Leben Laboratories drags ZAMRA to court, challenges disposal of its consignment of drugs


A pharmaceutical company has dragged Zambia Medicines Regulatory Authority (ZAMRA) to the High Court, challenging the pending disposal of its consignment of medicines.

Leben Laboratories (PVT) Limited has pleaded with the Court to grant it an interim preservation of its consignment of pharmaceutical products that were placed under quarantine by ZAMRA, by way of re-exporting the same back to India.

The applicant is also seeking an order for stay of execution of ZAMRA’s directive dated August 15, 2023, to initate the process of safe disposal of the drugs, pending the hearing and determination of its application.

Read more: Medicines regulatory body suspends Leben Laboratories for one year over failure to meet minimum standards

This is according to originating summons filed in the Lusaka High Court, citing ZAMRA and the Attorney-General as respondents in the matter.

In August, ZAMRA issued a statement that it had suspended Marketing Authorisations (MAs) for all medicines and allied substances manufactured by Leben Laboratories.

Leben Laboratories, Managing Director, Bharat Shah submitted to court that the company which began operations 34 years ago is specialized in the manufacture of general category oral like liquids, tablets, capsules and external preparations as well penicillin and cephalosporin kind of antibiotics.

Shah submitted that the respondent then placed the drugs under quarantine and directed that the pharmaceutical products would only be distributed once the respondent cleared the consignment.

“That the respondent rejected the applicant’s request to re-export the quarantined goods back to source, opting instead to issue a notice of recall dated July 14 ,2023 of all medicines manufactured by the applicant from the Zambian market,” he said.

Shah said the company on September 14, 2023, appealed to the Minister of Health against the respondent’s decision.

“That furthermore, if the respondent proceeds to destroy or otherwise dispose of the applicant’s consignment of medicines while the appeal itself before the Minister is still pending, then the appeal itself will have no legal effect and the decision of the Minister will be of no use as the subject matter of the appeal will have already been destroyed. That this is a proper case of this court to grant the reliefs prayed for,” he submitted.

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