Medicines Control Council timeline

What’s New DOC (WND) published a number of articles following an investigation into the registration and control of medicines. I greatly appreciate Mari Hudson, the Healt24.com Editor, What’s New DOC, for giving us permission to reprint those articles here.

  1. The MCC mess: Read here  / Health24.com website
  2. Questions the MCC refused to answer: Read here  / Health24.com website
  3. What the pharmaceutical industry says: Read here  / Health24.com website
  4. MCC timeline: Read below  / Health24.com website

Medicines Control Council timeline

Here’s timeline of the Medicines Control Council (MMC).

1965
The Medicines and Related Substances Control Act is passed, establishing the Medicines Control Council.

1960s and 1970s 
Every category of medicine for treating major diseases is called up for registration.

1972
Johan Schlebusch joins the MCC, starting as an inspector (medicine controller).

1981
Professor Peter Folb is appointed chairperson of the MCC. He is a leading international expert on drug safety and an outstanding scientist.

1984
Schlebusch is appointed registrar of the MCC.

1991
The MCC tries for the first time to regulate medical devices and complementary medicines.

1994
The US Congress passes the Dietary Supplement Health and Education Act that deregulates the supplements industry, making it easier to sell diet remedies and other dubious products alleged to improve health.

1996
Then director-general of health Dr Olive Shisana chairs a meeting of alternative practitioners to discuss their concerns. The concern is that such a meeting falls under the MCC and not the health department. The health department is thought to have undermined the MCC’s authority by hosting the meeting and rumours fly that change is in the offing. The sellers of complementary medicine seize on this time of uncertainty and illegal medicines start pouring on to the market. Drug policy is published for the first time in South Africa.

1997
The MCC convinces Shisana to change her mind and Schlebusch moots a plan that would have brought the market under control. The plan never sees the light of day. Wide-ranging changes to the Medicines Act are introduced which the pharmaceutical industry opposes, resulting in years of litigation. The MCC stands firm against Mbeki on the false Aids medicine Virodene. The MCC suspends a clinical trial of Virodene which had proceeded without the approval of an ethics committee or the MCC. Precious Matsoso joins the MCC.

1998
Folb is not reappointed when his term of office expires. Schlebusch and his deputy Christel Bruckner, who had both been with the MCC for over 20 years, are dismissed. Professor Helen Rees replaces Folb and Matsoso replaces Schlebusch. Deterioration of services is observed.

2001
A CCMA award reinstates Schlebusch and Bruckner and the Labour Court makes it an order of
the court. The department reaches a monetary settlement with Schlebusch, but continues to refuse to reinstate Bruckner in an appropriate position. She brings a contempt of court application against the department, minister and director general.

2002
The MCC publishes a notice in the Government Gazette superseding all previous calls for registration of medicines in the same class – the previous call-up notices for herbal drugs (1973), special foods for which a claim was made (1974), products using the terms ‘medicated’, ‘medicinal’, ‘medical use’ etc (1978) and vitamins and minerals (1985) are superseded. This allows quacks to claim their concoctions are ‘registered’ with the MCC just because they had lodged an application.

2003 
The court sentences Dr Manto Tshabalala-Msimang and Dr Ayanda Ntsaluba to 15 days in prison for contempt (re the Bruckner matter), but the sentence is suspended. Bruckner is reinstated and is still there today, but is not assigned any substantive work. Professor Peter Eagles is appointed chairperson of the MCC.

2004
Matsoso leaves the MCC and joins the World Health Organisation. The Code of Practice for the Marketing of Medicines is published for the first time in terms of the drug policy. This has never been finalised and leaves the door open for some of the marketing practices seen today with complementary medicines.

2005
After repeated calls, MCC registrar Dr Humphrey Zokufa claims they are investigating the operations of German vitamin seller Matthias Rath. These claims are exposed as untrue when the Treatment Action Campaign goes to court. It turns out that there was no investigation into Rath’s actions, nor into his unethical clinical trials. Zokufa leaves the MCC in November and becomes CEO of the Board of Healthcare Funders.

2006
It emerges that the health department director general, Thami Mseleku, has been appointed interim registrar as a stop-gap measure to avoid any further delays in the registration of medicines. The acting head of pharmaceutical planning in the health department, Mandisa Hela, is later appointed registrar, a position she still holds.

2008 
The department of health proposes the introduction of regulations dealing with the registration of complementary and alternative medicines differently from scientific medicines. The Medicines Act is revamped, but has not yet been implemented. It provides, inter alia, for the MCC to be replaced by a new authority called the Medicines Regulation Authority which must be more independent of the health department. Barbara Hogan is appointed health minister. She sets up several task teams, one of which has the task of examining the legislation and problems linked to drug regulation. It is headed by Matsoso and includes several well respected experts in the field, including Folb.

(Some of this information has been sourced from Debunking Denialism by Nathan Geffen (Jacana 2010))

(This is an edited extract of an article first published (pdf copy) in What’s New DOC, 10th issue, May 2010. What’s New Doc is a publication for medical doctors, produced in association with Health24.) 

  1. The MCC mess: Read here  / Health24.com website
  2. Questions the MCC refused to answer: Read here  / Health24.com website
  3. What the pharmaceutical industry says: Read here  / Health24.com website
  4. MCC timeline: This article

CamCheck posts related to MCC (Medicines Control Council)

13 Responses to Medicines Control Council timeline

  1. liz 21 June, 2011 at 1:44 pm #

    I would like to have the food supplement registered with MCC. What is the procedure and who should I contact. Is there any fees involved?
    Thank you
    Elizabeth

  2. Harris 21 June, 2011 at 2:26 pm #

    Hi Elizabeth,

    You would need to connect someone at the MCC to ask these questions. There are also a number of individuals who assist companies with having their products registered but I am unable to list who they are. I am sure that the MCC would be able to assist.

    Medicines Control Council of South Africa
    Postal Address: Private Bag X 828, Pretoria, 0001, South Africa. Phone: +27 (0)12 312 8000

  3. Resh 6 September, 2013 at 12:07 pm #

    I lodged a product for registration with the MCC in March this year. The product is an all natural, patented food supplement that assists in fat reduction. I have not received any correspondence from the MCC regarding my lodgement and have no idea how to go about enquiring on the status of the application. Please advise.

  4. Alfred 11 November, 2013 at 7:25 pm #

    Good day, i would like to register a pharmaceutical distribution company, but I don’t have any idea what to do. If there is someone who have the know how please help.

  5. Harris 11 November, 2013 at 8:40 pm #

    @Alfred
    Interesting question. If anyone knows the answer, please post. Else in the meanwhile you could contact the MCC for guidance.

  6. Alfred 11 November, 2013 at 9:28 pm #

    Who are the direct support group,for this kind of questions?

  7. Harris 11 November, 2013 at 9:49 pm #

    @Alfred
    I do not think there is a direct support group, but there are for groups of products. In this case, try the Health Products Association (www.hpasa.co.za/), South African Self Medication Association (SMASA) (www.smasa.cc/), Innovative Pharmaceutical Industry Association South Africa (IPASA) (www.imsa.org.za/‎), etc.

  8. milcah 9 January, 2014 at 10:22 am #

    Hi
    i would like to find out about the new regulations on complimentary products passed on by the MCC hw it affects us what are the procedures

  9. Yvonne 20 August, 2014 at 8:16 pm #

    Hi,

    Could you please tell/show me what a MCC registration certificate looks like? I have been sent one for one of my products, however it looks like the application form and not the registration!? Please help.

    Thank you
    Yvonne

    • Harris 20 August, 2014 at 10:50 pm #

      @Yvonne
      I do not know what the form may look like at present, it may have changed. It should state explicitly whether the product is registered or not. If you welcome to scan and send to me (and black out your details) so that I can give you an opinion.

  10. Charles 1 September, 2014 at 1:44 pm #

    Am due to register the following classes of products:
    (1) Traditional Chinese Medicine
    (2) Chinese food supplement
    (3) Chinese Nutritional drinks

    I have been to MCC at Pretoria but i couldn’t see any of the officials..i only spoke to someone on phone whose explanation was crystal clear. Please, i need help on how to go about it.

    • Harris 1 September, 2014 at 2:00 pm #

      @Charles
      Sorry, we do not have the expertise to help you with the registration of medicines and complementary medicines.
      There are individuals and companies who advertise their services in this area.
      Note, some of your items are medicines and others may be food, in which case the processes are different.

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