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NDA seizes fake hepatitis vaccines

 

The National Drug Authority (NDA) is investigating how eight private hospitals and clinics came to sell counterfeit hepatitis B vaccines in Mbarara, Kampala and Mbale.

As inquiries proceed, the authority has asked the public to remain calm awaiting further advice. Amos Atumanya, the NDA regulatory officer who led the three-week preliminary investigation, told journalists yesterday that the fake vaccines are allegedly manufactured by the Serum Institute of India.

NDA director, product safety, Hellen Ndagije (R) displays some of the fake vaccines as NDA’s regulatory officer Amos Atumanya looks on

“We got our first complaint from Mbarara. This person got the fake labels on Mbarara street and was able to inform our regional office,” Atumanya told journalists at NDA offices in Kampala. “From that tip, we investigated hepatitis B vaccines used within Mbarara and when we found initial information, we expanded it to other parts of the country.”

More counterfeits were then seized at immunization camps in Mbale central market that were being run by suspicious individuals, and another by Sanyu Medical Centre in Katabi, Entebbe.

Affected health facilities are UMC Victoria hospital Bukoto; Mbarara Community hospital, Devine Mercy, Mayanja Memorial hospital, Family Doctors’ clinic Ntungamo, Mbarara City clinic, Malcom Health Care Kisaasi and Kampala Medical Chambers along Buganda road.

Hellen Ndagije, the NDA director product safety, said the investigating team first operated under cover.

“At first, we thought it was something small in Mbarara but later agreed to move elsewhere, and as well inform the media about these hospitals and clinics,” Ndagije said.

This vaccine is administered to immunise against hepatitis B, a deadly virus that causes potentially fatal liver disease and inflammation of the liver. Health ministry figures show that more than 3.5 million Ugandans are living with chronic hepatitis B infection.

From the 2005 screening across the country, the highest prevalence was recorded in Karamoja (23.9%); West Nile (18.5%), and Western region (10.0%). Lowest incidence was in Central (6%) and South Western (3.8%).

There are various types of hepatitis viruses; A, B, C, D and E but B is the most prevalent in Uganda. Several hepatitis B vaccine brands are approved for supply in Uganda from various manufacturers, including Serum Institute of India.

The Serum brand, according to Ndagije, is available in only two registered pack sizes; 1ml ampoules and 10ml multi-dose vials. Norvik Enterprises Ltd located along Bombo road in Kampala are the only approved importer.

The 1ml pack supplied to private concerns can be identified by a white label with two green bands, while the 10ml vial to government facilities is identified by a white label with two purple bands at the top and bottom parts of the labels, respectively.

The government vaccines also bear the words: “Government of Uganda, Not for Sale”.

Ndagije explained that the genuine 10ml vial also has batch numbers, manufacturing and expiry dates with a shelf life of three years.

“Some of the fake vaccines were found with no manufacturing dates while others had four-year expiry dates. In other cases, the shelf life showed two years and below instead of three years,” Ndagije said, adding that markings on the vial would also easily be rubbed off.

All facilities found with fake vaccines had bought from unlicensed dealers with fake addresses on invoices/receipts. UMC Victoria hospital’s head of marketing, Mukesh Meharwal, yesterday declined to comment but gave his phone to another male staff.

“UMC doesn’t deal with fake drugs and suppliers. It is true we were found with the 10ml vial [meant for government facilities] and the 1ml. But when a person comes, we use the 1ml and only use the 10ml in medical camps,” the unidentified staffer said.

Later in the evening, the hospital’s chief medical officer, Dr Edrin Jjuuko, issued a statement to assure the public that all drugs, vaccines inclusive that are used by UMC Victoria hospital are authentic and approved by the relevant authorities.”

“In regards to hepatitis B, we have administered the same to many people and a wrong vaccine would cause a negative reaction in the body.   

We have parameters for testing the effectiveness of the vaccine and ascertain whether the vaccine really indeed worked or not. For hepatitis B, we do anti-HBs which if greater than 10mIU/ml will indicate immunity. We are, therefore, open to receiving any one that would like to get assurance in this regard.”

Yesterday, Ndagije appealed to all private health facilities stocking the 10ml multi-dose vials manufactured by Serum to immediately stop using them and take them to the nearest NDA office from where they will be collected for testing.

“People that have been vaccinated from the affected facilities need to stay calm until we give our final results. But if we find that all the three doses were counterfeit, you will have to repeat the cycle again,” she said.

nangonzi@observer.ug

Comments

0 #1 WADADA rogers 2018-03-14 15:51
I am feeling sorry for this country and the future generations, we have really created and left a very bad legacy that will haunt our children and grand children.

It looks like for every genuine product, there is a fake one. Question is, are these drugs manufactured here or they are imported.

if they are imported, why is it that UNBS and NDA have failed to establish check points at every immigration entry points to ensure that fake products are eliminated at source.
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0 #2 WADADA rogers 2018-03-14 15:57
The likes of Ndagijje-product safety and Amos Amanya-regulatory officer simply sit in their offices and wait for monthly salaries, they are not practical enough to understand that they need to be in the filed, i hope they have the technical know how to distinguish between real and fake drugs.

These fake products certainly have a serious danger to consumers.
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0 #3 Johns 2018-03-15 07:17
NDA
What i want to hear from you is to explain the impact of the so called fake medicine has on the people who have been injected with it as you claim expertise in this.

Stop playing on people's lives otherwise we treat as fighting for kickbacks because, this is a procurement that you did not get any bribe.
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0 #4 willcruiz 2018-03-15 10:28
The Ministry of Health, NDA are the ones to blame. Where does this fake vaccine pass to enter into the market?

You remember very well when ministry of health officials first denied the outbreak of congo fever in Nakaseke, then recently they came out with another view about the nodding disease, now the NDA is telling the entire country that we have been given fake Hep B vaccines??

Only God will save us from all these creatures who are now against humanity.

Why didn’t NDA come out first and informed us where to procure the right vaccines and where we can get genuine Hep B vaccines.

What is wrong with this country where the concerned officials only come out when damage has already been done? Fellow Ugandans we should prepare to go to court if some people are not doing their jobs right.
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0 #5 Zaitun 2018-03-15 10:37
What can one expect from a government destined to wipe out indigenous population to be replaced by exotic ones coming from other parts of African and Asia?

Uganda is doomed since the day the bush war men took over Kampala and installed their politic of extermination.

If this is not a well orchestrated government policy, how can we in the first place have hospitals that do not deserve the title; how can NDA officials come to verify the so-called fake medicine after they were imported and verified by their agents before being supplied to those hospitals?

Who benefits from the crime? And, what is the reaction of the Ministry of Health in all this crisis? Yes,Museveni and his men have a very dangerous and evil plans to do away with Ugandans, believe me or you will learn through tears!!!
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+1 #6 ABUBAKAR SSERUNKUUMA 2018-03-18 15:20
This is really hurting for my motherland however it happened but it should not happen.

As an idea, I would suggest that the government should avail access to methods of testing for anti HBs for those who might have received fake vaccine and make this free to all Ugandans not giving room to fraud.

It's our country is poor but it wouldn't show when it comes to healthy rather than waiting for donor and donor funds. ABUBAKAR a medical student. Thank you
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