Team JGJ

Oct 13, 2024 The sales and distribution of Emergency Contraceptive Pill (ECP) brands, including i-Pill and Unwanted – 72, will remain unchanged, sources with the Central Drugs Standard Control Organisation (CDSCO) said on Friday. This comes after various media reports suggested a proposed change in rules by the Central Drugs Standard Control Organisation (CDSCO) regarding over-the-counter sale of ECPs. One of the reports had suggested that an “expert panel proposes a prescription requirement for the morning-after pill.” The CDSCO sources said that certain media reports regarding the prescription requirement for Hormonal contraceptives misinterpreted the proposal for change in Rules reg Schedule H and K drugs. Top 6 contraception myths debunked: What ALSO READ: every woman needs to know Facts regarding prescription requirement for Hormonal contraceptives: Presently, contraceptive drugs like Centchroman and Ethinylestradiol are classified under Schedule ‘H’ of the Drugs Rules, which means they can only be sold with a doctor’s prescription. Also, for manufacturers, they are required to these products with the cautionary statement: “To be sold by retail on the prescription of a Registered Medical Practitioner only.” Further, certain strengths of these drugs, including DL- Norgestrel (0.30 mg Ethinyloestradiol – 0.30 mg), Levonorgestrel (0.15 mg Ethinyloestradiol – 0.03 mg),Centchroman (30 mg), Desogestrel (0.15 mg Ethinyloestradiol – 0.03 mg) and Levonorgestrel (0.10 mg Ethinyloestradiol – 0.02 mg) are also also included in Schedule ‘K’ of the Drugs Rules, meaning these specific strengths can be purchased without a doctor’s prescription. This has led to confusion among consumers, sellers, and other stakeholders due to contradictory statements regarding the need for a prescription as per point 1 and the lack of a prescription requirement in point 2. The proposed amendment to the rules is intended to clarify these regulations for the benefit of consumers and will not change the status quo. The strengths defined in Schedule ‘K’ will continue to be available without a prescription, as they are today, while all other remaining strengths will need a prescription, as they do currently. In view of above facts, the proposed amendment in the Drug Rules, whereby a clarifying statement ‘Class of drugs mentioned at entry no. 15 of Schedule K shall not be covered by this Schedule” will be added in Schedule H of the Rule. This will remove the ambiguity and simplify the process for sale of such drugs (of selected strengths). Therefore, media reports on this subject do not accurately interpret the situation. “There is no proposal to shift the drugs from the non- prescription to the prescription category, and there will be no change in the sales and distribution of Emergency Contraceptives,” they added. Source: Hindustan Times

Sep 14, 2024 New Delhi: In a significant step towards bolstering India’s clinical research capabilities, the Indian Council of Medical Research (ICMR) has signed Memorandum of Agreement (MoAs) with key industry players to conduct First-in-Human Phase-I Clinical Trials for four promising therapeutic candidates under its Phase 1 Clinical Trial Network. As part of these strategic collaborations, ICMR will work with Aurigene Oncology Limited on a small molecule for multiple myeloma, partner with Indian Immunologicals Limited for Zika vaccine development, coordinate a seasonal influenza vaccine trial with Mynvax Private Limited, and explore CAR-T cell therapy advancements for chronic lymphocytic leukemia with ImmunoACT. Union Health Minister J P Nadda lauded the partnerships, calling them a pivotal step toward “affordable and accessible cutting-edge treatments” that solidify India’s standing as a global healthcare innovation leader. “Establishing Phase 1 clinical trial infrastructure is a key component in fostering the development of indigenous molecules and cutting-edge treatments. Our vision is to expand this network fulther, ensuring that India continues to lead in the development of innovative and affordable healthcare solutions,” said Dr Rajiv Bahl, Secretary, Department of Health Research & Director General, ICMR, added. The clinical trials will take place at four premier institutions: KEMH & GSMC in Mumbai, ACTREC in Navi Mumbai, SRM MCH&RC in Kattankulathur, and PGIMER in Chandigarh. A Central Coordinating Unit at ICMR Headqualters, New Delhi, will oversee the operations, ensuring the trials’ smooth execution through dedicated infrastructure and manpower at each site. Source: Economic Times

Sep 20, 2024 New York: When researchers discovered enough proof that a medication used to treat bone marrow cancer and Kaposi sarcoma is safe and effective in treating hereditary hemorrhagic telangiectasia (HHT), a rare bleeding disorder that affects 1 in 5,000 people worldwide, they decided to terminate an early clinical trial funded by the National Institutes of Health (NIH). The New England Journal of Medicine published the trial results, which show that patients with HHT who were administered the medication, pomalidomide, had a significant decrease in the intensity of nosebleeds, required fewer blood transfusions and iron infusions than HHT frequently requires, and had a better quality of life. “Finding a therapeutic agent that works in a rare disorder is highly uncommon, so this is a real success stcny,” said Andrei Kindzelski, M.D., Ph.D., of NIH’s National Healt, Lung, and Blood Institute. “Before our trial, there was no reliable therapeutic to treat people with HHT. This discove1Y will give people who suffer with this disease a positive outlook and better quality of life.” HHT, also known as Osler-Weber-Rendu Syndrome, is characterized by serious defects in the way the body’s blood vessels form. Instead of growing linearly, they become unusually tangled and twisted. The disordered blood vessels are fragile and prone to leaking, which causes excessive nosebleeds or bleeding along the gastrointestinal tract and other mucosal surfaces. These bleeding episodes, which worsen with age, can result in anemia and reduced quality of life. In severe cases, they can be life-threatening. Current options to treat HHT involve closing off the malformed blood vessels in the nose and gastrointestinal tract or prescribing off-label medications that temporarily stabilize blood clotting at sites of bleeding vessels, which in turn reduces bleeding. There are currently no Food and Drug Administration-approved medications for long-term management of HHT. Researchers speculated that pomalidomide worked by blocking the growth of abnormal blood vessels. It may cause the blood vessels to have a more normal structure or thicker walls so they are less fragile. However, the research team, led by Keith McCrae, M.D., professor of molecular medicine at the Cleveland Clinic, says further study will be needed. Researchers enrolled 144 adults with HHT at 11 U.S. medical centers between Nov. 5, 2019, and June 27, 2023. All palticipants had moderate to severe nosebleeds requiring iron infusions or blood transfusions. Researchers gave 95 of the participants 4 mg of pomalidomide daily, though the dosage was reduced to 3 mg or 2 mg daily in patients with adverse reactions – mostly constipation, rashes, and lower than average white blood cell counts. The remaining 49 patients received a daily sugar pill designed to look exactly like the pomalidomide pill, in addition to their usual care. At the start of the trial, researchers used a validated HHT-specific bleeding assessment tool to score each patient’s nosebleed severity. To establish a baseline in other areas, palticipants self-repolted other data throughout the trial, palticularly the severity of their nosebleeds and the effect of their HHT symptoms on everyday activities using a special scoring system. The number of units of red blood cells transfused or iron infused was also recorded. In June 2023, 43 months into the scheduled four-year trial, an interim analysis found pomalidomide had met a prespecified threshold for efficacy, and the trial was closed to further enrollment. “These findings have broader implications for people with more severe forms of HHT,” said Kindzelski. “In those cases, malformed blood vessels can develop in organs such as the lung, liver, and brain, which can lead to hemorrhagic stroke, bleeding in the lungs, or heart failure. A treatment like this could be lifesaving for such patients.” Though researchers did not follow participants after the trial ended, McCrae noted that some of his patients from the study have gone four to six months without a recurrence of nosebleeds, even though they had stopped the medication. This suggests that the chug may have promise as a long-term or intermittent treatment. (ANI) Source: Economic Times

Oct 10, 2024 The pharmacare bill that was central to a political pact between the Liberals and NDP is now set to become law after the Senate passed the bill without making any changes. The legislation will inform the creation of any future national, universal pharmacare plan. It will also allow the government to sign deals with provinces and territories to cover diabetes and birth-control medications as part of the public health system. The wording and content of the bill was carefully negotiated as part of the now-defunct supply-and-confidence deal between the NDP and Liberals. British Columbia has already signed a memorandum of understanding with Ottawa to launch the program in that province. Health Minister Mark Holland hopes to have all provinces and territories on board by next spring, but the bill will need royal assent before he can officially sign those deals. Source: Global News

Oct 9, 2024 Exports of India’s pharmaceutical and meditech sectors are expected to sustain the growth momentum in the ongoing fiscal despite a slowdown in the global economy, a senior government official said on Wednesday. With the government revving up support for drug development in India, as many as 16 blockbuster molecules targeted for a wide range of therapeutic areas, including cancer, diabetes, HIV and tuberculosis, are in the pipeline to be produced in India, Department of Pharmaceuticals, Secretary Arunish Chawla told reporters on the sidelines of CII Pharma and Life Sciences summit here. “We have been analysing the export trends in the recent data. Even though there is a general slowdown in exports globally, the good news is that the Indian pharmaceuticals, biotech, and bulk drug exports have grown double- digit over the last year,” he said in response to a query on export prospects of the pharma industry amid a global slowdown. He further said, “In the first four months of this year, these exports have now become the fourth largest merchandise export item for the Indian economy. That’s a huge achievement, and it’s an important milestone that has been crossed.” Going forward, Chawla said,”We expect robust performance from both pharma and the meditech industry. In the last year, in the consumables and surgical space we became an export-oriented industry. In other segments as well, like imaging devices, body implants, in-vitro diagnostics, we are a rising power, and these exports are also showing a good growth this year.” Bullish on India’s pharma and meditech exports, he said,”We are confident that when the data comes finally for the current financial year, you will see impressive results for yourself.” On support of drug development in India, he said, “We’ve done both studies and applied research to identify blockbuster molecules and blockbuster drugs in the traditional pharma space and in the new rising biotech and biosimilar space.” He further said, “Patent cliff studies recently identified 26 blockbuster molecules, of these 16 are in the pipeline. They’re going to be produced in India. They are in various stages of approvals and manufacturing licences.” While he did not elaborate on the name of the companies which are developing these drugs, Chalwa said,”These are mostly Indian companies, and they are taking help from the PLI scheme, the incentives to develop, research, take clinical trials and get the necessary approvals for these blockbuster molecules.” These molecules are both small and large molecules aimed at most therapeutic segments including, cancer, diabetes, tuberculosis, HIV and anticoagulants, among others, he added. The Drugs Controller General of India (DCGI) has already granted approvals to some of the molecules, Chawla said, adding, “going further, we would also be working on their value chains upstream the way we have focused on bulk drugs as upstream value chains of chemical entities.” He further said the government is also now focusing on the upstreams of biological entities, which particularly includes basic molecules like amino acids, nucleotides and vaccine raw materials. “You will see a lot of work taking place in this direction going forward. We are also working on facilitating the cell and gene therapies and healthcare ecosystems that will come up going forward,” Chawla said. Source: Economic Times

Oct 10, 2024 New Delhi: Whenever people discuss healthcare in India the argument often circles back to core issues that is the accessibility and affordability of such efforts, but for society like ours, where the socio-economic stratification dictates the access to medical interventions confronting such issues is both inevitable and indispensable. Pioneering in this regard ETHealthworld at its annual flagship event the fom•th edition of Healthcare Leaders Summit convened inaugural panel discussion on ‘Promoting Inclusivity in Healthcare: Addressing Disparities and Access Barriers.’ The power-packed panelists for the session included Dr Soumya Swaminathan, Former Chief Scientist, WHO & Chairperson, M S Swaminathan Research Foundation; Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd; Vishal Bali, Executive Chairman, Asia Holdings; Annapurna Das, General Manager, Takeda Biopharmaceuticals India and the session was moderated by Vikas Dandekar, Editor, ETHealthworld. Through a video message, the former Chief Scientist of World Health Organisation (WHO) stressed that, “Pandemic-like phenomena are likely to happen more frequently in the future and the shocks we are experiencing because of climate change are impacting our health both directly and indirectly.” “It is very’ important to make equity the centre of the health system which will help to build a strong and resilient health system. Universal health coverage offers a promising solution in this regard by covering both the aspects i.e. delivery of services and financial protection (out of pocket expenditure),” she added. In her address Dr Swaminathan also flagged that, “While there is no doubt that the private sector is delivering healthcare sewices to people in India but at the same time there has to be a balance and if it is pushing more and more people into poverty then it is not the desired end result. To ensure this we need a system which is governed and managed by the government.” “The primary healthcare sector in India needs more investment considering that the majority of the services are delivered by the government as the private sector in India doesn’t play that bigger role in providing primary services,” she added. Sharing his insights another panelist, Vishal Bali said, “With respect to healthcare in India there is a massive demand and supply gap and we need different approaches and models to fill this gap. If we provide an aggressive push to those models which hold the potential to scale fast then we can create an opportunity to fill this gap.” “India is a country which is deficit in action across the entire healthcare ecosystem where it is the number of beds, professionals and given the massive prevalence of both communicable and non communicable diseases we (India) need to have a disease specific healthcare focus,” he added. Palticipating in the discussion, Annapurna Das said, “Private players in India need an end to end scalable strategy where incorporating digital technology and blending onground models is required to expand the target group of patients and deliver accessible quality healthcare. “These fundamental ways which are brick-and-mortar and digitally enabled will help to accelerate the access in private and public”, she added. Coveling the medical devices segment, Rajiv Nath shared, “Any entrepreneur (medical device maker) who sells the product finds that the system is against his/her low cost affordable ethical pricing. Ifthe labeled price is too low then procurement heads of financially driven hospitals are not happy to buy the product because they don’t make money on it and as a result the product becomes a failure. As a potential solution to this challenge, “MRP of medical devices needs to be rationalised by government regulations”, Nath suggested. Adding to his remarks Vishal Bali said, “For country like India which has a highly import-driven healthcare ecosystem and a currency which keeps depreciating the cost of care is growing constantly and especially in the post COVID era if you look at the international technologies their pricing is moving up 30-35 per cent per annum. So ultimately the solution lies in India technology and Indian entrepreneurs who can help to overcome the issues of affordability and accessibility while providing quality products.” Concluding the discussion Annapurna Das, said, “Affordable healthcare is fundamental in creating an inclusive ecosystem.. And to achieve so it requires a synergy between public and private healthcare players and there are some crucial products (drugs) which have a global manufacturing setup for which the private sector has to rely on import pathways. Therefore, it needs more enabling policies which assist them to bring access at the right price point for this countlY (India).” Source: Economic Times

Oct 8, 2024 New Delhi: The Drugs Controller General of India (DCGI) is planning to list the qualification criteria for medical device testing officers. At present, no qualification is needed, with mostly drugs inspectors deputed to do the job. This follows increasing complaints by the medical device industry – a market that is estimated to be around $11 billion, and expected to grow to $50 billion by 2030. Also read I Drugmakers to face action for submitting wrong and misleading info, DCGI The matter was discussed in the Drugs Technical Advisory Board (DTAB) last month, which agreed to amend the Drugs Rules. At present, the Central or state government, by notification, appoints any person it thinks fit to be Medical Devices Testing Officer who pick samples, test and evaluate such medical devices. Based on public interest The medical devices testing officer has the power to propose restricting or allowing the import, manufacture or sale of medical devices – in public interest”. “The samples of medical devices cannot be picked up the way drug are picked up. Devices like MRI or CT Scan machine have to be verified on the site itself for safety features. Therefore, it is very important to depute highly skilled technical officer for the purpose,” said an official aware of the matter. “There’s an acute shortage of competent medical devices officers at Central Drugs Standard Control Organisation (CDSCO) and State Licensing Authorities from an engineering and science background to adequately regulate medical devices that have recently come under regulations,” Rajiv Nath, forum coordinator, AiMeD (Association of Indian Medical Devices Industry). Also read I WHO evaluates India’s top drugrgulator, vaccine manufacturing_practices Due to these shortages pharmacists and drug inspectors have been redesignated as Medical Devices Officers and in many cases these are not experts at the diverse range of engineered medical devices they are supposed to regulate,” he said. “This becomes a huge challenge to manufacturers as they struggle to communicate with these regulators who see products like Defibrilator and ventilators from the eye of medicine. It’s like an Air Force officer telling a naval officer what’s expected by the Air Force. The government needs to address this staffing and competence urgently if we are aiming India to be the leading manufacturing hub for medical devices globally as stated in the National Medical Devices Policy 2023.” For safety and performance The government has approached various institution based for designating medical device testing laboratories so that medical devices and in-vitro diagnostic devices available in the market can be tested for safety and performance. Also read I DCGI issues fresh guidelines for drugjnspectors In India, medical devices are a category of almost 5,000 products. Different categories of medical devices may require different kinds of testing infrastructure. Queries sent to the health ministry remained unanswered till press time. Source: Live Mint

Oct 10, 2024 New Delhi: The government has made QR codes mandatory on all vaccines, in a bid to prevent counterfeits and validate the authenticity, the Drug Controller General of India (DCGI) on Wednesday told ET. “Recently we have notified that all vaccines would have the QR code. It makes it very easy for the consumer and other stakeholders to identify the genuine products,” Raghuvanshi said. The DCGI said that an aggressive campaign has been initiated in that direction and non compliance will not be accepted. “The other thing which is also helping us a lot is that the current Act has all the provisions to do the prosecutions. Once we find or identify such non compliance action is taken. In the last 2 years wherever we have found this we have actually taken it to a logical conclusion depending on the non compliance that has helped us send a very strong message in the indust1Y that this is not acceptable,” the DGCIsaid. “Things have improved a lot since we started this aggressive campaign against non-compliance. As a regulator we are taking all the measures which are showing us results. There is a lot of movement that we see in terms of awareness and in terms of maintaining the standards,” he added. Raghuvanshi said that in the next phase more products will be added. Source: Economic Times

Sep 28, 2024 New Delhi: A total of 170 AYUSH treatment packages will soon be included in the government’s flagship Ayushman Bharat health insurance scheme, Ayush minister Prataprao Jadhav said on Friday, adding that consultations are in the final stage. The minister also said that to guarantee easy access to Ayush medications, special medical stores on the lines of ‘Janaushadhi Kendras’ would be set up at tehsil level. “Access to a variety of herbal and traditional medicines will be made possible by these stores, improving public healthcare in both urban and rural areas,” Jadhav added during a press conference on 100 clays of the new government. “Discussions with insurance companies to finalise the package cost structures are underway and soon Ayush treatment packages could be availed by the AB-PMJAY beneficiaries. Consultations with the National Health Authority (NHA) are in the final stages,” he said. A total of 170 AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy) treatment packages covering non-communicable diseases such as diabetes and hypeltension will be included in the scheme, he said. The Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY), the largest publicly funded health insurance scheme, provides health cover of Rs 5 lakh per family per year for seconda1Y and tertiary care hospitalisation to 12 crore families. Jadhav, the Union Minister of State for Ayush (Independent Charge), said a Strategic Purchasing Committee has been established to finalise cost structures and guarantee affordable Ayush treatment under the programme. The National Health Authority (NHA) and Ministry of AYUSH have held meetings to discuss the implementation model for the proposed convergence of AYUSH packages with AB PM-JAY, he said. Wider stakeholder consultations involving implementing states and union territories have also been carried out, he added. Jadhav further said the Ministry of Ayush had earlier committed to organise 10,000 camps for elderly citizens within 100 days. “I feel proud to say that 14,692 Ayush camps were organised around the country in a massive outreach effort to meet the healthcare needs of the elderly. Free consultations, therapies, and guidance on holistic health using Ayurveda, Yoga, Unani, Siddha, and homoeopathy were offered at these camps,” he said. Jadhav informed that the Ayush minist1Y has established the National Institute of Ayurveda in Haryana’s Panchkula with a Rs 294.91-crore investment. This institute will function as a top-tier teaching and research facility with a 250-bed hospital and undergraduate, graduate, and doctorate programmes in Aymveda. Besides, the preliminmy process for establishing three Central Research Institutes for Yoga and Naturopathy (CRIYN) in Odisha, Chhattisgarh, and Andhra Pradesh has been completed. Fulther, Jadhav said that a donor agreement was signed by the Minist1Y of Ayush and WHO on July 31, 2024, at the WHO headquarters in Geneva. “This deal demonstrates India’s dedication to working with international health organisations and improving the integration of Ayush systems into the global healthcare system. The collaboration seeks to provide evidence-based traditional medicine with a stronger foundation,” he said. Jadhav also mentioned about the MoU (memorandum of understanding) signed between India and Vietnam centered on cooperation in medicinal plants on August 1, 2024. This agreement, witnessed by Prime Minister Narendra Modi and his Vietnamese counterpart, is a major step toward advancing traditional medicine practices worldwide, he said. The minister added, “India and Malaysia have taken a significant step in advancing traditional medicine by signing an agreement on Ayuwecla. This partnership will promote research, knowledge exchange, and the creation of Ayurvedic treatment regimens. It opens a new chapter in the development of India and Malaysia’s bilateral relations.” Jadhav said on August 6, 2024, the Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) and the Indian Pharmacopoeia Commission (IPC) signed a historic MoU to carry out the ‘One Herb, One Standard’ initiative. By standardising herbal medications, this initiative seeks to increase the efficacy and security of pharmaceuticals throughout India, he added.   He also mentioned about the “Har Ghar AyurYog” initiative started by the minist1Y with the goal of increasing the uptake of Ayurveda and Yoga among people. Including yoga in the Fit India School certification is one of the highlights, Jadhav said. Source: Economic Times

Sep 29, 2024 The National Medical Council (NMC) has backed out of its decision to include Physical Medicine and Rehabilitation in the MBBS curriculum. The Wheelchair Rights Organisation (WRO) has questioned the decision on grounds that it will lead to a generation of doctors who are ill equipped to treat the differently abled people. “This batch of doctors will not be aware of the problems faced by differently abled people and their treatment and hence incompetent to deal with it, which is not good news for us,” said Bavish Bal Thamarassery, president of WRO. The NMC had included Physical Medicine and Rehabilitation alongwith Respiratory Medicine and Emergency Medicine in the curriculum and came out with a stipulation that only those medical colleges that have these departments can enrol students for the MBBS programme. However, it backed out of the decision due to reasons unknown, though the WRO alleges that the NMC was guarding the interests of a section of people. “This has led to a serious crisis in the medical education sector as well as among patients confined to wheelchairs, as the NMC was yet to provide a satisfactory explanation to this,” Mr. Bavish Bal explained. With this decision, a generation of doctors will not study or be aware of ailments like paralysis, stroke or spinal injury. “Various organisations of the differently abled were trying to pressurise the Governments to improve the physical medicine and rehabilitation segment, with the number of patients who require the services on the rise. But this decision of the NMC will adversely affect such moves,” Mr. Bavish Bal added. Source: The Hindu