The Zambia Medicines Regulatory Authority claims it intercepted and destroyed a batch of ten thousand (10,000) doses of a suspected COVID 19 vaccine that was illegally brought into the country.
On July 2, 2021, an importer named Chrismar Earthmoving Equipment, a company controlled by Valden Findlay, a close acquaintance of former President Edgar Lungu, brought into the country the vaccine described as Hayat Vax [SARS-COV-2 Vaccine] (Vero Cell) inactivated, with batch number HV0025.
The consignment which was worth US$ 150, 000 was seized at Kenneth Kaunda International Airport by ZAMRA in conjunction with the Zambia Revenue Authority.
The named vaccine is unauthorized for use on the Zambian market as it is not registered by ZAMRA.
In addition, the vaccine is not under the World Health Organization (WHO) Emergency Use Listing (WHO EUL).
The WHO EUL procedure is one of the regulatory reliance mechanisms which ZAMRA utilizes, like other national regulatory authorities in other jurisdictions, to consider COVID 19 vaccines for national use.
According to the documentation (Invoice) which was furnished to ZAMRA, the purported manufacturer of Hayat Vax vaccine is Gulf Pharmaceutical Industries while the selling entity is G42 Medications Trading LLC of the United Arab Emirates (Middle East).
In conducting the due diligence, ZAMRA had engaged Chrismar Earthmoving Equipment by guiding the importer that the following were required to import the COVID-19 vaccine:
- Pharmaceutical Licence: The Medicines and Allied Substances Act No.3 of 2013 requires such a person who intends to bring medicines into country to be a holder of a Pharmaceutical Licence. However, a non-pharmaceutical entity importing medicines with an intent to donate to a licensed health institution may do so provided that the medicines are delivered to the recipient upon arrival;
- Marketing Authorisation: Prior to placing a medicine for use on the Zambian market, medicines, vaccines included, are required to be registered by ZAMRA in line with the said Act; and
- Import permit: A person who intends to import medicines is required to be in possession of an import permit issued by ZAMRA.
The above requirements which were communicated to the importer in writing were not fulfilled.
This followed a written notice by ZAMRA of seizure and destruction as the importer did not meet the legal requirements as stated above.
The notice was received by a representative of the procuring entity on 26th August 2021.
In addition, a seizure form was signed by the said representative to show consent, and this was used to release the vaccine consignment to ZAMRA by ZRA on 27th August, 2021.
On the same day, the vaccines were destroyed by incineration method at the ZAMRA Incineration Compound.
The procedural steps undertaken by ZAMRA to engage the importer, Chrismar Earthmoving Equipment, until when the vaccines were destroyed were routine.
In light of the foregoing, ZAMRA took steps to protect the Zambian public from the risk of utilising an unlicensed vaccine whose quality, safety, and effectiveness could not be guaranteed since the stated importer failed to meet regulatory standards.
Since then, ZAMRA has urged members of the public who intend to import COVID19 vaccines, as well as other medicines and allied substances, for use on the Zambian market to ensure that the proper processes and procedures are followed in accordance with the Medicines and Allied Substances Act No. 3 of 2013, in order to avoid stringent regulatory and legal action.