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Press release - counterfeit Hepatitis B vaccine on the market

Wednesday, 14th March 2018


National Drug Authority (NDA) was established by an Act of Parliament, the National Drug Policy and Authority Act, Cap 206 of the laws of Uganda. The Authority is mandated to ensure the availability at all times of essential, efficacious, and cost effective drugs to the  entire population of Uganda, as a means of providing satisfactory healthcare and safeguarding the appropriate use of drugs.  

NDA wishes to inform the general public that during the course of its duties, it encountered counterfeit hepatitis B vaccines from eight (8) private health facilities (hospitals and clinics). Namely; Mbarara Community Hospital, Devine Mercy, Mayanja Memorial Hospital, Family Doctors' Clinic Ntungamo, Mbarara City Clinic, UMC Hospital (Bukoto), Malcom Health Care (Kisasi), and Kampala Medical Chambers  (Buganda Road).

The exercise further led to impounding of more counterfeit hepatitis B vaccines from immunization camps at Mbale Central Market managed by unscrupulous personnel, and others at Mbarara University camp which was run by Sanyu Medical Centre, Katabi- Entebbe.

Hepatitis B Vaccine is a drug given to healthy people to immunize them against Hepatitis B disease. NDA has registered a number of Hepatitis B Vaccine brands for supply to Uganda from, various manufacturers, including the brand manufactured by Serum Institute of India. This brand is available in two registered pack sizes, i.e. 1ml ampoules and 10ml multi-dose vials.

The 1ml ampoule pack is 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, respectively.

The 10ml multi-dose vial is supplied to the public (government) sector and is identified by a white label with two purple bands at the top and bottom part of the label, respectively. The one supplied to the government also bears the words, ''Government of Uganda, Not for sale''. The registered importer of this product is Norvik Enterprises Ltd, located on Bombo road.

The genuine 10 ml vial of Hepatitis B vaccine from Serum Institute of India has the following features;

  •     Batch number
  •    Manufacturing and expiry dates with a shelf-life of 3 years
  •   Two purple bands (top and bottom) on the label.
  •    Only available in government health facilities and with the mark ''Government of Uganda, Not for Sale''

The Authority is conducting further investigations to establish the source of the product. The available information however shows that all facilities found with the suspected counterfeit had bought them from unlicensed dealers with fake addresses on the invoices/receipts. Some suspects have been arrested and are currently held at police to assist in investigations and others have recorded statements at the respective police stations.

NDA appeals to all private health facilities in possession of the 10 ml multi-dose Hepatits B vaccine vials manufactured by Serum Institute of India to immediately halt using them and take them to the nearest NDA office.

We urge all healthcare practitioners/providers and the public to be vigilant and report any suspicious drugs, dealers and drug outlets, and to desist from purchase of drugs from hawkers and any unlicensed medicine suppliers.

Your safety is NDA's priority.

Safe Drugs Save Lives.

Donna Kusemererwa


 Presentation on the counterfeit hepatitis B. View and Download