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MoH takes stringent measures after investigations confirm falsified Hepatitis B drugs

Investigations confirm that Hepatitis B vaccines were falsified, with MoH concluding that the vaccines were stolen from govt-issued batches for sale by private facilities that tampered with them.

HEALTH | The Ministry of Health has instituted a raft of measures to check future instances of falsification of drugs and vaccines in the country.

The decision was made after investigations into reports of suspected falsified Hepatitis B vaccine found on the market in March 2018 confirmed duplicity of the vaccines.

In an October 12 statement, signed by Health minister Jane Ruth Aceng, the ministry said that it 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,” Dr Aceng said in the statement.

The minister instructed district leadership, including Resident District Commissioners, 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.

To reduce the infiltration of poor quality medicines and health care products on the market, the ministry said National Drug Authority (NDA) is fast-tracking the establishment of a modern microbiology laboratory that will significantly increase the scope of testing.

The drug authority has also been tasked to check proliferation of substandard and falsified medicines by widening its footprint, especially at the border crossings.

“NDA will in 2018/2019 have physical presence at all the one stop boarder points,” Dr Aceng said, adding that NDA was liaising with Uganda Police in an effort to fight the vice.

She revealed that eight arrests had been made, with some prosecuted in courts of law, citing that of a one Maclean Biira who was convicted of drug falsification related fraud and fined Shs500,000.

The probe

In March, a routine post-market surveillance visits by NDA officials picked about 48vials of Hepatitis B from a street in Mbarara Municipality in western Uganda.

The vaccines bore standalone labels similar to those used to label the 10ml multi-dose Hepatitis B vaccine manufactured by the Serum Institute of India and distributed by the government.

“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,” Dr Aceng said.

In total, 196 suspected falsified 10ml units of the Hepatitis B vaccine purportedly manufactured by the Serum Institute of India were confiscated by NDA and taken for further investigation.

Medical investigators also recovered pre-printed vaccination cards, labelled with Sanyu Medical Centre branding, during the search and seizure operation. The cards in question were said to be part of a batch, previously used in an immunization camp at Mbarara University.

“NDA, together with other stakeholders such as Ministry of Health, Uganda Police, National Medical Stores, Joint Medical Store, Health Monitoring Unit and Ministry of Internal Security, then embarked on an extensive investigative process,” the minister said.

The investigations sought to establish the actual contents and composition of the suspect vaccines to ascertain their safety and potency, how they came into the market and how widespread the problem was, and whether there were any adverse drug reactions or side-effects from the recipients of the suspected vaccine.

The falsified vaccine was found to bear a slight difference in labelling, but the contents were similar and proved too difficult to put apart, forcing the Ministry of Health to call on the World Health Organisation for further assessment.

The ministry also had the samples tested by the UK Medicines Health Products Regulatory Agency and the manufacturer’s lab in India.

The tests results showed that three of the four falsified batches did not have functional labels and only one underwent the expected colour change upon heat treatment.

However, Aceng said the tests found no residual chemicals, contaminants, bacteria or fungi in samples, meaning that “there was no possible harm to even to those who received the falsified vaccine.”

“Potency tests, though, showed that the falsified vaccines had significantly lower antigen potency than the authentic vaccine- thus reducing its efficacy to those who received it,” the minister added.

Similarly, the falsified vaccines were found wanting iin terms of protective ingredient, presenting uncertainty in efficacy of the falsified vaccines.

Dr Aceng said the ministry has since concluded that the falsified Hepatitis B vaccine was governmentissued and was likely “diverted and or stolen for sale to private health facilities.”

The ministry called for vigilance from members of the public to help curb drugs fraud not only of Hepatitis B vaccine but any others on the market.

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