Frequently Asked Questions
IVERMECTIN AND COVID- 19 INTENDED USE: SAFETY AND EFFECTIVENESS
1. WHAT IS IVERMECTIN?
A: Ivermectin is a medication used to treat many types of parasite infections such as internal ( dibokwana) and external parasites ( mites and fleas) in livestock and companion animals.
Ivermectin may also be used in humans for the treatment of head lice, scabies, and other internal parasites ( dibokwana).
2. WHAT IS THE MEDICINES REGISTRATION PROCESS IN BOTSWANA?
A: Registration of medicines is provided for in the Medicines and Related Substances Act of 2013, section 23, it states that “
For medicines to be allowed for use in Botswana, they must go through a registration process that involves submission of an application by the applicant or manufacturer.
This process is followed by a thorough assessment of the information provided. If the information provided is found to be sufficient to assure the quality, safety, and effectiveness of the medicine, then the medicine gets registration approval. Once the medicine is registered, importers can source and avail the medicine to hospitals, clinics, pharmacies, and ultimately to patients.
3. SHOULD I TAKE IVERMECTIN TO PREVENT OR TREAT COVID- 19?
A: Ivermectin is not approved for the prevention or treatment of COVID- 19. You should not take any medicine to treat or prevent COVID- 19 unless it has been prescribed to you by your health care provider and registered for use by the Botswana Medicines Regulatory Authority ( BoMRA). Only regimens and protocols provided by the Ministry of Health and Wellness should be followed in the management of Covid- 19.
4. IS THERE AN EMERGENCY USE AUTHORIZATION FOR IVERMECTIN IN BOTSWANA TO PREVENT OR TREAT CORONAVIRUS OR COVID- 19?
A: BoMRA to date has not received any application for the registration of Ivermectin for prevention and/ or treatment of COVID- 19 therefore, BoMRA cannot ascertain the quality, safety, and effectiveness of any human or veterinary Ivermectin product for use in the prevention or treatment of COVID- 19.
Section 23 and Section 56 of the Medicines and Related Substances Act ( MRSA) gives BoMRA the authority after careful consideration to permit products that are unregistered in Botswana through exemption if there are no registered alternatives for the product or that it is for clinical trials or medical research, and there is valid motivation and evidence for use of the unregistered product;
• Ivermectin is established for use in the treatment of parasitic infections while COVID- 19 is a disease caused by a virus, i. e., viral infection. Therefore, its use for viral infections is not yet established.
5. WHAT IS IVERMECTIN APPROVED FOR IN BOTSWANA?
A: Ivermectin is approved for use in the control of parasites in animals and has not been approved for use in humans for COVID- 19. There has not been any research presented to the National Regulatory Authorities to demonstrate the effectiveness of the product for the condition.
The use of any medical product for indications that have not been approved may also have unwanted effects in humans which may prove detrimental to the health of the people.
6. ARE THERE ANY DANGERS TO HUMANS FOR TAKING IVERMECTIN?
A: There are approved uses for Ivermectin in people and animals, but it has not been approved for the prevention or treatment of COVID- 19. You are therefore advised not to take any medicine to treat or prevent COVID- 19.
7. WHAT SHOULD I DO IF I DON’T FIND THE ANIMAL IVERMECTIN IN THE OUTLETS?
A: Ivermectin is an important part of a parasite control program for certain species and should only be given to animals for approved uses or as prescribed by a veterinarian, due to the potentially elevated interest of the public over Ivermectin, some products may not be available.
If you are having difficulty in locating a particular Ivermectin product for your animal( s), BoMRA recommends that you consult with your veterinarian for alternative parasitic treatment.
8. WHAT IS BoMRA DOING TO PROTECT PEOPLE FROM FRAUDULENT COVID- 19 PRODUCTS?
A: Our Enforcement team is working closely with other agencies to monitor activities related to online sale promotion of fraudulent COVID- 19 products including Ivermectin on social media. Most products sold are subject to investigation and potential enforcement action if they claim to prevent, diagnose, treat, or cure COVID- 19 and have not demonstrated safety and effectiveness for that intended use.
The Authority warns that those who will be found to violate the MRSA will be subjected to legal action, prosecution, and possible jail time. The public is also encouraged to report any such claims of promotion, sale, and use of products to the BoMRA Legal Enforcement division via a toll- free number, mobile phone number, or email.