New Vision (Kampala) - September 9, 2009

How wide is the problem of counterfeit drugs?

Since we started testing drugs in 1998, the percentage of fake drugs has fallen from 25% to about 1.3%, which means that the number of counterfeit medicines has reduced. But we cannot claim we have solved the problem.

Recently, we found counterfeit Metakelfin (anti-malarial drugs) on the market and we suspect that it came through one of the porous borders or through the lake. Uganda is landlocked and has 52 entry points. NDA cannot be present at all of them. I that only inspectors at five or six border points.

The existence of NDA is based on a desire to give the population good quality medicine, which are safe and efficacious. At all times, we are fighting unscrupulous business people trying to bring counterfeit and substandard medicines onto the market. We have a registration department which registers medicines and grants market authorisation. We inspect factories in their countries of origin on good manufacturing practices. We have officers at the points of entry so that the medicines that are imported are the ones that have been authorised. We also have a quality control laboratory to check the imported medicines on a random basis and verify that the imported medicines are the ones registered. All those efforts are there to fight counterfeits.

In addition, we carry out market surveillance where we check products on the market. We visit pharmacies and drug stores, acting like anonymous buyers, to see whether there are products on the market which are sub-standard or counterfeits and we test those.

What do you do with drugs that are counterfeit yet of high quality?

Counterfeits take many forms. It can mean substandard, containing insufficient quantities of ingredients, but it also relates to the source of production. For us in NDA, if a product which arrives in Uganda is not from the source which was registered, it is a counterfeit product. It is possible for a product to be of the same quality as the one which is registered. However, any product which comes from a different source to us is counterfeit and will be confiscated.

Which drugs particularly are being counterfeited?

Most counterfeits are anti-malarials, lifestyle drugs like Viagra and anti-retroviral HIV drugs. These are fast moving medicines. Recently we found a Metakelfin consignment in which 10 out of the 15 batches were counterfeit. The price also plays a role. If the price is high, someone can counterfeit the drug because they know the profit margin will be high.

Which parts of the country were supplied with the fake Metakelfin?

We found most of them in the east and the north. We think that in the east, they entered through the lake at Iganga. We don't know how they ended up in the north. Where do these counterfeits mostly originate from?

We know that countries in the Far East (China and India) have a higher tendency of producing and exporting counterfeits. We try to collaborate with drug regulatory agencies there. However, we always insist that our officers visit each and every factory in Asia to check on good manufacturing practices.

How can local industries be protected from cheap drug imports?

Maybe the Government should think of ways to provide incentives, such as tax waivers. It is not a small thing to set up a pharmaceutical factory. There are about 15 products, such as Panadol, we believe local industries could produce. But there is the danger that the local industries become complacent as they enjoy this monopoly and that the population may not benefit. We have had situations where locally produced medicines were more expensive than the imported ones. However, as NDA, we are not able to protect local industries. It is not our business. But it is reasonable to think through it. What we have done is to help improve manufacturing processes of the local industries through continuous training.

Are cheaper, generic drug imports a threat to life?

Cheap does not necessarily mean of lower quality. People thought that generic medicines, which are about one fifth the price of European drugs, are not as effective. This is not true. Many of the generic medicines come from India. You cannot underestimate the quality of the Indian scientists. It is just that the cost of production is lower in India and China than in Europe.

Are you talking to the countries these drugs originate from? Should they not have an obligation to stop the production of counterfeits?

At the beginning, they were more concerned about their own population. But now, the US and the European Agency for Evaluation of Medicines pledged to penalise people making counterfeits. However, we cannot count on that. Without exception, we have to inspect any medicines from South East Asia and South America. We recently received a proposal from one of the states in China, called Tianjing, to cooperate with us in stamping out counterfeits. We have less problems with the US and Europe because the standards there are high and the regulators very strict. They fulfil all World Health Organisation requirements.

Is the Police assisting you?

Sometimes our inspectors, who move on motorbikes, are being stoned by people fearing they will close their shops. That is why, when we go for an operation, we inform the Police. We have been getting good co-operation from the Police. This month, we have been allocated a full time Police officer to help us with investigations, the collection of evidence and preparing cases to appear before the courts of law.

Otherwise, we have seven regional offices. We have small laboratories in these offices for on-spot testing so we can ascertain whether products are counterfeit or not. We are also closely working with Kenya and Tanzania to prevent the fake medicines from entering the country.

Otherwise, we have seven regional offices where we have small laboratories for on-spot testing.

We also work closely with Interpol, the World Health Organisation and neighbouring countries like Tanzania and Kenya, exchanging information and preventing fake medicines from entering the country.

How about Rwanda and Burundi? Are you also working with them?

We are harmonising our operations with all member states of the East African Community (EAC) so that people do not duplicate work.

By the end of this month, all drug regulation agencies in the EAC will produce a report on the state of medicines in their country. These will be discussed in Kampala on September 26.

What has been your input in the upcoming Counterfeit Goods Bill 2009?

We were concerned that the bill would affect the availability of cheap, generic medicines.

We wrote to the Ministry of Industry arguing that generic medicines should be available to the population.

But the Commissioner for Trade reassued us that the current law is only for goods, not for medicines.

He said we would be involved in revising the law on medicines under the National Drug Policy and Authority Act.

I will soon attend a meeting on this bill and on the draft EAC policy on counterfeits.

Does your mandate address the issue of infringement on trademarks?

The law authorises us to register medicines under their scientific names, their so-called non proprietary name.

This is the official name of the drug, regardless who manufactured it.

We do not handle intellectual property rights as such. That is the mandate of the Registrar General. For us, if the manufacturer presents the scientific name, the method he used in the manufacturing process, the raw materials he used and the toxic effect it might have, we shall register that product after we have satisfied ourselves that it is safe and effective.

Does NDA have the capacity to win the war on counterfeits?

We have regional offices in Mbarara, Hoima, Arua, Lira, Kampala, Tororo and Jinja.

We, however, have a small staff of only 120 people. Yet, there are 3,000 different medicines for human being and another 300 for animals.

There are also 450 pharmacies countrywide and 4,000 Class C drug shops, stores operated by people holding a diploma in pharmacy.

On the district level, we work closely with the district assistant drug inspectors. The war has not yet been won but NDA has certainly made a lot of progress in ensuring safe, effective and good quality medicines.

Ten tips for safe medicines

1. Refrain from self-medication

2. Obtain advice on which medicines to take from trained health professionals in government and licensed private health centres

3. Obtain medicines only from NDA licensed drug outlets

4. Do not buy medicines from hawkers, kiosks or grocery shops

5. Shun products that claim to treat every disease or perform miracles

6. Shun products that claim unverifiable benefits, such as enlargement of body parts

7. Check on the medicine expiry date and conditions of the box or container for spillage, breakage or broken seals

8. Report serious drug reactions to health professionals in government and licensed private health centres

9. Report quack drugstore operators, such as outlets that open irregularly, operators who do not give receipts or do not know how the drug is supposed to be taken.

10. Do not participate in clinical trials unless they are authorised by the health ministry.

090909
NV090904

Always watch for outdated information. This article first appeared in 2009. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2009. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .