14 March 2018

Uganda: NDA Seizes Fake Hepatitis Vaccines

Photo: The Observer
National Drug Authority director, product safety, Hellen Ndagije, right, displays some of the fake vaccines as NDA’s regulatory officer Amos Atumanya looks on.

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.

"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.

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