Tag: SAHPRA

Categories : Healthcare Politics and Regulations Medical IndustryTags :

SAHPRA Recalls Lubri-A, Sterile Lubricating Gel

On By ModernMedia
Photo by Jan Kopřiva on Unsplash

The South African Health Products Regulatory Authority (SAHPRA) is aware of the product Lubri-A (Sterile Lubricating Jelly) manufactured by Electro-Spyres, classified as Class B medical device and currently being distributed across the country. 

SAHPRA has been informed of multiple complaints received from health institutions, both public and private across the country. The complaints are as a result of a number of patients who became ill due to developing a fungal infection, caused by exposure to the fungal species, Wickerhamomyces anomalus (previously Candida pelliculosa) associated with use of Lubri-A (Sterile Lubricating Jelly).

Lubri-A is available in two presentations, the 2.5 g sachets and 50 g tubes.

Considering the wide usage of the product for lubricating purposes in medical and surgical procedures, the Regulator has taken a decision to urgently recall this product from the market as there are multiple contaminated batches, with the potential to cause serious and widespread nosocomial infections. SAHPRA is alerting healthcare professionals and the public to discontinue the use of the product, remove it from their inventory and return it through their normal distribution channel(s) with immediate effect.

As the source of the contamination of the product is still under investigation and not confirmed, all batches of Lubri-A are being recalled. Future manufacture and distribution of the product will be subject to review and authorisation by SAHPRA.

Classification of the recalls

The recall is being classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences. This is a countrywide recall. The product is being recalled from hospitals, retail outlets, health care professionals, authorised prescribers and individual customers or patients.

What the public should know

Healthcare professionals that have used this product should contact their patients to determine any symptoms of infection after use of product.

The recall is limited to the product called LUBRI-A (2.5g and 50g sachets) and does not affect other lubricating gel products authorised for sale in South Africa.

The contact telephone numbers for Electro-Spyres are:

Landline:         011-608-3998 or 011-402-7208

WhatApp:       +27-82-355-8862

“As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public. SAHPRA is recalling this product from the market as there are multiple suspected contaminated batches with the potential to cause serious and widespread nosocomial infections, ” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

Categories : Metabolic DisordersTags :

Public Urged To Use Registered Ozempic Products

On By ModernMedia
Photos supplied by Novo Nordisk

The South African Health Products Regulatory Authority (SAHPRA) is aware of the falsified Ozempic products currently being sold on the market and online.

SAHPRA has been informed of advertisements regarding unauthorised Ozempic/semaglutide-containing products that are being disseminated through radio stations and social media platforms.

The Regulator is warning the public to be wary of products claiming to be Ozempic (semaglutide) which are not approved by SAHPRA.  

Ozempic is a Schedule 4, prescription-only medicine, authorised by SAHPRA only for the treatment of type 2 diabetes mellitus in adults. SAHPRA has not authorised/registered Ozempic for weight-loss, therefore, use in that regard would be off-label. It must be noted that only a healthcare practitioner can make a Schedule 4 product available off-label as they would provide the requisite guidance and support to the patient/individual.

Novo Nordisk South Africa, who is the Holder of Certificate of Registration (HCR) has confirmed a national shortage of Ozempic stock; this resulted in limited access to treatment for diabetic patients. This may have created an opportunity for falsified/counterfeit products flooding the market claiming to be Ozempic and being used off-label for weight loss. Consumers should be wary of online offers for products claiming to be Ozempic or semaglutide.

Currently, there are no generic versions of this medicine being lawfully manufactured. Therefore, any product not manufactured by Novo Nordisk claiming to contain semaglutide is likely to be fake or counterfeit. The public is being exposed to many different types of unregistered/unauthorised products that are either substandard or falsified thereby putting their health at risk. See examples of registered vs counterfeit products.

Registered products safe to use
Ozempic solution for injection is a registered product by SAHPRA belonging to the HCR, Novo Nordisk South Africa.

There are only two (2) registered presentations of the pre-filled pen for Ozempic available in South Africa namely, Ozempic 0,25 mg and 0,5 mg/dose pen and Ozempic 1 mg/dose pen.

What the public should know

  • Using unregistered semaglutide products claiming to have the effects of Ozempic bought from unverified/illegally trading suppliers could be detrimental to your health as these have not been evaluated by SAHPRA for safety, quality, and efficacy.
  • These falsified/fake Ozempic products may contain certain active ingredients found in the registered Ozempic products; however, the formulations or manufacturing processes may be different. These formulations have not been evaluated by SAHPRA.
  • SAHPRA urges the public to first consult their medical professionals for their health treatment and prescriptions, and only purchase or use SAHPRA registered/authorised products sold at registered pharmacies.
  • Any medicines that are bought outside of the legal supply chain:
    • May not contain any active ingredient.
    • May contain dangerous levels of the active ingredient.
    • May contain another active ingredient such as insulin instead of semaglutide.
    • May contain harmful inactive ingredients.
    • May be nonsterile and contaminated with microbes, therefore not suitable for injection.

“Protecting the health of South Africans is top of mind for the regulator. The scourge of unregistered, substandard, and falsified medicines on the market is a serious health risk for the public. SAHPRA is listening to the public concerns, and we have an ongoing investigation into these falsified Ozempic and unregistered semaglutide-containing products”, indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

Public are urged to report any suspected products that are falsely claiming to work like Ozempic. You can report through these whistle blower platforms, SAHPRA’s 24-hour hotline (0800 204 307) or via our web reporting facility: .

Categories : Healthcare Politics and RegulationsTags :

SAHPRA Earns a Regulatory Accolade of Note

On By ModernMedia
Gloved hand holding vial of Janssen COVID vaccine
Photo by Spencer Davis on Unsplash

The South African Health Products Regulatory Authority (SAHPRA) has been designated as a Regional Centre of Regulatory Excellence (RCORE) for Vaccines Regulatory Oversight for a period of four (4) years in the following functions:

  • Overarching Regulatory Systems
  • Marketing Authorisation and Registration
  • Vigilance
  • Market Surveillance and Control
  • Licensing of Premises
  • Regulatory Inspections
  • Laboratory Access and Testing
  • Clinical Trials
  • Lot Release

The rationale behind the African Union Development Agency, New Partnership for Africa’s Development (AUDA-NEPAD) designating RCOREs is to support continent-wide regulatory systems strengthening through leveraging capacity in better resourced regulators. The reality of medicine regulatory capacity limitation on the continent continues to hinder access to essential medicines as well as limit progress in regulatory harmonisation efforts. The intention is to address this regulatory gap and ensure the acceleration and strengthening of regional medicines regulatory harmonisation initiatives. RCOREs are required to support regulatory workforce strengthening through training in regulatory functions and enhance skills through hands-on training and exchange programmes amongst National Medicines Regulatory Authorities.

About RCOREs

The Regional Centres of Regulatory Excellence (RCOREs) is an initiative of the AUDA-NEPAD. As part of its mandate to strengthen regulatory capacity development in Africa, AUDA-NEPAD through its AMRH programme has designated 11 RCOREs in eight different regulatory functions which include:

  • Pharmacovigilance
  • Training in core regulatory functions
  • Quality assurance and quality control of medicines
  • Medicine registration and evaluation, quality assurance/quality control and clinical trials oversight
  • Licensing of the manufacture, import, export, distribution and inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicine
  • Clinical trials oversight
  • Registration and evaluation and clinical trials oversight
  • Medicine evaluation and registration

Source: SAHPRA

Categories : COVID Healthcare Politics and RegulationsTags :

Supreme Court of Appeal Rejects Appeal Over COVID Vaccine Sale Restriction

On By ModernMedia

The Supreme Court of Appeal has dismissed an application for leave to appeal by Solidarity and Afriforum over a 2021 court case where they challenged a condition by South African Health Products Regulatory Authority (SAHPRA) that the Johnson & Johnson vaccine be restricted to the government. SAHPRA said that this was not a condition that they had imposed.

On 26 July 2023, the Supreme Court of Appeal (SCA) dismissed an application for leave to appeal filed by Solidarity and Afriforum (the Applicants) on the grounds that there is no reasonable prospect of success.

The Pretoria High Court struck Solidarity and AfriForum’s application from the court roll on the grounds of an alleged lack of urgency, and the court also ordered them to pay SAHPRA’s legal costs which was filed in June 2021 by the Applicants, wherein they alleged that when SAHPRA approved and registered the J&J vaccine, SAHPRA imposed a condition that the sale of the J&J vaccine is restricted to the National Government. The applicants argued that SAHPRA was not mandated to stipulate the condition that only the government may purchase the J&J vaccine and questioned the legality of such a condition.

SAHPRA refuted this claim because this is not a condition that SAHPRA had imposed. Subsequently, the applicants proceeded to lodge an application for leave to appeal with the SCA . SAHPRA CEO, Dr Boitumelo Semete-Makokotlela said, “This court ruling indicates that SAHPRA is judicious in adhering to its mandate responsibly. We welcome the outcome of this judgement.”

Categories : HIVTags :

First HIV Prevention Injection Approved in SA

On By ModernMedia
Image of a syring for vaccination
Photo by Mika Baumeister on Unsplash

By Marcus Low

The South African Health Products Regulatory Authority (SAHPRA) has authorised an injection containing the antiretroviral cabotegravir for use to prevent HIV infection, according to drugmaker ViiV Healthcare.

“We are very pleased that this week, SAHPRA granted regulatory approval of Apretude or cabotegravir long-acting injectable,” ViiV Healthcare spokesperson Catherine Hartley told Spotlight. “It brings a much-needed innovative HIV prevention option to the communities that need it most, including women and adolescent girls where challenges with adherence, limited efficacy, and stigma have hindered the impact of current PrEP options.”

At the time of publication, SAHPRA had not yet confirmed the registration, although Spotlight understands a media statement on the issue is imminent. The regulator received ViiV Healthcare’s initial application for approval in November 2021.

ViiV Healthcare has not disclosed at what price it will offer the shot in South Africa or other African countries. The company has, through a deal with the Geneva-based Medicines Patent Pool, agreed to grant voluntary licenses to at least three generic producers that could potentially supply the injection to South Africa. It is however expected to take three to five years before any of the generics will be ready.

Executive Director of the HIV prevention organisation AVAC confirmed news of the authorisation late Wednesday in a social media post, calling it a critical step in making the injection available to millions that could benefit from the shot.

Thursday’s announcement makes South Africa at least the third African country to approve the shot for use, following similar approvals in Zimbabwe, Uganda, and Botswana. A duo of large clinical trials led in part by South African researchers found that people who were given an injection of the antiretroviral cabotegravir every other month were about 80% less likely to contract HIV than those on the HIV prevention pill.

The bi-monthly shot likely outperformed the pill, the World Health Organization explains in new guidelines, mainly because it was easier for people to get an injection every two months than to take the pills every day.

Previously, Spotlight reported that pilot projects are slated to begin providing access to the HIV prevention shot early next year. Demonstration projects run in partnership with the national health department and research organisations the Wits Reproductive Health and HIV Institute and Ezintsha are expected to offer patients a choice of the HIV prevention shot, pill, or monthly vaginal ring.

The pilot projects, sometimes called “demonstration” projects, will be looking to help answer major questions about an eventual national rollout, including how to create national awareness campaigns about the HIV prevention injection and how to provide it outside of hospitals and clinics and closer to communities.

SAHPRA authorisation marks the first step toward an eventual national rollout, according to national health department HIV prevention technical advisor Hasina Subedar. Subedar spoke to Spotlight in July at the International AIDS Conference. In particular, the finer details of the registration – which are still not public – will guide who can and can’t receive the shot, for instance.

Many will be watching to see whether the injection will be made available to pregnant and breastfeeding people, who remain at high risk for contracting HIV in South Africa. Early data presented at the International AIDS Conference in July suggests that the injection is safe to use during pregnancy, although research is ongoing.

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : COVIDTags : 1 Comment

Ivermectin Approved to Treat COVID in SA on Limited Basis

On By ModernMedia

Ivermectin, which has some reports of high effectiveness in limited studies, has received approval from the SA government to be used under strict control for compassionate use.  

Dr Boitumelo Semete-Makokotlela, head of the South African Health Products Regulatory Authority (SAHPRA), said that practitioners applying to use the drug will be considered case-by-case.

Ivermectin has a long history of use as an antiparasitic treatment in animals, while in humans it’s used as an anthelmintic drug that is usually indicated for filarial and resistant scabies infections. While the World Health Organization has suggested the drug has encouraging effects on coronavirus, although it hasn’t been properly evaluated yet.

“We absolutely share everyone’s desperation at this point,” said Helen Rees, SAHPRA chairwoman. “So the question about ivermectin and self-medication goes back to what everyone in the scientific community is saying. And that is, we don’t know if it works and we don’t know if it doesn’t work. That’s why we need to get data.”

Physicians in Zimbabwe are reportedly treating COVID with ivermectin in combination with silver nanoparticles – normally used as an algaecide – to great success.

Rees, however, warned South Africans that people self-medicating “need to be very careful because we don’t have any information about the quality of what you’re taking.”

Dr Semete-Makokotlela said that clear guidelines for the rollout would be given tomorrow. She added that SAHPRA granted the health department permission to distribute the Oxford/AstraZeneca COVID vaccine, the first one for SA. It is also currently reviewing applications from Johnson & Johnson and Pfizer, but has yet to receive an application from Moderna, she said.

Source: BusinessTech