Medicines and Related Substances Control

South Africa controls the production of drug products (medicines) under the Medicines and Related Substances Control Act (Act 101 of 1965), which states that the Medicines Control Council may issue to a drug manufacturer a license to manufacture a drug product upon such conditions as to the application of such acceptable... 

Anonymous (2002), Medicines and Related Substances Control Act 101 of 1965, Medicines Control Council, available http //www.mccza.com/showdocument. asp Cat=27 Desc=Acts % 20and % 20Regulations. 

At a press conference in Pretoria on January 15, 2004 the Minister of Heaith of SA, Dr Manto Tshabalala-Msimang, informed the media of the contents of the draft Regulations Relating to a Transparent Pricing System for Medicines and Related Substances made in terms of the Medicines and Related Substances Control Amendment Act 90 of 1997. 

This statement was made in an environment when the relationship between the MoH and the multinational pharmaceutical industry was already on tenterhooks. The multinational pharmaceutical industry challenged the MoH in the courts of SA for provisions included in the Medicines and Related Substances Control Act that allowed the minister to parallel import medicines and issue compulsory licenses. Since 2001 the tenuous interaction between the multinational pharmaceutical industry and the government concerning the need to establish a means of providing medicines to the public at affordable prices, has opened other exciting debates that deserve attention in this paper. 

The Medicines Control Act 101 of 1965 (the Act) and its comprehensive Regulations govern the control of medicincil products. Licenses to manufacture and register as a pharmaceuticcil concern are issued by the Pharmacy Council. This aspect is addressed in the Medicines and Related Substances Control Amendment Act, No. 90 of 1997 (Act 90 of 1997) that must still become operational at an undisclosed date in the future. 

The Medicines and Related Substances Control Act 101 of 1965 (the Act) is an example of the laws of natural justice in operation. The Council is autonomous in its decision making. The Council must give proper and comprehensive reasons for its decisions. The applicant is given adequate time to respond to the Council s decisions, and an applicant may appeal a decision made by the MCC to a separate and distinct appeal committee, whose decisions are binding on the MCC. The Council s decisions are made by majority vote and the procedure of the meetings is prescribed by regulation. 

The Medicines and Related Substances Control Act No 101 of 1965 requires returns to be submitted in respect of Schedule 6, Schedule 7, and specified Schedule 5 Substances before 28 February of each year. The Act further requires that wholesalers and manufacturers keep registers of sales and receipts of both Schedule 6 and Schedule 7 Substances, and records of Schedule 5 Substances. 

By controlling the structural and electronic properties of sNPS which are related to the nanocrystallite dimensions and porosity, their surface selectivity and sensitivity to different gases (nitrogen and carbon oxide, vapors of water and organic substances) can be adjusted. This approach for the effective detection of acetone, methanol and water vapor in air was described in [13-15].The minimal detectable acetone concentration was reported to be 12 pg/mL. Silicon sensors for detection of SO2 and some medicines such as penicillin were created [16-18]. sNPS were used for the development of a number of immune biosensors, particularly using the photoluminescence detection. Earlier we developed similar immune biosensors for the control of the myoglobin level in blood and for monitoring of bacterial proteins in air [19-23]. 

Aromatherapists need to be aware of a number of legislative regulations. These include The Medicines Act (1968) COSHH, Control of Substances Hazardous to Health HSWA, Health and Safety at Work Act (1974) and CHIP, Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP 2 1994). The MCA (Medicines Control Agency) also has significant implications and constantly encroaches on the supply and use of products related to health. 

This technology is related to the immobilization of biotechnological substances mentioned previously. It consists in a durable combination and often a capsulation of a sensitive component in the stable structure that protects it against external factors. Additionally, in the systems characterized by such properties the protected component is released in a way controlled by external factors and time of exposure. So, complex systems of medicines (antibiotics and vitamins) are obtained which are slowly released in the organism. Due to this, the medicine is not excreted after a short time and its action is prolonged to many hours. The aim of encapsulation... 

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