TAC Electronic Newsletter

29 June 2010
Ubhejane is not registered Department of Health's Law Enforcement Unit must
investigate Zeblon Gwala MCC's recission of the 2002 notice must be given
immediate effect

**Ubhejane is marketed by a charlatan named Zeblon Gwala as a cure for AIDS.
On 22 June 2010 it was incorrectly reported in *Business Report *that
Ubhejane was registered with the Medicines Control Council (MCC). Ubhejane
has not been registered as a medicine in South Africa. There is no evidence
that it is of any benefit to people with HIV.
The Department of Health has stated that Ubhejane is not registered as a
medicine. The MCC has not yet publicly responded to the article.

The Law Enforcement Unit of the Department of Health must immediately
investigate the assertion made by Mr Zeblon Gwala that Ubhejane has been
registered.

Reporting that Ubhejane was registered by the MCC without verifying this
information with the MCC is irresponsible journalism by the Business Report.
The newspaper should immediately print a correction.

The document referred to by the Business Report as a ‘MCC Registration
Certificate’ is likely an acknowledgement of the submission of information
relating to Ubhejane to the MCC in terms of a 2002 notice related to
so-called complementary and alternative medicines (CAMS).

In an attempt to audit the nature and extent of CAMS on the market in South
Africa, in 2002, the MCC issued a notice asking for information on CAMS to
be submitted to the MCC. Marketers of such products continue to submit their
products to the MCC under this notice. The number referred to by the
Business Report as a ‘registration number’ is likely simply a reference
number by the MCC acknowledging receipt of the submission. This does not
indicate registration or intent to register.

The 2002 notice has been misused by charlatans to make false claims about
the registration, safety and efficacy of their drugs. It is common knowledge
that the MCC has taken a decision to rescind the 2002 notice but has not
brought the decision into force.

Further, Mr Gwala’s conduct possibly constitutes a criminal offence for
which he should be investigated. Mr Gwala claims that Ubhejane will increase
one’s CD4 count and decrease one’s viral load. When Ubhejane is given to
patients, it is claimed that it is a cure for AIDS. Since AIDS is caused by
a virus, i.e. HIV, Gwala is consequently selling Ubhejane as an antiviral
medicine. All antivirals must be registered by the MCC before they are
marketed in South Africa. Section 14(1) of the Medicines Act prohibits the
sale of medicines that are subject to registration and are not
registered. In addition, section 29(b) makes it clear that “ny person who …
contravenes or fails to comply with the provisions of section 14(1) … shall
be guilty of an offence.”

TAC has previously lodged a complaint with the Department of Health's Law
Enforcement Unit against Ubhejane but no action has been taken by the
Department.

In summary, TAC calls for the following action to be taken:

   - An investigation should be initiated against Mr Gwala by the Department
   of Health's Law Enforcement Unit. If he has acted in breach of the Medicines
   Act (and we strongly suspect he has), then he should be charged.
   - The MCC must move swiftly to give effect to the rescission decision.
   - The Business Report should print a correction.

**

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