Suspicious medical products quarantined

Central Medical Stores (CMS) is currently holding some medical products that were procured from international orgainsations, under quarantine pending investigation.

Minister of Health Dr. Edwin Dikoloti has revealed that one of the contracted companies being Nu World Industries(RSA), delivered two (2) products (Nifedipine 30mg SR Tablets and Metformin 1000mg F/c Tablets) with a total value of P24 million.

These, he said were found to not comply with the MRSA labelling standards. According to the minister the medicines were not labelled with the manufacturer's name on the primary and secondary packaging material.

“The package insert was also not printed with the manufacturer's name. Since this is a serious irregularity, the whole quantities of the consignment of these medicines have been quarantined at Central Medical Stores for further

investigations and no payment was processed for these medicines,” he said.

Dr. Dikoloti revealed that it was also observed that three (3) batches of Paracetamol 500mg Tablets supplied by Medwise Overseas PVT. Ltd from India have showed discolouration which is suspected to be due to exposure to excess moisture.

They are also quarantined for testing and analysis for further decisions, he added. He argued that such detections are successful due to the exercised vigilance during the normal utilisation of the product.

According to the minister such recalls are part of the normal post marketing surveillance activities undertaken by the regulator and manufacturers routinely.

“The common practice is for recalled products to be replaced or refunded. CMS as the procuring entity continues to work with BOMRA to ensure that products allowed into Botswana meet requirements as provided through the Medicines and Related Substance Act of 2013.

“All applications deemed not compliant are rejected and cannot be procured. Our quality assurance systems have proven effective in identifying quality deficiencies on received products as illustrated above,” Dikoloti told Parliament.

The minister who was answering a question from Leader of Opposition Dithapelo Keorapetse stated that BOMRA along with the CMS continue to seek ways of strengthening supply chain oversight to ensure that substandard or falsified medicines do not reach the public.

“My Ministry sources medicines from manufacturers and pharmaceutical wholesalers who fulfil the requirements of Good Manufacturing Practices (GMP) Standard, that has been inspected and approved for compliance by the Regulatory authorities at the countries of origin”, he said.

Dr Dikoloti said all the medicines sourced are registered and authorised for use and marketing in their countries of origin.

He told Parliament that since these international procurements are meant to handle the critical product shortages that affected the country during the post COVID-19 period, such procurements in future will be limited only to prevent any adverse product shortages that may affect the population.

“Simultaneously, CMS has been floating tenders reserved for citizens and local manufacturers, to place products on Framework Contracts. In this way, the Ministry will be able to reduce all such international procurements in future.

“Most products that are procured from international sources were only chosen, after locally soliciting the readily available ex stocks, that can be authorised to be procured by CMS. Therefore, at the time of initiation of these procurements, locally these goods were not available”, Dr Dikoloti explained.

He assured the public of the quality of the products, as due processes were followed to verify and ascertain the quality of the products before and after they were procured.

He said even after distribution of these products to the health facilities, routine post marketing surveillance and pharmacovigilance systems are in place to identify and report any product related quality complaints and potential adverse events for necessary action.

The minister assured Parliament that quality assurance is a continuous process and medicines quality is monitored throughout the logistics cycle until the medicines are dispensed and used by patients.

“Although emergency procurements are relatively costly, from the analysis of procurements made from India, the estimated cost savings are between 60 to 67 percent. This is due to the fact that India is the largest producer of pharmaceutical finished products to the world.”