HEALTH PORTFOLIO COMMITTEE’S SHOCKING DISCOVERY: SUBSTANDARD DRUGS SUPPLIED COUNTRYWIDE

MBABANE - The Ministry of Health Portfolio Committee in the House of Assembly has uncovered that drugs supplied across the country are substandard, often with short expiry dates.

Additionally, it was revealed that government is not procuring these drugs from World Health Organisation (WHO)-pre-qualified manufacturers. This is part of the committee’s findings detailed in the Ministry of Health’s Second Quarter performance report responses, tabled in Parliament yesterday. This follows the ministry’s second quarter debate, which was held on Monday, where Members of Parliament (MPs) raised concerns about drugs being recalled by the ministry. The MPs also wanted to know if there were actions taken against the suppliers responsible for the recalled drugs and if those suppliers were paid.

The ministry recently recalled medical drugs for various reasons. In one instance, government had placed an order for 59 514 units of drugs from suppliers, however, when the recall notice was issued, 17 513 were available. According to WHO, suppliers and/or manufacturers must offer products that conform to the WHO recommendations, with respect to Good Manufacturing Practices (GMP). The WHO states that the prequalification process for each product stream consists of a transparent, scientifically sound assessment, which may include dossier review, product testing, performance evaluation and inspection of manufacturing sites and contract research organisations.

The MPs wanted to know if the country has a facility where the authenticity of procured drugs is tested on delivery. The Minister of Health, Mduduzi Matsebula, reported to the committee that currently, they do not do chemical testing. Matsebula said the ministry is putting together a few strategies which include, improving their quality control laboratory.
According to Matsebula, the ministry is also in the process of having memorandum of understanding (MoU) with nearby countries’ regulatory authorities (South Africa and Zimbabwe).  “These countries, including Eswatini, are also involved with regulatory initiatives like Zazibona, which, as  Southern African Development Community (SADC) region, there is capacity building on regulatory issues,” Matsebula said.

Quality

He explained that they do quality checks in the procurement processes, when tendering and registering as a pharmaceutical importer, quality documents are requested, including good manufacturing practices, manufacturers licence and certificate of pharmaceutical products. He stated that these documents are the WHO pre-qualified or any stringent organisation/authority eg, the European Union (EU). Adding, the minister stated that they are also processing the implementation of the Medicine and Related Substance Act 9 of 2016, to establish a medicine and regulatory authority, while in the meantime, the Medicines Regulatory Unit is currently doing regulatory activities.

He said the suppliers who delivered the recalled drugs were engaged; to collect and replace the recalled drugs at their cost. “The tender contracts compel them to replace the recalled drugs at their cost and they are expected to replace the drugs within 14 days,” he said. He also reported that they have also advertised internationally to suppliers, manufacturers and embassies to ensure that a broad supplier base is being created on the supply of health commodities. He mentioned that they are also testing the model of buying directly from manufacturers in the ongoing emergency procurement of critical drugs.

Furthermore, the minister reported that they are taking steps to report the suppliers who provided the recalled drugs to the relevant authorities, including Eswatini Public Procurement Regulatory Agency (ESPPRA). He added that they have already advertised new tenders to improve the supplier base. According to Matsebula, the shrinking supplier base makes it easier for other suppliers to monopolise the supply of drugs.Meanwhile, the portfolio committee found that there are shortages of drugs in the country and the drugs when supplied are not tested by the Central Medical Stores (CMS). The committee also noted that the drugs supplied in the country are substandard and they have a short-dated stock.

Recalled

According to the committee, government does not procure drugs from the WHO pre-qualified manufacturers and the drugs are being recalled by the ministry. Furthermore, the committee recommended that the ministry needs to facilitate the supply of drugs and medicine in hospitals and health centres in the country. The committee also recommended that the ministry of health should ensure that there is complete testing of drugs and medicines in the country. Furthermore, it was recommended that drugs should be procured from the WHO pre-qualified manufacturers and those supplied should not be less than 18 months (shelf-life). The committee further recommended that there must be a possible visit to the manufacturers and the Drug Approval Authority in the countries of origin, to determine whether the recalled drugs were not fake or unapproved. “There must be a remediation process based on the outcome of the visits from the manufacturers and drug approval authority,” the committee said.

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