User talk:Harikasribhavani

Introduction
The Medicines Control Council (MCC) is a statutory body that was established in terms of the Medicines and Related Substances Control Act, (Act 101 of 1965), to oversee the regulation of medicines in South Africa. The registration of medicine in South Africa is governed by the provisions and requirements of the Medicines and Related Substance Control Act (Act 101 of 1965).

It is appointed by the Minister of Health and its main purpose is to safeguard and protect the public through ensuring that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality. To date, more than 20 000 medicines have been approved. Since the establishment of the Medicines Control Council, more than 220 meetings have been held to decide on the registration of medicines.

Applications for more than 11 800 complementary medicines have been submitted for evaluation by the Complementary Medicines Committee.

The South African Pharmacy Council has licensed 300 wholesalers and distributors. These must still be licensed by the Medicines Control Council in terms of the Medicines Act.

The Medicines Control Council approves more than 280 clinical trials annually.

Medicines Regulation in South Africa
The Medicines Control Council applies standards laid down by the Medicines and Related Substances Control Act, (Act 101 of 1965) which governs the manufacture, distribution, sale, and marketing of medicines. The prescribing and dispensing of medicines is controlled through the determination of schedules for various medicines and substances.

The MCC operates through external experts who are members of Council Committee structures. Most experts evaluate data sets submitted by the pharmaceutical industry for purposes of registration. These evaluators are from various academic institutions, mainly medical and pharmacy schools.

The office of the Registrar provides administrative and technical support to Council and its activities. The Registrar is also an executive secretary to Council. The Registrar’s office is a Chief Directorate, Medicines Regulatory Affairs, within the Department of Health. There are four Directorates, which are largely responsible for co-ordination and execution of various activities. A Deputy Registrar performs functions as determined by the Registrar.

The staff complement of Medicines Regulatory Affairs includes doctors, pharmacists, veterinarians, other scientists and administrative staff. A certain amount of technical evaluation of generic medicines is performed in-house. It is anticipated that this will increase over time as use of generic medicines increases, in line with government policy of improving access to medicines.

The structure of Council and its committees is described below. The skills of Council and its committees are written into law and include expertise in toxicology and medicine safety, clinical pharmacology, biotechnology, pharmaceutics, internal medicine, virology, pharmaceutical chemistry, neonatology, paediatrics, immunology, veterinary science, complementary medicines and law.

The Council has 11 technical committees, with 146 members from various institutions in the country. These include the Clinical Committee, Pharmaceutical and Analytical Committee, Clinical Trials Committee, Scheduling Committee, Veterinary Committee, Pharmacovigilance Committee, Biological Committee, Complementary Medicines Committee, and African Traditional Medicines Committee.

The Council, in considering whether a medicine is suitable for use for its intended purpose, assesses its relative risk against the benefits. The Medicines and Related Substances Control Act, (Act 101 of 1965), defines a medicine as any substance or mixtures of substances used or purporting to be suitable for use of manufacture or sold for use in -:

a) diagnosis, treatment, mitigation, modification, or prevention of a disease, or abnormal physical or mental state, or the symptoms thereof in man, or

b) restoring, correcting, or modifying any somatic or psychic or organic function in man, and includes any veterinary medicine.

All medicines for human use are subject to this law, including complementary and complementary biological medicines. Further, all veterinary medicines must be registered in terms of the Act excluding stock remedies registered in terms of Act 36.

Medicines Control Council timeline
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.

Reform of Regulatory Authority in South Africa
In 2008, a ministerial task team presented a report on the MCC and secretariat that made recommendations for a new regulatory authority for health products. These recommendations — known widely as the Green-Thompson report — were then incorporated into an amendment to the Medicines and Related Substances Act, and passed by parliament in late 2008. Although the Act was assented to by the President in April 2009, it has yet to be promulgated (formally declared). Once brought into effect by promulgation, the Act will replace the MCC with the South African Health Products Regulatory Authority (SAHPRA). SAHPRA will be an organ of state, but one that will operate outside of the existing public service. The new authority, which is expected to be in place by April 2013, will be led by a Chief Executive Officer (CEO) with the authority to appoint and supervise the staff of that body. SAHPRA and the CEO will report to the Minister of Health. The Act will also allow the CEO to appoint committees “to investigate and report to the authority on any matter within its purview”. In addition, the Minister will be able to appoint a committee of not more than five members to advise on corporate governance, but not on applications for registration.

A full-time commitment

Most importantly, decision-making power will be vested in the authority, not in the parttime experts who may be called upon to advise. This change will be the most fundamental. Many more will be needed to address the shortcomings identified in the Green-Thompson report. It will be vital to ensure that the CEO of SAHPRA has sufficient well-qualified staff to perform the tasks required of an effective drug regulatory authority. The decision-making process in SAHPRA will be similar to that used by the US Food and Drug Administration. The body will have to raise much of its funding in the form of user fees from companies applying to register health products. In March 2012, the Director-General of Health published a draft bill that would amend some of the elements put in place in 2008. The period allowed for comments has passed, but this bill has yet to be formally introduced in parliament. The draft bill appears to refocus some sections on the regulation of medicines. It also broadens the scope of the authority to include regulation of foodstuffs and cosmetics, and presumably, disinfectants. In addition, the authority will have to regulate medical devices, including in vitro diagnostic tests. However, many practical details are still missing from the draft bill. These include the size of SAHPRA, the structures to be put in place – including advisory committees – and how decisions will be taken and documented. A team led by external consultants is dealing with these organisational issues. As yet it has not communicated widely on the specifics.

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