New regulations for drugs

October 14, 2021

RYAN CHIGOCHE

 

The Medicine Control Authority of Zimbabwe (MCAZ) has amended drug regulations following the flooding of counterfeit and substandard drugs, Business Times can report.

The authority amended the distribution and storage practices guidelines.

The rules were developed to assist in the various responsibilities involved at the different stages of the supply chain and to avoid associated risks such as deterioration of product quality and the introduction of substandard and falsified medicinal products into the supply chain.

The new rules are also a risk management tool for securing the distribution system from counterfeits, which are smuggled into Zimbabwe.

Zimbabwe has seen an upsurge in abuse of substandard products. “The implementation of these guidelines will work as a risk management tool in curbing these unwanted medicines in the local market. It’s essential in keeping counterfeits out of the legitimate supply chain or distribution network.

We have challenges with counterfeit medicines, theft of medicines from the public health system, unregistered products in the supply system, medicines abuse among many other related challenges,” MCAZ said.

“The amended guidelines apply to all individuals that deal in the storage and distribution of medicinal products from the manufacturer of medicinal products to the person dispensing or providing medicines directly to the patient.

“This includes all parties involved in different stages of the supply chain of medical products; manufacturers and wholesalers, as well as brokers, suppliers, distributors, logistics providers, traders, transport companies, and forwarding agents and their employees,” MCAZ said.

The authority said the medicinal products are subject to various risks at different stages of the supply chain for example when purchasing, storing, repackaging, relabelling; and during transportation and distribution.

According to the amended regulations, all parties involved in the supply chain of medical products such as pharmaceutical manufacturers and pharmaceutical distributors as well the logistics providers they outsource like transporters, clearing agents should have a comprehensively designed, documented, and correctly implemented quality system that incorporates Good Storage Practises  (GSP) and Good Distribution Practises (GDP)  principles of quality risk management and management review.

According to MCAZ, the GSP and GDP quality system should ensure that: to ensure that the quality of medical products is maintained throughout their shelf-life in the supply chain; and medical products are appropriately procured, stored, distributed, and delivered to premises by the Authority. They should also ensure operations are clearly specified in written procedures; responsibilities are clearly specified in job descriptions; all risks are identified and necessary, effective controls are implemented and that processes are in place to assure the management of outsourced

The amended regulations also stipulate that personnel involved in the supply chain of medical products should be trained and qualified in the requirements of GDP, as applicable.

 

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