Since inception, NDA has grown from 10 members of staff in 1993 to over 120 today. Being a specialised field, NDA sees this increase in staffing as a big achievement. Out of the current staff, 30 are pharmacists with highly specialised skills in drug examination and analysis. SBR has learnt that NDA spends over 60,000 pounds sterling to train at least four experts annually, under the continuing education programme to keep staff up to date with new technologies and innovations in the breakthrough medicines.
NDA’s executive secretary, Hon. Sematiko Gordon Katende, justified it saying: “the specialised training is critical if NDA is to achieve her mandate and achieve the NRM’s manifesto. New drugs are churned out globally on a continuous basis. Each drug has different micro-biological composition and varied impact on human health. We cannot have an external person provide us quality assurance for drugs destined to Uganda. When a manufactures sends to us a blue print of what their new drug can do, we have to critically examine their assertions internally. It would be a disservice to this country, to have say an external consultant do that on the behalf of Ugandans. It is like putting the health of the 32 million Ugandans to an external party which is unacceptable. Even then, such specialised consultants would often charge not more than US $0.1m to 0.3m to assess each drug. For both the long term, it is far cheaper to develop internal capacity and we shall continue doing it.”
Hon. Gordons adds that “there is an annual training of pharmacists that take place in London annually. This training is done once a year and attracts the best drug enforcement professionals across the globe. Because NDA always sends a representative to this exclusive event, we have made key relationships with top national drug authorities in Europe and Asia. This has enabled us to tap into informal resource sharing and it is common for some of our friends to alert us of ferries destined for East Africa or Uganda containing counterfeit or pirated drugs. This helps us to exercise our mandate effectively at almost no cost. I would imagine obtaining such information or other resources shared would be too expensive for NDA and in the way, we save on tax payers money while achieving our mandate.”
One of the stuff in the drug enforcement at NDA who preferred to remain anonymous explained to SBR that, “the NDA team has helped to stop drugs coming from manufacturers in the developed countries like Germany. Such drugs were found to be sub standard contrary to the popular belief that anything from such countries is standardized, which is not often the case. Some drugs from South Africa which were at one time thought to be quality drugs have often failed NDA tests courtesy of this team. NDA benchmarks them to international best practices.” Taken together, such attention to detail have raised NDA and Uganda’s status not only in the region, but at the global stage. NDA boasts of being second to South Africa on the African continent in terms of good drug manufacturing inspection practices.
When SBR visited NDA’s drug testing lab in Makerere, one of the officers said that “we have people who have acquired skills in critical areas like lab chemists, drug assessment, drug inspection at international level. This has raised the bar of the quality of the drugs imported, as dealers know that NDA experts will always find out.’’ Asked about the potential to be bribed, he explained that NDA often rotates all the experts and does not allow a single expert to clear a particular drug from start to finish. Unless there is collusion, whose risk NDA accepts to take, there are few alternatives.
NDA’s Gordon explains that providing great training to its experts is often threatened by companies and countries who poach NDA’s highly skilled and experienced staff. For example, World Health Organisation (WHO) took one of our staff in prequalification department, last month; we also lost another of our employees to Canada. So you find that these are highly skilled peoplewhich makes them attractive to other countries and institutions willing to offer better terms. It should be noted that these are high paying organizations which NDA cannot raise.
Another challenge the authority faces is inadequate funding. NDA is among the few government bodies that do not get funding from government, so it depends on fees collected from stakeholders. The challenge NDA has is it cannot recover the operational costs through increasing the prices of medicines just like URA collects revenue though increasing the price of gasoline. If that was done, it would lead to an increase in the cost of medicine to final consumers and this deny them access. And this would be contrary to NDA’s mandate of ensuring availability of essential quality drugs at affordable prices because safe drugs save lives.
NDA’s achievements to date
Establishment of a drug testing lab
According to NDA executive secretary, NDA has established a state of the art Laboratory located in Mulago, which has increased the safety of drugs entering into Uganda. “With this state of art lab we can now test every health related product whether imported or locally manufactured. This laboratory tests a range of products including syringes (remember the time when patients used to proclaim about poor quality syringes) all this is gone. The extension on the structure alone cost us over Ugx. 1bn. Last year we invested over Ugx. 2 billion in equipping the lab and plan to spend another Ugx. 3bn in equipment. These are specialised and very expensive”, said Gordon Ssematikothe authority’s executive secretary.
Initially, NDA was testing only anti-malarial, anti-TB, ARV medicines. Now they have increased the range of all antibiotics, veterinary medicine and others. The authority plans to include microbiology tests for all drugs, including herbal medicines as they are equipping the new laboratory to include herbal medicine and also start registering devices like circumcision devices.
Information on NDA website reveals that some equipment are ready operation, like the Heat Ventilate Air Condition System (HVAC), for micro biology. And more equipment is yet to be purchased. This initiative guarantees the quality of medicines on the Ugandan market. This is a big achievement on the part of NDA. And when completed, the lab will be full fledged.
Construction of NDA’s HQs
For long, NDA did not have its own office block. The Authority started in Butabika being housed by the National Hospital. However, with the support of development partners, NDA has been able to secure her own home, and another strategic plot on Nkrumah Road which it lets out. NDA also has land in Entebbe which it had planned to develop for an incinerator. However, the growth of the town has rendered this plan useless, as a drug incinerator cannot be setup in a highly populated place. Informed gathered for this special focus on NDA by this magazine, shows that development of a storied office block at the NDA site is already underway. When complete, the building will give NDA a befitting identify as well as cater for office space which is becoming a problem. This building is critical to ensure NDA attain WHO pre-requisites and other global best practices for drug enforcement.
NDA’s ED says: “effective 1 July 2013, we shall be compliant with the international health standards e.g. International Committee on Harmonisation (ICH) – an exclusive membership of America, Europe and Japan. Once our office block is complete, we shall be compliant in terms of skills, tools and office with key recommendations by the top institutions like Food & Drug Administration (FDA) and European Medicines Agency (EMA) in addition to the WHO. For the ICH recent meeting, we applied as EA, and they allowed us to attend as observers for which I was nominated to represent the region in Spain.”
NDA has already applied to be a member to PICS, an Organization of European Medicine Regulatory Agencies, which acts as a club of regulators. NDA’s ED says “the advantage of PICS membership is that it will make it formal to share knowledge and resources with some of the best. For example if PICS members identify a ship carrying fake drugs, they can easily alert NDA or any concerned member for that matter. This makes information sharing easy and cheap. For example, If PICS identify a drug on European market which has problem they alert NDA and we will withdraw it even before we use our systems. Last year, PICS alerted NDA that there was fake ARV in Somalia, and Kenya, and NDA took action. These are some of advantages NDA is set to gain from being member of PICS.”
Despite these developments, NDA lacks a substantive Board of Governors. The ED explained that absence of the Board has meant that all decisions that must be made at that level are still on hold. According to the NDA act, 1993, the Board is responsible for taking all major decisions including administrative ones like recruitment. Already there are a number of vacant positions within NDA’s structure which cannot be filled. Also, NDA cannot register certain drugs unless the Board approves. There are other issues the secretariat cannot do without the Board’s go ahead and this frustrates the team efforts.
NDA is moving with changes in technology. Available information reveals that the organization is in advanced stages of going into electronic dossier submissions. The system is set to ensure confidentiality of the dossiers from stakeholders, since most of them are innovative products that are patented and thus it would be illegal to let them get out to the market.
What is the future of NDA?
The lack of board, has however, stalled work at NDA, for example failures to recruit yet they have vacant positions. this is something management claim might affect successful implementation of their strategy. According to insiders, without a sitting board, you can’t register new drugs. Besides there are inter organization and country collaboration decisions which require board decision. These issues have hampered orgazanation activities.
As regulators, there is need to rotate people to avoid complacence. However, the executive secretary cannot rotate since a regional inspector is a signatory to the bank account. The catch it the NDA’s executive secretary cannot write to the bank to effect changes on the NDA bank account as such a decision requires a board decision. Without effecting regional inspector transfers, NDA risks having her officers compromised. That is a big risk.
Dealers in drugs and pharmaceuticals have raised complains about lack of regional offices across the country. NDA currently has only seven zonal offices. NDA’s Public Relations Officer, Mr. Sekyazi agrees with traders “NDA is in advanced stages of expanding its coverage and reach.” NDA currently has seven regional offices in Mbarara, Hoima and Kampala, Jinja and Tororo and Arua and Lira. It plans to expand by creating more zonal offices to be present in at least every part of the country and at all boarder points of entry in Uganda. “We have been depending on Uganda Revenue Authority but now we intend to set our own checks as Uganda Revenue Authority (URA) staff may lack the technical capability drug smugglers use. We want to be in Nimule, Katuna and in Mutukula and Mpondwe”, he adds.
Above all, there have been major challenges in the NDA act where body lotion is classified as a cosmetic product and not a medicine. The new act which cabinet recently passed, transforming the NDA into a food and drug authority addresses these challenges. People mix practice and medicine. NDA’s focus is on the medicine. The new law will help to capture the areas that were ignored before. For instance cosmetics were not treated as drug and thus moved to URA and Uganda National Bureau of Standards (UNBS). UNBS looks at quality. However, NDA goes beyond quality.
• NDA has invested over Ugx. 3 billion in a drug testing lab and plans to spend more.
• NDA is making drug enforcement a key priority. They have invested in field operations including buying vehicles for people to monitor medicines on sale in the market. NDA undertakes country-wide operations to identify an unregistered drug distributors or users.
• NDA has stopped importation of drugs that are packed in loose packs. The challenge with loose parking is that in pharmacies they open the pack and keep removing few tables from the pack.
By the time all the tablets in the big pack is finished, it may have expired. That is how people buy expired drugs.