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

The Zambia Medicines Regulatory Authority (ZAMRA) says it has suspended Marketing Authorisations (MAs) for all medicines and allied substances manufactured by Leben Laboratories Private Limited of India.

ZAMRA Director General, Makomani Siyanga, said this suspension of the MAs was as a result of product quality problems and failure by the facility to comply with the World Health Organisation’s current Good Manufacturing Practices (cGMP) guidelines.

Siyanga in a statement issued on Thursday in Lusaka said based on this, the quality, safety and efficacy of products from the manufacturer was not guaranteed.

“Therefore, the Authority had suspended MAs for ALL medicines and allied substances manufactured by Leben Laboratories Pvt. Limited, India for twenty-four (24) months,” he said.

Siyanga said in this period, no products manufactured by Leben Laboratories Private Limited of India would not be allowed in Zambia.

“In view of the above, all health facilities, pharmaceutical outlets and members of the public in possession of any product manufactured by Leben Laboratories Private Limited, India are advised to stop distribution, dispensing or using these products and return them to their supplier for replacement with better quality assured products,” he said.

Siyanga said importers of these products have been directed to initiate the withdraw of these products from the market and plan for their safe disposal.

He said the Authority has heightened its post market surveillance activities for these products and will closely monitor the withdraw process to ensure that the products are completely removed from circulation in the interest of public health.

“Should the public need further clarification, please do not hesitate to contact the undersigned,” Siyanga said.

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