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.
Ubhejane not registered with the Medicines Control Council
Issued by the Department of Health
30 June 2010
Contrary to reports in the media recently regarding the registration of Ubhejane, the Department of Health would like to put it on record that this product has NOT been registered with the MCC.
In line with the MCC procedures, a request for the registration of this product has been lodged with the Council and until such registration has been finalised, any person(s)/party involved with the production, marketing, distribution and sale of Ubhejane should desist from making false claims that this product has been registered. For a registration of any medicinal product to be finalised a registration certificate signed by the Registrar of medicines has to be issued to this effect.
The registration of all medicines in South Africa is guided by stringent procedures which take into account quality, safety and efficacy in line with the Department and MCC’s responsibility to protect members of the public from harmful medical products.
For more information please contact Fidel Hadebe on 012 395-8493 or 079 517-3333.