Leben Laboratories discontinues case against ZAMRA
LEBEN Laboratories (PVT) Limited has discontinued proceedings against Zambia Medicines Regulatory Authority (ZAMRA) and the Attorney General, in a matter it was seeking an order to stop the disposal of its consignment of pharmaceutical products pending determination of the application before the High Court.
The Indian pharmaceutical company was also seeking an order for the interim preservation of its consignment of pharmaceutical products that were placed under quarantine by way of re-exporting the pharmaceutical products back to Mumbai.
This followed a directive issued by ZAMRA on August 15, 2023, directing Leben Laboratories through its distributors to immediately initiate the process of safe disposal of the products.
The company has now discontinued the case stating that the decision of the High Court would be an academic exercise as the said drugs are nearing expiration.
This is according to a notice of discontinue filed in the Lusaka High Court by the plaintiff's lawyers, Milimo Chooka & Associates.
"Take notice that the plaintiff herein has with immediate effect wholly discontinued this matter against the defendants on the ground that the medicines, drugs and or pharmaceutical products that were sought to be preserved are reaching their expiration date, therefore any further proceedings in the matter have been rendered nugatory," read the notice.
In its application filed last October, Leben Laboratories managing director, Bharat Shah, stated that in April,2022, ZAMSSA ,awarded the applicant a contract for the supply and delivery of its manufactured essential medicines with a delivery period of 16 weeks.
"That a contract was thereafter executed between ZAMMSA, the Ministry of Health and a Zambian company known as Karibu Pharmaceuticals Limited (the applicant's distributor) for the emergency supply and delivery of essential medicines," Mr Shah stated.
He said another Zambian company, Pharma Plus Limited ,also submitted a formal request to distribute medicines on behalf of Leban Laboratories.
He stated that ZAMRA rejected the application for an import permit by Pharma Plus Limited despite the containers having already been delivered to Zambia.
Mr Shah further said the respondent also refused to issue an import permit to Karibu Pharmaceuticals Limited.
He stated ZAMRA then proceeded to quarantine the consignment of medicines and directed that the pharmaceutical products would only be distributed once it cleared the consignment.
The managing director said the company in a letter dated September 12, 2023, appealed to the Minister of Health against the decisions of ZAMRA in accordance with the provisions of the Medicines and Allied Substances Act no. 3 of 2013.
He however said the appeal would take three months to be concluded, of which time the drugs could have neared the depletion of their shelf life and will be of no use as they will have expired.
He also contended that if ZAMRA proceeded to destroy the drugs while the appeal before the minister was still pending, then the decision will be merely an academic exercise.