The Citizen Observatory for Health (OCS), in the context of monitoring for improvement in the provision of public health services, became aware of the existence in the country of medicines such as paracetamol, in an inappropriate condition for human consumption.
The existence of these drugs was disclosed by Afri Farmácia, an importer and distributor of medicines and hospital supplies in Mozambique.
In its statement sent to health authorities, the company said that “as part of the Pharmacovigilance process, three batches of 500mg paracetamol tablets from the manufacturer Bharat Parenterals Limited-India, with references B1T0049A1, B1T0069A1 and B1T0027A1, were identified with organoleptic changes.”
According to the institution, the drug in question was distributed in the cities of Maputo, Beira and Nacala, and there is, however, a possibility of it having reached other parts of the country.
In our view point, this situation shows the weakness of State institutions with regard to quality control of products entering the country, taking into account their circulation and distribution.
According to Article 5, paragraph 1, of Law 12/2017 of 8 September, “the State ensures the quality of medicines, vaccines, biological and health products for human use, in circulation in the country, through a quality assurance system that integrates registration, pharmaceutical inspection, pharmacovigilance, the National Laboratory for Quality Control of Medicines and other internationally accepted mechanisms.”
Also according to Law 12/2017, in Article 7(1), it is the responsibility of the National Medicines Regulatory Authority (ARENE) to regulate, supervise, inspect vaccines and biological products for human and health use.
ARENE is also responsible for controlling the quality of the medicines in circulation in the country, as well as organizing and carrying out pharmaceutical inspection.
Therefore, the fact that these medicines have entered the country – distributed by the Health Centers and prescribed to patients, without having observed that they were unfit for administration and consequently for human consumption – means that the State has neglected its responsibility in the supervision of these medicines.
Furthermore, the situation is more serious by the fact that this is not the first case in which the circulation of inappropriate pharmaceutical products for human use has been recorded in the Mozambican market. This makes the inefficiency of State institutions redundant and therefore worrying.
In fact, the Deputy Health Minister, Ilesh Jani, admitted that “there is quality control at various levels. There are quality control processes in the production of the medicine itself, in the process of importing the medicine, but none of these processes is infallible. That is why there are also quality control mechanisms after the medicine is in circulation”, said Jani.
This statement, accordioning to the deputy minister, leads us to reaffirm the need for the Government to enforce the law, following all the stages of importing drugs, as a measure of preventing similar situations from occurring frequently in the country, putting the health of many Mozambicans at risk.
In order to prevent such cases from arising, Citizen Observatory for Health advocates the need to draw up an immediate plan for the withdrawal of these drugs from the market, after which medicines in good condition for use, in the health units, covered should be reinstated, as about 80% of the over 1,500 health units in the country depend on health kits.
Unknown Side Effects
Another question that arises regarding this issue are consequences that the consumption of these drugs can cause in patients who would have already taken the drugs under discussion.
For Jani, the side effects are unknown, which means that it is not known what might happen to people who have taken the medicine.
This is more worrying, because as the main health authority in Mozambique, the Ministry of Health (MOH), should have presented a protocol to monitor people who have taken these drugs in order to prevent them from risking their lives.
For the Citizen Observatory for Health, the MOH should identify patients who have ingested the paracetamol in question, as well as draw up some recommendations to avoid any adverse effects. In other words, patients should be reassured that there is no health risk.
In an attempt to bring answers about the number of kits already collected in the Health Units covered, as well as the plan to replace them, the OCS called Afri Farmácia twice but without success.
The Government recently launched (2023) a logistic management tool for medicines and health products, which is expected to have a positive impact on the supply chain.
“This system will facilitate the whole process of obtaining information to improve our management processes. This platform was developed in order to respond to pharmaceutical logistics. What we want is to ensure effective visibility and traceability of consumption and management data in real time, at all levels of the supply chain, envisaging an optimized operational model, supported by modern technologies”, stressed Ilesh jani. The OCS congratulates the Government for the platform and hopes that it will solve the existing problem in the management of pharmaceuticals, ensuring consumer welfare.