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The year of substandard drugs | How 2023 saw India crackdown on poisonous pharmaceuticals

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

A significant crackdown revealed over 50 companies manufacturing substandard cough syrups. In a substantial move, State and central drug regulators inspected 76 pharma companies nationwide, and the Drug Controller General, in collaboration with the government, revoked licenses of 18 pharmaceutical companies accused of producing spurious drugs.

The year 2023 was markedby repeated instances substandard drugs coming to the surface, but it was also marked by the Indian government’s proactive measures to tighten regulations and enhance drug standards.

The issues with poor-quality drugs first gained prominence in October 2022 when Maiden Pharma’s cough syrups were linked to the deaths of 70 children in Gambia, followed by Marion Biotech’s cough syrups causing 19 deaths in Uzbekistan within three months.

Throughout 2023, such issues persisted, even, in one, prompting the World Health Organisation (WHO) to raise concerns about QP Pharma Chem’s contaminated cough syrups in the Marshal Islands and Micronesia. Additionally, Nigeria’s regulatory authority NAFDAC flagged SyneCare, and the WHO issued an alert regarding a batch of cough syrup, COLD OUT, from FOURRTS Labs identified in Iraq.

Also Read | Indian hospital industry sees strategic shifts as Aster DM and Fortis Healthcare seal major deals

A common denominator in these instances was the presence of dangerous levels of toxic substances, specifically diethylene glycol and ethylene glycol. However, the problem extended beyond contamination by DEG & EG, with cases of substandard drugs, including eye drops, surfacing in Sri Lanka and the US.

Serious allegations were made against companies like Indiana Ophthalmics and Global Pharma. Indiana Ophthalmics’ steroid eye drop was accused of causing severe eye damage in Sri Lanka, and Global Pharma faced allegations of contamination in their eye drops and ointments for dry eyes in the US, linked to over 50 adverse events, including vision loss and one death.

Also Read | Cough syrups raw material makers under the scanner of India’s drugs regulatory body

In response to these challenges, the Indian government intensified efforts to ensure better drug quality and safeguard the country’s reputation as the ‘pharmacy of the world’. Measures included investigations, licence suspensions for implicated companies, and more rigorous and random quality checks for pharmaceutical manufacturers.

A significant crackdown revealed over 50 companies manufacturing substandard cough syrups. In a substantial move, State and central drug regulators inspected 76 pharma companies nationwide, and the Drug Controller General, in collaboration with the government, revoked licences of 18 companies accused of producing spurious drugs.

Lastly, recognising the need to address drug quality for international exports, the government directed state drug regulators to analyse cough syrups intended for export. The Directorate General of Foreign Trade mandated the testing of cough syrup samples and the production of a certificate of analysis before export, aiming to assure the quality of pharmaceutical products leaving the country.

Also read: Cough syrups raw material makers under the scanner of India’s drugs regulatory body

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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WHO authorizes emergency use of Novavax’s updated COVID vaccine

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Novavax missed out on the COVID-19 vaccine windfall, which benefited rivals, due to manufacturing issues that delayed its filing for approval during the peak of the pandemic.

Novavax’s updated vaccine has been granted emergency-use authorization by the World Health Organization (WHO) for active immunization to prevent COVID-19 in individuals aged 12 and older, the company said on Tuesday.

The single-target vaccine is aimed at the XBB.1.5 Omicron subvariant of the coronavirus, which was dominant in the U.S. for much of this year but has since been overtaken by other variants as the virus evolves.

Novavax missed out on the COVID-19 vaccine windfall, which benefited rivals, due to manufacturing issues that delayed its filing for approval during the peak of the pandemic.

The Maryland-based biotech’s updated COVID shot, which was authorized in the U.S. in October, uses a more traditional protein-based technology than the mRNA-based vaccines by rivals Pfizer and Moderna.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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National Epilepsy Day 2023: Types, causes and symptoms of this neurological disease

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

National Epilepsy Day was established by the Epilepsy Foundation in India. November is also observed as National Epilepsy Awareness Month.

Epilepsy, a neurological disorder, is a condition in which the affected person faces frequent seizures. The chronic brain disorder can affect people of all ages. According to the World Health Organization (WHO), nearly 5 crore people worldwide suffer from epilepsy while 80% of them live in low and middle-income countries. Despite being one of the most common neurological disorders in the world, nearly 70% of the people with the condition can live without seizures with early diagnosis and treatment.

In order to fight against this disorder and to create awareness, National Epilepsy Day is observed in India on November 17, every year.

Types of Epileptic Seizures

There are two primary seizure categories:

Focal Onset Seizures

These are the seizures which start in a particular part or group of cells on one side of the head. Two known types of focal onset seizures are – focal onset aware seizure and focal onset impaired awareness seizure.

While the focal onset aware seizure is characterised by sudden onset when the person is awake and aware, the second type of seizure may result in confusion or loss of consciousness.

Generalised Onset Seizures

These seizures affect widespread cell networks bilaterally. There are six types of generalised onset seizures that include:

Absence Seizures
Atonic Seizures
Tonic Seizures
Clonic Seizures
Tonic-clonic Seizures
Myoclonic Seizures

Symptoms of Epilepsy

The common symptoms of epilepsy include temporary loss of awareness, in voluntary movements, a blank state, uncontrollable muscles, confusion, slow thinking, disturbed sensual perceptions, a stomach upset, and psychic symptoms such as fear, overwhelming experience or hallucination.

Causes of epilepsy

Epilepsy can be caused by various factors such as genetics, head injuries, mesial temporal sclerosis, brain infections, abnormalities of brain condition and vessels, and immune, developmental, and metabolic disorders.

National Epilepsy Day 2023: History and Significance

While World Epilepsy Day is observed on the second Monday of February every year, National Epilepsy Day is observed in India on November 17. The National Epilepsy Day was first observed by the Epilepsy Foundation of India which was established in Mumbai by Dr Nirmal Surya.

National Epilepsy Day Significance

People with epilepsy have an alarmingly higher risk of dying prematurely. Therefore, due to the alarming stats, it is necessary that vital information on the prevention and diagnosis of epilepsy reaches the common people. The day is aimed at raising awareness about this neurological condition while extending support to the patients and their families. The day also marks several events and campaigns to support and fund the research and innovations for the treatment of epilepsy.

National Epilepsy Day 2023 Theme

Every year, the Epilepsy Foundation of India finalises a theme for the day. However, the theme for National Epilepsy Day 2023 is yet to be announced.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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WHO has made loneliness a health priority — here’s how it plans to tackle lack of social connections

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

According to WHO, people without strong social connections are at a higher risk of stroke, anxiety, dementia, depression amongst others. It also leads to an equal or even greater risk of early death as other risk factors such as smoking, excessive drinking, obesity and more.

The World Health Organization (WHO) has made loneliness a global health priority and launched a new Commission on Social Connection. The aim of the commission, which consists of 11 leading policy makers, thought leaders and advocates from across the globe, will be to address loneliness as a pressing health threat, promote social connections as a priority and accelerate the scaling up of solutions in countries of all incomes.

According to WHO, social isolation — having an insufficient number of social connections — and loneliness, the social pain of not feeling connected, are widely impacting the health and wellbeing of people across age groups around the globe.

Social isolation affects one in four older people while 5% to 15% of adolescents experiencing loneliness, the world health agency pointed out and noted that these figures are likely to be underestimations.

The impact of social isolation and loneliness is real

According to WHO, people without strong social connections are at a higher risk of stroke, anxiety, dementia, depression amongst others. It also leads to an equal or even greater risk of early death as other risk factors such as smoking, excessive drinking, obesity and more.

Being socially isolated has been linked to depression, anxiety and can increase the risk of cardiac diseases by 30%, WHO said.

Also Read: The rise of pop psychology and mental health advice on short video platforms — a quick fix or folly

The Commission formed by WHO, which will be co-chaired by US Surgeon General Dr Vivek Murthy, will hold its first leadership level meeting from December 2 to December 8 this year. The agenda of the panel has special significance at this time as per the WHO, given how the COVID-19 pandemic resulted in undermining of social connections.

For the next three years, the commission will analyse how social connections help in improving health for people of all ages and will also outline solutions to build social connections at scale

Also Read | Every second working professional is prone to mental health issues: Survey

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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India finds two more toxic syrups months after poisoning deaths

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The medicines were contaminated either with diethylene glycol (DEG) or ethylene glycol (EG), the same contaminants found in the cough syrups that caused the deaths in Gambia, Uzbekistan and Cameroon since the middle of last year.

Drug regulator has found that a cough syrup and an anti-allergy syrup made by Norris Medicines are toxic, according to a government report, months after country made cough syrups were linked to 141 children’s deaths worldwide.

The medicines were contaminated either with diethylene glycol (DEG) or ethylene glycol (EG), the same contaminants found in the cough syrups that caused the deaths in Gambia, Uzbekistan and Cameroon since the middle of last year.

This is the first time in at least two years that the Central Drugs Standard Control Organisation (CDSCO) has flagged any DEG and EG contamination in its monthly reports as the country tries to crack down on its $42 billion drug industry dominated by small players.

HG Koshia, commissioner of Gujarat state’s Food and Drug Control Administration, told Reuters on Wednesday that it had inspected Norris’s factory in September and ordered it to suspend production and recall the drugs.

“The company failed miserably on compliance parameters of good manufacturing practices,” Koshia said. “Adequate water system was not there. The air-handling unit was also not up to the mark. In the larger interest of public health, we ordered the unit to stop production.”

Norris Managing Director Vimal Shah declined to comment outside business hours.

The company’s Trimax Expectorant contained 0.118% of EG, while allergy drug Sylpro Plus Syrup had 0.171% of EG and 0.243% of DEG, according to tests at a CDSCO laboratory, according to its list of “not of standard quality/spurious/adulterated/misbranded” drugs for August uploaded on its website. Koshia said Norris used to export the cough syrup, but did not say where.

The World Health Organization (WHO) says the safe limit, based on internationally accepted standards, is no more than 0.10%.

“We are aware of the CDSCO report and have communicated with that agency to ascertain where the products have been exported,” said a WHO spokeswoman. “This information is pivotal when we consider whether or not to issue a medical product alert.”

It was not immediately clear if the Norris drugs had been recalled or if they caused any harm. Both medicines were listed on online pharmacies when Reuters checked.

The CDSCO also found three batches of COLD OUT syrup made by Fourrts (India) Laboratories contaminated with DEG and EG. The World Health Organisation said in August that a batch of COLD OUT sold in Iraq had unacceptable levels of DEG and EG.

Fourrts Chairman SV Veeramani did not respond to a request for comment.

Veeramani, who is the chairman of the government-backed Pharmaceuticals Export Promotion Council of India (pharmexcil), told Reuters in August that a recent “analysis of retention samples” of COLD OUT showed there was “no contamination or toxins”.

“There is no report of any adverse effect or death due to the product,” he said in a WhatsApp message. “As a matter of abundant caution, we have voluntarily recalled the product in Iraq market.”

The alerts on the toxic medicines come at a time when the government, through pharmexcil, is organising workshops for drugmakers across the country to stress the importance of drug quality and patient safety.

The CDSCO list also named a glycerine batch made by Adani Wilmar, despite it containing 0.025% EG, within the WHO safety limit. Adani Wilmar did not immediately respond to a request for comment outside business hours.

Indian pharmaceutical executives and regulators have told Reuters that it is common practice among some manufacturers in the country to substitute cheaper, commercial-grade ingredients when making cough syrups.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Health minister Mandaviya confirms Nipah virus as cause for two ‘unnatural’ deaths in Kerala

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

According to the World Health Organisation (WHO), Nipah virus infection is a zoonotic illness that is transmitted to people from animals. It can also be transmitted through contaminated food or from one person to another.

Two deaths reported from Kerala’s Kozhikode district were caused by Nipah virus, Union Health Minister Mansukh Mandaviya confirmed on Tuesday.

“It has been confirmed that the two deaths reported from Kozhikode were caused by Nipah virus. A central team of experts has been sent to the state to take stock of the situation. It will also help the state government in the management of the infection, he said.

The Kerala Health Department issued a health alert in Kozhikode district after two ‘unnatural’ deaths due to fever were reported at a private hospital on Monday, September 11.

According to official sources, samples of four more people from Kerala have been sent to the National Institute of Virology in Pune for testing for the deadly virus.

After the death, state Health Minister Veena George held a high-level meeting and reviewed the situation, the health department said. It added that relatives of one of the deceased are also admitted to the intensive care unit.

She said the entire health machinery in the district is on alert.

Earlier in the day, the Kerala government set up a control room in Kozhikode and advised people to use masks as a precautionary measure. In a Facebook post, Chief Minister Pinarayi Vijayan said his government is viewing the two deaths seriously. He, however, said there is no need to worry as most of those who were in close contact with the deceased are under treatment.

Kozhikode had also reported deaths due to Nipah virus in 2018 and 2021.

According to the World Health Organisation (WHO), Nipah virus infection is a zoonotic illness that is transmitted to people from animals. It can also be transmitted through contaminated food or from one person to another.

Among infected people, it causes a range of illnesses, from asymptomatic (subclinical) infection to acute respiratory illness and fatal encephalitis. The virus can also cause severe disease in animals such as pigs, resulting in significant economic losses for farmers, the WHO said.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

 Daily Newsletter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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COVID-19 still a global health threat, new variant under scanner: WHO chief

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The chief of the World Health Organisation (WHO) was speaking at the inaugural ceremony of the G20 Health Ministers’ Meeting at Mahatma Mandir Convention centre in Gujarat’s capital Gandhinagar.

Director-General of WHO Dr Tedros Ghebreyesus on Friday said though COVID-19 is no longer a health emergency for the world, it is still a ‘global health threat’ and a new variant of coronavirus is already under the scanner.

The chief of the World Health Organisation (WHO) was speaking at the inaugural ceremony of the G20 Health Ministers’ Meeting at Mahatma Mandir Convention centre in Gujarat’s capital Gandhinagar.

“Although COVID-19 is no longer a global health emergency, it remains a global health threat. WHO has recently classified a new variant with a large number of mutations. BA.2.86 variant is under monitoring at present, highlighting once again the need for all countries to maintain surveillance,” he said.

On the occasion, he urged all the countries to speed up the process of finalising the ‘Pandemic Accord’ so that it can be adopted in the World Health Assembly scheduled to be held next year.

“COVID-19 has taught us all an important lesson that when health is at risk everything is at risk. The world is learning the painful lessons of the pandemic,” said Dr Ghebreyesus in his address to the G20 member countries.

Beginning with the presidency of Saudi Arabia, he said, discussions led to the establishment of a joint “Finance Health Task Force” under the interim presidency supported by Indonesia and now India under their respective presidencies.

The WHO head said negotiations on the Pandemic Accord and amendments to the international health regulations are making good progress. He said both are essential for creating the legal and operational framework for inclusive, coherent and equitable global health security architecture.

“I seek your commitment for negotiating a comprehensive Pandemic Accord that encompasses all the essence of pandemic so that we never repeat the same mistakes again. Time is the essence here. The accord is scheduled to be considered by the World Health Assembly next year,” he said.

On the occasion, the WHO chief praised India for introducing telemedicine at primary healthcare level. He also congratulated India for “its commitment to universal health coverage at home especially through Ayushman Bharat, the world’s largest health insurance scheme”.

“I thank India and all the G20 countries for their leadership in developing the global initiative on digital health, which will be launched formally tomorrow. This important initiative will support the WHO global strategy on digital health and amplify other initiatives including the WHO global digital health certification network,” he said.

Union health minister Mansukh Mandaviya also spoke at the event.

Also Read:WHO declares Eris a ‘variant of interest’ — How severe the new COVID-19 strain is?

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sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Cough syrup row | India suspends license of QP Pharmachem after WHO flags contamination

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

India has tightened its testing rules after cough syrups made in the country were linked to at least 89 child deaths in Gambia and Uzbekistan in 2022. India has made it mandatory for companies to obtain a certificate of analysis from a government laboratory before exporting products.

India has taken action against drugmaker QP Pharmachem by suspending its manufacturing license following a warning from the World Health Organisation (WHO) regarding contamination in its cough syrups found in the Mashall Islands and Micronesia in April. The WHO raised concerns about the presence of harmful diethylene glycol and ethylene glycol in the cough syrup samples, substances that can be toxic and even fatal to humans if ingested.

Deputy Health Minister Bharati Pravin Pawar informed the Parliament that drug samples obtained from QP Pharmachem’s manufacturing premises were deemed “not of standard quality.” Consequently, the manufacturing licenses of QP Pharmachem Ltd, along with two other companies, Maiden Pharmaceuticals and Marion Biotech Pvt. Ltd, have been suspended, and their exports have been halted.

This move comes as India has strengthened its testing regulations after cough syrups manufactured in the country were linked to 89 child deaths in Gambia and Uzbekistan during 2022. To ensure product safety, India has now made it mandatory for companies to obtain a certificate of analysis from a government laboratory before exporting their products.

Status of drug manufacturing companies

Pawar told Rajya Sabha that out of the 88,844 drug samples tested between April 2021 and March 2022, less than 2,500 samples were not of standard quality, while 379 samples have been found to be spurious.

In his written reply, Pawar said 592 prosecutions were launched for manufacturing, sale and distribution of spurious or adulterated drugs between during the same period, as per the information received from drug controllers of various states and union territories.

Sources in the Health Ministry told CNBC-TV18 that the government has stopped production of drugs at 31 firms and cancelled or suspended the product licenses of another 50 firms on finding non-adherence to quality control norms over the last few months. The sources added that showcause notice has been issued to 73 firms, and warning letters 21 other firms.

Recent incidents of drug contamination

The Central Drug Standard Control Organisation or the CDSCO has initiated a probe into eye drops linked to vision damage in Sri Lanka. There were allegations that a eyedrop Prednisolone manufactured by Gujarat-based Indiana Opthalmics and supplied by Mumbai-based Alvita Pharma caused severe damage to the eyesight of patients in Sri Lanka.

As many as 35 patients were impacted after eyedrops were administered to them following cataract surgeries. The batches were withdrawn and samples were being sent to the Central Drug Lab for investigation. There were reports that the drug has been tested by the manufacturer in an accredited lab in India. Also, Indiana Opthalmics is believed to be one the larger manufacturers of eye drugs in India and is officially registered with the Ministry of Health in Sri Lanka. It has been supplying the same products for the last seven years.

Earlier this year, Tamil Nadu-based private pharma company Global Pharma was mired in the allegations that the eyedrops and ointments used for dry eyes manufactured by them for the US market were contaminated. There were over 50 reports of adverse events in the US including vision loss and a death.

In 2022, Maiden Pharma’s cough syrups was being allegedly linked to the death of over 65 children in Gambia; Marion Biotech’s cough syrup linked to the alleged death of 18 children in Uzbekistan.

The government has refuted allegations on Maiden Pharma.

With inputs from Reuters

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nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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World Health Organization: Anonymous donations to new foundation raise concerns

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The World Health Organization’s foundation launched in 2020 to help raise private sector funds for the WHO, said it received $66 million in direct gifts through 2022, with $26 million coming from donors who chose not to be publicly named, according to AP.

Nearly 40 percent of the money raised by the WHO Foundation in its first two years came from anonymous sources, worrying some that donors may be trying to influence the World Health Organization and its role in shaping global health policy with their gifts.

The foundation, launched in 2020 to help raise private sector funds for the WHO, said it received $66 million in direct gifts through 2022, with $26 million coming from donors who chose not to be publicly named. Anil Soni, WHO Foundation CEO, told The Associated Press the foundation’s board, which includes a representative from the WHO, knows the donors’ identities and that the foundation will not accept a gift if there is a conflict of interest.

“They want to be anonymous because they’re otherwise solicited or even targeted because they’re seen to be a source of wealth,” Soni said in an interview. “And I respect that.”

The foundation, which is based in Switzerland, is not required to disclose its donors.

Some global health practitioners worry anonymous donations make it harder to spot potential conflicts of interest. They say companies may donate to the foundation to influence the WHO’s global health policies and reports that often have wide-ranging ramifications. For example, food and beverage companies took note last week when two branches of the WHO found that the sweetener aspartame — used in diet soda and countless foods — may be a “possible” cause of cancer.

“For the integrity of the WHO, I think it’s really important that there’s some greater transparency around this,” said Sophie Harman, professor of international politics at Queen Mary University of London, of the anonymous donations, which include a single anonymous gift of $20 million to the foundation’s operating expenses.

Private and philanthropic funding have long supported other large global health organizations like Gavi, the Vaccine Alliance, and the Global Fund to Fight AIDS, Tuberculosis and Malaria, but Harman said the WHO has stood out as the publicly funded body that also sets standards across all areas of health.

“This is a big step change for the WHO that it’s now doing this,” Harman said.

The bulk of the WHO’s funding comes from governments. But in 2020 with the onslaught of the pandemic and then-President Donald Trump’s move to withdraw from the WHO, many hoped the WHO Foundation might generate new financing from wealthy individuals, the private sector and public fundraising campaigns.

Soni, the first leader of the foundation, has become an evangelist of sorts for bringing in new private sources of funding for the WHO. A veteran of major global health organizations like the Global Fund and the Clinton Health Access Initiative, he most recently worked eight years at the pharmaceutical company Viatris.

Soni said he is committed to transparency. The foundation published a list of donors and their donations online, including the anonymous ones. Soni pointed to the foundation’s gift acceptance and whistle-blower policies as examples of how it guards against undue outside influence. It also bundles gifts to support specific work, such as the WHO’s Ukraine and COVID-19 responses.

“What they’ve set out in their gift policy is a really good start,” said Quinn Grundy, assistant professor with the Lawrence S. Bloomberg Faculty of Nursing at the University of Toronto, who has studied the interactions of industry with health systems. She also encouraged the foundation to decline gifts from donors who do not want to be publicly named.

The WHO already receives private support from major philanthropies, like the Bill & Melinda Gates Foundation, which directs much of its donations toward eradicating polio. The WHO Foundation does not aim to redirect that support, but rather motivate new donors.

Among the companies that have donated to the foundation are Meta, the parent company of Facebook, medical technology company Masimo Corp., luxury travel company DFS Group, and food giant Nestle. That donation elicited outcry from some global health professionals because of Nestle’s history of marketing baby formula. WHO guidelines advocate for breastfeeding and say that formula should be available when needed, but not be promoted.

The foundation eventually reallocated Nestle’s $2.1 million donation to the vaccine-sharing initiative COVAX rather than to the WHO’s COVID-19 response. Nestle did not comment on the donation but said it complies with national laws on marketing formula. It has also voluntarily extended a policy not to promote formula for babies up to six months to all countries, including those like the U.S. that do not have regulations, among other commitments.

“Any donor to the WHO, whether a company or a government, the entirety of what they’re doing is not necessarily going to be compliant with WHO norms and standards,” Soni said, adding that the foundation’s acceptance of those gifts should not limit the WHO’s ability to hold those countries or companies accountable.

Another new vehicle that the foundation has created is an impact investment fund, which launched last year. The Global Health Equity Fund will be run by the Israeli-venture group OurCrowd and seeks to raise $200 million to invest in “breakthrough” technologies for health care and in industries that impact health, like energy and agriculture. The foundation will not select the investments but will work with companies to make their technologies accessible and appropriate for markets in low- and middle-income countries.

Javier Guzman, director of global health policy at the Center for Global Development, thinks it is inappropriate that the WHO Foundation is involved with the development of any technology that might eventually be evaluated by the WHO, which he said has the power to shape industries and markets.

“The foundation should not be associated with any global venture firm, should not be associated with picking winners and deciding what companies and what technologies should or should not be developed,” Guzman said.

Soni pointed to his experience working on access to treatments for HIV and AIDS as one motivation for the fund. While great strides have been made, he said, it generally takes years for new medications and interventions to reach poorer countries. The fund will ask the companies it invests in to make a plan to incorporate those countries into their business models.

“Too often in these debates about development, whether it’s health, education or climate, we’re focused on public capital or charitable capital,” said Soni, adding the foundation is seeking to influence return-seeking capital to be better aligned with public good.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Gambia tightens rules for Indian drugs after cough syrup deaths, says report

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

At least 70 children, most of them under the age of 5, died in Gambia last year due to acute kidney injury that doctors have linked to adulterated cough syrups from India.

Gambia will make it mandatory for all pharmaceutical products from India to be inspected and tested prior to shipment from July 1, according to Gambian government documents reviewed by Reuters, the first known restrictions on national exports following the deaths of dozens of children linked to Indian-made cough syrups.

The new rule highlights how governments are reassessing their reliance on India’s $42 billion pharmaceutical industry since the contamination came to light in 2022. India’s industry supplies nearly half of the pharmaceuticals used in Africa. In April, India’s government said its officials had held meetings in Africa to ensure its drug exports did not suffer after at least 70 children died in Gambia after ingesting the cough syrup last year.

Gambia’s latest move is to “address issues related to substandard and falsified (counterfeit) medicines entering the country”, the executive director of its Medicines Control Agency (MCA), Markieu Janneh Kaira, wrote in a letter to India’s drug controller general, Rajeev Singh Raghuvanshi, dated June 15. The letter said that the MCA had appointed Quntrol Laboratories, an independent inspection and testing company for pharmaceuticals based in Mumbai, to issue a so-called Clean Report of Inspection and Analysis (CRIA) for all shipments from India.

“Quntrol shall conduct document verification, physical inspection of the consignment and sampling, for laboratory testing for each shipment,” the letter said. “If conformity is established at all levels, Quntrol shall issue the mandatory CRIA document. If conformity is not established with regards to the quality of the product, the shipment will be quarantined or seized by the MCA and the necessary regulatory actions shall be taken.”

Janneh Kaira told Reuters the rule “applies to India for now only”. Since June 1, India has made tests mandatory for all cough syrups before they are exported.

Raghuvanshi did not immediately respond to a request for comment outside regular business hours.

With 2.5 million people, Gambia is one of Africa’s smallest and poorest countries. The World Bank is funding a testing laboratory in Gambia but it is not yet finished. The letter said Quntrol would send samples for testing to “one of the analytical laboratories approved by MCA”. It did not say if the laboratory would be based in India or elsewhere.

At least 70 children, most of them under the age of 5, died in Gambia last year due to acute kidney injury that doctors have linked to adulterated cough syrups from India. The World Health Organization said last year that the India-made cough syrups contained lethal toxins ethylene glycol and diethylene glycol — commonly used in car brake fluid and other products not fit for human consumption. These ingredients can be used by unscrupulous actors as a substitute for propylene glycol, which is a key base of syrupy medicines — because they can cost less than half the price — manufacturing experts say.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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