THE Zambia Medicine Regulatory Authority (ZAMRA) says it did not test the substances that were illegally imported by Valden Findlay’s company to ascertain if they were truly Covid-19 vaccines.
And when asked whether the Authority has considered taking any legal action against Findlay, ZAMRA declined to comment.
According to The Medicines and Allied Substances Act of 2013, Part IX, Section 59, any person who imports sub-standard, counterfeit or misbranded medicines is guilty of a crimes and must be prosecuted before the said substances can be forfeited and destroyed.
Meanwhile, Ministry of Health permanent secretary Dr Kennedy Malama declined to respond to questions contained in a press query regarding how the drugs were brought into the country, saying his ministry only got to know about the purported vaccines once they were at the airport.
Responding to a follow up press query from News Diggers, ZAMRA acting director general Makomani Siyanga said the substances which were guised as Hayat-Vax vaccines were destroyed on grounds that the importer did not have the necessary documents, adding that testing or verifying them would have been a waste of resources.
“The purported vaccine was not tested as basic requirements were not satisfied and therefore, not going to be used on the Zambian market. Therefore, testing of the vaccine for verification purposes without being used would have been a waste of scarce resources which can be used for other equally important regulatory activities. Thus, a risk based approach was used to arrive at the decision for the vaccine whose suitability for use was not ascertained,” Siyanga said.
Findlay, who is Lusaka businessman and close associate of former president Edgar Lungu, has been at the centre of a fake Covid vaccine importation scandal, with some people questioning why ZAMRA destroyed the drugs without testing to see if they were vaccines or other illegal substances concealed as vaccines.
On Wednesday, the Ministry of Health distanced itself from the alleged vaccine consignment, but Findlay told Millennium Radio yesterday that the drugs were meant for donation to the government.
ZAMRA availed News Diggers a drugs donations regulatory guideline form which shows that no one can import drugs into the country meant for donation without prior notice and consent from the recipient.
According to ZAMRA, Findlay’s consignment did not meet the conditions for being donated to the government or any other recipient.
“All drug donations should be based on an expressed need and be relevant to the disease pattern in Zambia. The recipient of the drug donation should specify their needs well before the intended donation is sent. Drugs should not be sent without prior consent by the recipient. The donation should be in line with the Zambian Essential Drugs List a copy of which may be obtained from the Central Board of Health. However, exceptions can be made for drugs needed in sudden outbreaks of uncommon or newly emerging diseases. The presentation, strength and formulation of donated drugs should be similar to the drugs used in Zambia and as stipulated in the Zambia Essential Drugs List and Standard Treatment Guidelines. Restricted drugs containing narcotics and psychotropic substances should be should be imported in accordance with the international Conventions on Narcotics and Psychotropic Substances. Details on this may be obtained from the Pharmacy and Poisons Board Secretariat,” read the Pharmaceutical Regulatory Authority’s guidelines for drug donations to Zambia.
And when asked why there was a time lag between when the illegal consignment was discovered and when it was destroyed, he said ZAMRA was conducting investigations during that period.
“This was due to ZAMRA conducting follow ups with the importer and also undertaking investigations regarding the authenticity of the vaccine through [an] external network of experts on substandard and falsified medical products to which ZAMRA belongs,” he responded.
When asked what documentation Chirsmar Earthmoving Equipment presented to the ZAMRA officers to justify the importation of vaccines worth $150,000, Siyanga said “the Packing List and the Invoice from the exporter.”
When further asked if his office reached out to the purported manufacturers, Gulf Pharmaceutical Industries, to ascertain what documentation Findlay’s company presented when he ordered the vials, Siyanga said ZAMRA made attempts to contact the national regulator of the exporting country, through a third party but that there was no feedback.
“The onus was on the importer of the unauthorised vaccine to provide the required documentation as requested for by the regulator (ZAMRA). The said importer is an entity that the Authority was dealing with. In addition, ZAMRA made attempts to contact the national regulator of the exporting country, through a third party, to obtain more information about the vaccine and has not received feedback to date. However, if the purported manufacturer initially contacted ZAMRA for registration of the vaccine to be placed on the Zambian market, then ZAMRA would have directly requested appropriate documentation from them,” Siyanga said.
Asked if any legal action had been taken against the proprietors of Chirsmar Earthmoving Equipment who, according to PACRA records are Valden Findlay, Dessislava Findlay and Chrismar Hotel, Siyanga said “no comment”.
But according to The Medicines and Allied Substances Act of 2013, part IX, section 59, any person who imports such substances is liable to a fine not exceeding two million penalty points or four years imprisonment or both.
“59 (1) A person shall not manufacture, import, export, distribute, sell, store or deal in any manner with sub-standard, counterfeit, adulterated or misbranded medicines or allied substances.
(2) A person who contravenes subsection (1) commits an offence and is liable, upon conviction, to a fine not exceeding two million penalty units or to imprisonment for a period not exceeding four years, or to both. (3) In addition to the penalty provided in subsection (2), the court before which a person is convicted of an offence under this section may order that any medicines or allied substances in respect of which the offence is committed be forfeited to the State to be destroyed,” reads the Act.
When asked if the authority kept any of the purported vaccines to present as evidence in case of litigation, he referred this question to the statement ZAMRA issued on August 31, 2021 which indicated that all the samples were destroyed.
Siyanga also said Chirsmar Earthmoving Equipment is not a licensed entity with ZAMRA.
Meanwhile, Dr Malama refused to respond to all, but one questions in a press query regarding Findlay’s vaccines.
Below were the questions in the query:
1. According to The Pharmaceutical Regulatory Authority’s guidelines for drug donations to Zambia, no one can import drugs into the country meant for donation without prior notice and consent from the recipient. Did Mr Findlay have the Ministry of Health’s consent to import this vaccine?
2. ZAMRA has told News Diggers that it would have been a waste of resources to test and verify the contents of the vails which were imported by Chrismar Earthmoving Equipment. Does your ministry support that position?
3. The Medicines and Allied Substances Act of 2013, Part IX, Section 59, stipulates that any person who illegaly imports such substances is guilty of a crime. Why hasn’t there been any legal action taken against the proprietors of Chrismar Earthmoving Equipment,?
4. The above quoted law also stipulates that “the court before which a person is convicted of an offence under this section may order that any medicines or allied substances in respect of which the offence is committed be forfeited to the State to be destroyed”. Was ZAMRA in order to destroy these vails without due court process?
But in response, Dr Malama said ZAMRA’s responses were sufficient.
On the first question, however, Dr Malama said his ministry only got to learn about the purported vaccines once they were at the airport.
“You know the way things we are, we have the Medicines and Allied Substances Act of 2013 on which ZAMRA was formed and it has the mandate to execute. So whatever answers ZAMRA is giving, they are using this law. So you will just go by what ZAMRA has given you. Then on your first question, you are saying did the importer have the ministry’s consent, no, there was no consent. Yesterday we mentioned that there was no connection, we came to know about this when they were already at the airport. What we said from the word go, we were not part of the planning, importation and everything,” said Dr Malama.
“If you see all these (questions), ZAMRA has given its position so if you are not happy with what ZAMRA has given you, you can rephrase the question to them so that it is clear what you are trying to get.”