CHAPTER One Foundation Limited has sued the Zambia Medicines Regulatory Authority (ZAMRA) and Zambia Medicines and Medical Supplies Agency (ZMMSA) for allegedly failing to ensure that the public is provided with accurate description of all recalled medicines and medical supplies procured from Honeybee Pharmaceuticals.
It has stated that ZAMRA and ZMMSA have endangered public health and that all members of the public are at risk as the precise extent of the public’s exposure to the substandard medicines and medical supplies and subsequent damage cannot truly be determined.
The Non-Governmental Organization therefore wants a declaration that ZAMRA breached its duties under the Medicines and Allied Substances Act; and a declaration that ZMMSA breached its duties under the Zambia Medicines and Medical Supplies Agency Act.
It also wants an order that the defendants give a detailed account and descriptions including, but not limited to, the names and batch numbers of all the recalled medicines and medical supplies supplied by International Drug Company Limited, Honeybee Pharmaceuticals Limited and Shalina Pharmaceuticals (Zambia) Limited.
Chapter One Foundation further wants an order that the defendants give an account of the extent to which all the recalled medicines and allied substances have been distributed including quantities distributed, dates of distribution, locations and an estimate of the number of people exposed to them.
It also wants an order that the defendants publish in a national newspaper the details requested above, each party to bear its own costs, and any other relief as the court may deem fit.
In a statement of claim filed in the Lusaka High Court on March 19, 2021, Chapter One Foundation stated that between January 1, 2020 and December 31, 2020, ZMMSA (formerly Medical Stores Limited) procured and stored medicines and medical supplies from Shalina Pharmaceuticals (Zambia) Limited, International Drug Company and Honeybee Pharmaceuticals Limited on behalf of the Ministry of Health.
It stated that said medicines and medical supplies were distributed to the public on unknown dates but between January 1, 2020 and December 31, 2020.
The NGO further stated that between December 1, 2020 and February 15, 2021 ZAMRA recalled several of the said medicines and medical supplies on grounds that tests conducted on them after their distribution revealed that they were substandard or of poor quality.
“The recalls were instituted by ZAMRA by way of letters addressed to the Pharmaceutical companies. Several of these recalls were only brought to the attention of the public through the private media. By a press statement dated February 2, 2021, ZAMRA sought to inform the public that the recalls which had been reported in the media were a common practice. ZAMRA further requested members of the public to report adverse events and suspected medical product quality problems,” read the claim.
Chapter One Foundation stated that the said substandard medicines and medical supplies had already been in circulation for an undisclosed period of time and distributed to unsuspecting members of the public.
It stated that the distribution and subsequent recall of substandard medicines and medical supplies were caused by a breach of statutory duty on the part of the defendants.
Chapter One Foundation further stated that the manner in which the recall process had been effected by the defendants was equally a breach of their duties.
It stated that ZAMRA failed or neglected to verify the safety, quality and efficacy of the recalled medicines and medical supplies prior to their distribution.
The NGO stated that in the alternative, ZAMRA failed to ensure that a set standard of drug testing was complied with at all stages of the procurement and distribution process such that tests after distribution detected anomalies that tests prior to distribution failed to uncover.
It also stated that ZMMSA failed or neglected to establish internal quality assurance systems to ensure that the medicines and medical supplies it procured, stored and distributed were to the required standard and fit for use and consumption prior to their distribution.
“With regard to medicines and medical supplies procured from Honeybee Pharmaceuticals the defendants have failed and/or neglected to ensure that the public is provided with accurate descriptions of all the recalled substandard medicines and medical supplies such as batch numbers. With regard to all the recalled medicines and medical supplies the defendants have failed and/or neglected to account for the recalled medicines and medical supplies in such a way that informs the public what quantity of substandard medicines and medical supplies were procured and what quantity were distributed,” read the claim further.
Chapter One Foundation stated that by their failure to perform their statutory duties, the defendants exposed the citizens of Zambia to substandard medicines and medical supplies that will have untold effects on their health.