import of pre owned medical equipment into India. The investments made by Indian and overseas manufacturers under the Make in India initiatives by the government are now under threat of becoming non- performing assets, he said. He said the ministry has expanded the list of equipment which is “very confusing and unsettling for investors who will only bring manufacturing technologies to India if the policy environment is predictable and consistent with the National Medical Devices policy 2023 that was meant to be binding on all government departments. Now not only many projects recently put up for high end medical equipment are jeopardised, but also patients are at risk of being treated with non-calibrated non- regulated medical equipment,” he said. Nath said India is being treated as a dumping ground for e-waste as obsolete equipment gets resold in the countlY while overseas manufacturers make hay “doubling sales.” Earlier in May, the Patient Safety and Access Initiative of India Foundation (PSAIIF), a not-for-profit organisation based in Delhi that works on improving access to quality healthcare, filed a Public Interest Litigation (PIL) before the Delhi High Court raising objections over the regulatory framework concerning the quality, safety, and efficacy of second-hand or used medical devices in India. The writ petition filed before the court had demanded a complete review of the regulatory mechanism related to the import of medical devices into the country that are used or refurbished. In a letter to the health minister, medical device manufacturers have sought intervention to stall and recall the intemninisterial policy issue from further execution. They have also sought setting up an expert committee to propose regulatory controls and amendments for enabling re-manufacturing and resale of Indian made refurbished equipment by the original equipment manufacturer beyond the warranty life cycle to ensure patient safety and calibrated accuracy. Source: Economic Times

Oct 21, 2024 New Delhi: Imaginarium, a multi-speciality digital manufacturing business, announced that the company’s customised, bio- compatible 3D printed orthotic device is supporting the recove1Y of 15 year old teenager, Anamta Ahmad – who underwent a complex hand transplant post her amputation. Anamta Ahmad, the youngest person in the world to undergo a shoulder- level limb transplant, faced a daunting recovery journey as she got electrocuted by 11000-volt electric wires. The complex nature of the surgery and extended recovery period required a specialised approach to ensure proper healing and minimised discomfort. Imaginarium’s custom 3D printed orthotic device, tailored to Anamta’s needs, has been crucial in overcoming these challenges. “We are proud to have played a role in Anamta’s recovery by pushing the boundaries of personalised healthcare,” said Aashay Mehta, Managing Director and Co-Chairman at Imaginarium, said in a statement. “There’s nothing that requires more customization than the human body, no two people are the same, and even our left and right sides aren’t identical. That’s why our work is so vital. Whether it’s for this surgery or developing patient-specific implants, we’ve been at the forefront of 3D- printed healthcare solutions for two decades. Our goal is to keep innovating and finding new ways to meet the unique medical needs of each individual.” Crafted from durable, biocompatible hard plastics, the device prioritises both comfort and long-lasting performance, making it ideal for extended use. “I had complete trust in the doctor and his team of professionals; they made me feel optimistic about the surgery. Once after the procedure was done I had to enter my recovery phase with a brace which was custom made by Imaginarium. To know that I’m the first transplant patient to get a custom 3D printed brace excites me even more. The brace was not only functional but also had an aesthetic appeal to which I could relate to as a teenager which I find quite essential given the length of the recovery period,” said Anamta Ahmad. “Also, being exposed to high-end technologies and processes was a fascinating experience and the members at Imaginarium were incredibly supportive. I hope this innovation helps many more like me to have a peaceful recovery process. Imaginarium is pioneering healthcare applications such as custom surgical guides, patient-specific implants, and orthotics. Source: Economic Times

Oct 26, 2024 Lucknow: As part of its plan to establish a medical device park, the UP govt has also stirred the indigenous medical device manufacturing industry to boost exports, an official spokesperson said on Friday. “Govt has laid out a comprehensive action plan to increase exports of locally manufactured medical devices. Efforts are underway to enhance logistics, connectivity, and land bank access across various authorities to facilitate the development of medical devices and pharmaceutical parks,” he said. The spokesperson further said that simultaneous work has begun on creating a mobile app-based digital IT platform for the Export Promotion Council-Medical Device (EPC-MD) to support the growth and export of medical devices. “This app-based digital platform, which will feature a web portal and various IT solutions, is being built using modern technology to meet future needs,” he added. Listing out benefits of the IT platform, he said that it would enable the review of project approvals and support the advancement of medical device production in the state and streamline various aspects of the production process, provide necessary support, and compile export- related data to aid export promotion efforts. Notably, the Yamuna Expressway Industrial Development Authority (YEIDA) is developing North India’s first dedicated medical device park in two phases, covering an area of 350 acres. Allottees will benefit from subsidised electricity, water, warehousing, and reimbursement for skill development, patents, and quality certification. To facilitate access to cost-effective testing and scientific resources within this park, apps, web portals, and IT solutions will be created for the EPC-MD. This initiative will allow regular monitoring of various projects and activities through role-based access to the business blueprint. The app-based digital IT platform will feature numerous advanced functionalities, including three-layered security, disaster recovery, a data centre server, social media integration, COO activation, real-time deployment, reimbursement claims, member documentation, payment gateway installation, a micro-website for international and national exhibitions, SMS integration, and a help desk. – Provide necessary guidance and support to exporters of medical devices and related products. – Prepare a framework for promotional activities to create awareness about Indian medical devices in international markets. – Establish phase-wise communication along with informing exporters on regulat01Y issues, technical standards, and other trade-related matters. – Prove helpful in formulating and implementing action plans to showcase the contribution of the Indian medical device industry and Uttar Pradesh on international forums. – Work as a one-stop solution to address challenges faced by the industry, including issues related to manufacturing, quality standards, and trade barriers. Source: Economic Times

Oct 26, 2024 New Delhi: Union Health Minister J P Nadda launched five Department of Health Research-Indian Council of Medical Research (DHR- ICMR) health research initiatives planned under the 100 days agenda here on Friday. One of the key initiatives launched is the ‘First in the World’ Challenge, inspired by the success of Chandrayaan-3, according to a statement. These initiatives aim to propel India to the forefront of global health research and innovation, aligning with the nation’s vision of a Viksit Bharat. “These ground-breaking initiatives exemplify our commitment to a healthier and more self-reliant India. By fostering indigenous innovation and investing in advanced research, we are equipping our nation to tackle pressing health challenges effectively,” Nadda said. Dr Rajiv Bahl, Secretary DHR and DG ICMR, said, “Initiatives like the ‘First in the World’ Challenge will empower our scientists and innovators to develop cutting-edge technologies that can benefit not just India but the entire world. We are committed to fostering an environment where research thrives, ultimately leading to improved health outcomes and a stronger global standing in medical research for our nation.” The statement said this high-risk, high-reward research and development scheme is designed to foster the creation of health technologies that are unprecedented globally. The programme will fund projects at various stages from proof of concept design to prototype and final product development. Additionally, under the Pradhan Mantri Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), ICMR is upgrading existing Viral Research and Diagnostic Laboratories (VRDLs) to Infectious Disease Research and Diagnostic Laboratories (IRDLs). This enhancement includes bacteriology, mycology and parasitology, expanding diagnostic capabilities beyond virology. These laboratories will strengthen India’s capacity for comprehensive surveillance and rapid response to infectious diseases, it said. ICMR also launched the ICMR Data Repository, a centralised, secure and accessible platform of high-quality datasets, ensuring data integrity and privacy. Moreover, ICMR is initiating efforts to develop drugs for rare diseases, focusing on affordable and effective therapies for conditions such as Gaucher Disease, Sickle Cell Disease and others, it said. Ongoing projects range from clinical trials to animal studies and design phases, aiming to reduce dependence on imported treatments and improve accessibility for patients in India, the statement said. Source: Economic Times

Oct 21, 2024 The Goods and Services Tax on premiums paid by senior citizens for health insurance and premiums paid by all for term life insurance may be exempted as most members of a ministerial panel set up specifically to study this agreed in favour of extending such relief on Saturday. Separately, the Group of Ministers (GoM) on rate rationalisation also discussed Saturday a GST rejig for several items and proposed cutting rates for some items such as packaged water above 20 litres (5 per cent from 18 per cent), bicycles priced less than Rs 10,000 (5 per cent from 12 per cent) and exercise notebooks (5 per cent from 12 per cent). Shoes above Rs 15,000 and wrist watches above Rs 25,000 are likely to be shifted to the topmost slab of 28 per cent GST from 18 per cent now, a state finance minister said. This rate rejig exercise will help the states and Centre to realise revenue gain of Rs 22,000 crore, which will help cover the revenue loss from reduction in GST rates for insurance premiums and other items, the minister said. For the insurance sector, GST on term life insurance premiums are likely to be exempted for all persons, including plans that consist of family members. Health insurance premium paid by senior citizens irrespective of coverage would also be exempted. For other citizens, health insurance cover till Rs 5 lakh is likely to be exempted and the existing rate of 18 per cent will be charged for health insurance cover over Rs 5 lakh. “Every GOM member wants to give relief to people. Special focus is on senior citizens. We will submit a report to the Council. Work is being done to reduce the GST rate from 18 per cent, exemption will be given for certain categories (of insurance premium). The final decision will be taken by the GST Council,” Bihar Deputy Chief Minister Samrat Choudhary, who is the convenor of both the GoMs on insurance and rate rationalisation, said after the two meetings. In its 54th meeting held on September 9, the GST Council had broadly converged on the need to reduce the tax rate for health and life insurance premiums from 18 per cent but the specific proposal was referred to the GOM on life and health insurance premium for further discussion. The existing six-member GOM on rate rationalisation was expanded to form a 13-member GOM on life and health insurance premium with the mandate to submit their report by October-end. The GST Council will meet in November to take a final decision on the rate recommendations by both the GoMs. “There were discussions held in the meeting. Most states are on board for exempting term life insurance premium from GST. Term life insurance plans which include family members are also going to be exempt. For health insurance, total relief would be given for insurance premiums paid by senior citizens and exemption would be given for health insurance cover up to Rs 5 lakh for others. The existing 18 per cent GST rate will be retained for health insurance cover above Rs 5 lakh,” a state finance minister, who is a member of the GOM, said after the meeting on Saturday. The revenue implication of the exemption proposal for senior citizens for health insurance is expected to be around Rs 2,200 crore and Rs 200 crore for exemption to term cover premiums. The revenue loss is going to be offset by gains of around Rs 22,000 crore from the proposed hike in rates on several high-end items, sources said. Rate rationalisation was discussed in the second meeting of the GOM that included rate changes for several common-use items such as packaged water, bicycles and exercise notebooks. The broad consensus was to provide relief on consumer goods and charge a higher rate for items with premium value. The GoM has proposed a reduction in the GST rate for packaged drinking water bottles above 20 litre to 5 per cent instead of 18 per cent at present. Bicycles costing less than Rs 10,000 are likely to be charged 5 per cent GST as against 12 per cent at present, whereas GST on exercise books may get reduced to 5 per cent from 12 per cent. The GoM on rate rationalisation will continue to discuss proposals for rate rejig including merger of slabs, another state finance minister said. “Rate rationalisation is an ongoing process. Several items of common use have been discussed. More discussions are pending, especially for demerit goods in the 28 per cent slab and for items which were reduced earlier from the 28 per cent slab to 18 per cent or 12 per cent,” the minister said. In December 2018, the GST Council had reduced rates for several items in the 28 per cent slab including movie tickets priced above Rs 100, television screens and monitors up to 32 inches, digital cameras, video games consoles and power banks with lithium-ion batteries. Items such as dishwashing machines, pan masala, cigarettes, air conditioners, cars, and aircrafts for personal use continue to be in the 28 per cent slab. The decision to reduce GST on insurance premiums has come after several Opposition leaders raised the issue of high tax on premiums. Opposition leaders including Leader of Opposition in Lok Sabha Rahul Gandhi Trinamool Congress chief Mamata Banerjee have demanded withdrawal of GST on life and health insurance premiums. Banerjee had also written a letter to Union Finance Minister Nirmala Sitharaman for rollback of GST on life insurance and health insurance premiums. Earlier on July 28, Union Minister of Road Transport and Highways Nitin Gadkari wrote to Finance Minister Sitharaman, saying GST on life and medical insurance premiums amounted to taxing the “uncertainties of life”. Sitharaman had said in August that tax was levied on insurance premiums even before the imposition of GST and that GST revenues are shared between states and the Centre. In 2023-24, the Centre and states had collected Rs 8,262.94 crore through

Oct 18, 2024 The Patient Safety and Access Initiative of India Foundation (PSAIIF) has filed a Public Interest Litigation (PIL) in the Delhi High Court, raising concerns about the growing trend of refurbished medical equipment imports in India. The petition highlights the significant risks posed to patient safety and questions the reliability of these devices. PSAIIF pointed out that the illegal import of refurbished medical devices, such as CT scanners, MRI machines, ultrasound equipment, and surgical robotics, threatens the integrity of India’s healthcare system. In compliance with the directions issued by the Delhi High Court, PSAIIF recently received responses from the Directorate General of Health Services (DGHS) and the Ministry of Environment, Forest, and Climate Change (MoEFCC). The responses address the issues surrounding the unauthorised import of refurbished medical equipment without appropriate certifications. This trend compromises the safety standards set under the Medical Device Rules, 2017, which are designed to ensure that only safe and effective medical devices enter the market. India has seen an increase in the import of refurbished medical devices without necessary approvals, with associations such as AiMeD and FICCI, along with several domestic companies, urging the government to take action. They argue that these imports undermine the country’s self-reliance and pose potential risks to patients. The illegal importation of refurbished devices, including high-end and high-value (HEHV) medical equipment, has been a focus of the PIL filed by PSAIIF. The petition names several respondents, including the Central Board of Indirect Taxes and Customs, DGHS, MoEFCC, DGFT, and Intuitive Surgical India Pvt Ltd. Professor Bejon Kumar Misra, the Founder of PSAIIF, said, “The petition had been filed seeking issuance of directions to the Respondents to identify and furnish a list of all second-hand and re-furbished High-End And High-Value (HEHV) Used Medical Equipment other than Critical Care Medical Equipment that have been imported into India since 2019 without permission of the Ministry of Environment Forest and Climate Change (MoEFCC) and for directions to Companies including the Intuitive Surgical to immediately recall all such Refurbished HEHV Medical Equipment that are installed without prior approval as per the Rules and Regulations and stop the import of Refurbished HEHV Medical Equipment including the systems that are at customs cleared and not installed at customer locations until the Government inter-ministerial committee of Respondents decides on implementation of policy framework that would regulate the import of such devices.” The petition points to one company, Intuitive India Private Limited, a subsidiary of Intuitive Surgical Inc., which allegedly imported refurbished equipment worth over INR 250 crores since 2019, presumably without the required MoEFCC approval. The petition notes that prior to 2023, the import of refurbished medical devices, particularly HEHV devices, was not permitted. Even after the DGHS notification in June 2023 allowed select devices under strict conditions, MoEFCC’s approval remained mandatory. The Delhi High Court directed PSAIIF to submit representations to the concerned respondents and granted permission to approach the court again if the responses were deemed unsatisfactory. Recently, PSAIIF received responses from both MoEFCC and DGHS. According to MoEFCC’s 133rd meeting in May 2024, Intuitive India had approval to import one refurbished Da Vinci X robot in 2019. However, the company allegedly continued importing equipment worth over INR 250 crores without the required approvals in subsequent years. Professor Misra stated, “Since the responses have been received pursuant to court order, no statements can be made on the same until conclusive legal advice is taken on the same.” Despite these concerns, MoEFCC granted further approvals in 2024, which is in conflict with DGHS’s position that imported devices should not be allowed if similar devices are manufactured in India under the “Make in India” initiative. Professor Misra noted that this inconsistency undermines domestic manufacturers’ confidence and threatens the success of the government’s policy, describing the situation as an “Un-make in India” campaign. The illegal import of refurbished medical devices without proper certification and oversight not only violates India’s regulatory framework but also jeopardises patient safety. PSAIIF calls for immediate action to enforce compliance and increase public awareness to ensure that only safe, certified medical devices are available in the Indian market. Source: Economic Times