Ministry of Health has come out to clarify that the Hepatitis B vaccines that were recently found on sale in western Uganda, and suspected to be fake, were actually stolen from government stores, and rebranded to be sold in private clinics.
The vaccines were discovered on the market in March this year by National Drug Authority (NDA) during its routine post-market surveillance visits.
About 48 vials of vaccines were picked from High Street Mbarara Municipality.
These were found with standalone labels similar to those used to label the government-issued 10ml multi-dose Hepatitis B Vaccine manufactured by the Serum Institute of India (SII).
This finding raised suspicion of possible falsification of that particular packaging unit of the vaccine, leading to a series of operations by NDA in 18 drug outlets mainly in Western and Central Uganda.
Altogether, 196 suspected falsified 10ml units of the Hepatitis B Vaccine purportedly manufactured by the Serum Institute of India were confiscated by NDA and forwarded to its Quality Control Laboratory where it was examined.
Also, pre-printed vaccination cards, labelled with Sanyu Medical Centre branding were recovered. The cards were said to be part of abatch, previously used in an immunization camp at Mbarara University.
NDA, together Ministry of Health, Police, National Medical Stores, Joint Medical Store, Health Monitoring Unit and Ministry of Internal Security started investigating the matter.
Health Minister Dr Jane Ruth Aceng, in a statement yesterday, revealed that the probe was also joined by officials from the World Health Organization (WHO) United Kingdom’s Medicines Health Products
The investigations according to the minister concluded that this falsified vaccine had several visual similarities with the Government-issued 10ml multi-dose Hepatitis B Vaccine manufactured by the Serum Institute of India (SII).
“There was however some variations especially in the labelling and related details such as batch numbers, expiry dates, colour and design schemes,” she said.
“There was also a deliberate attempt in some cases to erase the red inscription “Government of Uganda for public use, not for sale” and or complete re-labelling on the falsified vaccine.”
Endotoxin and in-vitro potency tests showed some differences between the two samples, with the suspect samples returning lower specifications.
The minister says however, that this could have been as a result of poor cold-chain management of the suspect samples during the falsification process.
“Given the above similarities, we believe that the falsified hepatitis B Vaccine was government-issued vaccine and was likely diverted and or stolen for sale to private health facilities.”
The minister also confirmed that Chemical tests done on both samples did not find any harmful Active Pharmaceutical Ingredients (API) that would be injurious to the recipients. Additional field monitoring confirmed no Adverse Drug Reactions (ADRs).
The Ministry of Health has since suspended vaccination camps for Hepatitis B by private health providers.
“All private medical camps seeking to offer Hepatitis B vaccination must be cleared by the Ministry of Health. DHOs and RDCs are instructed to ensure that no private health service provider offers hepatitis B vaccination except with clearance from the Ministry of Health and the Uganda Medical and dental Practitioners council and other medical councils,” she said.
To reduce on the proliferation of substandard and falsified medicines NDA is also widening its footprint especially at the border crossings.
To this effect, Aceng said NDA will in 2018/2019 have physical presence at all the one stop boarder point of Mutukula, Mirama Hills in addition to Busia and Malaba.
Meanwhile, NDA together with Police, are still working on eight cases which are at various stages of investigation and court hearing.
One of the suspects, Ms. Biira Maclean was recently convicted and fined 500,000 Ug shillings.
All other suspects are undergoing trial in courts of law;