CHAPTER One Foundation has written to the Zambia Medicines and Medical Supply Agency demanding an account of how the internal quality assurance systems within the Agency failed to uncover defects in medicines and medical supplies that were procured or stored by it prior to their distribution.

The organisation has further written to the Zambia Medicines Regulatory Authority (ZAMRA) demanding that the public be given an account not only of the medicines and medical products recalled, but of the extent of the public’s exposure to such supplies.

It also wants an account of how the defects discovered in the tests conducted after distribution were not discovered in tests conducted prior to the distribution if any such tests were in fact conducted.

Chapter One Foundation warned that if they did not receive an adequate response from both ZAMMSA and ZAMRA within seven days of the date of the letters (February 11, 2021), they would be forced to commence an action in order to seek the said reliefs and any other relief the court may deem fit.

In a letter addressed to the Zambia Medicines and Medical Supply Agency (ZAMMSA) director general, February 11, Chapter One Foundation stated that the Medicines and Medical Supplies Agency Act placed several duties upon ZAMMSA, one such duty being to establish and maintain an internal quality assurance system for efficient operations, compliance with regulations and quality of medicines and medical supplies.

It added that members of the public who come into contact with such medicines and allied substances, which have passed through the Agency’s internal systems were, therefore, entitled to believe that they were safe for consumption and use.

“We write to your office in relation to the recent recalls of medicines and medical supplies, which were stored and distributed by your institution. We believe the matter is one of public interest that affects all Zambians alike not only because it is a matter of public health, but because at any given time any member of the public may unwittingly ingest or use the recalled medicines or medical supplies at their detriment. As such, all members of the public are at risk,” it stated.

“We believe that the Medicines and Medical Supplies Agency Act places several duties upon your institution in the exercise of its functions. One such duty is to establish and maintain an internal quality assurance system for efficient operations, compliance with regulations and quality of medicines and medical supplies. Members of the public, who come into contact with such medicines and allied substances which have passed through your internal systems are, therefore, entitled to believe that they are safe for consumption and use on the basis that the duty bearers who authorize their distribution and sale have ensured this.”

It, therefore, demanded an account of how the internal quality assurance systems within the institution failed to uncover defects in medicines and medical supplies that were procured and/or stored by the Agency prior to their distribution.

Chapter One Foundation added that: “…In addition, we note that your institution is charged with the procurement and distribution of medicines and medical supplies and that although the Zambia Medicines Regulatory Authority has instructed that certain medicines and medical supplies be recalled, there has been no corresponding notice to the public regarding the extent of their exposure to the same. The public has not been furnished with details such as what quantity of medicines and medical supplies was purchased, how much of it was recalled, where the products were dispatched to or distributed and how much was distributed and or is still on the market. The ordinary Zambian citizen, whose interests are our chief concern, is not able to distinguish batch numbers or safe products from unsafe ones. We, therefore, demand an account in this regard in the public interest.”

And Chapter One also wrote to the ZAMRA director general, demanding that the public be given an account not only of the medicines and medical products recalled, but of the extent of the public’s exposure to such supplies.

“We write to your office in relation to the recent recalls of medicines and allied substances by your institution. We believe that the Medicines and Allied Substances Act places several duties upon your institution in the exercise of its functions. One such duty is to establish and enforce standards for drug quality control laboratories and to utilise the resource of the National Drug Quality Control Laboratory to verify the safety, quality and efficacy of medicines and allied substances. We, therefore, demand, on behalf of the people of Zambia, an account of how it is that the defects discovered in the tests conducted after distribution were not discovered in tests conducted prior to distribution if any such tests were in fact conducted,” stated Chapter One.

“Furthermore, we note that although your office has instructed several private companies, most notable of which is one Honeybee Pharmaceuticals, to recall several medicines and medical supplies, there has been no corresponding notice to the public regarding the same. We bemoan the failure on your part to advise the public in this regard and we demand that the public be given an account not only of the medicines and medical products recalled, but to the extent of the public’s exposure to such supplies.”