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 Substandard (contaminated) paediatric medicines
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Momodou



Denmark
11104 Posts

Posted - 06 Oct 2022 :  10:15:32  Show Profile Send Momodou a Private Message  Reply with Quote
Medical Product Alert N°6/2022: Substandard (contaminated) paediatric medicines
Substandard (contaminated) paediatric medicines identified in WHO region of Africa

5 October 2022 Medical product alert Geneva Reading time: 2 min (455 words)


https://www.who.int/news/item/05-10-2022-medical-product-alert-n-6-2022-substandard-(contaminated)-paediatric-medicines


Alert Summary
This WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to WHO in September 2022. Substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore "out of specification"[1].

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.

Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.

[1] WHO definitions: https://www.who.int/teams/regulation-prequalification/incidents-and-SF/background/definitions


Risks
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal

Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities.

The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.

Advice to regulatory authorities and the public
It is important to detect and remove these substandard products from circulation to prevent harm to patients.

WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised.

All medical products must be approved and obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional when in doubt.

If you have these substandard products, please DO NOT use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre.

National regulatory/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country. If you have any information concerning the manufacture or supply of these products, please contact WHO via rapidalert@who.int

Please click here for details and photos of the substandard products referenced in Alert N°6/2022.

Alert n°6/2022 may be updated at a later stage as and when necessary.


WHO Global Surveillance and Monitoring System

for Substandard and Falsified Medical Products

For more information, please visit our website

Email: rapidalert@who.int

A clear conscience fears no accusation - proverb from Sierra Leone

Momodou



Denmark
11104 Posts

Posted - 06 Oct 2022 :  10:20:05  Show Profile Send Momodou a Private Message  Reply with Quote
Related Topics:
- Criminal Investigation Should Open for the Death of 66 Children

- STATEMENT FROM MEDICINES CONTROL AGENCY TO ALL IMPORTERS, WHOLESALERS, DISTRIBUTORS, AND RETAILERS OF PARACETAMOL SYRUP WHICH IS SUSPECTED IN THE CASES OF ACUTE KIDNEY INJURY AND DEATHS IN CHILDREN IN THE GAMBIA.
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Momodou



Denmark
11104 Posts

Posted - 06 Oct 2022 :  21:28:11  Show Profile Send Momodou a Private Message  Reply with Quote
The catastrophe surrounding the dangerous drugs that killed what the WHO pegs at 66 confirmed cases is an urgent national crisis . Because our health surveillance system is woefully adequate , it is extremely important for The Gambia government to seek immediate assistance from multiple sources beginning with the WHO already at the forefront , FDA and others to help them determine the scope of this devastation. In a country with no organized system of tracking importation, distribution , sale and consumption of pharmaceuticals , establishing precisely how many children took these fatal drugs and at what location and when is a task not within the capacity of the government . Establishing the extent and scope of the disaster is key to addressing the important underlying issue of culpability and accountability.

The culprit company and the government of India can both be expected to assert that it is the responsibility of Gambian regulators to test and assure the quality of drugs imported in the country in a bid to both skirt responsibility for the deaths as well as protect the reputation of the huge pharmaceutical industry of India with clients all over the world . Therefore in addition to seeking outside help in determining the extent of this tragedy , the government should engage the services of specialized outside counsel with extensive experience in product liability issues to ensure there is full accountability for these tragic deaths. Government bureaucrats even with the best of intentions are not fully equipped to effectively address the inherent liability issues that arise from this tragedy. The same outside counsel can establish the extent of regulatory failure in both India and Gambia . The Indian regulators have already said this product was only sold to Gambia and the company involved is not licensed to sell their drugs in India suggesting they are trying shirk their responsibility to ensure companies based in their country are selling safe and effective pharmaceuticals . Unless Gambia approaches this in a serious and determined way , our victims and their families will not get the answers they deserve .

By Karamba Touray

A clear conscience fears no accusation - proverb from Sierra Leone
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Momodou



Denmark
11104 Posts

Posted - 06 Oct 2022 :  21:56:51  Show Profile Send Momodou a Private Message  Reply with Quote
Indian government press release



Ministry of Health and Family Welfare
azadi ka amrit mahotsav

Press Note on WHO Medical Product Alert regarding Maiden Pharmaceuticals Ltd

Posted On: 06 OCT 2022 6:32PM by PIB Delhi
WHO on 29.09.2022 informed DCGI, the National Drug Regulator of India, that WHO it is currently providing technical assistance and advice to Gambia, where children have died and where a contributing factor, is suspected to be the use of medicines which may have been contaminated with Diethylene glycol or Ethylene glycol (in some of the samples it was claimed to have been confirmed by further analysis conducted by WHO).

CDSCO took up the matter immediately with Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of M/s Maiden Pharmaceutical Limited, Sonepat is located. Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana.

From the preliminary enquiry of CDSCO, it has been made out that M/s Maiden Pharmaceutical Limited, Sonepat, Haryana is a manufacturer licensed by the State Drug Controller for the products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup under reference, and holds manufacturing permission for these products for export only. The company has manufactured and exported these products only to Gambia.

It is a usual practice that the importing country tests these imported products on quality parameters, and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country.

As per the tentative results received by WHO, out of the 23 samples of the products under reference which were tested, 04 samples have been found to contain Diethylene Glycol/ Ethylene Glycol. It has also been informed by WHO that the certificate of analysis will be made available to WHO in near future and WHO will share it with the Indian Regulator which is yet to be done. The exact one to one causal relation of death has not yet been provided by WHO to CDSCO.

As a robust National Regulatory Authority, CDSCO has requested WHO to share at the earliest with CDSCO the report on establishment of causal relation to death with the medical products in question etc.

The State Drug Controller had given licenses to the said Company only for export of these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Further all these 04 drugs manufactured only for exports by M/s. Maiden Pharmaceuticals Limited are not licensed for manufacture and sale in India. In effect, none of these four drugs of M/s. Maiden Pharmaceuticals is sold domestically in India.

The samples (controlled samples of the same batch manufactured by M/s. Maiden Pharmaceuticals Limited for all the four drugs in question) have been taken and sent for testing to Regional Drug Testing Lab, Chandigarh by CDSCO, the results of which will guide further course of action as well as bring clarity on the inputs received/ to be received from WHO.

****

MV

HFW/WHO Medical Product Alert/6thOctober/4
https://pib.gov.in/PressReleasePage.aspx?PRID=1865655&fbclid=IwAR10Pn1l7LhZ6DvqG5cs2QFiOWlPQxHzkaiLlFxnvh3A7e6-V5JBYy93xqo

A clear conscience fears no accusation - proverb from Sierra Leone
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Momodou



Denmark
11104 Posts

Posted - 08 Oct 2022 :  10:10:25  Show Profile Send Momodou a Private Message  Reply with Quote
STATEMENT BY
HIS EXCELLENCY, THE PRESIDENT OF THE REPUBLIC, MR. ADAMA BARROW,
ON THE DEATH OF 66 CHILDREN FROM ACUTE KIDNEY INJURY

7th OCTOBER 2022

Fellow Gambians,
Residents of The Gambia,

In July of this year, the Ministry of Health detected an unusual rise in the number of cases of diarrhea and vomiting among children under the age of five within the six health regions of the country, in areas affected by flash floods.

Many of the children infected later developed Acute Kidney Injuries (AKI), resulting in the untimely death of sixty-six (66) children within the last three months, even though they had the best medical attention and care available.

Various laboratory tests conducted on the samples from the victims show that bacteria are the likely cause of their deaths. Doctors noticed a trend among the patients, which indicate that some of them had taken similar drugs. This suggests a link between the Acute Kidney Injuries and the drugs, as detected in some other countries.

Acting on this evidence, the Ministry of Health issued a statement to suspend the use of the suspected drugs. After receiving the first test results, the Ministry also ordered an immediate recall of the drugs from all pharmacies and households.

Fellow Gambians,
Residents of The Gambia,

The Ministry of Health has since been working closely and relentlessly with the World Health Organization (WHO) and the Centre for Disease Control of the United States of America (CDC) on this matter. Investigations are in progress, and we hope that they will get to the bottom of the outbreak soon.

With the support of WHO, the Ministry sent the drug samples to laboratories in Senegal, Ghana, France, and Switzerland for further investigation. The results received on Thursday, 6th October 2022 confirm contamination of four of the samples.

I commend the Ministry of Health for their diligence, particularly for the early detection of the outbreak and their sustained investigative efforts and control strategies. Due to their timely intervention and the support of our partners, the outbreak is now under control, with only two cases reported in the last two weeks.

Fellow Gambians,
Residents of The Gambia,

I must state that the child mortality figure of sixty-six (66) is not at much variance with the recorded data for similar periods in the past. This notwithstanding, my government remains deeply concerned about every death in the country, as well as all causes of premature deaths.






In view of this unfortunate incident, I direct, for immediate action, that:

• the Ministry of Health works with the Attorney General’s Chambers to review and update the Medicines and Related Product Act, the Pharmacy Council Act and all other related legislative frameworks and regulations;

• the Ministry of Health collaborates with all relevant partners and stakeholders to strengthen its detection capabilities and establish a quality control national laboratory for drugs and food safety; and,

• in collaboration with relevant partners and stakeholders, the Ministry of Health investigates the source of the contaminated drugs, the circumstances and procedures for importation of medicines into the country and establish safeguards to eliminate the importation of sub-standard drugs.

• Already, the World Bank is supporting the Government, and steps have been initiated to establishing a quality control laboratory at the Medicine Control Agency.
Fellow Gambians,
Residents of The Gambia,

I assure you all that the Government will leave no stone unturned to get to the bottom of this incident. I urge you, however, to be vigilant enough to ensure that all medicines sold or used are safe and effective. We owe it to the nation and to ourselves to protect the lives of every citizen and resident of the country.

In the meantime, my thoughts and prayers are with the families that have lost their loved ones. Loss of life is always a sad moment, especially when it involves tender lives. We regret the loss of each of the sixty-six (66) children and pray that Allah consoles the bereaved families.

I thank you for your attention.

A clear conscience fears no accusation - proverb from Sierra Leone
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Momodou



Denmark
11104 Posts

Posted - 08 Oct 2022 :  12:43:54  Show Profile Send Momodou a Private Message  Reply with Quote
Related Topic: https://www.gambia.dk/forums/topic.asp?whichpage=1&TOPIC_ID=18443
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Momodou



Denmark
11104 Posts

Posted - 08 Oct 2022 :  19:39:18  Show Profile Send Momodou a Private Message  Reply with Quote
STATEMENT: POLICE SET UP AN INVESTIGATION PANEL INTO THE DEMISE OF SIXTY-SIX CHILDREN.

Following the demise of sixty-six children whose horrific deaths are largely associated with Acute Kidney Injury, The Gambia Police Force Sets up an investigation panel to immediately probe into the matter to identify those responsible for such an irreparable loss and hold them adequately accountable.

As an institution responsible for internal security and the protection of lives and properties, we are duty-bound to address such compelling issues that are capable of compromising the peace and security of this Nation.

In our bid to swiftly respond to this national security issue, the office of the Inspector General of Police has constituted an investigation panel consisting of senior police officers with the prerequisite knowledge and relevant skills relating to this important matter at hand.

While the general public is assured of our ardent resolve of exhausting all accountability measures, we call for calm and restraint in this difficult time.

Source: The Gambia Police Force

A clear conscience fears no accusation - proverb from Sierra Leone
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toubab1020



11932 Posts

Posted - 07 Nov 2022 :  16:23:33  Show Profile Send toubab1020 a Private Message  Reply with Quote

==========
https://trumpet.gm/concern-citizens-calls-for-justice-for-66-babies/
==========

Concerned Citizens Demands Justice for 66+ Babies

Posted by Fabakary B Ceesay on October 10, 2022

The JusticeFor66+ Campaign comprising of concern citizens at public press conference held at Child Protection Alliance office at Bakoteh on Sunday 9th October noted with serious concerns that the Gambia Government has announced that the total number of child deaths from these fake syrups is now 69. However, we are using the figure 66 being the original figure that prompted this campaign and knowing that we are not yet at the final number.

In this regard, we wish to welcome you all to this press conference to provide an update on the campaign and to respond to the presidential address on this crisis on Friday October 7 and the press conference given by the Minister of Health Amadou Lamin Samateh on Saturday October 8.

At the outset we wish to pay our respects once again to the departed children and wish them eternal peaceful rest in heaven. We wish to express our heartfelt condolences to all the bereaved families as well as the entire nation given that this is a national loss. We wish to renew our demand for transparency, justice, and accountability from the Gambia Government whom we hold to be wholly responsible for this irreparable loss of lives of young children, and to their families and the nation as a whole.

As a campaign, we are a group of sovereign citizens who are determined to fulfill our moral, legal, and political obligation to demand justice for the unnecessary, illegal, and untimely death of these children. We wish to call on all Gambians to be part of the campaign wherever we are to demand justice. This includes to demand the necessary system change that this country badly requires to ensure a greater protection and fulfillment of rights; to end corruption and ensure efficiency and responsiveness in the delivery of public services.

As a campaign, we are making efforts to reach out to the families of these children in order to help them better organize themselves to lead the demand for justice for their children. We consider the families of the deceased to be leaders and not backbenchers in the demand for justice. In this regard, we are also reaching out to the Gambia Bar Association and individual lawyers to come to the defense of these families in seeking justice for their children.

As a campaign, we hold that the chief perpetrator is the Government of the Gambia. We therefore demand the Government to act with honesty, openness, and urgency in addressing this national crisis. This crisis is symptomatic of a wider and deeper systemic failure of the State which needs fixing with urgency, in honesty and openness. We do not see this current crisis as an isolated case but rather indicative of a longstanding series of failures of public institutions to be responsive to the needs of the people.

Therefore, our response to the statement of the President on Friday is that it was inadequate, misleading, and intended to undermine justice and accountability. The President had failed to respond to the core of this crisis, which is the disregard of the rule of law, lack of effective monitoring and abuse of office by public officials. The fact that these fake drugs from a fake company from India could be sent directly and only to the Gambia without the necessary institutions being able to detect and prevent it indicates inefficiency, corruption, hence criminal.

We strongly believe that the Ministry of Health and its related regulators have the capacity to detect and prevent the entry of fake drugs into the country. Hence the only reason these fake products could have entered the country is due to negligence, inefficiency and corruption that must be investigated.

For that matter, we take great exception to the statements released by the Minister of Health Amadou Lamin Samateh at his press conference on Saturday that the Gambia has the best health system as he attempts to dodge responsibility and create scapegoats to blame. We remind Minister Samateh of his own lamentations on the floor of the National Assembly that corruption is endemic in his office, which he failed to address since then.

In this regard, we demand that the Minister of Health Amadou Lamin Samateh resign with immediate effect in order to restore public confidence in the health system and to protect the integrity of the investigations that are to be carried out. The continued presence of Dr. Samateh at the helm of health affairs has discredited his Ministry in the eyes of Gambians. He has failed to live up to the expectations of Gambians who continue to face serious challenges in securing healthcare. His leadership has not served in any way to maintain trust and confidence in the health system. He cannot add any more value to that Ministry and so the sooner he leaves the better for the Ministry and the overall delivery of healthcare in this country.

Together with Dr. Samateh, we also call for the resignation of the Executive Director and the dissolution of the Board of Directors of the Medicines Control Agency for the failure of the Agency to enforce its own ‘GUIDELINE FOR IMPORT AND EXPORT OF MEDICINES AND RELATED PRODUCTS’ and their ‘GUIDELINE FOR REGISTRATION OF MEDICINES’ in line with Medicines and Related Products Act, 2014. If the processes and actions outlined in these instruments were adequately and diligently enforced, we would not have witnessed the loss of 69 young lives today.

In that same vein, we also call for the dissolution of the Pharmacy Council of the Gambia for its failure to ensure that pharmacies provide safe and healthy products which has led to the loss of these young lives.

We find the management of pharmacy licenses to be unethical. The Medicines Control Agency and the Pharmacy Council are oversight and monitoring bodies over medicine importers and exporters and pharmacies. Information we have obtained is that some key members of the Agency and the Council are renting out their licenses to pharmacies. This is a clear conflict of interest, which directly undermines effective oversight and accountability. The members of the Agency and the Council should be individuals who should not have any direct financial benefits earned by virtue of holding both licenses and positions in these institutions at the same time.

We also received with great reservation the press statement from State House and the IGP on Saturday that some importers and pharmacies were suspended and that some officials from the Medicines Control Agency have been called for questioning. We wish to demand the State House and the IGP to be open and truthful by disclosing the names of the affected importers, pharmacies, and officials for the public has a right to know. We wish to question the IGP as to why the suspended importers and pharmacies have not been arrested since they are suspected of committing a crime. Similarly, we wish to also ask the IGP to indicate the duration of the investigation. This information is necessary to ensure that indeed the path to justice and accountability shall reach its logical conclusion without any interference and derailment.

We wish to remind all public institutions and officials to bear in mind that the mandates given to them carry life and death consequences hence when the slightest act of negligence and the lack of due diligence takes place, they take away lives. This is what has happened leading to the loss of 69 young lives.

Finally, we wish to call on all citizens to realize that the state of affairs of Gambian children is dire due to the continued failure of the Gambia Government to protect and fulfill the rights of children. Where conditions of children are poor, unhealthy, and uncertain then life and future of that society itself is gloomy. It is in realization of this unfortunate situation that we hold that all citizens have a moral duty to ensure that society and services are safe and healthy for children. We hereby call on citizens to stop being complacent, indifferent, and taking things for granted for the next child victim could be your child.

Justice for all children who died as a result of taking fake syrup.

Thank you for your kind attention.

JusticeFor66+ Campaign
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