09 May 2021

Botswana Regulatory Authority (BoMRA)  is worried about the continuing importation of banned products containing substances deemed dangerous.

BoMRA director of licensing and enforcement director, Dr Seima Dijeng said in an interview that despite these products being banned they continue to flood the market, smuggled into the country through different channels.

He said BoMRA discovered this trend in the course of carrying out enforcement work.

The director said that some products contained substances such as Hydroquinone two per cent among other prohibited substances.

He said it was possible for a banned product  to return following investigations satisfying that corrective action had been applied to close identified gaps concerning such.

However Dr Dijeng said such was not the case with banned products containing harmful substances.

He indicated that various unregistered medicines suspended from registration by market authorisation holders or manufacturers such as ranitidine-containing products as well as Grandpa powder, were regularly removed from market during spot inspections and joint operations.

On why they were only removing such products while they had been in the market for a while, Dr Dijeng explained that with the strengthening of regulation as had been the case, through the establishment of BoMRA, it was not uncommon that through higher vigilance, products that had been freely available by illegal means would be halted.

Further, he explained that regulators were generally established to ensure good practices and standards were upheld throughout the supply chain to promote access to good quality safe medical products.

On the list of some of the unregistered products or illegal medicines and related substances according to the Medicines and related Act, he noted, was Grandpa powder with active ingredient paracetamol, aspirin and/or caffeine.

He added that some products containing Hydroquinone two per cent included Carotone blackspot Corrector Crème, Carotone Brightening Cream, Clereman Cream for men and skin beautifying milk.

Other products, he said were Control L Tablets containing active ingredient Levonorgestrel/Ethynlestradiol and Iron, while Actif Plus Lotion and Dermo Gel contained Clobetasol, Top class Indian Hemp Hair Dress and conditioner containing Hemp seed oil (Cannabis Sativa) and Cytotec Tablet containing Misoprostol 200mg.

Meanwhile, Dr Dijeng indicated that in carrying out its mandate, BoMRA had duties and responsibilities, among others, as set out in the Board Charter, such as targeting to be the World Health Organisation (WHO) maturity level 3 (ML3) where eight core regulatory functions were set to be operational and meet the criteria and standards set.

He also noted that BoMRA developed and implemented the Institutional Development Plan (IDP), addressing identified gaps and interventions required as per the WHO Global Benchmarking Tool, with core functions including, among others, enhancing its registration to ensure that medical and veterinary pharmaceutical products and related substances were registered and met the efficacy, quality and safety standards.

Further, he said they were mandated to enhance clinical trials controls to ensure good pharmaceutical processes were adhered to, establish post-marketing surveillance to monitor and reduce unregistered, sub-standard and falsified medicines in the market and also strengthen inspection and licensing of pharmaceutical premises and import and export controls. Ends