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The Drugs Controller General of India (DCGI) has recommended that Serum Institute of India’s Covid vaccine Covovax be approved for use as a heterologous booster dose for those who have already received two doses of Covishield or Covaxin.

Previously, DCGI approved Covovax for restricted use in emergency situations in adults on December 28, 2021, for children aged 12 to 17 on March 9, 2022, and for children aged 7 to 11 on June 28, 2022, subject to certain conditions. Covovax is made possible by a technology transfer from Novavax. It has received conditional marketing authorization from the European Medicines Agency.

On December 17, 2021, the World Health Organization (WHO) granted it an emergency-use listing.

The Government of India recently approved Bharat Biotech’s nasal Covid vaccine for adults over the age of 18 for use as a heterologous booster dose.

Private hospitals will be able to obtain the vaccine.

The World Health Organization (WHO) has advised that two cough syrups manufactured by the Noida-based Marion Biotech should not be used on children in Uzbekistan.

In a medical product alert on Wednesday, the WHO said the “substandard medical products”, manufactured by Marion Biotech, “are products that fail to meet quality standards or specifications and are therefore out of specification.” “This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical products are products that fail to meet quality standards or specifications and are therefore out of specification,” the WHO said in an alert released on its website.

“The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the alert added.

Pharma company based in Noida Marion Biotech has come under fire after reports of children dying after consuming cough syrup from Uzbekistan surfaced.

According to WHO, laboratory analysis of cough syrup samples performed by national quality control laboratories of the Republic of Uzbekistan’s Ministry of Health revealed that both products contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants.

“Both of these products may have marketing authorizations in other countries in the region. They may also have been distributed, through informal markets, to other countries or regions,” the WHO alert added.

The UN health agency added that “the substandard products referenced in this Alert are unsafe and their use, especially in children, may result in serious injury or death.”

On December 22, Uzbekistan alleged that 18 children had died after consuming medicines manufactured by Marion Biotech company. On Tuesday, Uttar Pradesh Food Safety and Drug Administration department suspended the production licence of Marion Biotech company linked to Uzbekistan’s deaths of 18 children.

“We have suspended the production license of Marion Biotech company after not providing enough documents, show-cause notice was also given by the state licensing authority depending upon the documents asked during the inspection which they didn’t provide,” said Gautam Buddh Nagar Drug inspector Vaibhav Babbar.

He further said that sample results are still pending.

Union Health Minister Mansukh Mandaviya stated last month that all manufacturing activities of the Noida-based pharma company had been halted due to reports of contamination in cough syrup Dok1 Max.

Following the World Health Organization’s (WHO) recommendation against using two cough syrups manufactured by Noida-based Marion Biotech due to “substandard quality,” the Central Drugs Standard Control Organization collected four samples of AMBRONOL syrup for investigation on Thursday.

“The team of CDSCO has collected four samples of AMBRONOL syrup for investigation from Marion Biotech Pvt Ltd,” the Drug inspector of Gautam Buddh Nagar, Uttar Pradesh Vaibhav Babbar said. It’s a joint inspection by team of state drugs inspectors and CDSCO.

WHO on Wednesday said that two cough syrups made by Noida-based company Marion Biotech should not be used for children in Uzbekistan.

In a medical product alert on Wednesday, the WHO said the “substandard medical products”, manufactured by Marion Biotech, “are products that fail to meet quality standards or specifications and are therefore out of specification.”

“This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical products are products that fail to meet quality standards or specifications and are therefore out of specification,” the WHO said in an alert released on its website.

“The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the alert added.

Noida-based pharma Marion Biotech has come under a cloud as reports emerged about the death of children after consuming cough syrup came in from Uzbekistan.

According to WHO, laboratory analysis of samples of cough syrups, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants.

“Both of these products may have marketing authorizations in other countries in the region. They may also have been distributed, through informal markets, to other countries or regions,” the

WHO alert added. On December 22, Uzbekistan alleged that 18 children had died after consuming medicines manufactured by Marion Biotech company. On Tuesday, Uttar Pradesh Food Safety and Drug Administration department suspended the production licence of Marion Biotech company linked to Uzbekistan’s deaths of 18 children.

“We have suspended the production license of Marion Biotech company after not providing enough documents, a show-cause notice was also given by the state licensing authority depending upon the documents asked during the inspection which they didn’t provide,” said Gautam Buddh Nagar Drug inspector Vaibhav Babbar.

According to Union Health Minister Mansukh Mandaviya, nearly 200 flight travellers were discovered COVID-positive with the BF.7 strain after random sampling at airports. According to him, almost 15 lakh flight travellers were examined for Covid-19. “More than 15 lakh aviation travellers have been checked for Covid19 as of today. More than 200 passengers tested positive for Covid, and samples sent for genome sequencing revealed that the BF.7 variation was present in majority of them. Our immunisations work against this variation “Union Health Minister Mansukh Mandaviya stated.

He stated that, given the global spread of the Covid fourth wave, 8,700 flights have been identified thus far. “Amid the COVID fourth wave in the world, we’re monitoring every airport. So far 8,700 flights have been monitored. Over 15 lakh passengers have been traced and out of them over 200 passengers have been detected as Covid positive,” said Mansukh Mandaviya.

He further added that the vaccine is effective to fight the BF.7 variant.
“All of them were sent for isolation and their samples were sent for genome sequencing. Through genome sequencing, we’ve found Covid BF.7 variant in some passengers. However, our vaccine is effective enough to fight the BF.7 variant. We’re taking all necessary measures,” said Mansukh Mandaviya.

On Wednesday, India recorded 171 new COVID-19 cases in the previous 24 hours, according to the Ministry of Health and Family Welfare. The country’s active caseload now stands at 2,342. According to the health ministry, 4,41,47,322 persons have recovered since the epidemic began, with 148 recoveries occurring in the previous 24 hours. Active cases account for 0.01 percent of all infections, with a recovery rate of 98.8 percent. According to the ministry, the daily positivity rate was 0.09 percent and the weekly positivity rate was 0.11 percent.

“The sewage sampling is being done and there also we are not getting any indication that either a new variant is here or there is a possibility of the upsurge of cases in the coming days or weeks,” Chairman of COVID-19 working group NTAGI, Dr NK Arora said.

In the previous 24 hours, the country conducted 1,80,926 tests, for a total of 91.25 crore tests. More than 220.15 crore vaccine doses have been provided to eligible persons across the country as part of the countrywide immunisation programme. Approximately 44,397 dosages were provided in the previous 24 hours. The Nationwide Vaccination Drive resulted in the administration of 220.15 crore total vaccine doses (95.14 crore second dose and 22.44 crore precaution dose). Meanwhile, examination of sewage samples has shown no new COVID variants, according to a leading health specialist on Tuesday.

According to the official, India has been in a “fairly comfortable situation” during the previous year. “Our genomic surveillance system has identified almost 300 plus sub-variants of Omicron and they are spread all over the place. From time to time a certain sub-lineage becomes dominant. But the important point is that throughout the years we did not have any massive increase or surge in hospitalizations or deaths,” he said.

On Monday Union Health Ministry also said, “Sentinel sequencing of 324 COVID Positive Samples reveals the presence of all Omicron Variants in Community. No mortality or rise in transmission was reported in areas where these variants were detected”.

“Our genomic surveillance system has identified almost 300 plus sub-variants of Omicron and they are spread all over the place. From time to time a certain sub-lineage becomes dominant. But the important point is that throughout the years we did not have any massive increase or surge in hospitalizations or deaths,” he said.

On Monday Union Health Ministry also said, “Sentinel sequencing of 324 COVID Positive Samples reveals the presence of all Omicron Variants in Community. No mortality or rise in transmission was reported in areas where these variants were detected”.

Dr. Mansukh Mandaviya, Union Health Minister, stated on Wednesday that the vaccinations available in India are effective against Omicron Sub-variant BF.7. “We discovered the BF.7 variant in a few travellers. Our vaccine, on the other hand, is effective against the BF.7 strain. We’re taking all essential precautions “Mandaviya made the remarks at the presentation of a book titled Braving A Viral Storm: India’s Covid-19 Vaccine Story. He stated that, given the global spread of the Covid fourth wave, 8,700 flights have been identified thus far.

On Wednesday, India recorded 171 new COVID-19 cases in the previous 24 hours, according to the Ministry of Health and Family Welfare. The country’s active caseload now stands at 2,342. According to the health ministry, 4,41,47,322 persons have recovered since the epidemic began, with 148 recoveries occurring in the previous 24 hours.

Active cases account for 0.01 percent of all infections, with a recovery rate of 98.8 percent. According to the ministry, the daily positivity rate was 0.09 percent and the weekly positivity rate was 0.11 percent. In the previous 24 hours, the country conducted 1,80,926 tests, for a total of 91.25 crore tests.

“The sewage sampling is being done and there also we are not getting any indication that either a new variant is here or there is a possibility of the upsurge of cases in the coming days or weeks,” Chairman of COVID-19 working group NTAGI, Dr NK Arora said.

The official said that India has maintained to be in a “reasonably comfortable position” during the last 12 months.
“Our genomic surveillance system has identified almost 300 plus sub-variants of Omicron and they are spread all over the place. From time to time a certain sub-lineage becomes dominant. But the important point is that throughout the years we did not have any massive increase or surge in hospitalizations or deaths,” he said.

On Monday Union Health Ministry also said, “Sentinel sequencing of 324 COVID Positive Samples reveals the presence of all Omicron Variants in the Community. No mortality or rise in transmission was reported in areas where these variants were detected”.

Overweight and obese adults are more likely to acquire diabetes, although the specific process is unknown.
A new study from Washington University School of Medicine in St. Louis may help explain how obesity contributes to diabetes and may present researchers with a target to help prevent or postpone diabetes in some at-risk individuals. The findings reveal that many patients with increased insulin levels – an early indicator of diabetes risk – also have abnormalities in an enzyme involved in the digestion of a crucial fatty acid from the diet. The findings were published in the journal Cell Metabolism on January 11th.

“Between 30 million and 40 million people in the United States have Type 2 diabetes, and another 90 million to 100 million have risk factors that make them likely to develop Type 2 diabetes in the future,” said senior investigator Clay F. Semenkovich, MD, director of the Division of Endocrinology, Metabolism & Lipid Research at the School of Medicine.

When a person has too much body fat, the pancreas’s beta cells release more insulin. When insulin levels rise and stay high, the body becomes insulin resistant, and the beta cells that generate insulin eventually die, resulting in diabetes.

Semenkovich, the Irene E. and Michael M. Karl Professor; lead author Guifang Dong, PhD, a senior scientist; Xiaochao Wei, PhD, an assistant professor of medicine; and other Washington University researchers discovered that insulin overproduction is caused by a process known as palmitoylation. Cells link the fatty acid palmitate to proteins by this mechanism.

Thousands of human proteins can be connected to palmitate, but the researchers discovered that diabetes occurs when this fatty acid is not removed from proteins in beta cells. The researchers discovered that persons with diabetes were weak in an enzyme that removes palmitate from beta cells when they examined tissue samples from people who were thin or overweight, and with and without diabetes.

David W. Piston, PhD, the Edward W. Mallinckrodt Jr. Professor and Head of the Department of Cell Biology & Physiology, and Maria S.

“We’ve found several candidate drugs, and we’re pursuing those,” Semenkovich said. “We think that by increasing APT1 activity, we might reverse this process and potentially prevent people at risk from progressing to diabetes.”

The research team, led by Remedi, PhD, a professor of medicine and cell biology & physiology, and Fumihiko Urano, MD, PhD, a professor of medicine and pathology & immunology, also genetically engineered a mouse that was deficient in the enzyme APT1, which is responsible for palmitate removal from proteins. Diabetes developed in the altered mice. Because reduced APT1 function increased the risk of diabetes, the researchers collaborated with the university’s Center for Drug Discovery to screen and find drugs that potentially improve APT1 enzyme activity.

“We’ve found several candidate drugs, and we’re pursuing those,” Semenkovich said. “We think that by increasing APT1 activity, we might reverse this process and potentially prevent people at risk from progressing to diabetes.”

Although Semenkovich stated that the new discoveries identifying APT1 as a target are a significant step, he added that APT1 is merely one therapy target among several. “There are several ways that Type 2 diabetes may develop,” he said. “This enzyme is not the answer, but it’s an answer, and it appears we have some promising tools that might keep some people with prediabetes from developing diabetes.”

According to a new study, significant inflammation impairs the body’s capacity to eradicate malignant blood cells in people with acute myeloid leukaemia (AML). Experiments in human cells also demonstrated how increased levels of inflammation, as indicated by an aggressive response of immune cells in the bone marrow, affected the makeup of immunity B and T cells required to combat the disease as if it were an invading pathogen or virus. Researchers at NYU Langone Health and its Perlmutter Cancer Center were able to rate each patient’s level of inflammation using bone marrow samples from 20 adults and 22 children with the fatal condition.

These “iScores” were then associated to survival rates, with people with the lowest iScores often outliving those with higher iScores. Patients with leukaemia who had high iScores died at least four years earlier than those who had modest levels of inflammation. According to the NYU researchers, the new “iScore” method may be added to current instruments for detecting AML severity and utilised by clinicians and patients when choosing on immunotherapy, chemotherapy, or bone marrow transplantation.

“Our scoring system gives an accessible tool for clinicians and patients to quantify their risk from inflammation associated with their leukaemia and alter their treatment programmes accordingly to reduce this risk,” research co-lead scientist Audrey Lasry, PhD, explains. She claims that the measurements required to determine a patient’s iScore are openly available to academic researchers and doctors in the study article, which was published in the journal Nature Cancer.

According to Lasry, a postdoctoral fellow at NYU Grossman School of Medicine and Perlmutter Cancer Center, some patients may prefer immunotherapy to enhance immune cells needed to combat cancer if their inflammation score is high. Others may prefer alternate therapy in situations of mild inflammation related to cancer since their immune system does not require strengthening.

The study also discovered that in both adults and children with AML, bone marrow levels of defective (atypical) immunological B cells were connected to inflammation. A dozen gene mutations, or flaws in the genetic code, were discovered to be associated with high iScores and severe instances of the disease. Another significant result was that the efficiency of certain immunological T cells, which directly attack cancer cells, was inhibited in kid instances of leukaemia with high inflammation but not in adult cases.

“Our study is the first to provide a detailed description of how inflammation alters the tumour microenvironment in both adults and children with acute myeloid leukaemia,” says study co-lead investigator Bettina Nadorp, PhD, who is also a postdoctoral fellow at NYU Grossman School of Medicine and Perlmutter Cancer Center.

“These study findings suggest that monitoring inflammation in patients with AML and possibly lowering inflammation levels with drug therapy should be considered as part of treatment for the disease,” says study senior investigator Iannis Aifantis, PhD.

The team plans to analyse bone marrow samples from people with myelodysplastic syndrome, another blood cancer related to acute myeloid leukaemia, to see if the same risk stratification applies based on inflammation, according to Aifantis, the Hermann M. Biggs Professor and chair of the Department of Pathology at NYU Grossman and Perlmutter.

Researchers compared bone marrow samples from patients with acute myeloid leukaemia to bone marrow samples from 10 healthy adults of comparable age, race, and gender who did not have cancer. In adults with the condition, 246 genes associated with inflammation were found to be highly or less active, whereas 187 genes associated with inflammation were found to be similarly active in children.

Researchers reduced their investigation to 38 important genes in adults and 11 in children by factoring in how long each patient had survived with the condition, and were then able to construct a score that linked inflammation levels to survival. When a group of patients’ iScores are compared, researchers claim it’s straightforward to identify who’s iScore is higher or lower than the average and by how much, which may then be used to direct a patient’s therapy.
For any economic activity stemming from the usage of the iScore, the research team has a patent application filed. The terms and conditions of this patent are controlled in line with NYU Langone’s regulations.

Acute myeloid leukaemia develops in the bone marrow and is characterised by the accumulation of aberrant blood cells, which can interfere with the formation of healthy blood cells. The most prevalent kind of blood cancer affects largely adults and kills around 11,500 Americans each year. Chemotherapy, radiation therapy, and immunotherapy are all treatment possibilities. If all other methods fail, bone marrow transplantation may be considered.

Lupin stated on Tuesday that the United States Food and Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA), Prasugrel tablets for 5 mg and 10 mg, which is a generic counterpart of Cosette Pharmaceuticals Inc.’s Effient tablets, 5 mg and 10 mg.

According to a statement from Lupin, the product would be manufactured in the company’s Goa site.
According to IQVIA, prasugrel tablets of 5 mg and 10 mg have expected annual sales of USD 18 million in the United States.

A release said Lupin, headquartered in Mumbai, develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific, Latin America, Europe, and Middle East regions.

Lupin said it has 15 manufacturing sites, seven research centres, more than 20,000 professionals working globally, and has been consistently recognised as a ‘Great Place to Work’ in the biotechnology and pharmaceuticals sector.

According to recent research, people who are depressed or anxious can help themselves heal by helping others.

The study discovered that performing acts of kindness resulted in benefits when compared to two different therapeutic procedures used to treat sadness or anxiety. Most crucially, according to research co-author David Cregg, who conducted the experiment as part of his PhD dissertation in psychology at The Ohio State University, the acts of kindness strategy was the only intervention examined that made individuals feel more connected to others.

“Social connection is one of the ingredients of life most strongly associated with well-being. Performing acts of kindness seems to be one of the best ways to promote those connections,” Cregg said.

Cregg conducted the research with Jennifer Cheavens, professor of psychology at Ohio State. Their study was published recently in The Journal of Positive Psychology.

The research also revealed why performing acts of kindness worked so well: It helped people take their minds off their own depression and anxiety symptoms.

This finding suggests that one intuition many people have about people with depression may be wrong, Cheavens said.

“We often think that people with depression have enough to deal with, so we don’t want to burden them by asking them to help others. But these results run counter to that,” she said.

“Doing nice things for people and focusing on the needs of others may actually help people with depression and anxiety feel better about themselves.”

The study included 122 adults from central Ohio who had moderate to severe depression, anxiety, and stress symptoms.
Following an introduction session, participants were divided into three groups. Two of the groups were randomly allocated to strategies commonly used in cognitive behavioural therapy (CBT) for depression: social activity planning and cognitive reappraisal.

The social activities committee was given the task of organising social events for two days every week. Another group was taught one of CBT’s mainstays: cognitive reappraisal. These participants kept diaries for at least two days each week, which assisted them in identifying negative thinking patterns and revising their ideas in a way that might lessen sadness and anxiety.

Members of the third group were instructed to perform three acts of kindness a day for two days out of the week. Acts of kindness were defined as “big or small acts that benefit others or make others happy, typically at some cost to you in terms of time or resources.”

Some of the acts of kindness that participants later said they did included baking cookies for friends, offering to give a friend a ride, and leaving sticky notes for roommates with words of encouragement.

Participants followed their instructions for five weeks, after which they were evaluated again. The researchers then checked with the participants after another five weeks to see if the interventions were still effective.

The findings showed that participants in all three groups showed an increase in life satisfaction and a reduction of depression and anxiety symptoms after the 10 weeks of the study.

“These results are encouraging because they suggest that all three study interventions are effective at reducing distress and improving satisfaction,” Cregg said.

“But acts of kindness still showed an advantage over both social activities and cognitive reappraisal by making people feel more connected to other people, which is an important part of well-being,” he said.

In addition, the acts of kindness group showed greater improvements than the cognitive reappraisal group for life satisfaction and symptoms of depression and anxiety, results showed.

Cheavens noted that just participating in social activities did not improve feelings of social connection in this study.

“There’s something specific about performing acts of kindness that makes people feel connected to others. It’s not enough to just be around other people, participating in social activities,” she said.

Cregg said that while this study used techniques of CBT, it is not the same experience as going through CBT. Those who undergo the full treatment may have better results than those in this study.

But the findings also show that even the limited CBT exposure given in this study can be helpful, Cheavens said.

“Not everyone who could benefit from psychotherapy has the opportunity to get that treatment,” she said. “But we found that a relatively simple, one-time training had real effects on reducing depression and anxiety symptoms.”

And beyond traditional CBT, acts of kindness may have additional benefits in creating social connections, Cregg said.
“Something as simple as helping other people can go above and beyond other treatments in helping heal people with depression and anxiety,” he said.