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The Medicines Control Authority of Zimbabwe (MCAZ) has advised members of the public against using Benylin Paediatric 100ml Syrup, batch numbers 329303 and 329304 manufactured by Johnson and Johnson, South Africa.
This comes after the National Agency for Food and Drug Administration (NAFDAC) of Nigeria raised alarm over the medicine after laboratory analysis showed that it contains unacceptably high levels of Diethylene glycol, a contaminant which is toxic for humans when consumed.
In a statement issued this Monday, April 15, MCAZ Director–General Richard Rukwata said those who may have accessed the medicine should immediately desist from administering it to children. Reads the statement:
<blockquote>
The Medicines Control Authority of Zimbabwe (MCAZ) would like to inform all stakeholders of a critical communication received from the National Agency for Food and Drug Administration (NAFDAC) of Nigeria regarding the recall of Benylin Paediatric 100ml Syrup, batch number 329304, manufactured by Johnson and Johnson, South Africa. 
According to NAFDAC, recent laboratory analysis has revealed unacceptably high levels of Diethylene glycol in this formulation. Diethylene glycol is a contaminant which is toxic for humans when consumed.
Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, potentially leading to death.
Additionally, the South African Health Products Regulatory Authority (SAHPRA) and the manufacturer identified an additional batch that is affected bringing the affected batches to two; 329303 and 329304.
While the Authority confirms that this product was registered in 2023 for use in Zimbabwe, our import database does not show a record of the importation of this product and more specifically these two batches.
However, there is a concern that through illegal means, the aforementioned batches of Benylin Paediatric Syrup may find their way into the local market. As a precautionary measure, the Authority is issuing a recall notice for this product.
In the unlikely event that members of the public are in possession of and/or come across this product, please notify the Authority and/or healthcare provider immediately and desist from administering them to children.
The cooperation of all stakeholders is essential in ensuring the right of citizens to safe and good quality medicines is protected.
Meanwhile, the Authority will intensify its market surveillance activities through strict premises inspections and public awareness to ensure that these products are not circulated.
The mandate of the MCAZ is to protect public health by ensuring that all medicines and medical devices on the market are safe, effective, and of good quality and will continue to monitor the situation in line with the WHO guidelines.
The Authority also urges members of the public to access medicines from licenced persons and premises for easier monitoring.
The Authority and law enforcement agencies continue to work together to eradicate any substandard and falsified health products.
</blockquote>
More: <a href="https://www.pindula.co.zw/">Pindula News</a>

Pindula News

Benylin Paediatric Cough Syrup Recalled In Zimbabwe, Several African Countries

A research paper conducted by the United Nations Children’s Fund (UNICEF) in collaboration with the government, Muthengo Development Studies (MDS), Zimbabwe Civil Liberties and Drug Network (ZCLDN), and Youth Advocates Zimbabwe (YAZ) has revealed that approximately 60% of school dropouts in Zimbabwe are a result of drug and substance abuse.
The research identified common drugs abused by students, including cannabis, cough syrup, crystal meth, illegal alcohol, pharmaceuticals, crack, cocaine powder, and heroin. The study further highlighted that drug abuse contributes to a cycle of poverty and crime as it leads to students leaving school prematurely. The report read in part:
<blockquote>
 The study revealed disturbing patterns directly attributable to alcohol, drug and substance (ADS) abuse: 70% of gang violence is among school children; 15% of Intimate Partner Violence (IPV) and Gender Based Violence (GBV) cases involve adolescents and young people; and an increase in school dropouts with 60% having dropped out of school after being expelled for ADS abuse...
An increase in public education and awareness campaigns about substance abuse, especially directed at adolescents and young people. The establishment of partnerships between schools, communities, and local authorities to promote healthy behaviours among adolescents and the young people.
</blockquote>
The organizations involved in the research also discovered that 40% of suicide attempts were connected to drug abuse. The study revealed that adolescents and young people from wealthier families tended to consume more expensive substances like cocaine, crack, heroin, and legal alcohol, while those from disadvantaged families used cheaper substances.
The main reasons for substance abuse included parental death, poverty, idleness, and peer pressure, among other factors. The report highlighted that Manicaland province had the highest drug usage, followed by Mashonaland Central, Mashonaland West, and Bulawayo. The organizations emphasized the need for more outreach programs to promote positive behavioural changes among young people.
In Zimbabwe, there is a lack of sufficient rehabilitation facilities for drug abusers. These individuals receive therapy in healthcare institutions but are released back into an environment that contributes to relapse. Clement Nhunzvi, a lecturer and mental health practitioner at the University of Zimbabwe, <a href="https://www.pindula.co.zw/Drug_Abuse_in_Zimbabwe/#cite_note-nhunzvi-3">explains in his 2014 publication</a> that they return to a setting characterised by poverty, unemployment, and frustration, which leads them back to drug abuse. Hospital records indicate that a significant number of readmissions were due to substance-induced disorders, with less than 3% of individuals achieving long-term recovery and follow-up. The psychiatric rehabilitation team faces challenges in both clinical practice and an unsupportive community environment for their clients’ recovery.
<h3><a href="https://www.pindula.co.zw/">More Pindula News</a></h3>

UNICEF Says About 60% Of School Dropouts In Zimbabwe Are A Result Of Drug Abuse

The Medicines Control Authority of Zimbabwe (MCAZ) and CID Drugs and Narcotics arrested a suspected drug peddler in Harare on Wednesday, 03 October.
In a statement, MCAZ Director-General, Richard Tendayi Rukwata, said the suspect was found in possession of 450 bottles of BronCleer, an illegal cough syrup.
The raid was conducted at Old Trafford flats located at 13 Edmond Avenue, Belvedere, Harare. Reads the statement:
<blockquote>
After an anonymous tipoff, the Medicines Control Authority of Zimbabwe (MCAZ) has successfully confiscated a total of 450 Bottles of illegal cough syrups (BronCleer and Adco-Salterpyn) during a raid conducted at Old Trafford flats located at 13 Edmond Avenue, Belvedere, Harare yesterday.
This significant seizure is part of the Authority’s ongoing efforts to combat drug and substance abuse as well as the illegal distribution and misuse of pharmaceutical products within the country.
During the operation, MCAZ Inspectors working with Officers from the CID Drugs and Narcotics discovered and seized 350 bottles of BronCleer cough syrup and 100 bottles of Adco-Salterpyn syrup.
The suspect present at the scene is currently cooperating with law enforcement agencies to assist with their investigations into this matter.
BronCleer and Adco-Salterpyn Syrup are opioid-containing cough syrups that are not registered in Zimbabwe.
Opioids are considered Dangerous Drugs and these cough syrups are being abused by opioid drug addicts.
Its misuse poses serious health risks and can lead to various complications if not used under proper medical supervision.
The MCAZ remains committed to safeguarding public health by ensuring that only authorized and regulated medicines are available on the market.
The Authority will continue to work closely with law enforcement agencies to identify and apprehend individuals involved in the illicit trade of such substances.
MCAZ urges members of the public to be vigilant and report any suspicious activities related to drug and substance abuse and the distribution or sale of unregulated pharmaceutical products.
Your cooperation is vital in our collective efforts to protect public health and safety. For further information or inquiries, please contact the Authority.
</blockquote>
More: <a href="https://www.pindula.co.zw/">Pindula News</a>

MCAZ Seize 450 Illegal Cough Syrup Bottles From Belvedere Flat

The Medicines Control Authority of Zimbabwe (MCAZ) has delisted 10 local pharmaceutical dealers for allegedly promoting the abuse of Histalix cough syrup by youths.
In a statement on Monday, MCAZ announced it had revoked six operating permits for wholesale dealers and licences for four pharmacists.
Histalix is a locally-produced cough mixture containing codeine, an opioid medicine used for the short-term relief of mild to moderate pain.
MCAZ Histalix was being illegally sold in such places as Mbare and Chitungwiza while others were exporting it to Zambia and Mozambique.
The revocation of permits and cancellation of licences, which runs up to March 2025, is part of efforts to fight drug and substance abuse among youths.
In a statement, MCAZ director-general Richard Rukwata said they are working to get unregistered drug manufacturers and counterfeit drugs off the streets.
MCAZ has classified Histalix cough syrup as a prescription-only drug.
In a speech read on his behalf by MCAZ’s head Licensing and Enforcement divisions Caroline Dandira-Samatanga, Rukwata said:
<blockquote>
We aim to prevent the circulation of counterfeit drugs and unregistered substances that can contribute to drug abuse.
In this regard, the authority, has revoked six permits for wholesale dealers and cancelled four persons licences who were promoting abuse of Histalix, a locally-produced cough mixture containing codeine, by illegally selling it at Mbare and places likes Chitungwiza and others were exporting to countries like Zambia and Mozambique.
Drug abuse is a complex issue that affects individuals, families, and communities across Zimbabwe.
</blockquote>
Rukwata said MCAZ has noted that there is an influx of over-the-counter medicine that is being smuggled into the country. He said:
<blockquote>
The authority, however, notes with concern that over-the-counter medicines from other countries are continuously being imported illegally.
MCAZ is working with various stakeholders, including the Police, CID Drugs, National Prosecuting Authority, Zimra and port health officials to educate them on the entry of these drugs through ports of entry or illegal channels.
The authority holds training with these stakeholders on a regular basis and has had five trainings in various provinces this year in Masvingo, Beitbridge, Zvishavane, Victoria Falls and Mutare.
Police regularly confiscate some of these cough syrups, and we assist them in writing statements that have penalties.
</blockquote>
Adept, Bestpharm, Action 24 Medical Supplies and Murity Pharmaceuticals had their permits revoked while the firms’ directors and supervisors were banned from operating.
More: <a href="https://www.pindula.co.zw/">Pindula News</a>

Medicines Control Authority Revokes Permits For Dealers Promoting Abuse Of Cough Syrup

Drug abusers will no longer be treated as victims but as criminals, a senior government official has said.
Harare Metropolitan Affairs and Devolution secretary Tafadzwa Muguti on Friday said treating drug users as victims will not help in ending the scourge of drug abuse.
He was speaking at the launch of a national anti-drug operation dubbed No To Dangerous Drugs And illicit Substances; See Something Say Something. <a href="https://www.newsday.co.zw/local-news/article/200006999/govt-declares-war-on-drug-abusers">NewsDay</a> quoted Muguti as saying:
<blockquote>
We have stopped looking at rehabilitation first before arrest because that is the mistake we were doing.
If we find someone who is under the influence of drugs, the law says that you can be arrested for being drunk and intoxicated in public.
So as it is, anyone who is found under the influence of drugs is eligible to arrest and they will tell us when they get sober where they would have bought the drug.
If we continue treating drug users as victims while they know exactly where the drugs are coming from, we won’t stop this pandemic.
</blockquote>
Police in Harare on Friday arrested 10 drug users and peddlers, with one of them found in possession of 50 bottles of Bron Cleer cough syrup.
During the raid yesterday, several drug users were nabbed at police roadblocks in Southerton.
Muguti said drug dealers are operating mainly from high-density suburbs and transporting the drugs using passenger vehicles. He said:
<blockquote>
As you saw today, we have captured a number of drug lords who were actually transporting drugs using passenger vehicles.
We are now aware that drug lords are now using high-density suburbs as safe havens. 
Government raised concern over the increasing involvement of schoolchildren in drug and substance abuse and implored school heads to treat drug offences as criminal offences, not as disciplinary offences.
</blockquote>

Drug Abusers To Be Treated As Criminals, Not Victims - Muguti

The World Health Organization (WHO) has warned against the use of four Indian cough syrups saying they could be linked to the deaths of 66 children in The Gambia, according to a WHO alert seen by Pindula News.
The United Nations health body said the syrups have been “potentially linked with acute kidney injuries and 66 deaths among children”.
The products were manufactured by an Indian company, Maiden Pharmaceuticals, which had failed to provide guarantees about their safety, the WHO added.
Indian officials say they have asked the WHO to share evidence of the link between the syrups and the deaths.
The WHO identified the medicines as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. Reads the alert published on the WHO’s website on Wednesday:
<blockquote>
WHO has today (05 October 2022) issued a medical product alert for four contaminated medicines identified in The Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children.
The loss of these young lives is beyond heartbreaking for their families.
The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India.
WHO is conducting further investigation with the company and regulatory authorities in India.
While the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries.
WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients.
</blockquote>
The Gambia’s government has since suspended the use of all paracetamol syrups and has urged people to use tablets instead.
The number of deaths has declined since the ban but two more have been recorded in the past two weeks, Gambia health services director Mustapha Bittay told the <a href="https://www.bbc.com/news/world-africa-63150950">BBC’s Focus on Africa programme</a>.
He said that The Gambia did not currently have a laboratory capable of testing whether medicines were safe and so they had to be sent abroad for checking. 
Mr Bittay added that The Gambia was in discussions with the World Bank to get funding for a quality-control laboratory.
The WHO said that laboratory analysis of samples of the products “confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”.
The substances were toxic, and their effects “can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.”
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WHO Warns Against Indian Cough Syrups After Death Of 66 Children In The Gambia

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