THE Zambia Medicines Regulatory Authority (ZAMRA) and Zambia Medicines and Medical Supplies Agency (ZMMSA) have denied exposing citizens to substandard medicines and medical supplies through failure to perform their statutory duties.
ZAMRA and ZMMSA have further denied the claims by Chapter One Foundation Limited that they failed or neglected to ensure that the public was provided with accurate description of all recalled substandard medicines and medical supplies procured from Honeybee Pharmaceuticals.
ZMMSA has argued that the said information was provided to the entities which required to be notified by law.
In this matter, Chapter One Foundation Limited has sued ZAMRA and ZMMSA in the Lusaka High Court seeking an order that they 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.
It also 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.
Chapter One Foundation further wants, among others, 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 argued that ZAMRA and ZMMSA had endangered public health and that all members of the public were at risk as the precise extent of the public’s exposure to the substandard medicines and medical supplies and subsequent damage could not truly be determined.
But in its defence filed in the Lusaka High Court recently, ZAMRA submitted that the functions of procurement, storage and distribution were not within its mandate, but that it issued recalls on medical products.
It submitted that Chapter One Foundation’s assertion that seemed to suggest that it was irregular to only discover after distribution that the medicines and medical supplies were substandard and/or poor quality, was incorrect.
ZAMRA submitted that this was because the sampling and testing of medical products for quality assessment may be carried out at any point of the supply chain and that its actions were not irregular but in line with its mandate.
It further stated that the manufacturer or importer whose medical products were found not to comply with quality requirements were directed by notice to recall their medical products from the market as provided in section 46 of the Medicines and Allied Substances Act, 2013.
“ZAMRA will aver at trial that it discharged its statutory obligation as required and the recalls of medical products were done in accordance with the Medicines and Allied Substances Act, 2013 and the guidelines issued by ZAMRA,” read the defence.
“Save wherein specifically admitted the defendant denies each and every content of the plaintiff’s statement of claim as if the same were set out herein and traversed seriatim.”
In a separate defence filed recently, ZMMSA admitted that it stored the medicines and medical supplies from International Drug Company and Honeybee Pharmaceuticals Limited on behalf of the Ministry of Health, but that the procurement was done by the Ministry of Health.
It submitted that it had never dealt with Shalina Pharmaceuticals (Zambia) Limited and that Chapter One Foundation shall be put to strict proof.
ZMMSA argued that it was not in breach of its statutory duty as its mandate was at all material times to the proceedings to store and distribute the medicines and medical supplies received.
“ZMMSA will state that it did not expose the citizens to substandard medicines and medical supplies and will put the plaintiff to strict proof thereof,” submitted ZMMSA.