India probes deaths in Gambia linked to Indian-made cough syrup

[finalfantasy7]

India probes deaths in Gambia linked to Indian-made cough syrup

WHO chief earlier said UN agency is investigating deaths in the African country.

India is investigating the deaths of dozens of children in The Gambia that the World Health Organization said may be linked to a cough syrup made in the South Asian nation.

India is investigating the deaths of dozens of children in The Gambia that the World Health Organization (WHO) said may be linked to a cough syrup made in the South Asian nation, two people from India’s health ministry have told the Reuters news agency.

WHO Director-General Tedros Adhanom Ghebreyesus on Wednesday told reporters the UN agency was investigating the deaths from acute kidney injuries with India’s drug regulator and New Delhi-based cough syrup manufacturer Maiden Pharmaceuticals.

The agency informed the Drugs Controller General of India of the deaths late last month, after which the regulator launched an investigation with state authorities in tandem with the WHO probe, the people said.

Maiden Pharmaceuticals manufactured and exported the syrup only to the West African nation, the people said.

Calls from Reuters to a listed telephone number for Maiden Pharmaceuticals went unanswered, as did an emailed request for comment. Calls to the Drugs Controller General of India outside of office hours also went unanswered.

India’s government has asked the WHO to share its report linking the deaths with the cough syrup and says it will take “all required steps in the matter,” the officials said.

https://www.aljazeera.com/economy/2...s-in-gambia-linked-to-indian-made-cough-syrup



Reuters:
India tests samples of cough syrup linked to deaths of children in Gambia

NEW DELHI, Oct 6 (Reuters) - India said it is testing samples of cough syrups produced by local manufacturer Maiden Pharmaceuticals for export after the World Health Organization said its products were linked to the deaths of dozens of children in Gambia.

The deaths of 66 children in the West African country could deal a major blow to India's image as a "pharmacy of the world".

The WHO this week said laboratory analysis of four Maiden products - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup - had confirmed "unacceptable" amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.

Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups.

India's health ministry said samples of all four products that had been exported to Gambia had been sent for testing to a federal laboratory and the results would "guide the further course of action as well as bring clarity on the inputs received/to be received from WHO."

It asked the WHO to share its report on the "establishment of causal relation to death with the medical products in question."

WHO spokesperson Margaret Harris did not directly reply to a Reuters query on when the report might be shared with the health ministry.

She said, however, that information from Maiden and India's director of the Central Drugs and Standard Control Organisation indicated that authorities had visited the company's factories "to investigate this specific incident and WHO awaits the findings".

Anil Vij, the health minister of Haryana state where Maiden has its factories, warned of "strict action if anything is found wrong" after the tests.

WHO Director-General Tedros Adhanom Ghebreyesus told reporters on Wednesday that the U.N. agency was investigating the deaths from acute kidney injuries with India's drug regulator and the drug maker.

The agency informed the Drugs Controller General of India of the deaths late last month after which the regulator launched an investigation with state authorities in tandem with the WHO.

Naresh Kumar Goyal, a Maiden director, told Reuters, however, that the company had heard about the deaths only on Thursday morning and was trying to find out details.

"We are trying to find out the situation because it cropped up only today," he said by phone. "We are trying to find out with the buyer and all that what has happened exactly. We are not selling anything in India." He declined to speak further.

Maiden, which launched its operations in November 1990, manufactured and exported the syrup only to Gambia, the Indian health ministry said. Maiden on its website says it has two manufacturing plants, in Kundli and Panipat, both near New Delhi in Haryana, and has recently set up another one.

Maiden has an annual production capacity of 2.2 million syrup bottles, 600 million capsules, 18 million injections, 300,000 ointment tubes and 1.2 billion tablets.

Maiden on its website says it sells its products at home and exports to countries in Asia, Africa and Latin America, although Goyal said they were not currently selling in India.

The health ministry said importing countries typically test such products before allowing their use.

 

[sweep_shot]

Inna lillahi wa inna ilaihi rajiun.

Shocking.

Does WHO not have quality assurance division?

 

[KingKhanWC]

I wouldnt take any medication made in India.

 

[sweep_shot]

I wouldnt take any medication made in India.

After this incident, I also do not want to consume any medicine made in India.

 

[DeadlyVenom]

Innalilahi wa inna ilyhi rajioon.

This is equivalent to a terrorist attack.

I wonder if the manufacturers sacrificed quality checks because it was a poor african nation.

 

[BunnyRabbit]

Why doesn't WHO ensure the medications are manufactured by reliable pharmaceuticals like GSK, Abbott, Pfizer, Novartis, Roche etc?

 

[cricketjoshila]

A company that doesn't sell its products in India, is chosen by who to export the products to Africa. This is very strange.

 

[Cpt. Rishwat]

Why doesn't WHO ensure the medications are manufactured by reliable pharmaceuticals like GSK, Abbott, Pfizer, Novartis, Roche etc?

Probably to get them made as cheap as possible. India is one of the world's poorest countries, that's why you can set up factories and industry there. Why do tech companies send low level work to India rather than employ locals who could do the same job?

 

[gazza619]

Very disturbing news. Poor souls

 

[DeadlyVenom]

As a parent of two this news really shook me to the core last night.

Imagine giving your child cough syrup and it ends up killing them. AstaghfirAllah.

Gambia is a poor country with no clout but I hope that they are able to pursue justice and really hammer the negligent Indians responsible.

I don't think any of our medicine's in the UK come from the UK but this news has certainly causes a hysteria in our nursery whatsapp groups etc.

 

[gani999]

A company that doesn't sell its products in India, is chosen by who to export the products to Africa. This is very strange.

The company in question has been fined and blacklisted in the past by several Indian agencies and state governments. Yet the Gambian authorities have ordered from them. Companies like these don't operate ethically and there must have been some palm greasing involved somewhere.
In any case, I hope this unfortunate event results in the company shutting down and the people involved getting locked up for a long time.

 

[Champ_Pal]

I wouldnt take any medication made in India.

Don’t buy cheap medicines from little known pharma companies in India.

Pakistan buys tons of medicines from India. When you cannot manufacture your own and have no money to buy quality controlled medicines from India, cheap medicines become an alternative.

Blame Gambian government. Not India.

 

[MenInG]

A red toy motorbike sits in the corner of Mariam Kuyateh's home gathering dust.

It was meant for her 20-month-old son, Musa, but he passed away in September.

He is one of the 66 children in The Gambia who are thought to have died after being given a cough syrup that had been "potentially linked with acute kidney injuries", according to the World Health Organization.

No-one in the family touches Musa's toy - a reminder of what has been lost.

His 30-year-old mother, who has four other children, was in tears remembering what had happened to her son.

Sitting in her home in a suburb of The Gambia's largest city, Serrekunda, she explained that his sickness started as a flu. After he was seen by a doctor, her husband bought a syrup to treat the problem.

"When we gave him the syrup, the flu stopped, but it led to another problem," Ms Kuyateh said.

"My son was not passing urine."

She returned to the hospital and Musa was sent for a blood test, which ruled out malaria. He was given another treatment, which did not work, and then a catheter was fitted, but he did not pass urine.

Finally, the small child was operated on. There was no improvement.

"He couldn't make it, he died."

Earlier this week, the WHO issued a global alert over four cough syrups in connection with the deaths in The Gambia.

The products - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup - were manufactured by an Indian company, Maiden Pharmaceuticals, which had failed to provide guarantees about their safety, the WHO said.

The Indian government is investigating the situation. The firm has not responded to a BBC request for comment.

There is a lot of anger in The Gambia over what has happened.

There are growing calls for the resignation of Health Minister Dr Ahmadou Lamin Samateh, along with the prosecution of the importers of the drugs into the country.

"Sixty-six is a huge number. So we need justice, because the victims were innocent children," Ms Kuyateh said.

Five-month-old Aisha was another victim.

Her mother, Mariam Sisawo, realised one morning that after having taken the cough syrup, her baby was not passing urine.

On an initial visit to the hospital, the 28-year-old was told that there was nothing wrong with her daughter's bladder. It took two more trips there on consecutive days before Aisha was referred to a hospital in the capital, Banjul, which was 36km (22 miles) away from their home in Brikama

But after five days of treatment there, she died.

"My daughter had a painful death. At a certain time when the doctors wanted to fix a drip on her, they could not see her veins. Myself and two other women in the same ward, we all lost our children.

"I have two sons and Aisha was the only girl. My husband was very happy to have Aisha and he still can't come to terms with her death."

The Gambia does not currently have a laboratory capable of testing whether medicines are safe and so they have to be sent abroad for checking, Gambia health services director Mustapha Bittay told the BBC's Focus on Africa programme.

But Ms Sisawo believes the government should be more vigilant.

"This is a lesson for parents, but the greater responsibility is with the government. Before any drugs get in to the country, they should be properly checked if they are fit for human consumption or not," she said.

Isatou Cham was too distressed to talk about the death of her two-year-and-five-month-old son, Muhammed.

She left the living room of their home in Serrekunda crying with her two other children.

Muhammed's father, Alieu Kijera, explained what had happened to his little boy.

He said he was taken to hospital when he had a fever and was unable to pass urine. But the doctors were treating Muhammed for malaria and his condition was getting worse.

The medics then said he should be treated in neighbouring Senegal, where the health service is thought to be better, but while there was some improvement, it still did not save him.

Mr Kijera is angry that his country does not have a good enough health system and he was forced to travel abroad.

"If there was equipment and the right medicine, then my son and many other children could have been saved," he said.

BBC

 

[cricketjoshila]

The company in question has been fined and blacklisted in the past by several Indian agencies and state governments. Yet the Gambian authorities have ordered from them. Companies like these don't operate ethically and there must have been some palm greasing involved somewhere.
In any case, I hope this unfortunate event results in the company shutting down and the people involved getting locked up for a long time.

As a doctor, i prescribe medicines daily. Get visits from Med Reps daily. Had never heard of this company. These are probably what we call

PD companies. Promoter-Distributor companies. Poor quality medicines, poor manufacturing practices, and sold mostly by their people going to small medicine shops.

 

[MenInG]

Police in The Gambia have started an investigation into the deaths of 66 children, which have been linked to four brands of imported cough syrup.

Senior officials from the Medicine Control Agency and the importers have been called for questioning, the president's office said.

President Adama Barrow said that the authorities would "leave no stone unturned" in the investigation.

Gambians, angry about what happened, are wondering who is to blame.

On Wednesday, the World Health Organization (WHO) issued a global alert over the four cough syrups - warning they could be linked to acute kidney injuries and the children's deaths in July, August and September.

Bereaved parents have told the BBC how their children stopped being able to pass urine after being given the syrups. As their condition worsened, efforts to save their lives were fruitless.


The products - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup - were manufactured by an Indian company, Maiden Pharmaceuticals, which had failed to provide guarantees about their safety, the WHO said.

The Indian government is also investigating the situation. The firm has not responded to a BBC request for comment.

Gambian health officials and Red Cross workers are now going door-to-door, as well as to pharmacies and markets, searching for the syrups as well as other medicines.

More than 16,000 products have been located so far and have been taken away for destruction, a Red Cross official told the BBC.

On Friday, President Barrow addressed the nation, expressing his regret for the loss of life saying that "the source of the contaminated drugs" would be investigated.

He announced plans to open a laboratory capable of testing whether medicines are safe and a review of relevant laws and guidelines for imported drugs.

He also said that "the child mortality figure of 66 is not at much variance with the recorded data for similar periods in the past", which left some wondering whether the authorities thought that these deaths were unusual.

The president followed this up on Saturday evening with a more robust statement, suspending the licence of the suspected importer and announcing the police investigation.

Some of the parents who lost their children have told the BBC that they are considering taking legal action of their own against the authorities.

BBC

 

[daytrader]

Haryana Maker Of Cough Syrups Flagged By WHO Didn't Do Testing: Notice
The state drug controller has issued show cause notice to Maiden pharmaceuticals as to why their manufacturing licence may not be cancelled.

New Delhi: Days after Indian pharma company Maiden Pharmaceuticals was flagged by the World Health Organisation (WHO) following the death of 66 children in the Gambia, Haryana Food and Drug Administration has flagged lapses in the company's manufacturing facility for cough syrups.
Haryana state drug officials have listed out detailed 12 points of contraventions which were detected by officials during inspection of the manufacturing facility in Sonepat.

The state drug controller has issued show cause notice to Maiden pharmaceuticals as to why their manufacturing licence may not be cancelled.

The company has to reply to the show cause notice by October14.

Violations detected by the Haryana FDA at Maiden Pharma's factory

Missing log book: Maiden Pharmaceuticals failed to produce the log books of equipment and instruments regarding manufacturing and testing for the cough syrups in question.

Batch numbers of propylene glycol, sorbitol solution, and sodium methylparaben which were used in manufacturing of the drug in question were not mentioned.

Maiden Pharmaceuticals has not performed process validation and analytical method validation for the four cough syrups, which have been red flagged by the WHO.

Several drugs by the pharma company were earlier not found to be up to quality standards by four states of the country.

Vietnam had in 2011 banned the company.

Following WHO's red flag, India had immediately sent samples of the cough syrups for testing.

"Samples have been sent to a central pharmaceutical laboratory for testing," Anil Vij, Haryana's Health Minister, where Maiden has its factories, had told reporters. "Strict action will be taken if anything is found wrong."

NDTV

 

[ex-q-zit]

"Unimaginable Shame": Narayana Murthy On Deaths Due to Indian Cough Syrup

Bengaluru: Infosys founder N R Narayana Murthy on Tuesday said the country faces huge challenges in the field of research in sciences despite the country achieving the feat of producing COVID-19 vaccine and inoculating the people of the country.

He underlined also the death of 66 children in Gambia in Africa due to India-produced cough syrup and that shamed the country.

He was speaking at an event to present Infosys prize to six luminaries by the Infosys Science Foundation. The prize carries a purse of USD 1,00,000.

Lauding companies which manufactured and supplied a billion COVID-19 vaccines, Mr Murthy said this was an achievement by any standard.

The IT czar appreciated the rollout of the new national education policy, which is based on the recommendations of professor Kasturirangan Committee.

The Infosys founder appreciated professor Gagandeep Kang and several others becoming fellows of the Royal Society in London, and professor Ashok Sen winning the Millenium prize.

"These are all encouraging and happy events that show that India is on a path of growth absolutely but we still have huge challenges," the IT tycoon said.

“There is not a single Indian institution of higher learning in the top 250 of the world university global ranking that was announced in 2020. Even the vaccines we have produced, or either based on technology from advanced countries, or based on research from the developed world. Consequently, we still have not produced a vaccine for dengue and chikungunya, which have been ravaging us for the last 70 years now,” said Mr Murthy.

“That death of 66 children in Gambia, resulting from an India-produced cough syrup has brought unimaginable shame to our country and has dented the credibility of our pharmaceutical regulatory agency,” Mr Murthy said.

He, however, said there was a solution, which is a difficult one, and according to him, the country opted for it.

According to Mr Murthy, many experts feel that India's inability to use research to solve immediate pressing problems is due to lack of inculcating curiosity at an early age, disconnect between pure and applied research, inadequate cutting-edge research infrastructure in the higher educational institutions, insufficient grants and inordinate delays in creating incentives for research and inadequate fora for knowledge sharing with global research institutions.

The Infosys founder opined that money is not the primary resource for success in invention or innovation.

Mr Murthy said there were two critical components for success in research -- the first component is to re-orient teaching in schools and colleges towards Socratic questioning and relating what they learn in the classroom to the real world problems around them, rather than passing the examinations after learning by rote.

The second step is for researchers to focus on solving the immediate problems. Such a mindset would inevitably lead to solving bigger challenges, he opined.

The software industry icon said the IITs are becoming a victim of learning by rote, too.

“Even our IITs have become victims of this syndrome, thanks to the tyranny of coaching classes,” Murthy said.

He said nation's progress on the economic and social front depends on the quality of scientific and technological research.

According to Murthy, research thrives in an environment of honour and respect for intellectuals, meritocracy and the support and approbation of such intellectuals from society.

“Therefore, recognising and rewarding the outstanding research efforts of researchers is necessary. By doing so, we will encourage not only other researchers, but also create role models and inspire young people to consider careers in research,” Murthy said ahead of announcing the researchers selected for the Infosys Prize-2022.

He said scientific research is about curiosity, daringness, healthy skepticism and questioning status quo.

He told the gathering that the country has had a healthy run in scientific and technological progress in the last few years.

NDTV

 

[Major]

Don’t buy cheap medicines from little known pharma companies in India.

Pakistan buys tons of medicines from India. When you cannot manufacture your own and have no money to buy quality controlled medicines from India, cheap medicines become an alternative.

Blame Gambian government. Not India.

poor post.

So you dont think its the Indian govts responsibility to make sure people manufacturing drugs are following standards.

 

[cricketjoshila]

Gambia says it has not yet confirmed cough syrup as cause of child deaths
By Pap Saine

https://www.reuters.com/business/he...ed-cough-syrup-cause-child-deaths-2022-10-31/

 

[ex-q-zit]

Samples from pharma firm linked to Gambia deaths within guidelines: India to WHO

The samples had not been be contaminated with ethylene glycol and diethylene glycol, India's drugs controller general, V.G. Somani, said in a letter to the WHO and shared with reporters by the Indian health ministry.

India has told the World Health Organization that samples taken from Indian pharmaceutical company Maiden Pharma, whose products were linked to the deaths of children in Gambia, have been found to be within specifications.

The samples had not been be contaminated with ethylene glycol and diethylene glycol, India's drugs controller general, V.G. Somani, said in a letter to the WHO and shared with reporters by the Indian health ministry.

Gambian police said in October that they were investigating if the deaths of 69 children from acute kidney injury were linked to four cough syrups made in India and imported into the West African country.

https://www.hindustantimes.com/indi...-guidelines-india-to-who-101671120845232.html

 

[ex-q-zit]

WHO Drew Premature Link Between Gambia Child Deaths, Indian Cough Syrups: Drug Regulator

The WHO drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country's pharmaceutical products across the globe, India's drug regulator has told the global health body.

In a latest letter to Dr Rogerio Gaspar, Director (Regulation and Prequalification) at WHO, Drugs Controller General of India (DCGI) Dr V G Somani said a statement issued by the global health body in October in the wake of the deaths "was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products".

The DCGI said Gambia has informed, according to media, that there has been no direct causal relation established yet between the cough syrup consumption and the deaths, and that certain children who had died had not consumed the syrup in question.

In the letter, Mr Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia which were tested in government laboratory here were found to be complying with specifications and not to have been contaminated with DEG or EG according to the test reports.

These reports have been made available to the technical committee of experts constituted to examine and analyse the details of the reports and adverse events received from WHO. The DCGI reiterated full cooperation and collaboration with WHO and said Central Drugs Standard Control Organisation(CDSCO) has already shared available details with WHO regularly.

He said prior to the committee taking over this role, CDSCO had requested WHO on October 4 and 10, for details on causality relationship to which WHO, on October 10 communicated that its team in Gambia is finalising the causal relations. Thereafter, in a mail dated October, 13 WHO communicated that it is yet to receive any further information in this regard and several partners on the ground are working on it.

"The technical committee mentioned above, has met several times. Each time the committee had requested for specific information from WHO on further details essential to establish the causality. Communications were sent to the WHO on 15th October, 20th October and on 29th October, 2022. Every time WHO has maintained that they are in contact with their team handling the case assessment and would get back at the earliest or that their ground partners were working on it. But no information so far has been exchanged by WHO with CDSCO," Mr Somani stated in the letter written on December 13.

The DCGI said India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in quality control of drugs and cosmetics.

In the aftermath of the alerts received from WHO regarding the incidents in Gambia, an independent inspection was conducted in the premises of Maiden Pharmaceuticals, the firm in question.

A show cause notice was issued to the firm under provisions of India's Drugs and Cosmetics Act for violation of various Good Manufacturing Practices (GMP), and for not producing the complete records of manufacturing and testing as per the extant rules.

"In the present communication WHO has declared its mandate to be of 'identification of global public health risks alone' and has announced that the responsibility of "establishment of causality of deaths" rests with the countries in question.

"This is a strangely contrary position to the one adopted in the earlier communications where WHO had affirmed its commitment to provide granular details of the incident on causal relation. It is also a departure from the inflections expressed in the statements issued earlier by the WHO," the DCGI mentioned in the letter.

Further, it would be interesting to note that all the alerts and the communications received from the onset of the unfortunate event in Gambia have contained references to the deaths of the children and have been formulated in such a manner as to hint that the cough syrup consumption was the primary cause of the mortality, the letter said.

"In fact as your email itself indicates, the earlier communication dated September, 29 2022 contains "...whose cause of death, or significant contributing factor, was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol or Ethylene glycol."

"It is clear that perhaps premature deduction was drawn on September 29th itself regarding the cause of death. Every subsequent alert or publication from the WHO only seems to be a reaffirmation of this deduction, without waiting for independent verification," Mr Somani said.

The statement issued by the WHO in October was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products, he said.

"This in turn has adversely impacted the image of India's pharmaceutical products across the globe, and caused irreparable damage to the supply chain of pharmaceutical products, as well as repute of the national regulatory framework over an assumption that has yet not been substantiated by the WHO or its partners on ground," the DCGI said.

NDTV

 

[daytrader]

Uzbekistan Says 18 Deaths Linked To India-Made Syrup, Centre Responds
Uzbekistan Cough Syrup Deaths' Claim: The health ministry of Uzbekistan, in a statement, said that the 18 children who died had consumed cough syrup Doc-1 Max - manufactured by Noida-based Marion Biotech.

New Delhi: Uzbekistan has claimed that at least 18 children in the country have died after allegedly taking an India-manufactured cough syrup.

The health ministry of Uzbekistan, in a statement, said that the children who died had consumed cough syrup Doc-1 Max - manufactured by Noida-based Marion Biotech.

India has launched a probe into the matter and the manufacturing of the cough syrup has been halted at the Noida unit of the pharmaceutical company until the samples are tested.

...
https://www.ndtv.com/india-news/uzb...ed-in-india-3646444#pfrom=home-ndtv_topscroll

 

[Robert]

As a parent of two this news really shook me to the core last night.

Imagine giving your child cough syrup and it ends up killing them. AstaghfirAllah.

Gambia is a poor country with no clout but I hope that they are able to pursue justice and really hammer the negligent Indians responsible.

I don't think any of our medicine's in the UK come from the UK but this news has certainly causes a hysteria in our nursery whatsapp groups etc.

They are however members of ECOWAS which amplifies their clout somewhat.

 

[daytrader]

"Substandard": WHO Alert On 2 Indian Syrups After Uzbekistan Child Deaths
According to WHO, the two Indian cough syrups--- AMBRONOL syrup and DOK-1 Max syrup failed to meet quality standards or specifications.

Geneva: The World Health Organization (WHO) has recommended that two cough syrups made by Noida-based company Marion Biotech should not be used for children in Uzbekistan.
In a medical product alert on Wednesday, the WHO said the "substandard medical products", manufactured by Marion Biotech, "are products that fail to meet quality standards or specifications and are therefore out of specification."

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

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

...
https://www.ndtv.com/india-news/who...-uzbekistan-3684741#pfrom=home-ndtv_topscroll

 

[MenInG]

A joint probe by the Centers for Disease Control and Prevention (CDC) of the US and the Gambian health authorities has suggested a strong link between the death of many children in Gambia and the consumption of made-in-India cough syrups that were allegedly contaminated. In October, the World Health Organization (WHO) had issued an alert stating that the four cough syrups being supplied to Gambia by the India-based Maiden Pharmaceuticals Ltd were of substandard quality and claimed that they were linked to the death of many children in Gambia.

A CDC report released on Friday stated, "This investigation strongly suggests that medications contaminated with Diethylene Glycol [DEG] or Ethylene Glycol [EG] imported into the Gambia led to this Acute Kidney Injury (AKI) cluster among children." "Patients with DEG poisoning can experience a range of signs and symptoms, including altered mental status, headache, and gastrointestinal symptoms; however, the most consistent manifestation is AKI, characterized by oliguria (low urine output) or anuria, progressing over 1-3 days to renal failure (indicated by elevated serum creatinine and blood urea nitrogen),” read the report.

According to the CDC, they were contacted by Gambia's Ministry of Health (MoH) to assist in characterizing the illness (multiple cases of Acute Kidney Injury and deaths in children), describing the epidemiology, and identifying potential causal factors and their sources in August last year.

The report also said that in past DEG outbreaks, manufacturers have been suspected of substituting DEG in the place of more expensive, pharmaceutical-grade solvents.

"Among reports of AKI associated with DEG-contaminated medical products, this is the first in which DEG-contaminated medications were imported into a country, rather than being domestically manufactured,” it said.

NDTV

 

[MenInG]

The Government of India has cancelled licenses of 18 pharma companies for manufacturing of spurious medicines following inspection by Drugs Controller General of India (DCGI) on 76 companies across 20 states, official said on Tuesday.

The huge crackdown was undertaken on pharma companies across the country related to manufacturing of spurious medicines, sources said.
The licences of 18 pharma firms were cancelled for manufacturing spurious drugs following inspection by state and central regulators, officials said.

It may be noted that the crackdown came after Uzbekistan reported deaths of children following consumption of two made-in-India cough and cold syrups.

It may be recalled that the World Health Organisation (WHO) issued an alert against substandard medicines manufactured by a company located in Noida.

“Laboratory analysis of samples of both products - Ambronol syrup and DOK-1 Max syrup by Marion Biotech - undertaken by national quality control laboratories of the Uzbekistan Ministry of Health found both products contained unacceptable amounts of diethylene glycol and or ethylene glycol as contaminants,” the WHO had stated in a statement.

In December 2022, the Indian government told Parliament that cough syrup samples of Maiden Pharmaceuticals were found to be of standard quality.

The four drugs were Promethazine Oral Solution BP, KOFEXMALIN Baby Cough Syrup, MaKOFF Baby Cough syrup and MaGrip n Cold Syrup.

Timesnow

 

[daytrader]

Government's New Rule For Cough Syrup Exports From June 1
The direction has come after quality concerns were raised globally for cough syrups exported by Indian firms.

Cough syrup exporters will have to undertake testing of their products at specified government laboratories from June 1 before getting permission for the outbound shipments.
The direction has come after quality concerns were raised globally for cough syrups exported by Indian firms.

"The export of cough syrup shall be permitted to be exported subject to export samples being tested and production of a certificate of analysis issued by any of the laboratories..., with effect from June 1, 2023," the Directorate General of Foreign Trade (DGFT) said in a notification on Monday.

The specified central government labs include Indian Pharmacopoeia Commission, regional drug testing lab (RDTL - Chandigarh), central drugs lab (CDL - Kolkata), central drug testing lab (CDTL - Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments.

Explaining further, an official said that to re-emphasize India's commitment towards assuring the quality of various pharmaceutical products exported from India, the central government has decided to initiate a process of a pre-quality check of the cough syrup formulations being exported.

"The finished goods (cough syrup in this case) are to be tested at laboratories before being permitted for export," the official said, adding that necessary steps are being taken to ensure the smooth implementation of this testing requirement, and MoHFW would partner with the state governments and the exporters to ensure smooth implementation of this notification.

...
https://www.ndtv.com/india-news/cou...from-june-1-4057631#pfrom=home-ndtv_topscroll

 

[daytrader]

7 India-Made Syrups On List Of 20 Products Flagged By WHO Probe
20 syrups, manufactured by pharmaceuticals from India and Indonesia, have been flagged by the WHO, a WHO spokesperson told NDTV.

The World Health Organisation today flagged seven India-made syrups during a probe on contaminated medicines and syrups linked to over 300 deaths globally.
20 syrups, manufactured by pharmaceuticals from India and Indonesia, have been flagged by the WHO, a WHO spokesperson told NDTV. These medicines include cough syrups and vitamins manufactured by various pharmaceuticals.

A few countries, including Uzbekistan, Gambia, and Nigeria, have recently linked India-made medicines with deaths.

WHO also raised medical product alerts on India-made cough syrups that were linked to deaths in Gambia and Uzbekistan earlier.

Listen to the latest songs, only on JioSaavn.com
India's drug controller had launched a swift probe on manufacturers, including Noida's Marion Biotech, Haryana-based Maiden Pharmaceuticals, Chennai-based Global pharma, and Punjab's QP Pharmachem, halting their operations.

Sources at the Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for cosmetics, pharmaceuticals and medical devices, said the Health Ministry's new mechanism of making sure that all medicines are tested for quality control before exports will make sure there are corrective measures.

NDTV