British pharmaceutical company GSK said on Wednesday that it has agreed to pay $2.3 billion to put an end to lawsuits in the United States alleging that its heartburn drug Zantac caused cancer.

British pharmaceutical company GSK said on Wednesday that it has agreed to pay $2.3 billion to put an end to lawsuits in the United States alleging that its heartburn drug Zantac caused cancer. "GSK today announced that it has reached agreements with 10 plaintiff firms who together represent 93 per cent (approximately 80,000) of the Zantac state court product liability cases pending against GSK," the company said in a statement. Under the agreement, whose terms are confidential, GSK will make an "aggregate payment of up to $2.2 billion" to resolve these cases, the statement added. The company also said on Wednesday that it had reached another agreement in principle to pay $70 million to settle a separate Zantac case with US laboratory Valisure -- which is still subject to final approval by the US Department of Justice. Also Read | ‘It needs to go’: Tim Walz calls for scrapping of electoral college system Class action and personal injury lawsuits have been filed in US courts after the Food and Drug Administration warned in 2019 that some ranitidine drugs, including Zantac, contained low levels of an environmental contaminant considered a probable carcinogen. However the pharmaceutical giant said it "has not admitted any liability" by settling the case as "the scientific consensus remains that there is no consistent or reliable evidence" that ranitidine is carcinogenic. Also Read | ‘Your behaviour not unnoticed,’ Philippines embarrasses China at ASEAN summit The over-the-counter treatment, known also by its non-commercial name ranitidine, was manufactured by several rivals, including the French group Sanofi and US drugmaker Pfizer, before it was withdrawn in 2019. In recent years, GSK has won several court cases on the issue in the United States, while signing several other settlements to avoid litigation. Disclaimer: This story has been published from a news agency feed with minimal edits to adhere to WION's style guide. The headline may have been changed to better reflect the content of the story or to make it more suitable for WION audience.

Pharma company GSK agrees to pay $2.3bn in US settlements on lawsuits over Zantac cancer claims

US&nbsp;pharma company Eli Lilly is gearing up to introduce its flagship diabetes medication and popular obesity treatment, Mounjaro, into the Indian market, Reuters news agency reported citing the company's CEO. 
 
India is a significant market opportunity due to its high population, escalating rates of obesity, particularly among women, and a substantial number of individuals grappling with type-2 diabetes, ranking second globally.

Concurrently, Indian pharmaceutical firms are exploring their formulations for weight-loss drugs, while counterfeit versions proliferate online.

Eli Lilly CEO&nbsp; David Ricks, speaking during the BioAsia conference in the south Indian state of Telangana,&nbsp; expressed optimism about Mounjaro's entry into India, pending regulatory approval.

The company remains open to partnerships to enhance market reach, ensuring both patient access and company viability, he said.

"Our famous Mounjaro – it's under review now. So, perhaps as early as next year to the Indian market," Ricks told Reuters on the sidelines of the BioAsia conference.

<a href="https://www.wionews.com/world/explained-ozempic-wegovy-and-now-zepbound-the-era-of-magic-pills-for-treating-obesity-656969">Also read |&nbsp;Explained | Ozempic, Wegovy and now Zepbound: The era of magic pills for treating obesity</a>

Sold as Mounjaro in the UK and Europe, and as Zepbound for weight loss in the US, the drug, chemically known as tirzepatide, is undergoing regulatory review in India. Lilly leverages data from global trials, which include participants from India.

Mounjaro, alongside Novo Nordisk's Wegovy and Ozempic, belongs to a class of medications known as GLP-1 receptor agonists. These drugs, originally developed to manage blood sugar in type 2 diabetes, have gained popularity for their additional benefit of inducing satiety.

Also watch |&nbsp;Gravitas | Oprah admits to using weight-loss drug

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Analysts project the global market for these therapies to exceed $100 billion by the decade's end.

Novo Nordisk aims to introduce Wegovy in India by 2026, while Indian pharmaceutical giants including Zydus Lifesciences, Sun Pharma, Cipla, Dr. Reddy's, and Lupin, are already in the race, developing their versions, Reuters said in a report.

Ricks stressed on&nbsp;the need for India to streamline its regulatory processes, enhance patent protection, and rationalise policies to attract greater investment from global pharmaceutical companies.

Simplifying regulations would facilitate the entry of innovative medicines into the market and bolster the export capabilities of local biotech firms.

(With inputs from agencies)

US pharma company Eli Lilly is gearing up to introduce its flagship diabetes medication and popular obesity treatment, Mounjaro, into the Indian market, Reuters news agency reported citing the company's CEO.

US pharma company Eli Lilly is gearing up to introduce its flagship diabetes medication and popular obesity treatment, Mounjaro, into the Indian market, Reuters news agency reported citing the company's CEO. India is a significant market opportunity due to its high population, escalating rates of obesity, particularly among women, and a substantial number of individuals grappling with type-2 diabetes, ranking second globally. Concurrently, Indian pharmaceutical firms are exploring their formulations for weight-loss drugs, while counterfeit versions proliferate online. Eli Lilly CEO David Ricks, speaking during the BioAsia conference in the south Indian state of Telangana, expressed optimism about Mounjaro's entry into India, pending regulatory approval. The company remains open to partnerships to enhance market reach, ensuring both patient access and company viability, he said. "Our famous Mounjaro – it's under review now. So, perhaps as early as next year to the Indian market," Ricks told Reuters on the sidelines of the BioAsia conference. Also read | Explained | Ozempic, Wegovy and now Zepbound: The era of magic pills for treating obesity Sold as Mounjaro in the UK and Europe, and as Zepbound for weight loss in the US, the drug, chemically known as tirzepatide, is undergoing regulatory review in India. Lilly leverages data from global trials, which include participants from India. Mounjaro, alongside Novo Nordisk's Wegovy and Ozempic, belongs to a class of medications known as GLP-1 receptor agonists. These drugs, originally developed to manage blood sugar in type 2 diabetes, have gained popularity for their additional benefit of inducing satiety. Also watch | Gravitas | Oprah admits to using weight-loss drug Analysts project the global market for these therapies to exceed $100 billion by the decade's end. Novo Nordisk aims to introduce Wegovy in India by 2026, while Indian pharmaceutical giants including Zydus Lifesciences, Sun Pharma, Cipla, Dr. Reddy's, and Lupin, are already in the race, developing their versions, Reuters said in a report. Ricks stressed on the need for India to streamline its regulatory processes, enhance patent protection, and rationalise policies to attract greater investment from global pharmaceutical companies. Simplifying regulations would facilitate the entry of innovative medicines into the market and bolster the export capabilities of local biotech firms. (With inputs from agencies)

Launch of obesity medicine in India by next year, says pharma firm: Report

Addressing the financial barriers in treatment of rare diseases, Indian pharmaceutical firms have initiated the production of medicines for conditions such as Tyrosinemia Type 1, Gaucher’s Disease, Wilson’s Disease, and Dravet-Lennox Gastaut Syndrome, resulting in cost reductions of up to 100 fold.

Indian drug companies have successfully manufactured medicines for Tyrosinemia Type 1, Gaucher’s Disease, Wilson’s Disease, and Dravet-Lennox Gastaut Syndrome, significantly lowering the treatment costs.

An additional four medicines, expected to be available by early 2024, promise further affordability compared to their imported counterparts.

In tandem with addressing rare diseases, the Indian government has urged the pharmaceutical industry to produce an affordable oral solution for hydroxyurea, essential for treating children up to 5 years old with sickle cell disease.

<a href="https://www.wionews.com/india-news/four-dead-60-injured-during-stampede-at-concert-in-university-in-indias-kerala-662870">Also read |&nbsp;Four dead, 60 injured during stampede at concert in university in India's Kerala</a>

<h2>Cost reduction examples</h2>

<ul>
	<li>
	Eliglustat Capsules (Gaucher’s Disease): Costs reduced from Rs 1.8 crore (around 0.2 million USD) -Rs 3.6 crore (around 0.4 million USD)&nbsp;annually&nbsp;to Rs 3 lakh (3,600 USD)-Rs 6 lakh (7,201 USD), benefitting adults with this condition causing fatty deposits on organs.
	</li>
	<li>
	Trientine Capsules (Wilson’s Disease): Price drop from Rs 2.2 crore (around 0.26 million USD) for a 10 kg child to Rs 2.2 lakh (around 2,600 USD), addressing excess copper deposition leading to psychiatric symptoms.
	</li>
	<li>
	Nitisinone Capsules (Tyrosinemia Type 1): Cost decreased from Rs 2.2 crore&nbsp;(around 0.26 million USD) annually for a 10 kg child to Rs 2.5 lakh&nbsp;(around 3,000&nbsp;USD), addressing a metabolic condition causing liver diseases.
	</li>
	<li>
	Cannabidiol Oral Solution (Dravet-Lennox Gastaut Syndrome): Reduced from Rs 7 lakh (around 8,400 USD) - Rs 34 lakh (40,809 USD) per year to Rs 1 lakh (around 1,200 USD - Rs 5 lakh (6,000 USD) for a 10 kg child, offering relief for genetic epilepsy syndromes.
	</li>
</ul>

Government collaboration with the pharmaceutical industry has been crucial in identifying priority conditions and facilitating non-profit production of these vital therapies. The companies have agreed to manufacture these medicines without a profit motive, recognizing the limited demand due to the rarity of these conditions.

Also watch |&nbsp;Uttarakhand tunnel rescue: 41 construction workers remain trapped since November 12

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With 6-8 per cent&nbsp;of the population estimated to have rare diseases, affecting 8.4 crore to 10 crore Indians, the government is actively working to make cheaper, locally manufactured therapies available for at least 13 priority conditions.

Considering the dispersed population of rare disease patients, the government is exploring ways to make these medicines available beyond centers of excellence for rare diseases.&nbsp;

(With inputs from agencies)

Addressing the financial barriers in treatment of rare diseases, Indian pharmaceutical firms have initiated the production of medicines for conditions such as Tyrosinemia Type 1, Gaucher’s Disease, Wilson’s Disease, and Dravet-Lennox Gastaut Syndrome, resulting in cost reductions of up to 100 fold.

Addressing the financial barriers in treatment of rare diseases, Indian pharmaceutical firms have initiated the production of medicines for conditions such as Tyrosinemia Type 1, Gaucher’s Disease, Wilson’s Disease, and Dravet-Lennox Gastaut Syndrome, resulting in cost reductions of up to 100 fold. Indian drug companies have successfully manufactured medicines for Tyrosinemia Type 1, Gaucher’s Disease, Wilson’s Disease, and Dravet-Lennox Gastaut Syndrome, significantly lowering the treatment costs. An additional four medicines, expected to be available by early 2024, promise further affordability compared to their imported counterparts. In tandem with addressing rare diseases, the Indian government has urged the pharmaceutical industry to produce an affordable oral solution for hydroxyurea, essential for treating children up to 5 years old with sickle cell disease. Also read | Four dead, 60 injured during stampede at concert in university in India's Kerala Cost reduction examples Eliglustat Capsules (Gaucher’s Disease): Costs reduced from Rs 1.8 crore (around 0.2 million USD) -Rs 3.6 crore (around 0.4 million USD) annually to Rs 3 lakh (3,600 USD)-Rs 6 lakh (7,201 USD), benefitting adults with this condition causing fatty deposits on organs. Trientine Capsules (Wilson’s Disease): Price drop from Rs 2.2 crore (around 0.26 million USD) for a 10 kg child to Rs 2.2 lakh (around 2,600 USD), addressing excess copper deposition leading to psychiatric symptoms. Nitisinone Capsules (Tyrosinemia Type 1): Cost decreased from Rs 2.2 crore (around 0.26 million USD) annually for a 10 kg child to Rs 2.5 lakh (around 3,000 USD), addressing a metabolic condition causing liver diseases. Cannabidiol Oral Solution (Dravet-Lennox Gastaut Syndrome): Reduced from Rs 7 lakh (around 8,400 USD) - Rs 34 lakh (40,809 USD) per year to Rs 1 lakh (around 1,200 USD - Rs 5 lakh (6,000 USD) for a 10 kg child, offering relief for genetic epilepsy syndromes. Government collaboration with the pharmaceutical industry has been crucial in identifying priority conditions and facilitating non-profit production of these vital therapies. The companies have agreed to manufacture these medicines without a profit motive, recognizing the limited demand due to the rarity of these conditions. Also watch | Uttarakhand tunnel rescue: 41 construction workers remain trapped since November 12 With 6-8 per cent of the population estimated to have rare diseases, affecting 8.4 crore to 10 crore Indians, the government is actively working to make cheaper, locally manufactured therapies available for at least 13 priority conditions. Considering the dispersed population of rare disease patients, the government is exploring ways to make these medicines available beyond centers of excellence for rare diseases. (With inputs from agencies)

'Made in India' drugs to cut treatment costs of rare diseases by nearly 100 times

Pfizer on Monday announced a deal to buy Seagen Inc in a $43 billion deal that brings together one of the world's top US-based pharmaceutical companies and the American biotech firm pioneering cancer medicines.

“Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health,” said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer.&nbsp;

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As Pfizer is now all set to acquire Seagen, the combined strength is seen to be benefitting Pfizer's position on oncology.&nbsp;The acquisition will further bring together the power of Seagen’s antibody-drug conjugate (ADC) technology with the scale and strength of Pfizer’s capabilities and expertise.&nbsp;

According to Seagen's statement, the company has led the way in novel cancer therapeutics for over 20 years as well as discovering safe and effective solutions to challenging clinical needs.&nbsp;

Also Read | <a href="https://www.wionews.com/india-news/india-hosts-first-sco-conference-on-shared-buddhist-heritage-571559">India hosts first SCO conference on Shared Buddhist Heritage</a>

Pfizer has acquired the company for $229 per Seagen share in cash. The Boards of Directors of both companies have unanimously approved the transaction, as per the statement.&nbsp;

US giant Pfizer expects to achieve nearly $1 billion in cost efficiencies in the third full year after the completion of the transaction. The completion of the transaction is expected to be achieved by late 2023 or early 2024.&nbsp;

Watch | <a href="https://www.wionews.com/videos/not-easy-to-achieve-target-need-to-double-our-efforts-for-the-target-li-qiang-571556">Not easy to achieve target, need to double our efforts for the target: Li Qiang</a>

"Oncology continues to be the largest growth driver in global medicine, and this acquisition will enhance Pfizer’s position in this important space and contribute meaningfully to the achievement of Pfizer’s near- and long-term financial goals," Bourla said.&nbsp;Seagen expects to generate approximately $2.2 billion of revenue in 2023.&nbsp;

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Pfizer on Monday announced a deal to buy Seagen Inc in a $43 billion deal that brings together one of the world's top US-based pharmaceutical companies and the American biotech firm pioneering cancer medicines.

Pfizer on Monday announced a deal to buy Seagen Inc in a $43 billion deal that brings together one of the world's top US-based pharmaceutical companies and the American biotech firm pioneering cancer medicines. “Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health,” said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer. Also Read | Indian SC directs petitions seeking same-sex marriage legalisation to constitutional bench As Pfizer is now all set to acquire Seagen, the combined strength is seen to be benefitting Pfizer's position on oncology. The acquisition will further bring together the power of Seagen’s antibody-drug conjugate (ADC) technology with the scale and strength of Pfizer’s capabilities and expertise. According to Seagen's statement, the company has led the way in novel cancer therapeutics for over 20 years as well as discovering safe and effective solutions to challenging clinical needs. Also Read | India hosts first SCO conference on Shared Buddhist Heritage Pfizer has acquired the company for $229 per Seagen share in cash. The Boards of Directors of both companies have unanimously approved the transaction, as per the statement. US giant Pfizer expects to achieve nearly $1 billion in cost efficiencies in the third full year after the completion of the transaction. The completion of the transaction is expected to be achieved by late 2023 or early 2024. Watch | Not easy to achieve target, need to double our efforts for the target: Li Qiang "Oncology continues to be the largest growth driver in global medicine, and this acquisition will enhance Pfizer’s position in this important space and contribute meaningfully to the achievement of Pfizer’s near- and long-term financial goals," Bourla said. Seagen expects to generate approximately $2.2 billion of revenue in 2023. WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Pfizer to acquire US biotech firm Seagen for $43 billion to accelerate fight against cancer

India may issue a notice regarding cough syrup sold by Marion Biotech, whose medicines have been linked to the deaths of several children in&nbsp;Uzbekistan, as&nbsp;testing revealed that many of the company's medicine samples contained toxins, an Indian drug inspector stated on Saturday (March 4), as per an exclusive Reuters report.&nbsp;

After tests in a government laboratory that revealed 22 of 36 samples of the syrup to be "adulterated and spurious," Indian police detained three Marion workers on Friday (March 3) and are searching for the firm's two directors.

According to Vaibhav Babbar, an inspector working on the Marion probe, who spoke to Reuters, the samples were contaminated with ethylene glycol and diethylene glycol, which the World Health Organization claims were present in the items marketed by the two corporations in the two nations.

There have been 19 child deaths in Uzbekistan and up to 70 in the Gambia.

ALSO READ |&nbsp;<a href="https://www.wionews.com/india-news/from-april-india-jewellers-required-to-sell-hallmarked-gold-568542">From April 1, only gold jewellery with hallmarking to be sold in India</a>

As per&nbsp;data released by the World Health Organiazation (WHO) in January, acute renal damage brought on by adulterated medications claimed the lives of more than 300 children, most of whom were under the age of five, in Gambia, Indonesia, and Uzbekistan last year.

The Philippines, Timor Leste, Senegal, and Cambodia were all mentioned as possible impacted countries since they may have the drugs available for purchase. Moreover, it urged its 194 member nations to take "urgent and coordinated measures" to stop further fatalities.

ALSO WATCH |&nbsp;Antony Blinken takes auto-rickshaw ride during New Delhi visit

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The WHO claimed that four of Maiden's cough syrups, another pharmaceuticals company in India&nbsp;may have killed dozens of children in Gambia, prompting India to halt production at Maiden for breaking manufacturing regulations in October, 2022.&nbsp;

Maiden has refuted claims that the deaths in the Gambia were caused by its medications, and testing conducted by an Indian government laboratory detected no contaminants in its samples.

(With inputs from agencies) 
&nbsp;

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India may issue a notice regarding cough syrup sold by Marion Biotech, whose medicines have been linked to the deaths of several children in Uzbekistan, as testing revealed that many of the company's medicine samples contained toxins, an Indian drug inspector stated on Saturday (March 4), as per an exclusive Reuters report.

India may issue a notice regarding cough syrup sold by Marion Biotech, whose medicines have been linked to the deaths of several children in Uzbekistan, as testing revealed that many of the company's medicine samples contained toxins, an Indian drug inspector stated on Saturday (March 4), as per an exclusive Reuters report. After tests in a government laboratory that revealed 22 of 36 samples of the syrup to be "adulterated and spurious," Indian police detained three Marion workers on Friday (March 3) and are searching for the firm's two directors. According to Vaibhav Babbar, an inspector working on the Marion probe, who spoke to Reuters, the samples were contaminated with ethylene glycol and diethylene glycol, which the World Health Organization claims were present in the items marketed by the two corporations in the two nations. There have been 19 child deaths in Uzbekistan and up to 70 in the Gambia. ALSO READ | From April 1, only gold jewellery with hallmarking to be sold in India As per data released by the World Health Organiazation (WHO) in January, acute renal damage brought on by adulterated medications claimed the lives of more than 300 children, most of whom were under the age of five, in Gambia, Indonesia, and Uzbekistan last year. The Philippines, Timor Leste, Senegal, and Cambodia were all mentioned as possible impacted countries since they may have the drugs available for purchase. Moreover, it urged its 194 member nations to take "urgent and coordinated measures" to stop further fatalities. ALSO WATCH | Antony Blinken takes auto-rickshaw ride during New Delhi visit The WHO claimed that four of Maiden's cough syrups, another pharmaceuticals company in India may have killed dozens of children in Gambia, prompting India to halt production at Maiden for breaking manufacturing regulations in October, 2022. Maiden has refuted claims that the deaths in the Gambia were caused by its medications, and testing conducted by an Indian government laboratory detected no contaminants in its samples. (With inputs from agencies) WATCH WION LIVE HERE:

India may issue alert on Marion cough syrup exports as lab tests find toxins

The shortage of antibiotics in Europe made headlines late last year, with most manufacturers citing supply-chain issues and a rise in demand across the continent for medicines. However, a report by Reuters published on Wednesday (February 8), suggests that their problems might not be over just yet. The news agency spoke to 13 European manufacturers and six generic drug industry associations and trade groups and noted that many firms are struggling to make enough money to continue to justify making antibiotics.&nbsp;

What has happened so far?

In December, pharmacies across the United Kingdom and France reported they are running out of key antibiotics which came amid a surge of post-Covid winter infections like strep throat. Some of these medicines included amoxicillin (used to treat a number of respiratory infections) as well as the common painkiller paracetamol.&nbsp;

However, even at the time, the phenomenon was not unheard of as a similar situation took place during the COVID-19 pandemic while the recent one was also attributed to the ongoing conflict in Ukraine and supply chain issues. Additionally, it was also attributed to the fact that India and China produced at least 60 to 80 per cent of the world’s active pharmaceutical ingredients and with this kind of market concentration comes risks.&nbsp;

ALSO READ |&nbsp;<a href="https://www.wionews.com/world/doctors-show-concern-as-countries-across-europe-face-shortages-of-antibiotics-542094">Doctors show concern as countries across Europe face shortages of antibiotics</a>

As China was still facing Covid-related restrictions, even though they were later dropped, to some extent it delayed the European procurement of ingredients, packaging and other components needed to manufacture medicines. Additionally, since the Russian invasion of Ukraine and subsequent sanctions, Europe also faced a spike in energy costs which made energy-intensive production difficult to maintain.&nbsp;

According to a survey of 29 European countries including the EU members and Turkiye, Kosovo, Norway and North Macedonia, reported a shortage of some 600 medicines while 20 per cent reported a shortage of at least 200-300 drugs, as per Politico. Additionally, the survey conducted between mid-November and December 31, last year, also showed that three-quarters of those countries that responded witnessed worse shortages this winter when compared to 2021’s winter.&nbsp;

EMA decides antibiotic shortage not a “major event”

Since the beginning of the year, many reports regarding the antibiotic shortage in Europe continue to emerge as seasonal infections saw a surge after all COVID-19 restrictions ended and people went back to their daily lives. Experts attributed this rise in seasonal infections to our weaker immune systems not used to the germs we encounter in day-to-day life. This surge of infections also caught drugmakers off guard who were also largely unprepared for the rise in demand.&nbsp;

ALSO READ |&nbsp;<a href="https://www.wionews.com/world/antibiotics-shortage-is-getting-scary-is-it-really-significant-know-everything-about-it-542341">Antibiotics shortage is getting scary, is it really significant? Know everything about it</a>

On January 26, the drug regulator, European Medicines Agency (EMA) termed the antibiotic shortage on the continent not a “major event”. However, if the situation was to be categorised it would allow EMA to coordinate action with countries across Europe as well as increase the reporting obligations of manufacturers. Notably, the drug regulatory body’s decision accounted for shortages of certain widely used antibiotics, including amoxicillin.&nbsp;

The EMA did acknowledge that nearly all European countries are currently witnessing antibiotic shortages. Furthermore, reports suggest that drugmakers also cut output when the demand decreased at the height of the Covid pandemic. Prior to the release of the statement by EMA, a group of patient and consumer groups wrote to the regulatory body and said there was not enough action being taken to tackle the shortages.&nbsp;

Additionally, they also noted, the use of alternative antibiotics was affecting the supplies of other medicines and called for the EMA to declare the situation as a “major event”. They also acknowledged that although it would not solve the crisis immediately it would at least offer some regulator visibility into the extent to which the antibiotics shortage is affecting different countries across the continent, reported Reuters.&nbsp;

What are the drug manufacturers saying about the shortage this time around?

According to a report by Reuters, drug manufacturers are reluctant to increase production with prices of generics regulated at a time when the conflict in Ukraine has led to an increase in the cost of virtually everything including components like energy to run the factories, cardboard for packaging and even aluminium for bottle caps.&nbsp;

ALSO WATCH |&nbsp;<a href="https://www.wionews.com/videos/europe-hit-by-shortage-of-antibiotics-doctors-and-officials-express-concern-542051">Europe hit by shortage of antibiotics; doctors and officials express concern</a>

“We cannot keep this capped pricing when all of our production, logistics and regulatory compliance costs are increasing at double digits or more”, said the director general of lobby group Medicines for Europe, Adrian van den Hoven to Reuters. The group represents makers of generic drugs in the region and this reluctance suggests that the issue of antibiotic shortages is not going to be tackled any time soon or even worsen.&nbsp;

How is the cost of generic medicine decided?

According to Medicines for Europe, generic medicines account for nearly 70 per cent of all dispensed medicines in the continent but only 29 per cent of the money is spent on drugs by national health agencies. Prior to launching tenders, many European governments compare the price of generic medicines to other markets in the region or similar ones within the country which then becomes the reference price and also serves as a benchmark for negotiations with suppliers, as per Reuters. Therefore, the contract typically goes to those who offer the lowest price which, according to the drugmakers, puts pressure on prices in tenders that come after.&nbsp;

ALSO WATCH |&nbsp;<a href="https://www.wionews.com/videos/europe-uk-reports-shortage-in-supply-of-antibiotics-doctors-to-recommend-shorter-courses-542105">Europe: UK reports shortage in supply of antibiotics; doctors to recommend shorter courses</a>

Reportedly, over the past decade or so, this has led many European companies to either cut output or move the manufacturing of this type of medicine and active pharmaceutical ingredients (APIs) out of the continent. This includes countries like India and China where the costs are much lower and where the production is now concentrated.&nbsp;

The European generic medicine makers have attributed this tender system and regulated prices to their downfall while also saying that they are being undercut by suppliers from Asia. Therefore, industry experts have called for an overhaul of pricing schemes which could encourage production in Europe to both avoid future shortages and reduce dependency on Asian countries for essential medicines, reported Reuters.&nbsp;

(With inputs from agencies)&nbsp; 
 
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The shortage of antibiotics in Europe made headlines late last year, with most manufacturers citing supply-chain issues and a rise in demand across the continent for medicines.

The shortage of antibiotics in Europe made headlines late last year, with most manufacturers citing supply-chain issues and a rise in demand across the continent for medicines. However, a report by Reuters published on Wednesday (February 8), suggests that their problems might not be over just yet. The news agency spoke to 13 European manufacturers and six generic drug industry associations and trade groups and noted that many firms are struggling to make enough money to continue to justify making antibiotics. What has happened so far? In December, pharmacies across the United Kingdom and France reported they are running out of key antibiotics which came amid a surge of post-Covid winter infections like strep throat. Some of these medicines included amoxicillin (used to treat a number of respiratory infections) as well as the common painkiller paracetamol. However, even at the time, the phenomenon was not unheard of as a similar situation took place during the COVID-19 pandemic while the recent one was also attributed to the ongoing conflict in Ukraine and supply chain issues. Additionally, it was also attributed to the fact that India and China produced at least 60 to 80 per cent of the world’s active pharmaceutical ingredients and with this kind of market concentration comes risks. ALSO READ | Doctors show concern as countries across Europe face shortages of antibiotics As China was still facing Covid-related restrictions, even though they were later dropped, to some extent it delayed the European procurement of ingredients, packaging and other components needed to manufacture medicines. Additionally, since the Russian invasion of Ukraine and subsequent sanctions, Europe also faced a spike in energy costs which made energy-intensive production difficult to maintain. According to a survey of 29 European countries including the EU members and Turkiye, Kosovo, Norway and North Macedonia, reported a shortage of some 600 medicines while 20 per cent reported a shortage of at least 200-300 drugs, as per Politico. Additionally, the survey conducted between mid-November and December 31, last year, also showed that three-quarters of those countries that responded witnessed worse shortages this winter when compared to 2021’s winter. EMA decides antibiotic shortage not a “major event” Since the beginning of the year, many reports regarding the antibiotic shortage in Europe continue to emerge as seasonal infections saw a surge after all COVID-19 restrictions ended and people went back to their daily lives. Experts attributed this rise in seasonal infections to our weaker immune systems not used to the germs we encounter in day-to-day life. This surge of infections also caught drugmakers off guard who were also largely unprepared for the rise in demand. ALSO READ | Antibiotics shortage is getting scary, is it really significant? Know everything about it On January 26, the drug regulator, European Medicines Agency (EMA) termed the antibiotic shortage on the continent not a “major event”. However, if the situation was to be categorised it would allow EMA to coordinate action with countries across Europe as well as increase the reporting obligations of manufacturers. Notably, the drug regulatory body’s decision accounted for shortages of certain widely used antibiotics, including amoxicillin. The EMA did acknowledge that nearly all European countries are currently witnessing antibiotic shortages. Furthermore, reports suggest that drugmakers also cut output when the demand decreased at the height of the Covid pandemic. Prior to the release of the statement by EMA, a group of patient and consumer groups wrote to the regulatory body and said there was not enough action being taken to tackle the shortages. Additionally, they also noted, the use of alternative antibiotics was affecting the supplies of other medicines and called for the EMA to declare the situation as a “major event”. They also acknowledged that although it would not solve the crisis immediately it would at least offer some regulator visibility into the extent to which the antibiotics shortage is affecting different countries across the continent, reported Reuters. What are the drug manufacturers saying about the shortage this time around? According to a report by Reuters, drug manufacturers are reluctant to increase production with prices of generics regulated at a time when the conflict in Ukraine has led to an increase in the cost of virtually everything including components like energy to run the factories, cardboard for packaging and even aluminium for bottle caps. ALSO WATCH | Europe hit by shortage of antibiotics; doctors and officials express concern “We cannot keep this capped pricing when all of our production, logistics and regulatory compliance costs are increasing at double digits or more”, said the director general of lobby group Medicines for Europe, Adrian van den Hoven to Reuters. The group represents makers of generic drugs in the region and this reluctance suggests that the issue of antibiotic shortages is not going to be tackled any time soon or even worsen. How is the cost of generic medicine decided? According to Medicines for Europe, generic medicines account for nearly 70 per cent of all dispensed medicines in the continent but only 29 per cent of the money is spent on drugs by national health agencies. Prior to launching tenders, many European governments compare the price of generic medicines to other markets in the region or similar ones within the country which then becomes the reference price and also serves as a benchmark for negotiations with suppliers, as per Reuters. Therefore, the contract typically goes to those who offer the lowest price which, according to the drugmakers, puts pressure on prices in tenders that come after. ALSO WATCH | Europe: UK reports shortage in supply of antibiotics; doctors to recommend shorter courses Reportedly, over the past decade or so, this has led many European companies to either cut output or move the manufacturing of this type of medicine and active pharmaceutical ingredients (APIs) out of the continent. This includes countries like India and China where the costs are much lower and where the production is now concentrated. The European generic medicine makers have attributed this tender system and regulated prices to their downfall while also saying that they are being undercut by suppliers from Asia. Therefore, industry experts have called for an overhaul of pricing schemes which could encourage production in Europe to both avoid future shortages and reduce dependency on Asian countries for essential medicines, reported Reuters. (With inputs from agencies) WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Explained: Is Europe’s antibiotic shortage going to get worse? Here’s what we know

A French court has ordered a formal investigation of German pharmaceutical firm Merck for failing to inform patients about the side effects of its thyroid drug, Levothyrox.

The lawyer representing Merck’s France unit, Mario-Pierre Stasi, has assured that the company would cooperate with the investigative authorities saying that all legal proceedings must be allowed to run their course.

On Tuesday, the pharma company was charged with “aggravated deceit” after its president was questioned by a judge in southern Marseille city.

Merck said the ruling did not raise concern on the quality of the new formula for Levothyrox, and added that it would provide “all necessary information to show there was no criminal fault of any kind”, reports AFP.

According to Merck, France is the world’s biggest consumer of Levothyrox, with around 2.5 million users taking the drug.

In 2017, a new version of Levothyrox was introduced. However, around 30,000 people in France complained of headaches, insomnia, hair loss or dizziness from taking the new concoction.

Levothyrox drug is used to treat underactive thyroids or following surgery for cancer of the organ, which regulates the body’s metabolism.

The patients accused Merck of misleading them about the potential new side effects, following which a petition was filed calling on the company to bring back the old formula. The petition had gained around 170,000 signatures.

In march 2022, the French Supreme Court rejected the company’s appeal against a lower court’s ruling in 2020 that ordered Merck to compensate 3,300 plaintiffs in a civil case.

(With inputs from agencies)

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A French court has ordered a formal investigation of German pharmaceutical firm Merck for failing to inform patients about the side effects of its thyroid drug, Levothyrox.

A French court has ordered a formal investigation of German pharmaceutical firm Merck for failing to inform patients about the side effects of its thyroid drug, Levothyrox. The lawyer representing Merck’s France unit, Mario-Pierre Stasi, has assured that the company would cooperate with the investigative authorities saying that all legal proceedings must be allowed to run their course. On Tuesday, the pharma company was charged with “aggravated deceit” after its president was questioned by a judge in southern Marseille city. Merck said the ruling did not raise concern on the quality of the new formula for Levothyrox, and added that it would provide “all necessary information to show there was no criminal fault of any kind”, reports AFP. According to Merck, France is the world’s biggest consumer of Levothyrox, with around 2.5 million users taking the drug. In 2017, a new version of Levothyrox was introduced. However, around 30,000 people in France complained of headaches, insomnia, hair loss or dizziness from taking the new concoction. Levothyrox drug is used to treat underactive thyroids or following surgery for cancer of the organ, which regulates the body’s metabolism. The patients accused Merck of misleading them about the potential new side effects, following which a petition was filed calling on the company to bring back the old formula. The petition had gained around 170,000 signatures. In march 2022, the French Supreme Court rejected the company’s appeal against a lower court’s ruling in 2020 that ordered Merck to compensate 3,300 plaintiffs in a civil case. (With inputs from agencies) WATCH WION LIVE HERE:

French court charges German pharma firm Merck with ‘deceit’ over thyroid drug

Six persons were charred to death and 12 injured in a massive fire accident that took place in a chemical factory called Porus Private Limited in the Musunuru village of Andhra Pradesh's Krishna district on Wednesday.

The fire broke out in the factory delivering polymer raw material after a container leaked and the flames started hitting the factory through an opened manhole, police said. A container leaked in the factory and suddenly, the flames came out through a manhole.&nbsp;

A total of five people died on the spot and one was killed on the way to the hospital. As many as 12 people are also injured in the accident," Srinvasulu, DSP Nujiveedu told ANI.

Also read |&nbsp;<a href="https://www.wionews.com/india-news/jaishankar-reacts-to-blinkens-rise-in-human-rights-abuses-in-india-remarks-shows-concerns-over-cases-in-us-470876">Jaishankar reacts to Blinken's 'rise in human rights abuses in India' remarks</a>

Rahul Dev Sharma, Eluru SP said, "There were 18 workers on duty at the time of the accident. The victims were shifted to Vijayawada and Nuziveedu for better treatment. Upon receiving the information, firefighters and police rushed to the scene and took relief measures. Two floors were completely burnt in the fire."

Police also informed that out of six died, a total of four deceased people belonged to Bihar state.&nbsp;

Andhra Pradesh Chief Minister YS Jagan Mohan Reddy on Thursday condoled the death of six people and announced Rs 25 lakh compensation for the family members of the victims of the gas leak-triggered explosion.

Watch |&nbsp;India's software giant Infosys announces withdrawal from India

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The chief minister also declared Rs 5 lakh compensation for each of those critically injured and Rs 2 lakh for those who sustained minor injuries.

Officials have been instructed to monitor the condition of those injured and the SP along with the district collector have been directed to conduct a thorough investigation into the reason for the incident.

Also read |&nbsp;<a href="https://www.wionews.com/india-news/whatsapp-gets-approval-to-hike-users-to-100-mn-for-payments-service-in-india-says-report-470816">WhatsApp payment service gets nod for 100 mn users in India: Report</a>

Meanwhile, Andhra Pradesh Governor Biswabhusan Harichandan also expressed anguish over the accident. The district officials informed the Governor that the fire broke out in the chemical factory on Wednesday night and the injured have been shifted to a hospital in Vijayawada for better treatment.

The Governor also expressed his condolences to the bereaved family members and wished for the speedy recovery of those injured in the accident.&nbsp;

Six persons were charred to death and 12 injured in a massive fire accident that took place in a chemical factory called Porus Private Limited in the Musunuru village of Andhra Pradesh's Krishna district on Wednesday.

Six persons were charred to death and 12 injured in a massive fire accident that took place in a chemical factory called Porus Private Limited in the Musunuru village of Andhra Pradesh's Krishna district on Wednesday. The fire broke out in the factory delivering polymer raw material after a container leaked and the flames started hitting the factory through an opened manhole, police said. A container leaked in the factory and suddenly, the flames came out through a manhole. A total of five people died on the spot and one was killed on the way to the hospital. As many as 12 people are also injured in the accident," Srinvasulu, DSP Nujiveedu told ANI. Also read | Jaishankar reacts to Blinken's 'rise in human rights abuses in India' remarks Rahul Dev Sharma, Eluru SP said, "There were 18 workers on duty at the time of the accident. The victims were shifted to Vijayawada and Nuziveedu for better treatment. Upon receiving the information, firefighters and police rushed to the scene and took relief measures. Two floors were completely burnt in the fire." Police also informed that out of six died, a total of four deceased people belonged to Bihar state. Andhra Pradesh Chief Minister YS Jagan Mohan Reddy on Thursday condoled the death of six people and announced Rs 25 lakh compensation for the family members of the victims of the gas leak-triggered explosion. Watch | India's software giant Infosys announces withdrawal from India The chief minister also declared Rs 5 lakh compensation for each of those critically injured and Rs 2 lakh for those who sustained minor injuries. Officials have been instructed to monitor the condition of those injured and the SP along with the district collector have been directed to conduct a thorough investigation into the reason for the incident. Also read | WhatsApp payment service gets nod for 100 mn users in India: Report Meanwhile, Andhra Pradesh Governor Biswabhusan Harichandan also expressed anguish over the accident. The district officials informed the Governor that the fire broke out in the chemical factory on Wednesday night and the injured have been shifted to a hospital in Vijayawada for better treatment. The Governor also expressed his condolences to the bereaved family members and wished for the speedy recovery of those injured in the accident.

6 killed, 12 injured in Andhra Pradesh’s pharma unit fire, CM announces compensation for victims

US&nbsp;Trade&nbsp;Representative Katherine&nbsp;Tai&nbsp;said on Thursday that World&nbsp;Trade&nbsp;Organization negotiations over intellectual property&nbsp;waivers for COVID-19&nbsp;vaccines are a&nbsp;chance&nbsp;for the deeply divided&nbsp;trade&nbsp;body to make&nbsp;itself relevant to the world's needs.

Tai, speaking to the House Ways and Means Committee, said she was committed to entering negotiations that take into account concerns from all sides, including drug companies.

Also read |&nbsp;<a href="https://www.wionews.com/world/vaccine-makers-oppose-ip-waiver-say-manufacturing-hurdles-slowing-rollout-379755">Vaccine makers oppose IP waiver, say manufacturing hurdles slowing rollout</a>

"The&nbsp;WTO&nbsp;has not got a record of moving quickly, or getting to yes, across 164 members who must all agree, very often,"&nbsp;Tai&nbsp;said. "This is the opportunity for the&nbsp;WTO&nbsp;to&nbsp;show&nbsp;its&nbsp;relevance&nbsp;for mankind."

For the second day in a row,&nbsp;Tai&nbsp;heard criticism from Republican lawmakers that the intellectual property rights&nbsp;waiver&nbsp;will give critical biopharmaceutical technology to China, Russia and other strategic rivals while failing to increase&nbsp;vaccine&nbsp;supplies.

Also read | <a href="https://www.wionews.com/world/south-africa-warns-of-vaccine-apartheid-if-rich-countries-hog-shots-384074">South Africa warns of 'vaccine apartheid' if rich countries hog shots</a>

Republican Representative Devin Nunes told&nbsp;Tai&nbsp;that he is concerned China is one of the few countries that could quickly manufacture messenger RNA&nbsp;vaccines, a technology partly developed with&nbsp;US&nbsp;tax dollars.

"It really seems like they (China) want to steal this very new technology, especially as it relates to the Moderna and Pfizer&nbsp;vaccines."

Tai&nbsp;said the administration was working to exercise leadership on the issue to try to reach a solution that saves lives and puts&nbsp;the world back on a faster growth track, which will benefit the United States.

India and South Africa, the proponents of the original, much broader proposal are expressing "that they feel extremely vulnerable in not having access to&nbsp;vaccines and not being able to make them either,"&nbsp;Tai&nbsp;said.

On Wednesday,&nbsp;Tai&nbsp;told a Senate hearing that companies making&nbsp;vaccines could be "a hero" by helping the world gain increased access to COVID-19&nbsp;vaccines.

She declined to discuss&nbsp;details of her consultations with drug companies before announcing the decision to join&nbsp;WTO&nbsp;waiver&nbsp;negotiations last week but said that some are driven by more than their obligations to shareholders.

"Some of them do see themselves as important actors in the public health ecosystem in the world."

Tai&nbsp;said that the intellectual property&nbsp;waiver&nbsp;was just one of a number of actions that would be required to increase manufacturing and equitable distribution of&nbsp;vaccines around the world.

US Trade Representative Katherine Tai said on Thursday that World Trade Organization negotiations over intellectual property waivers for COVID-19 vaccines are a chance for the deeply divided trade body to make itself relevant to the world's needs.

US Trade Representative Katherine Tai said on Thursday that World Trade Organization negotiations over intellectual property waivers for COVID-19 vaccines are a chance for the deeply divided trade body to make itself relevant to the world's needs. Tai, speaking to the House Ways and Means Committee, said she was committed to entering negotiations that take into account concerns from all sides, including drug companies. Also read | Vaccine makers oppose IP waiver, say manufacturing hurdles slowing rollout "The WTO has not got a record of moving quickly, or getting to yes, across 164 members who must all agree, very often," Tai said. "This is the opportunity for the WTO to show its relevance for mankind." For the second day in a row, Tai heard criticism from Republican lawmakers that the intellectual property rights waiver will give critical biopharmaceutical technology to China, Russia and other strategic rivals while failing to increase vaccine supplies. Also read | South Africa warns of 'vaccine apartheid' if rich countries hog shots Republican Representative Devin Nunes told Tai that he is concerned China is one of the few countries that could quickly manufacture messenger RNA vaccines, a technology partly developed with US tax dollars. "It really seems like they (China) want to steal this very new technology, especially as it relates to the Moderna and Pfizer vaccines." Tai said the administration was working to exercise leadership on the issue to try to reach a solution that saves lives and puts the world back on a faster growth track, which will benefit the United States. India and South Africa, the proponents of the original, much broader proposal are expressing "that they feel extremely vulnerable in not having access to vaccines and not being able to make them either," Tai said. On Wednesday, Tai told a Senate hearing that companies making vaccines could be "a hero" by helping the world gain increased access to COVID-19 vaccines. She declined to discuss details of her consultations with drug companies before announcing the decision to join WTO waiver negotiations last week but said that some are driven by more than their obligations to shareholders. "Some of them do see themselves as important actors in the public health ecosystem in the world." Tai said that the intellectual property waiver was just one of a number of actions that would be required to increase manufacturing and equitable distribution of vaccines around the world.

Vaccine waiver talks a chance for WTO to show its relevance: US trade chief Tai

The new US position in support of lifting&nbsp;patents&nbsp;on&nbsp;Covid-19&nbsp;vaccines&nbsp;has&nbsp;taken attention away from an equally significant change by Washington, which plans to open up trade in the raw materials used to make them.

After&nbsp;having recently taken heat for blocking such exports, Commerce Secretary Katherine Tai said Wednesday that the US government would "work to increase the raw materials needed to produce those&nbsp;vaccines".

The assertion was hidden at the bottom of the statement unveiling Washington's remarkable reversal of its position&nbsp;on&nbsp;Covid-19&nbsp;vaccine&nbsp;patents, which coincides with a shortage of doses in emerging and developing nations as cases surge in some countries.

Also read |&nbsp;<a href="https://www.wionews.com/world/us-backs-india-led-fight-to-waive-covid-vaccines-patents-383092">US backs India-led fight to waive Covid vaccines patents</a>

Long legal and economic policy debates likely lie ahead about waiving&nbsp;vaccine&nbsp;patents, particularly at the World Trade Organisation (WTO).

Meanwhile, the difficulties faced by some laboratories in obtaining components to manufacture&nbsp;vaccines&nbsp;look set to stymie the drive to ramp up production.

Two labs have recently spoken out about their difficulties, laying the blame at Washington's door.

Germany's Curevac said it could&nbsp;not secure supplies of certain materials from the United States.

Several days earlier, India's Serum Institute, the world's largest&nbsp;vaccine&nbsp;manufacturer, called&nbsp;on&nbsp;US President Joe Biden to step in.

"Respected @POTUS, if we are to truly unite in beating this virus,&nbsp;on&nbsp;behalf of the&nbsp;vaccine&nbsp;industry outside the US, I humbly request you to lift the embargo of raw material exports out of the US so that&nbsp;vaccine&nbsp;production can ramp up," the company's president Adar Poonawalla wrote&nbsp;on&nbsp;Twitter.

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Respected <a href="https://twitter.com/POTUS?ref_src=twsrc%5Etfw">@POTUS</a>, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up. Your administration has the details. 🙏🙏
— Adar Poonawalla (@adarpoonawalla) <a href="https://twitter.com/adarpoonawalla/status/1382978713302683653?ref_src=twsrc%5Etfw">April 16, 2021</a></blockquote>
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There is no actual embargo&nbsp;on&nbsp;exporting&nbsp;vaccine&nbsp;components. Instead, Biden, like his predecessor Donald Trump, invoked the Defense Production Act,&nbsp;which normally concerns wartime,&nbsp;to confront the pandemic.

While it does not explicitly ban exports, it puts the US government first in line to buy certain products made in the country.

US officials have previously played down the possible effect of the law&nbsp;on&nbsp;global&nbsp;vaccine&nbsp;production.

"There's just more global manufacturing happening everywhere in the world than suppliers can currently support,"&nbsp;a US official told a White House briefing late last month&nbsp;on&nbsp;condition of anonymity.

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Dry ice and sorbitol

Over the past two months, a number of public and private actors have noted the shrinking supply of components needed to manufacture&nbsp;vaccines.

At least 50 components, perhaps as many as 100, go into the jabs.

They include items like the glass vials to ship them, as well as certain types of plastics needed for containers used in the manufacturing process.

Then there are the ingredients themselves.&nbsp;

Curevac is particularly concerned about nucleotides, a building block for the messenger RNA&nbsp;vaccines&nbsp;like the one it is developing.

Also read |&nbsp;<a href="https://www.wionews.com/world/us-germany-rift-on-covid-vaccine-waiver-endangers-fight-against-deadly-virus-383349">US-Germany rift on Covid vaccine waiver endangers fight against deadly virus</a>

The shortage of raw materials is hardly surprising as the pharmaceutical industry expects to double production to 10 billion doses this year.

Richard Hatchett, who heads the Coalition for Epidemic Preparedness Innovations (CEPI), which along with the World Health Organization and Gavi co-runs the Covax&nbsp;vaccine&nbsp;distribution initiative, spoke already in March of seeing "increasing signs of strain within supply chains".

Companies were "beginning to report spot shortages of critical materials, raw materials, critical consumables, even equipment that is necessary for&nbsp;vaccine&nbsp;manufacturing," he said.

He was speaking at a meeting of the principal actors in the sector, including WHO and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

Already the consensus was that the free circulation of&nbsp;vaccine&nbsp;components was critical, given that a large number of countries are involved in their production.

OECD data from 2018 show how thoroughly&nbsp;component&nbsp;production is intertwined across the globe.

China dominates production of the glass storage vials, while the United States leads in the manufacturing of syringes.

France is a major producer of certain stabilisers like sorbitol, while Germany is big in the production of&nbsp;vaccine&nbsp;preservatives, and Mexico and China both are important manufacturers of additives that enhance the effects of&nbsp;vaccines.

Meanwhile, the Netherlands is a leader in the production of dry ice used to transport&nbsp;vaccines&nbsp;that need to be kept at ultra-low temperatures.

The new US position in support of lifting patents on Covid-19 vaccines has taken attention away from an equally significant change by Washington, which plans to open up trade in the raw materials used to make them.

The new US position in support of lifting patents on Covid-19 vaccines has taken attention away from an equally significant change by Washington, which plans to open up trade in the raw materials used to make them. After having recently taken heat for blocking such exports, Commerce Secretary Katherine Tai said Wednesday that the US government would "work to increase the raw materials needed to produce those vaccines". The assertion was hidden at the bottom of the statement unveiling Washington's remarkable reversal of its position on Covid-19 vaccine patents, which coincides with a shortage of doses in emerging and developing nations as cases surge in some countries. Also read | US backs India-led fight to waive Covid vaccines patents Long legal and economic policy debates likely lie ahead about waiving vaccine patents, particularly at the World Trade Organisation (WTO). Meanwhile, the difficulties faced by some laboratories in obtaining components to manufacture vaccines look set to stymie the drive to ramp up production. Two labs have recently spoken out about their difficulties, laying the blame at Washington's door. Germany's Curevac said it could not secure supplies of certain materials from the United States. Several days earlier, India's Serum Institute, the world's largest vaccine manufacturer, called on US President Joe Biden to step in. "Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the US, I humbly request you to lift the embargo of raw material exports out of the US so that vaccine production can ramp up," the company's president Adar Poonawalla wrote on Twitter. Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up. Your administration has the details. 🙏🙏 — Adar Poonawalla (@adarpoonawalla) April 16, 2021 × There is no actual embargo on exporting vaccine components. Instead, Biden, like his predecessor Donald Trump, invoked the Defense Production Act, which normally concerns wartime, to confront the pandemic. While it does not explicitly ban exports, it puts the US government first in line to buy certain products made in the country. US officials have previously played down the possible effect of the law on global vaccine production. "There's just more global manufacturing happening everywhere in the world than suppliers can currently support," a US official told a White House briefing late last month on condition of anonymity. Dry ice and sorbitol Over the past two months, a number of public and private actors have noted the shrinking supply of components needed to manufacture vaccines. At least 50 components, perhaps as many as 100, go into the jabs. They include items like the glass vials to ship them, as well as certain types of plastics needed for containers used in the manufacturing process. Then there are the ingredients themselves. Curevac is particularly concerned about nucleotides, a building block for the messenger RNA vaccines like the one it is developing. Also read | US-Germany rift on Covid vaccine waiver endangers fight against deadly virus The shortage of raw materials is hardly surprising as the pharmaceutical industry expects to double production to 10 billion doses this year. Richard Hatchett, who heads the Coalition for Epidemic Preparedness Innovations (CEPI), which along with the World Health Organization and Gavi co-runs the Covax vaccine distribution initiative, spoke already in March of seeing "increasing signs of strain within supply chains". Companies were "beginning to report spot shortages of critical materials, raw materials, critical consumables, even equipment that is necessary for vaccine manufacturing," he said. He was speaking at a meeting of the principal actors in the sector, including WHO and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Already the consensus was that the free circulation of vaccine components was critical, given that a large number of countries are involved in their production. OECD data from 2018 show how thoroughly component production is intertwined across the globe. China dominates production of the glass storage vials, while the United States leads in the manufacturing of syringes. France is a major producer of certain stabilisers like sorbitol, while Germany is big in the production of vaccine preservatives, and Mexico and China both are important manufacturers of additives that enhance the effects of vaccines. Meanwhile, the Netherlands is a leader in the production of dry ice used to transport vaccines that need to be kept at ultra-low temperatures.

After shift on vaccine patents, US backs freer flow of components

Drugmakers&nbsp;on Thursday said US President Joe&nbsp;Biden's support for waiving&nbsp;patents of COVID-19&nbsp;vaccines could disrupt a fragile supply chain, and that, rich countries should instead share more generously with the developing world.

Biden&nbsp;on Wednesday threw his support behind waiving intellectual property rights for COVID-19&nbsp;vaccines, angering research-based pharmaceutical companies.

Also read |&nbsp;<a href="https://www.wionews.com/world/us-backs-india-led-fight-to-waive-covid-vaccines-patents-383092">US backs India-led fight to waive Covid vaccines patents</a>

If adopted by the World Trade Organisation, the proposal would invite new manufacturers that lack essential know-how and&nbsp;oversight from the inventors to crowd out established contractors, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said.

"I have heard many (vaccine&nbsp;makers) talking about 'our resources are stretched, our technicians are stretched'," IFPMA Director General Thomas Cueni told Reuters. He warned of a possible free for all if "sort of rogue companies" were allowed to become involved.

Vaccine&nbsp;developers echoed his comments that waiving intellectual property rights was not a solution.

"Patents are not the limiting factor for the production or supply of our&nbsp;vaccine. They would not increase the global production and supply of&nbsp;vaccine&nbsp;doses in the short and middle term," said Germany's BioNTech, which aims to supply up to three&nbsp;billion doses together with Pfizer this year.

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BioNTech said it took more than a decade to develop its&nbsp;vaccines manufacturing process and replicating it required experienced personnel and a meticulous technology transfer, among several other factors beyond&nbsp;patents.

Another German company CureVac, which hopes to release trial results on its messenger ribonucleic acid (mRNA)&nbsp;vaccine&nbsp;as early as this month, said&nbsp;patents were not to blame for supply bottlenecks.

"Since mRNA technology has emerged as the key technology in the fight against COVID-19, the world now needs the same raw materials in unfathomable amounts. The biggest problem is how to coordinate this," a spokeswoman said.

IFPMA's Cueni said the real bottlenecks were trade barriers, in particular the US Defense Production Act (DPA).

The DPA is a decades-old US law that prioritised procurement orders related to US national defence, but it has been widely used in non-military crises, such as natural disasters.

Cueni said the way to kickstart low-income countries' vaccination campaigns, was for rich countries to donate&nbsp;vaccine, rather than widen eligibility to young and healthy people at home.

Moderna, which on Thursday reported quarterly results, said waiving intellectual property rights would not help to increase the supply of its&nbsp;vaccines in 2021 and 2022.

The US drugmaker said last year it would not enforce its&nbsp;vaccine&nbsp;patents. CureVac said on Thursday it would also not enforce its&nbsp;patents during the pandemic and that it knew of no other developer that would.

Italy's ReiThera which is in late-stage tests on an experimental COVID-19&nbsp;vaccine was also critical of&nbsp;patent&nbsp;waivers.

"There is proprietary know-how that has to be transferred by the owner. And then there is the problem with process materials, which at the moment have delivery times of almost a year," ReiThera's chief of technology Stefano Colloca said.

In contrast to the industry reaction, the GAVI&nbsp;vaccine&nbsp;alliance, which co-leads the COVAX dose-sharing programme with the WHO and faces major supply constraints, welcomed&nbsp;Biden's support for waiving intellectual property rights.

Drugmakers on Thursday said US President Joe Biden's support for waiving patents of COVID-19 vaccines could disrupt a fragile supply chain, and that, rich countries should instead share more generously with the developing world.

Drugmakers on Thursday said US President Joe Biden's support for waiving patents of COVID-19 vaccines could disrupt a fragile supply chain, and that, rich countries should instead share more generously with the developing world. Biden on Wednesday threw his support behind waiving intellectual property rights for COVID-19 vaccines, angering research-based pharmaceutical companies. Also read | US backs India-led fight to waive Covid vaccines patents If adopted by the World Trade Organisation, the proposal would invite new manufacturers that lack essential know-how and oversight from the inventors to crowd out established contractors, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said. "I have heard many (vaccine makers) talking about 'our resources are stretched, our technicians are stretched'," IFPMA Director General Thomas Cueni told Reuters. He warned of a possible free for all if "sort of rogue companies" were allowed to become involved. Vaccine developers echoed his comments that waiving intellectual property rights was not a solution. "Patents are not the limiting factor for the production or supply of our vaccine. They would not increase the global production and supply of vaccine doses in the short and middle term," said Germany's BioNTech, which aims to supply up to three billion doses together with Pfizer this year. BioNTech said it took more than a decade to develop its vaccines manufacturing process and replicating it required experienced personnel and a meticulous technology transfer, among several other factors beyond patents. Another German company CureVac, which hopes to release trial results on its messenger ribonucleic acid (mRNA) vaccine as early as this month, said patents were not to blame for supply bottlenecks. "Since mRNA technology has emerged as the key technology in the fight against COVID-19, the world now needs the same raw materials in unfathomable amounts. The biggest problem is how to coordinate this," a spokeswoman said. IFPMA's Cueni said the real bottlenecks were trade barriers, in particular the US Defense Production Act (DPA). The DPA is a decades-old US law that prioritised procurement orders related to US national defence, but it has been widely used in non-military crises, such as natural disasters. Cueni said the way to kickstart low-income countries' vaccination campaigns, was for rich countries to donate vaccine, rather than widen eligibility to young and healthy people at home. Moderna, which on Thursday reported quarterly results, said waiving intellectual property rights would not help to increase the supply of its vaccines in 2021 and 2022. The US drugmaker said last year it would not enforce its vaccine patents. CureVac said on Thursday it would also not enforce its patents during the pandemic and that it knew of no other developer that would. Italy's ReiThera which is in late-stage tests on an experimental COVID-19 vaccine was also critical of patent waivers. "There is proprietary know-how that has to be transferred by the owner. And then there is the problem with process materials, which at the moment have delivery times of almost a year," ReiThera's chief of technology Stefano Colloca said. In contrast to the industry reaction, the GAVI vaccine alliance, which co-leads the COVAX dose-sharing programme with the WHO and faces major supply constraints, welcomed Biden's support for waiving intellectual property rights.

Drugmakers say Biden misguided over vaccine patent waiver

The Indian&nbsp;drug reglator has pulled up&nbsp;Glenmark Pharma and&nbsp;had&nbsp;sent a notice to&nbsp; the company for&nbsp;overpricing of Fabi-Flu, an anti-viral drug that has potential to treat COVID-19.

The issue came up after a member of parliament wrote a letter to the health minister. The letter claims the cost proposed by Glenmark is definitely not in the interest of the poor, lower middle class and middle class people of India. Glenmark says&nbsp;a patient must take 122 Fabi-Flu tablets over a period of 14 days. Until last week, a single tablet cost Rs 103.&nbsp;Given that the total cost of treatment would run up to Rs 12,500.

India's per capita income is pegged at Rs&nbsp;1,20,000. For most indians, a&nbsp;full course of Fabi-Flu will cost nearly 10 percent of their yearly income. For the poor it's out of reach.&nbsp;Last week, Glenmark cut the price to Rs 75 per tablet.

Now the government has asked Glenmark for explain the cost structure. Inevitably, Glenmark's shares closed in the red on Indian stock exchanges. Meanwhile, Boris Johnson is trying to boost his stock with britishers. He is busy signing agreements, laying claim to potential vaccines. He has secured 90 million doses of two vaccines -- 60 million doses of the French Valneva vaccine and 30 million doses of the German Pzifer-bio-n-tech vaccine. Uk already has an agreement in place to get 100 million doses of the&nbsp;Oxford-AstraZeneca coronavirus vaccine.

Why are rich countries investing millions of dollars in vaccines that have not got approval yet?

The answer is self-interest. Uk's Business Secretary Alok Sharma's comments make it amply clear. He said ''We are doing everything we can to ensure the British public get access to a safe and effective coronavirus vaccine as soon as possible''.

So, these deals will help UK get the vaccine much before the world. There is another reason: Unlike the Oxford-AstraZeneca coronavirus vaccine or the Pfizer-bio-n-tech vaccine, the French Valneva vaccine is not a frontrunner. Why then is the British government ready to partner with the company?

To ensure there is enough manufacturing capacity to deliver any successful candidate. The vaccine is for its people and not for the entire world. Valneva has its factory in Scotland. This is brilliant forward-planning by Boris Johnson to get a monopoly over the vaccine. He is even ready to fund clinical trials and the expansion of the factory.

The UK is&nbsp;not the only country doing this. The US is equally guilty of monopolising access to vaccines. In June, US bought all the Remdesivir&nbsp;doses available in the world -- more than 500,000 doses which is all of drugmaker Gilead's production for July, August and September. It is one of the few drugs that seems to work against COVID-19.

Pharma companies are going after profits during the pandemic while rich countries are looking after their self-interest. It's turning into a nexus between pharma companies and governments.

The Indian drug reglator has pulled up Glenmark Pharma and had sent a notice to the company for overpricing of Fabi-Flu, an anti-viral drug that has potential to treat COVID-19.

The Indian drug reglator has pulled up Glenmark Pharma and had sent a notice to the company for overpricing of Fabi-Flu, an anti-viral drug that has potential to treat COVID-19. The issue came up after a member of parliament wrote a letter to the health minister. The letter claims the cost proposed by Glenmark is definitely not in the interest of the poor, lower middle class and middle class people of India. Glenmark says a patient must take 122 Fabi-Flu tablets over a period of 14 days. Until last week, a single tablet cost Rs 103. Given that the total cost of treatment would run up to Rs 12,500. India's per capita income is pegged at Rs 1,20,000. For most indians, a full course of Fabi-Flu will cost nearly 10 percent of their yearly income. For the poor it's out of reach. Last week, Glenmark cut the price to Rs 75 per tablet. Now the government has asked Glenmark for explain the cost structure. Inevitably, Glenmark's shares closed in the red on Indian stock exchanges. Meanwhile, Boris Johnson is trying to boost his stock with britishers. He is busy signing agreements, laying claim to potential vaccines. He has secured 90 million doses of two vaccines -- 60 million doses of the French Valneva vaccine and 30 million doses of the German Pzifer-bio-n-tech vaccine. Uk already has an agreement in place to get 100 million doses of the Oxford-AstraZeneca coronavirus vaccine. Why are rich countries investing millions of dollars in vaccines that have not got approval yet? The answer is self-interest. Uk's Business Secretary Alok Sharma's comments make it amply clear. He said ''We are doing everything we can to ensure the British public get access to a safe and effective coronavirus vaccine as soon as possible''. So, these deals will help UK get the vaccine much before the world. There is another reason: Unlike the Oxford-AstraZeneca coronavirus vaccine or the Pfizer-bio-n-tech vaccine, the French Valneva vaccine is not a frontrunner. Why then is the British government ready to partner with the company? To ensure there is enough manufacturing capacity to deliver any successful candidate. The vaccine is for its people and not for the entire world. Valneva has its factory in Scotland. This is brilliant forward-planning by Boris Johnson to get a monopoly over the vaccine. He is even ready to fund clinical trials and the expansion of the factory. The UK is not the only country doing this. The US is equally guilty of monopolising access to vaccines. In June, US bought all the Remdesivir doses available in the world -- more than 500,000 doses which is all of drugmaker Gilead's production for July, August and September. It is one of the few drugs that seems to work against COVID-19. Pharma companies are going after profits during the pandemic while rich countries are looking after their self-interest. It's turning into a nexus between pharma companies and governments.

The ugly nexus between pharma companies and rich countries

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