• Jun 27, 2021 . 3 min Read
  • NDA encourages drug innovation and research

NDA encourages drug innovation and research
NewVision Reporter
Journalist @NewVision

By Abiaz Rwamwiri

There have been several misguided attacks, especially on social media, directed to National Drug Authority (NDA) about its role and how it conducts its regulatory mandate.

The most recent misinformation came after NDA released a statement on June 14, 2021 informing the public that it had not undertaken any assessment or approved Covidex, neither had it received any application from the innovator of the Covidex, a drug that was on the market with claims that it treats COVID-19.

I attended an NDA meeting with Prof Ogwang on June 14, where he opened his remarks by apologising for having erroneously put the drug on the market without following the necessary registration procedures. Prof Ogwang has been a close partner with NDA.

He took part in the development of Herbal Medicine Guidelines for research and we have authorised several of his herbal products.  When NDA learnt about the sale of Covidex and sought a meeting with its innovators, the intention was not to stop the production, but to ensure that innovators follow simple established regulatory procedure of ensuring that the drug meets minimum standards for the safety of all Ugandans!

Following our engagement, Prof. Ogwang and his team submitted an application to NDA and we have offered further guidance on how the product can comply.

We all appreciate that the COVID-19 pandemic, especially this new wave, has put the public in a desperate state that we will try anything to survive, which is human. But we also have to understand that NDA is duty-bound to ensure any drug on the market is authorised, of good quality, safe and efficacious as required by National Drug Policy and Authority Act cap 206.

Some people are condemning NDA for intervening, saying that the drug in question is actually relieving symptoms of COVID-19. When NDA intervenes, it is not saying that this particular drug doesn’t work, no! it is to ensure that it is safe and meets the minimum standards. If we wait for the worst scenarios like wide range of side effects of the drug to occur, we will have failed on our mandate and put the health and lives of Ugandans at risk.

I would like to inform those who think that NDA is there to suppress local drug and herbal research to know that the NDA Board has a representative from Uganda Herbalist Association and we have a herbal unit that engages, trains and provides technical support to herbal medicine manufacturers to improve the quality of their products.

In the last three years, NDA has authorised over 190 local herbal products, provided technical support to over 20 local herbal medicine manufacturers and this year, we have undertaken over 20 trainings to herbalists through their respective herbal associations. We have also collaborated with the Directorate of Industrial Training under Ministry of Education to develop the Herbalists Assessment and Training Package that caters for the production of herbal medicine from the garden to the finished product.

To further support herbal research, we established memorandum of understanding with different institutions and academia, including Natural Chemotherapeutic Research Institute, Makerere University, Mbarara University of Science and Technology, Gulu University to foster research and development of herbal medicine.

These have enhanced the capacity of herbalists and continue to provide technical assistance to test and carryout research. Our laboratory also tests herbal medicine for quality assurance, through our post-market surveillances, in the last years we have picked over 208 samples of herbal products and tested their quality. Those we find adulterated are recalled from the market to protect the public.

To encourage production of local herbal medicine, NDA charges just sh10,000 to notify a local product compared to $250 for imported herbal drugs. We remain committed to providing the highest standard of drug regulatory service to ensure quality, safety and efficacy of drugs and healthcare products used in Uganda which we deliver through regulation and control of drug production, importation and distribution. We are devoted to continue engaging with the general public to understand how NDA delivers its mandate, remember; safe drugs save lives.

 

The writer is the Public Relations Manager

National Drug Authority

arwamwiri@nda.or.ug

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