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The Medicines Control Authority of Zimbabwe (MCAZ) has ordered healthcare professionals to advise patients to stop taking pholcodine-containing medicines.
Pholcodine is an opioid medicine that is used in adults and children for the treatment of non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and flu.
In Zimbabwe, pholcodine-containing products are marketed under the brand names Pholtex Plus and Pholtex Forte with the registration numbers 2018/22.2.5/5734 and 99/22.2.1/3624 respectively.
In a recent statement, MCAZ director general Richard Rukwata said:
<blockquote>
MCAZ would like to advise all stakeholders of a significant safety issue with pholcodine-containing medicines.
Available data indicate that the use of pholcodine in the 12 months before general anesthesia with neuromuscular blocking agents (NMBA) such as suxamethonium, and atracurium is a risk factor for developing an anaphylactic reaction upon administration of the NMBA.
The Authority would like to draw the attention of all licensed pharmaceutical wholesalers, pharmacies, public and private clinics, and hospitals that they must quarantine the stated products.
… due to the seriousness of the safety risk, all pholcodine-containing products are being withdrawn from the Zimbabwean market.
Health care professionals, advise patients to stop taking pholcodine-containing medicines and consider appropriate alternatives to treat their symptoms.
Check whether patients scheduled to undergo general anesthesia with NMBAs have used pholcodine in the previous 12 months and remain aware of the risk of anaphylactic reactions in those patients.
</blockquote>
The UK government says there is already a known link between pholcodine and an increased risk of the very rare event of a severe allergic reaction (anaphylaxis) to muscle relaxants (neuromuscular blocking agents) that are used during general anaesthesia in surgery.
More: <a href="https://zero.pindula.co.zw/">Pindula News</a>

Pindula News

Zimbabwe Bans Use Of Cough Medicine Containing Pholcodine

The <a href="https://www.pindula.co.zw/Medicines_Control_Authority_of_Zimbabwe">Medicines Control Authority of Zimbabwe (MCAZ)</a> has ordered health institutions to withdraw Tetracycline Hydrochloride Ophthalmic Ointment after quality-related issues were detected.
Mrs Caroline Samatanga, MCAZ Chief Regulatory Officer in the Licensing and Enforcement Division, said the Tetracycline Hydrochloride Ophthalmic Ointment alert report indicated that a range of quality issues was detected upon physical examination of random samples of the following product batches: 
<blockquote>
AF20011, AF21160, AF21161, AF22031, AF22032, AF22093, AF22100, AF22101, AF22107, AF20097, AF22021, AF22105, AF20060A, AF22025, AF22026 &amp; AF22061.
</blockquote>
<a href="https://healthtimes.co.zw/2023/03/03/breaking-zim-pharmacies-and-hospitals-ordered-to-immediately-remove-tetracycline-eye-ointment-from-shelves/">Health Times</a> cite Samatanga as saying:
<blockquote>
Reference is made to WHO product alert No. 2/2023 for Tetracycline Hydrochloride Ophthalmic Ointment USP 1%, which was received on the 22nd of February 2023. Quality issues detected included particles ranging in colour, size, and shape on the nozzle, in the cap and in the ointment inside each tube, black spots and brown splotches on the inner foil layer of the tube, and phase separation.
The above are further instructed to advise the Authority of their stock status if they have any of the affected batches.
The Authority shall communicate a plan of action once investigations are complete.
</blockquote>
Tetracycline ophthalmic preparations are used to treat infections of the eye. They may also be used along with other medicines that are taken by mouth for infections of the eye. Tetracyclines are available only with your doctor’s prescription.
<h2><a href="https://zero.pindula.co.zw/">More Pindula News</a></h2>

MCAZ Withdraws Tetracycline Hydrochloride Ophthalmic Ointment From Health Institutions

The Medicines Control Authority of Zimbabwe (MCAZ) has warned those who are using social media to promote illegal drugs that they run the risk of going to jail.
In a statement, MCAZ stated that it was against the Medicines and Allied Substances Control Act to advertise medications on social media platforms. Read the statement:
<blockquote>
The Medicines Control Authority of Zimbabwe (MCAZ) has expressed concern over the increased advertising of medicines on social media platforms such as Facebook, WhatsApp, and Twitter.
</blockquote>
They claimed that the Medicines and Allied Substances Control Act (Chapter 15:03) forbade the promotion of any medicine through any kind of advertising, including written, graphical, visual, or other descriptive material as well as verbal statements or references.
MCAZ said Section 65(1)(b) prohibits advertising any other medicine without the approval of the authority in writing.  
Anyone who violates the terms of these regulations will be found guilty and sentenced to a fine, a six-month prison sentence, or both.
MCAZ declared that it would work with the police to take the required actions, such as filing charges against persons who unlawfully advertise medications on social media.
<h2><a href="https://zero.pindula.co.zw/">More Pindula News</a></h2>

MCAZ Warns Those Advertising Medicines On Social Media Risk Being Jailed

The <a href="https://www.pindula.co.zw/Medicines_Control_Authority_of_Zimbabwe">Medicines Control Authority of Zimbabwe (MCAZ)</a> is reportedly considering banning some hair-straightening creams and skin-lightening cosmetics that have been linked to cancer.
Stakeholder consultations are underway ahead of the promulgation of the Medicines and Allied Substances Control (Cosmetics) Regulations later this year.
This follows recent research by the United States’ National Institute of Environmental Health Sciences (NIEHS), which linked hair-straightening chemicals to increased risk of hormone-related breast, uterine and ovarian cancers.
MCAZ public relations officer Mr Davison Kaiyo told <a href="https://www.sundaymail.co.zw/hair-straightening-creams-face-ban">The Sunday Mail</a> that the hair-straightening creams market is presently unregulated since most products are not legally defined as medicines. Kaiyo said:
<blockquote>
The authority is currently engaging the Ministry of Health and Child Care and other stakeholders to draft regulations to standardise this sector.
This is in the interest of public health and in line with international best practices.
The regulations will also prohibit an unlicensed person from selling, manufacturing or importing for sale any cosmetic that may cause damage to human health when used under normal or reasonably foreseeable conditions of use.
</blockquote>
MCAZ has lined up stakeholder engagements to solicit input to facilitate the drafting of the regulations.
Kaiyo said cosmetics will be defined as any substance or mixture that is intended to be placed in contact with the external parts of the human body such as the epidermis, hair system, nails, lips and external genital organs or with the teeth and the mucous membranes of the oral cavity.
<h2><a href="https://zero.pindula.co.zw/">More Pindula News</a></h2>

New Law On The Cards To Ban Some Hair-straightening Creams And Skin-lightening Cosmetics

Zimbabwe’s medical products regulator, the <a href="https://www.pindula.co.zw/Medicines_Control_Authority_of_Zimbabwe">Medicines Control Authority of Zimbabwe (MCAZ)</a> has warned against the sale and use of unregistered skin-lightening products better known as bleaching.
 The Authority flagged after finding no supporting guidelines for proper dosages and length of treatment, Health Times reported citing a circular by MCAZ Acting Director General Mr Richard Rukwata. Read the circular:
<blockquote>
The MCAZ warns the public on the dangers associated with the use of skin-lightening products such as oral /injectable Glutathione and injectable Vitamins. To date, there are no published clinical trials that have evaluated the use of oral/injectable Glutathione and injectable Vitamins for skin lightening. There are also no published guidelines for appropriate dosing regimens and duration of treatment. Glutathione and Vitamins are registrable products. The MCAZ has not approved/registered any injectable products or such products for skin lightening. 
Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and the nervous system. Furthermore, the side effects may include severe skin reactions such as Stevens Johnson syndrome, hives or allergic reactions, weight gain, losing pigmentation of hair, eye infections and disorders.
Glutathione also affects the production of melanin, the pigment that gives the human skin, hair and eyes their color. Injectable Glutathione is sometimes paired with intravenous Vitamin C, and Vitamin C injection may form kidney stones if the urine is acidic. Large doses of Vitamin C have resulted in hemodialysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. This is of particular concern when non-medical practitioners administer these treatments.
The Authority has noted with concern that several beauty salons, wellness and beauty shops are offering all kinds of beauty enhancements, services, and skin treatments. It is alarming that these also offer services such as intravenous drips or infusions using skin lightening agents including Glutathione tablets or injectables combined with injectable vitamins.
It is an offence to sell unregistered medicines without authorisation. As the Authority responsible for protecting public and animal health, MCAZ enforces adherence to the use of registered medicines and will exercise its statutory mandate against perpetrators of these criminal acts. Thus, in order to uphold this mandate, all medicines should be registered by the MCAZ prior to marketing and use. To know which medicines are approved to be sold in Zimbabwe you should visit the MCAZ online register, https://onlineservices.mcaz.co.zw/onlineregister/frmRegistersHome.aspx  where a list of all registered medicines is found.
</blockquote>
The authority is mandated to safeguard public and animal health by ensuring all medicines and medical devices on the market are safe, effective and of good quality.
MCAZ said it will take legal action against offenders who import, sell and administer unregistered medicines in Zimbabwe.
<h2><a href="https://zero.pindula.co.zw/">More Pindula News</a></h2>

MCAZ Flags Bleaching Products, To Take Legal Action Against Users And Dealers

Medicines and medical devices regulator, the Medicines Control Authority of Zimbabwe (MCAZ) says Superlife Total Care (STC30), a trending herbal medicine on social media, is illegal for it has not been registered with the Authority.
<a href="https://healthtimes.co.zw/2022/09/16/herbal-product-stc-30-illegal-in-zimbabwe-mcaz/#:~:text=MEDICINES%20and%20medical%20devices%20regulator,been%20registered%20with%20the%20Authority.">Health Times’ Kudakwashe Pembere</a> reports that STC30 is touted to cure almost every other disease and condition.
In a statement, MCAZ Acting Director General Mr Richard Rukwata said as a Regulator mandated to safeguard the safety of public and animal health, STC 30 does not have regulatory approval to be on sale in Zimbabwe. 
He said STC30 and other herbal products claiming to be registered with the Authority are not found on their register. https://onlineservices.mcaz.co.zw/onlineregister/frmCompsRegister.aspx. Reads the statement:
<blockquote>
Superlife Total Care (STC30) and many similar products with their numerous medicinal and health claims make them registrable products. However. STC30 is currently not registered and not approved for sale in Zimbabwe. As the Authority we have noted the continued advertising and marketing of STC30 products especially on social media.
We urge members of the public to desist from buying such products which have not gone through any clinical trials and therefore their safety and efficacy has not been proven. Members of the public are encouraged to buy medicines from registered premises and person. These lists can be found on the online register found on our website htms://onlineservices.mcaz.co.zw/onlineregisterformPersonsRegister.aspx.
The continued marketing and advertising of such unregistered “medicinal” products is not only an act of criminality but also puts the lives of the citizens at risk. As the Authority responsible for protecting public and animal health, MCAZ enforces adherence to standards by manufacturers and distributors and will exercise its statutory mandate against these perpetrators of these criminal acts.
</blockquote>
<ul>
<li><a href="https://news.pindula.co.zw/2022/05/13/pindula-banned-stc-30-stemcell-therapy/">Why we banned “StemCell Therapy” products like STC-30 from Pindula Market</a></li>
</ul>
<h2><a href="https://zero.pindula.co.zw/">Pindula News</a></h2>

MCAZ Says Superlife Total Care (STC30) Is Illegal In Zimbabwe

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