22 October 2007
Last month, the Department of Health stated that according to the internal
audit at the South African Bureau of Standards (SABS) there were anomalies
requiring a further investigation of more batches of condoms supplied by at
least three of the seven companies responsible for the tender. These companies
were Kohr Medical, Juel Health and Sekunjalo. The audit followed the charges
that Zalatex (which distributed condoms produced by Latex Surgical Products)
bribed an official of the SABS to approve condoms that were not conforming to
the quality standards. The department acted swiftly in removing from
circulation condoms supplied by Zalatex that were suspected of not meeting the
quality standard. More than five million condoms were recalled and another
seven million quarantined at the company's warehouse.
The SABS recommended at the time that the department quarantine the most
recent batches of condoms supplied by these companies for retesting. This was
intended to verify the quality of these condoms and inform the final
conclusions of the audit process that was underway. The SABS has reported to
the department that this verification process has been completed and the
findings were as follows:
1. At least five batches belonging to Kohrs were sampled and they failed an
airburst test. The SABS has reported to the Department of Health that based on
the results, SABS was suspending Kohrs' use of the SABS mark or certificate
until remedial action is taken by the company to rectify the quality
issues.
2. Samples tested relating to Juel Health and Sekunjalo were found to be of
adequate quality.
Based on the conclusions of this audit process, the department is recalling
the products supplied by Kohrs. We appeal to the public and all partners
involved in the distribution and promotion of the use of condoms to assist with
the recall of these condoms. The condoms produced by Kohrs are identifiable
with the manufacturer's code 6809/MED/. SABS has reported that, currently,
there is no information suggesting collusion between Kohrs and the official of
the SABS who is charged of corruption. However, the Department of Health notes
that a large stock of condoms that was dumped at Inanda in KwaZulu-Natal were
produced by Kohrs. This matter is under police investigation.
During this financial year, Kohrs has supplied five million condoms to the
department. Of this, more than one million condoms have been quarantined at the
distribution sites as part of the audit process. In the same way as we acted
against Zalatex, the department will no longer be procuring any stock from
Kohrs. The quantities that would have been supplied by Zalatex and Kohrs which
is nine and 15 percent respectively of the projected 425 million male condoms
supplied per annum will be shared equitable amongst the other five companies
over the remaining period of the contract ending in February 2008. SABS is
satisfied with the quality of the condoms supplied by these five companies.
The SABS has indicated that extensive controls and verifications have been
implemented throughout the testing and certification process to ensure that all
condoms supplied under the SABS mark and under the Choice brand, comply with
standards set by the World Health Organisation (WHO).
Condoms are a crucial element of the Department of Health's programme to
prevent sexually transmitted infections including HIV and unwanted pregnancies.
The two incidents involving Zalatex and Kohrs should not be allowed to impact
negatively on the significant progress we have made in promoting condom use in
the country. Through the Khomanani Campaign, the Department of Health will be
making efforts to emphasise the messages that correct and consistent use of
condoms is important in preventing sexually transmitted infections. We hope
that other partners involved in the response to HIV, sexually transmitted
infections (STIs) and unwanted pregnancies can assist us in reinforcing the
message that condoms are important in protecting our health.
Enquiries:
Sibani Mngadi
Cell: 082 772 0161
Issued by: Department of Health
22 October 2007
