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Sun Pharma receives approval from the USFDA to market generic medications

Sun Pharmaceutical Industries announced on Friday that its subsidiary has been given the go-ahead to market a generic medication for the treatment of multiple myeloma by the US health regulator. According to a statement from Sun Pharma, the US Food and Drug Administration (USFDA) has given the company final approval for the generic lenalidomide capsules in multiple strengths. Sun Pharma and Celgene Corporation (Celgene) reached a settlement in June 2021 to end the legal dispute over the patent for Sun Pharma’s generic lenalidomide capsules. In accordance with the settlement’s terms, Celgene gave Sun Pharma a licence to the patents necessary to produce and market a specific number of generic lenalidomide capsules in the US, starting sometime after March 2022. In addition, starting on January 31, 2026, the licence enables Sun Pharma to produce and market an unlimited number of generic lenalidomide capsules in the US. On the BSE, Sun Pharma shares were down 0.48 percent, trading at Rs 1,002 per share.

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Bharat Biotech dispatches first shipments of intranasal vaccine, iNCOVACC across India

The first shipments of the world’s first intranasal Covid19 vaccine, iNCOVACC, were sent by Bharat Biotech on Monday to various locations throughout India. “The first shipments of #iNCOVACC are being dispatched to various locations across #India. A moment of pride and accomplishment for team @BharatBiotech,” Bharat Biotech said in a tweet. On Sunday, Dr. Krishna Ella, Executive Chairman of Bharat Biotech, announced that the company has begun sending hospitals the world’s first intranasal heterologous booster dose. “We have just dispatched nasal vaccines two days ago to the hospitals,” he said. Dr. Ella informed about the distribution of vaccines during the UW-Madison Global Health Institute, and Ella Foundation agreement to establish the first-ever “UWMadison One Health Center” in India to improve vaccines, medicines, and global health education. iNCOVACC is the first intranasal COVID vaccine in the world to be approved for both a heterologous booster dose that is given as nasal drops after the first 2-dose schedule. It is a Covid19 vaccine that does not need syringes, needles, alcohol wipes, bandages, etc., saving money on expenditures associated with procurement, distribution, storage, and biomedical waste disposal, which are often necessary for injectable vaccines. For purchases in large quantities by State Governments and the Government of India, iNCOVACC is priced at Rs 325 per dosage. The first COVID intranasal vaccine for Primary series and Heterologous booster, iNCOVACC (BBV154), was today dedicated to the nation by Bharat Biotech International Limited (BBIL), a global pioneer in vaccine innovation and development of vaccines for infectious diseases. On the occasion of Republic Day, it was launched by Union Health Minister Mansukh Mandaviya in the presence of Minister of Science and Technology Jitendra Singh. Read: Health minister Mandaviya launches the nasal Covid vaccination from Bharat Biotech Adenovirus vaccine with a pre-fusion stabilised spike protein called iNCOVACC is a recombinant replication-deficient vaccine. Phase I, II, and III clinical studies on this vaccine candidate were reviewed with favourable outcomes. The intranasal vaccine has been created for effective distribution and simple, pain free administration. It is stable at 2 to 8 degrees Celsius for easy distribution and storage. Dr. Krishna Ella, the Executive Chairman, stated earlier in January that “With the rollout of iNCOVACC today, we have achieved our goal of establishing a novel vaccine delivery platform for intranasal delivery. It proves that India can innovate for itself and for the world. We and the country are well prepared for future COVID-19 variants and future infectious diseases.”  He continued by stating that Bharat Biotech is a leading global vaccine developer and manufacturer, having produced more than 7 billion doses to date. Source: ANI

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Karkinos and IIT Bombay collaborate to fight cancer using next-generation omics technology

Karkinos Healthcare and the Indian Institute of Technology (IIT) Bombay collaborate to bring together the expertise of more than 100 medical professionals and academics in order to enhance cancer treatment. Through this partnership, industry and academic expertise will be combined to develop next-generation omics technologies to fight cancer. A project has been started on brain tumours, which are still among the deadliest cancers, by teams from Karkinos and IIT Bombay. The team intends to extend its research to other cancers that are often diagnosed in India. Proteins or genes alone can only provide a limited amount of information. As a result, new efforts have been made by the researchers to expand proteogenomics investigations in cancers by combining mass spectrometry-based proteomics data with genomics. “The advancements in genomics and proteomics in recent years has given a remarkable boost to our understanding about the disease pathology. Proteogenomics are adding new capabilities of providing novel insights at an unprecedented scale, which was not possible earlier,” a statement said. Prof. Sanjeeva Srivastava of IIT Bombay commented on the collaboration, saying, “At IIT Bombay, we have setup large infrastructure of proteomics-based technologies using mass spectrometry and protein microarrays to identify protein-based biomarkers.”  To speed up biological and biomedical research, Karkinos has established cutting-edge genomics technology and data analysis. “In a short time, we have enabled the latest next generation sequencing platforms and multi-omics data analysis workflow to sequence alterations in cancer genomes. We have streamlined the whole genome sequencing process which will offer rapid, accurate variant analysis,” said Dr Prashant Kumar,Chief Scientific Officer, Karkinos Healthcare.

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Govt to provide sickle cell anaemia status cards to tribals below 40

Health Minister Mansukh Mandaviya said on Wednesday that tribals under the age of 40 will be given cards stating their sickle cell anaemia status and pre-marital counselling regarding the risk of their child to get the disease if they marry another person who has the disease. After the presenting of the Union Budget, Mandaviya declared that the government will take on the eradication of sickle cell anaemia as a mission and perform extensive screening in the afflicted tribal areas for the early discovery of cases. According to Mandaviya, the tribal population in India and other vulnerable populations are frequently affected by the genetic disease, Sickle Cell Disease (SCD). “Going forward, the government will also issue cards after screening to tribal persons below 40 years affected by the disease mentioning their sickle cell anaemia status and also provide premarital counselling to make the patients aware of the detrimental effects of the disease if they marry another sickle cell anaemia patient and give birth,” he said. The aim of the screening is to lower the disease’s prevalence. A strategy for screening about 7 crore people under the age of 40 in 200 districts with the most affected residents has been developed by the Union Health Ministry in consultation with the tribal ministry and the states. The rapid “point of care” histological test, which just requires blood, will be used for the screening. According to Mandaviya, the establishment of 157 new nursing colleges in conjunction with the 157 medical colleges that have already been operating since 2014 is another significant health-related highlight of the budget. A mission will be launched to eradicate sickle cell anaemia by 2047, according to Finance Minister Nirmala Sitharaman, who made the announcement earlier on Wednesday when presenting the Union Budget for 2023–2024 in the Lok Sabha. “A mission to eliminate sickle cell anaemia by 2047 will be launched. It will entail awareness creation, universal screening of seven crore people in the age group of 0-40 years in affected tribal areas and counselling through collaborative efforts of central ministries and state governments,” she said.

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Health minister Mandaviya launches the nasal Covid vaccination from Bharat Biotech

On the occasion of Republic Day on Thursday, Union Health Minister Mansukh Mandaviya and Science and Technology Minister Jitendra Singh introduced the nasal Covid vaccine, iNCOVACC, from Bharat Biotech. At Mandaviya’s residence, the first intranasal vaccine produced in India was introduced to the world. The Drugs Controller General of India (DCGI) has approved the nasal vaccine, BBV154, in November for restricted emergency use among adults as a heterologous booster dose. Bharat Biotech previously issued a statement stating that “iNCOVACC” is priced at Rs. 800 for private markets and at Rs. 325 for supplies to the Indian government and state governments. Adenovirus-vectored vaccine called iNCOVACC has a spike protein that has been stabilised before fusing and recombinant replication deficiencies. The Hyderabad-based vaccine manufacturer had stated that this vaccine candidate had undergone successful evaluation in phase I, phase II, and phase III clinical trials. The efficacy of iNCOVACC as a primary dose schedule and a heterologous booster dose for individuals who have already received two doses of either Covishield or Covaxin were assessed in clinical trials.

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WHO seeks $2.5 billion for health emergency responses in 2023

In an appeal made on Monday, the World Health Organization requested $2.54 billion for its operations in 2023 to assist millions of people throughout the world who are experiencing medical emergencies. According to the UN health agency, there are currently an unprecedented number of interlinked health emergencies that require attention. It referred to the brutal war in Ukraine, the effects of war on health in Yemen, Afghanistan, Syria, and Ethiopia, as well as disaster brought on by climate change, such as the enormous floods that hit Pakistan last year and the rising food shortages in the Sahel and the Horn of Africa. Additionally, it emphasised that all of these emergencies coincide with the significant health system disruptions brought on by the Covid-19 pandemic and outbreaks of other deadly diseases like measles and cholera. As the WHO launched its appeal, its director Tedros Adhanom Ghebreyesus stated, “We’re witnessing an unprecedented convergence of crises that demands an unprecedented response. ” “The world cannot look away and hope these crises resolve themselves.”  According to him, the WHO is now addressing 54 health crises around the world, 11 of which are classified as high-level emergencies that demand a comprehensive response. Jarno Habicht, WHO’s representative in Ukraine, emphasised that since Russia began its full-scale invasion about a year ago, the war-torn nation has experienced more than 700 attacks on healthcare, including strikes against hospitals and ambulances. At the same time, widespread attacks on vital infrastructure throughout Ukraine “mean healthcare facilities cannot perform their duties,” he said, highlighting how they frequently operate under “very difficult circumstances” without electricity, heating, or water. The numerous health crises are occurring at a time when the demand for humanitarian aid as a whole is soaring. According to UN estimates, this year will see an unprecedented 339 million people throughout the world require some type of emergency assistance, up roughly a quarter from 2022. Gordon Brown, a former British prime minister and present WHO ambassador for global health financing, stated that “Specialised medical supplies and expertise are needed immediately, if we are not to abandon the sick to disaster, disease and death.” During the appeal event, he added, “I want to plead with donors to respond urgently to this emergency appeal to fund vaccines, drugs treatments, equipment and medical expertise.” “Give hope a shot, inject optimism, inoculate us against more avoidable deaths.”

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Cipla develops a point of care testing device “Cippoint”

Cipla has introduced Cippoint, a point-of-care testing device in Mumbai. It offers testing for things like coagulation markers, thyroid function, metabolic markers, diabetes, infectious diseases, and cardiac markers. The device has CE IVD approval. According to the company, this indicates that it has received approval from the European In-Vitro Diagnostic Device Directive, ensuring accurate testing procedures. With the entry into these new markets, Cipla has increased the range of products it offers to diagnostics laboratories. Cipla hopes to close the current gap in India’s diagnostic ecosystem by supplying reliable, accurate tests at reasonable costs. A faster clinical decision-making process will be possible due to Cippoint, an immunofluorescence-based quantitative analyser that gives healthcare providers access to test results in 3–15 minutes. Cippoint offers an automated system and a user-friendly interface that can be used even in remote locations with weak infrastructure, mobile vans, and rural areas. Achin Gupta, CEO of One India Business at Cipla, commented on the launch by saying, “Cipla has always been at the forefront of addressing the global diseases burden. We are actively working towards delivering innovative solutions that enable prompt and effective diagnosis, thereby plugging gaps in the diagnostic ecosystem. This development further strengthens our vision of supporting patients across the healthcare continuum.”

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Over 10 crore health records are digitally linked to the Ayushman Bharat Health Account

Under the Ayushman Bharat Digital Mission (ABDM), over 10 crore health records have been digitally linked to the Ayushman Bharat Health Account, a move that helps people compile a thorough medical history across various healthcare providers. So far, more over 30 crore people have created their own Ayushman Bharat Health Accounts (ABHA). Digitally linking their health records to their ABHA accounts will allow citizens to manage and access their records whenever it’s convenient for them. It will make it possible for citizens to compile thorough medical histories from different healthcare providers, enhancing clinical decision making. A digital exchange of relevant health records between citizens and ABDM-registered healthcare providers is also feasible. “I am happy to share that ABDM has touched another milestone. With 10 crore health records linked to Ayushman Bharat Health Account, we appreciate all citizens for coming forward to support our efforts in making healthcare digital in India.” The National Health Authority’s CEO, Dr. R. S. Sharma, stated in a tweet. With the assistance of state governments, numerous health facilities around the nation are implementing this digital linkage of people’s health records with ABHA. The Ayushman Bharat Digital Mission (ABDM), which aims to build the foundation required to enable the nation’s integrated digital health infrastructure, will be implemented nationwide, the prime minister announced in September 2021.

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Health Minister Mandaviya wants the diaspora to raise awareness of the traditional medical system

Mansukh Mandaviya, the union minister for health, chemicals, and fertilisers, stated on Monday that members of the Indian diaspora may educate people in other nations about India’s traditional medical system, yoga, homoeopathy, naturopathy, and trained health workers. The minister said that efforts are being made in the health sector to ensure that everyone has access to basic infrastructure and health services. He was speaking at a plenary session on “Role of Overseas Indians in Expanding Indian Health Facilities in Azadi ka Amrit kaal of – Vision 2047” in Pravasi Bharatiya Diwas. During the Azadi ka Amrit kaal, Mandaviya asked the NRI community to support in the expansion of India’s health services since “India has become an important medical tourism destination today due to its quality and affordable health services.” According to him, India meets about 15% of the demand for generic medicines in Africa, 40% in the United States, and 25% in the United Kingdom. Speaking to NRIs, Mandaviya stated that the number of MBBS seats has increased from 53,000 in 2014 to 96,000 in order to support the expansion of health services. The number of seats for post-graduation has increased from 31,000 to 63,000. Dr. Rajkumar Ranjan Singh, Union Minister of State for External Affairs, stated: “The healthcare sector is a huge opportunity for the development of the country and India is ready to seize the opportunity with its quality tech-savvy healthcare services.” The minister also provided a brief overview of India’s expanding healthcare sector. Sushri Janaina Tewaney Mencomo, Panama’s first cabinet minister of Indian origin, said: “The message of India’s spirituality and unity is contained within every citizen of Indian origin, which gives them a unique identity in the whole world.”

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India’s pharma industry expands by 8% in ’22, driven primarily by price hikes

According to market research firm AWACS, the Indian pharmaceutical market (IPM) expanded by 8% annually to 1.8 lakh crore in 2022, primarily due to price rises even as volumes held steady. A low base and the large volume offtake of Covid-19 and associated drugs such anti-infectives, vitamins, and medications for gastrointestinal and respiratory issues, pain, and fever were the main drivers of the market’s 14.9% increase in 2021. Sales of anti-infectives, including antibiotics and antifungals, fell by 5% in 2022 after increasing by 25% in 2021. Anti-infective sales volume decreased by 1%. With sales of $22,531 crore, “Anti-infectives” was the second-largest segment in 2022. Although volume growth was negative, the cardiac category, the largest therapy segment with a 13% market share, experienced an 8% gain to reach 23,561 crore in 2022. The third-largest segment, gastrointestinal, experienced a 10% increase in sales, while volumes were unchanged. Anti-diabetes sales increased by 6% in value and 1% in volume. In 2022, both in terms of value and volume, the therapeutics segment—which includes products for respiratory, gynaecology, ophthalmology, urology, and sex stimulants—was an outlier. The respiratory market continued to perform well, with volume growth of 12.4% and market growth of 19% both attributed to the worsening air quality that is aggravating respiratory diseases like asthma and chronic obstructive pulmonary disease. At 14,428 crore, the respiratory market was the sixth-largest pharmaceuticals category.

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