31 October 2012

Tanzania: Drug Authority Says Company Made Fake Drugs

Photo: Kate Holt/IRIN
A patient holds drugs: there are more than two million HIV positive people in Tanzania.

TANZANIA Food and Drugs Authority (TFDA) broke its silence, saying that the suspended Tanzania Pharmaceutical Industries (TPI) Ltd sold fake ARVs (TT-VIR) to the Medical Stores Department (MSD).

TFDA Director General, Mr Hiiti Sillo, told journalists in Dar es Salaam that contrary to TPI's denials, his authority has documents and exhibits proving that the company was behind the production of the ARVs. "The documents and exhibits have been submitted to security organs for further action," he stated.

He reassured the public that the company has been suspended from manufacturing ARVs through a letter with reference number CA/C.80/222/01A/47 of October 4 this year, and that the authority has suspended the supply of the drugs through a letter with reference number CA/C.80/222/01A/55 of October 10, this year.

"The letters were sent by dispatch to the TPI headquarters at Mikocheni area in Dar es Salaam and they (letters) were received on October 10, 2012," he stressed. Mr Sillo also denied reports that TPI is continuing with production of the drugs, noting that inspection conducted by TFDA on October 23, 2012 confirmed that there was no production of the drugs.

Investigations on the fake drugs by security organs is in progress, he said, and added that they would continue to keep a close eye on drugs quality and safety to protect people's health. "We want to assure that the ARVs which are in the market are safe and the public should keep on consuming them," he said.

The fake drugs saga took a new twist after the owners of the Arusha based TPI distanced the company from manufacturing and selling of the same. "We would like to categorically distance ourselves from the allegations. The said drugs did not emanate from TPI and are made using technology which we do not have in our factory," said TPI Executive Director, Mrs Zarina Madabida.

Mrs Madabida told a press conference recently that TPI produces TT-VIR 30 with oval shaped tablets whereas the fake drugs are round shaped TT-VR 30. She said that while the TT-VIR 30 tablets they produce are white in colour and marked TPI on one side and T 30 on the other side, the fake TT-VR 30 are white on one side and yellow on the other.

"We do not have the technology that can produce tablets in a round shape and in two colours, the product is simply not ours," she said. When asked over the package, Mrs Madabida said that TPI does not manufacture packages, but orders the same from Nairobi, Kenya.

"Our bottles are special with slender and longer neck but bottles that contained the fake drugs have a different shape altogether. Those bottles are not ours," she said. The reaction came a day after the Minister for Health and Social Welfare, Dr Hussein Mwinyi, suspended three top officials at the Medical Stores Department (MSD) and halted production at the TPI factory over allegations of producing and distributing fake ARVs.

Dr Mwinyi said that the government has also stopped distribution of all drugs manufactured by TPI, including those stored by pharmacists and other outlets. Those suspended pending investigations at the MSD are the Director General, Mr Joseph Mgaya, the Quality Assurance Manager, Mr Sadick Materu and the Quality Assurance Officer, Mr David Masero.

Dr Mwinyi said investigations conducted in August by his ministry through the Tanzania Food and Drug Authority (TFDA), established the presence of fake ARV drug type TT-VIR 30; batch no OC.01.85 at Tarime District Hospital.

After laboratory tests were conducted, Dr Hussein noted, the ARV drugs, manufactured in March, 2011 with an expiry date of February 2013, were counterfeit with documentations showing that TPI had sold them to MSD. However, Ms Madabida denounced the allegations, saying:

"We had our products submitted to MSD and all quality assurance tests were done and it is about 15 months now since we distributed the drugs and in between, two inspections have been conducted and no fake drugs were found." Ms Madabida also denied having received any formal communication from the ministry informing her of suspension of their company's production of the said drugs.

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