NDA probes source of fake Hepatitis B vaccine in Uganda

NDA probes source of fake Hepatitis B vaccine in Uganda
Helen Byomire Ndagije the NDA Director Product Safety displaying some of the counterfeit Hepatitis B Vaccines on the market

National Drug Authority (NDA) is investigating the source of counterfeit Hepatitis B vaccines currently circulating on the Ugandan market. The Authority has already impounded counterfeit Hepatitis B vaccines from 8 private health facilities and two immunization camps.

The vaccines were impounded from Family Doctors’ Clinic- Ntungamo, UMC Hospital-Bukoto, Malcolm Health Care-Kisaasi and Kampala Medical Chambers. The others were Mbarara Community Hospital, Devine Mercy, Mbarara City Clinic and Mayanja Memorial Hospital.

Helen Byomire Ndagije, the Director of Product Safety at NDA says that they also impounded counterfeit vaccines from immunization camps at Mbale Central Market and Mbarara University camp which was organized by Sanyu Medical Centre, Katabi-Entebbe.

The counterfeit drugs are a replica of the Hepatitis B Vaccine brand manufactured by Serum Institute of India. The brand is available in two registered pack sizes including the 1ml bottles and 10ml multi-dose vials. Byomire told journalists at the NDA head office in Kampala that a process is underway to analyse the content of the fake vaccines through laboratory analysis.

The original 1ml bottle pack is specifically supplied to the private market and is identified by a white label with two green bands at the top and bottom part of the label. The 10ml multi-dose vial is supplied to the public sector and identified by a white label with two purple bands at the top and bottom part of the label respectively.

Byomire said that the vaccine supplied to the public sector bears the words, “Government of Uganda, Not for sale” also identifying the product registered importer as Norvik Enterprises Ltd.

She noted that the genuine 10ml vial vaccine from Serum Institute of India has a batch number, manufacturing, and expiry dates with a shelf-life of 3 years, two purple bands on the label and only available in government health facilities with a ‘Not for sale’ mark.

According to NDA, most of the counterfeit 10ml vial vaccines have no manufacturing date while those with one indicated have their expiry dates exceeding 4 years. She appealed to all private health facilities in possession of the 10ml vaccine to immediately halt using them and take them to the nearest NDA office.

“The fake 1m vaccines also have no batch numbers and if they have the expiry date, they do not have the manufacturing date. They have a shelf life of two years and below and words on the bottle can be easily rubbed off,” Byomire added.

Amos Atumanya, the NDA Regulatory Officer said that once NDA establishes what is in the counterfeit vaccines, they will be in a position to advise the public on what to do. Atumanya said that fillers so far point to people dealing with laboratory instruments and chemicals. He, however, could not tell the quantities so far impounded saying that they are still compiling the report.

Atumanya appealed to healthcare practitioners and providers to desist from purchasing drugs from hawkers and any unlicensed medicine suppliers. He says that most of the private facilities found with the counterfeit vaccine bought from suppliers whose addresses are non-existent.

Some of the non-existent addresses used to supply the counterfeit vaccine are Kumate Diagnostics Ltd located at Wilson Road and Forever Green Enterprises located in Old Kampala. This is according to receipts issued to different private health facilities.