No patient received unregistered malaria drug, Ithindi says
Health ministry executive director Penda Ithindi said no patient received the unregistered quinine malaria drugs from India, which entered the country illegally after being controversially procured without open bidding.
The consignment has been confiscated by Namibia Revenue Agency ( NamRA), Ithindi told Namibian Sun.
Ithindi's comments followed a revelation by the health minister Esperance Luvindao in a statement in parliament on Tuesday that the drugs in question were imported through a myriad of regulatory and customs violations.
According to Ithindi, the drugs worth N$450 000 were imported last month and confiscated at the importer, West Pharmaceuticals's cost.
Ithindi said the consignment is the only one involving an unregistered product brought in without approval or exemption as required under the Medicines and Related Substances Control Act.
“There are other anti-malaria drugs duly procured and in use to serve the needs of the public. For this specific consignment, no payment has been made.
"This is due to the unprocedural manner by which the consignment was brought into the country without the necessary approvals,” he told Namibian Sun.
?“The quinine sulphate drugs in this consignment remain embargoed. The consignment is confiscated and quarantined by NamRA in collaboration with the Medical Regulatory Council,” he added.
Inflated cost
Activist and lawmaker Job Amupanda, who first raised the matter on social media, alleged that the drugs were procured at an inflated cost.
In response, the ministry said: “The cost of pharmaceutical products is heavily influenced by global market dynamics, including supply and demand. In the context of an outbreak, such conditions often result in elevated prices for high-demand items like quinine.”
At the time, medical experts also questioned the use of quinine, describing it as a cheap and outdated treatment for malaria.
The ministry responded: “While Artemether-Lumefantrine remains the first-line treatment for uncomplicated malaria, Quinine 300 mg tablets continue to play a vital role as a second-line treatment.
These tablets are especially crucial for patients who experience adverse reactions to first-line medications or who fall into vulnerable groups such as pregnant women.”
Disturbing details
Luvindao confirmed several disturbing details about the consignment, including serious breaches of Namibia Medicines Regulatory Council (NMRC) rules.
She cited multiple violations of the Medicines and Related Substances Control Act 2003, including the sale of unregistered medicines.
“Section 27 [of the Act] requires NMRC authorisation for the sale of unregistered medicines, and no such approval was granted. Section 45 mandates exemptions from the minister or authorised officials, and none was issued in this case,” Luvindao said.
“Regulation 37 prohibits entry through unauthorised ports, yet this product entered via the Ngoma border post, which is not designated for pharmaceutical imports,” she added.
Additionally, the supplier failed to deliver the approved product as promised.
Instead of the registered Aspen Pharmaceuticals brand from South Africa, an unregistered brand from India was brought into the country.
“These contraventions are unacceptable and represent a serious breach of the regulatory framework,” Luvindao said.
Immediate corrective action
“We need to deploy medicine inspectors at all ports of entry and decentralise regulatory oversight. We are actively exploring solutions across the government to close these dangerous gaps in border control and inspection," she said.
Before now, the health ministry had defended awarding West Pharmaceuticals the contract to supply the drugs without issuing an open tender, citing the urgency of the situation due to a surge in malaria cases.
In May, the ministry said, “West Pharmaceuticals was selected based on its ability to deliver the required commodities within one week, thereby ensuring continuity of treatment and preventing possible stockouts that could have led to more avoidable deaths,” the ministry said at the time.
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The consignment has been confiscated by Namibia Revenue Agency ( NamRA), Ithindi told Namibian Sun.
Ithindi's comments followed a revelation by the health minister Esperance Luvindao in a statement in parliament on Tuesday that the drugs in question were imported through a myriad of regulatory and customs violations.
According to Ithindi, the drugs worth N$450 000 were imported last month and confiscated at the importer, West Pharmaceuticals's cost.
Ithindi said the consignment is the only one involving an unregistered product brought in without approval or exemption as required under the Medicines and Related Substances Control Act.
“There are other anti-malaria drugs duly procured and in use to serve the needs of the public. For this specific consignment, no payment has been made.
"This is due to the unprocedural manner by which the consignment was brought into the country without the necessary approvals,” he told Namibian Sun.
?“The quinine sulphate drugs in this consignment remain embargoed. The consignment is confiscated and quarantined by NamRA in collaboration with the Medical Regulatory Council,” he added.
Inflated cost
Activist and lawmaker Job Amupanda, who first raised the matter on social media, alleged that the drugs were procured at an inflated cost.
In response, the ministry said: “The cost of pharmaceutical products is heavily influenced by global market dynamics, including supply and demand. In the context of an outbreak, such conditions often result in elevated prices for high-demand items like quinine.”
At the time, medical experts also questioned the use of quinine, describing it as a cheap and outdated treatment for malaria.
The ministry responded: “While Artemether-Lumefantrine remains the first-line treatment for uncomplicated malaria, Quinine 300 mg tablets continue to play a vital role as a second-line treatment.
These tablets are especially crucial for patients who experience adverse reactions to first-line medications or who fall into vulnerable groups such as pregnant women.”
Disturbing details
Luvindao confirmed several disturbing details about the consignment, including serious breaches of Namibia Medicines Regulatory Council (NMRC) rules.
She cited multiple violations of the Medicines and Related Substances Control Act 2003, including the sale of unregistered medicines.
“Section 27 [of the Act] requires NMRC authorisation for the sale of unregistered medicines, and no such approval was granted. Section 45 mandates exemptions from the minister or authorised officials, and none was issued in this case,” Luvindao said.
“Regulation 37 prohibits entry through unauthorised ports, yet this product entered via the Ngoma border post, which is not designated for pharmaceutical imports,” she added.
Additionally, the supplier failed to deliver the approved product as promised.
Instead of the registered Aspen Pharmaceuticals brand from South Africa, an unregistered brand from India was brought into the country.
“These contraventions are unacceptable and represent a serious breach of the regulatory framework,” Luvindao said.
Immediate corrective action
“We need to deploy medicine inspectors at all ports of entry and decentralise regulatory oversight. We are actively exploring solutions across the government to close these dangerous gaps in border control and inspection," she said.
Before now, the health ministry had defended awarding West Pharmaceuticals the contract to supply the drugs without issuing an open tender, citing the urgency of the situation due to a surge in malaria cases.
In May, the ministry said, “West Pharmaceuticals was selected based on its ability to deliver the required commodities within one week, thereby ensuring continuity of treatment and preventing possible stockouts that could have led to more avoidable deaths,” the ministry said at the time.
[email protected]
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