Team JGJ

June 27,2024 New Delhi: All citizens aged above 70 years will be provided free treatment under the Ayushman Bharat health insurance scheme, President Droupadi Murmu said on Thursday. The opening of 25,000 Jan Aushadhi Kendras in the country is also progressing at a fast pace, she said while addressing the joint sitting of Parliament. Under the Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana (AB-PMJAY), free health services are being provided to 55 crore beneficiaries, Murmu said. “Further, the Government is going to take yet another decision in this area. Now all the elderly above 70 years of age will also be covered and get the benefit of free treatment under Ayushman Bharat Yojana,” the President said. The AB-PMJAY, the largest publicly funded health insurance scheme in the world, aims to provide health cover of Rs 5 lakh per family per year for secondary and tertiary care hospitalisation to 12 crore families. Hospital Empanelment and Management (HEM) guidelines for empanelment of hospitals under AB-PMJAY mandates the State Health Agencies (SHAs) with the responsibility of empanelling hospitals under the scheme. Source: Healthworld

June 27,2024 New Delhi: Throwing expired medicines with household trash is not an ideal way to get rid of them. The country’s drug controller is working on a guidance document detailing methods to be followed for safe disposal of unused and expired medicines. “The need was felt for safe and proper disposal of expired/unused medicines/drugs for protecting the environment and public health,” a government official aware of the development told ET. The document is in the final stages of completion. It will include procedures to be followed for disposal, collection, storage and transportation of expired and unused drugs. Improper disposal of medications that have crossed the expiry date mentioned on the label or not used by the individual for whom they were prescribed and purchased may be hazardous to public health, animal health and environment, officials said. The recently notified Schedule M under Drug Rules prescribed the requirements for manufacturers for proper and safe storage of waste material awaiting disposal. The guidance document in works has been prepared to provide the best practices that may be followed for safe and proper disposal of expired/unused drugs, the official cited above said. The document has been prepared keeping in view various international guidelines including those issued by the World Health Organisation (WHO) and the US Food and Drug Administration (USFDA). The Biomedical Waste (Management and Handling) Rules, 2016, have also been considered, officials said. The Central Drugs Standard Control Organisation (CDSCO) had received a letter from researchers, referring to an article regarding a study aimed to assess the extent of exposure of active pharmaceutical compounds (APCs) in the hydrologic cycle in and around New Delhi. The study stated the role of ecological exposure due to the disposal of unused and expired pharmaceutical compounds into landfills and indicated that un-segregated drug disposal could be a reason for the emergence of drug resistance with special reference to antibiotics. Discussions to make sure proper disposal of these medications have been going on for long. The guidance documents will have methods for disposal of expired/unused medicines in landfills. It will also specify ways to dump antineoplastic drugs, officials said. Source: Pharma

June 29,2024 New Delhi: Nearly 80 per cent of public health facilities in India do not meet the minimum essential standards for infrastructure, manpower, equipment and other benchmarks set by govt. This shocking detail has emerged from a self-assessment exercise carried out by govt in which public health facilities from states and UTs covered under the National Health Mission (NHM) were asked to fill in details, such as the number of doctors, nurses or basic medical equipment they have. There are more than two lakh public healthcare facilities, including district hospitals, sub-district hospitals, community health centres, primary health centers, and Ayushman Arogya Mandir (erstwhile sub health centres) that are covered under NHM – a flagship scheme of govt. Of them, data shared by govt on the Indian Public Health Standards (IPHS) dashboard shows, 40,451 filled in key statistics about their respective facilities in the Open Data Kit – a digital tool – developed by the health ministry. When the scoring was done based on the statistics shared, it was revealed that only 8,089, approximately 20% of the facilities, scored 80% or higher which is needed to qualify as IPHS compliant. Simply put, these facilities had the required infrastructure, human resources, drugs, diagnostics and equipment available to provide essential services as desired. Total 17,190 (42%) of the facilities that participated in the self-assessment exercise scored less than 50% while the rest, 15,172 facilities, scored anywhere between 50 to 80%. All these details have been put out in public domain on the IPHS dashboard. A senior health ministry official said the self-assessment and its real time monitoring has been started to ensure that the health facilities maintain the required standards of infrastructure, equipment, and human resources, leading to better health outcomes and fostering a healthier and more equitable society. The Centre, an official said, is aiming to make 70,000 health institutions IPHS compliant within the first 100 days of the new govt’s formation. “The aim of this self-assessment exercise is to identify the gaps and push the states/UTs to fill them with full support from the Centre so that quality of services provided to the public improves,” a senior health ministry official said. She added that self-assessment is the first step and the Centre also plans to carry out surprise inspections to verify the claims being made by health facilities against the benchmarks set by IPHS. While the IPHS assesses health facilities for basic services, National Quality Assurance Standards (NQAS) is another higher level of evaluation which rates them on the basis of best practices followed such as availability of essential medicines, equipment, waste management, infection control practices, support services and patient’s rights. The official said that while NQAS assessment for district hospitals, sub-district hospitals, community health centres and primary health centers will continue to be carried out physically, they have introduced a new provision of virtual assessment for the Ayushman Arogya Mandir that constitute the highest number of public health facilities under NHM. The Centre bears 60 per cent of the expenditure in a public health facilities under the NHM while the rest of the expenditure is borne by the state. Source: Healthworld

July 05,2024 New Delhi: Indian Medical Association chief Dr R V Asokan on Thursday issued a public apology for his remarks in an interview regarding an observation made by the Supreme Court during the hearing of a case to which the IMA was a party, saying he regrets his statement and it was never his intention to lower the court’s dignity. . “The IMA National President Dr R V Asokan has released an apology regretting his statement to the press regarding a comment by the Supreme Court while IMA was party to the case,” the statement issued by the doctors’ association said. The Indian Medical Association (IMA) was equally concerned about the issues of malpractice, Dr Asokan said in the statement referring to the April 23 order in which the apex court during the hearing of a matter related to Patanjali Ayurved Ltd’s misleading advertisements case had observed that it was of the opinion that IMA also needs to put its house in order. In an affidavit filed in the top court, Dr Asokan had also tendered an unconditional apology for his statement against the Supreme Court. “IMA has filed a writ petition before the Supreme Court against misleading advertisements and malicious campaigns by some persons and entities against modern medicine professionals. With reference to certain statements made by me during an interview with PTI News, I have expressed regret to the Supreme Court and have also submitted my affidavit to the court for tendering my unconditional apology,” Dr Asokan said. “I never had any intention to lower the majesty or dignity of the Supreme Court,” he added in his apology. “There are several complaints relating to the alleged unethical acts on the part of the members of the Association who are abusing the trust reposed in them by patients and not only prescribing prohibitively expensive medicines, but also recommending avoidable/unnecessary investigations as a part of the line of treatment, for purely extraneous considerations,” the bench had said. Constant updating and dissemination of ethical practices was one of the main activities of the IMA, Dr Asokan said. Recently, the IMA engaged patient groups in a dialogue for addressing the concerns of patients and a joint declaration was released in Bangalore, the statement said. Source: Healthworld

July 01,2024 Hyderabad: An Indian government-approved expert panel has advised the country’s drug regulator to approve the import and sale of U.S. drugmaker Eli Lilly’s Mounjaro, a blockbuster diabetes drug and a wildly popular obesity treatment, a document on a government website showed on Monday. Lilly’s Mounjaro, chemically known as tirzepatide, and Zepbound and Danish rival Novo Nordisk’s Wegovy and Ozempic belong to a class of therapies known as GLP-1 receptor agonists, developed to control blood sugar in patients with type 2 diabetes. They also slow digestion, helping patients feel full longer, making them a wildly popular choice for weight loss. “After detailed deliberation, the committee recommended for grant of permission for import and marketing” of certain doses of tirzepatide “for chronic weight management subject to the condition that firm should conduct Phase 4 clinical trial (post-marketing surveillance),” the Subject Expert Committee said in a notification dated June 19. The committee advises India’s drug regulator on approvals of drugs and trials. “A recommendation from the subject expert committee is like the penultimate step of the approval,” said Sheetal Sapale, vice president of research firm Pharmarack. Lilly did not immediately respond to a Reuters request for comment. CEO David Ricks had told Reuters a few months back that the company expected to launch Mounjaro in India as early as next year. India has the world’s second-highest number of people with type 2 diabetes and high obesity rates. Around 11% of Indian adults will be obese by 2035, per the World Obesity Federation Atlas. The global weight-loss drugs market is estimated to reach at least $100 billion by the decade’s end. Lilly should also submit the required manufacturing and controls data, the expert panel added. The notification was first reported by a local medical journal, The Indian Practitioner. (Reporting by Rishika Sadam; Editing by Dhanya Skariachan and Savio D’Souza) Source: Pharma

June 27,2024 Mumbai: The Drug Controller General of India (DCGI) Rajeev Raghuvanshi on Thursday revealed that the Central Drugs Standard Control Organization (CDSCO) has conducted risk-based inspections of over 400 pharmaceutical manufacturing units over the past year and a half, resulting in the closure of 36% of these facilities. “We have been successfully doing risk-based inspections and inspected about 400 manufacturing units and I am not very happy to say that more than 36% of them had to be closed because there was a reason to close them,” Raghuvanshi said at an Indian Pharmaceutical Alliance (IPA) event. “These MSMEs had to shut down as they realised that they cannot meet the expectations of the regulators.” As the quality assurance of drugs manufactured in the country continues to be a cause of concern, CDSCO is about to start four key projects that will help the Indian pharmaceutical industry to continue improving and maintaining the quality of the drugs coming out of India, the ‘pharmacy capital of the world’. One of the four projects, the regulatory body CDSCO will be coming out with is a digital platform—Digital Drug Regulatory System, he said. “So four big-ticket projects are in the pipeline and one of them we are coming out with is our digital platform, which would cover the complete regulatory value chain in this country,” said Raghuvanshi. The organisation plans to structure the platform in a way that brings aboard all the stakeholders involved in the industry from regulatory bodies to manufacturers and retailers. “Each and every stakeholder, government, private, semi-government, whoever has any stake in the regulatory value chain would be brought onto that platform. And so, you have solutions to all kinds of quality issues. We are waiting on the final approval from the government but to design this we have already floated the RFP and the final tender is yet to be done,” he added. Raghuvanshi then disclosed the second project the organisation is working on – the regulatory rationalisation initiative, under which CDSCO has hired two internationally renowned consultancy organisations. One of the two consultancy firms is tasked to look at CDSCOs’ internal process, while the second one will take a look at The Drugs and Cosmetics Act, 1940 and rules to rationalise while removing the redundancies and simplifying the whole regulation. The first one he disclosed will start its working from 1 July while the second one will begin its work in a couple of weeks time. “Third being, increasing the internal scientific cadre at CDSCO. Unfortunately today there is not a single scientific cadre to do an internal review of the files, which the stakeholders are not comfortable with. So we are initiating a process to get the internal scientific cadre at CDSCO so that more than 50-60% of the activities of the final review can happen internally,” he continued. Finally the fourth project, Raghuvanshi added, is not part of the CDSCO but for the Indian Pharmacopoeia Commission (IPC) to set up the Digital IP. IPC is an autonomous institution of the Ministry of Health and Family Welfare committed to ensuring quality and safety of drugs. “The product is in its final stages and will be in use by the next month as it is under final testing,” he added. Raghuvanshi is also the secretary-cum-scientific director of IPC. Source: Livemint

June 26,2024 New Delhi: India’s apex drugs regulatory body has found the samples of around 50 drugs, including that of widely-used paracetamol, pantoprazole and some antibiotics for treating bacterial infections, as not of standard quality. Of these sub-standard drugs, 22 are manufactured in Himachal Pradesh, according to the alert issued by the Central Drugs Standard Control Organisation (CDSCO) for the month of May. Besides Himachal Pradesh, the samples were collected from Jaipur, Hyderabad, Waghodia and Vadodara in Gujarat , Andhra Pradesh and Indore, among other places. A total of 52 samples have failed the quality test conducted by the CDSCO, according to the drug alert issued on June 20. Sources said state drug regulators have reportedly sent notices to the pharmaceutical companies concerned and the failed samples would be recalled from the market. The list of the sub-standard drugs contains Clonazepam tablets that are used to treat seizures and anxiety disorders, pain reliever Diclofenac, anti-hypertension drug Telmisartan, Ambroxol, which is used in the treatment of respiratory diseases, Fluconazole, an antifungal, and some multivitamin and calcium tablets. The samples of around 120 drugs manufactured in Himachal Pradesh had failed the test parameters last year. Source: Pharma