Medicines and Related Substances

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. 

Institute of Medicine (1999) The medical value of marijuana and related substances. In Joy JE, Watson SJ, Benson JA (eds) Marijuana and medicine assessing the science base. National Academic Press, Washington, 137-191... 

Chen K, Schmidt C. Ephedrine and related substances. Medicine 1930 9 1-94. 

British Journal of Industrial Medicine 48 234-238, 1991 Neuberger M, Rape C, Bergek S, et al Persistent health effects of dioxin contamination in herbicide production. Environ Res 81 206-214, 1999 O Donoghue JL Cyclic halogenated hydrocarbons and related substances, in Neurotoxicity of Industrial and Commercial Chemicals, Vol II. Edited by O Donoghue JL. Boca Raton, FL, CRC Press, 1985, pp 155-168 Oliver RM Toxic effects of 2,3,7,8 tetrachlorodibenzo 1,4 dioxin in laboratory workers. British Journal of Industrial Medicine 32 49-53, 1975 Ott MG, Holder BB, Olson RD A mortality analysis of employees engaged in the manufacture of 2,4,5-trichlorophenoxyacetic acid. Journal of Occupational Medicine 22 47-50, 1980... 

K. K. Chen and C. F. Schmidt, Ephedrine and Related Substances, Medicine... 

Starch, cellulose, and related substances are widely used in pharmaceutical, food, and other industries (Whistler et al. 1984, Young 1986, Frazier et al. 1997, Stenius 2000, Eliasson 2004), and their extraction from natural materials is carried out by water or water/organic mixtures (Minina and Kaukhova 2004) that can influence the product structure and other characteristics. Composites with starch or cellulose, drugs and highly disperse adsorbents can be used in medicine. These nanocomposites are characterized by enhanced activity of biopolymers and drugs because of their transformation into a nanostructured state during interactions with sohd nanoparticles that enhance their bioaccessibiUty. 

The British Phamacopoeia (B.P.) comprises of six volumes. Volume I and II encompass monographs of medicinal and pharmaceutical substances. Volume HI contains monographs on formulated preparations. Volume IV is about herbal active substances, herbal preparations and herbal medicinal products, material for use in the manufacture of homeopathic preparations, blood-related products, immunological products, radiopharmaceutical preparations and surgical materials. Volume V contains infrared reference spectra, appendices and supplementary chapters. There is also a single volume of the B.P. (Veterinary) containing monographs on products used in veterinary medicines. 

Many compounds of chlorine with benzene and related substances have found use in medicine, public health, and agriculture. An outstanding example is DDT, which is used as an insecticide and pediculicide. The amount distributed over the earth in thirty years after its introduction in 1940 is about 3 billion kilograms. Its use is now restricted because of its toxicity to humans, birds, and other animals. 

Phencyclidine (l-[l-phenylcyclohexyl] piperidine, PCP) was originally developed as an intravenous anesthetic in the 1950s. Used for this indication, it causes a trance-like state without loss of consciousness and was hence classified as a dissociative anesthetic. However, it was soon withdrawn from human use because it produced unpleasant hallucinations, agitation, and delirium. The product was later used in veterinary medicine. Ketamine, a chemically closely related substance, was developed to replace PCP and is stiU in use as a dissociative anesthetic in children. Ketamine is less potent than PCP, and its effects are of shorter duration. However, it may also cause hallucinations (see the section on ketamine in Chapter 7, Club Drugs ). Much of the ketamine sold on the street (special K, cat Valium) has been diverted from veterinarians offices. 

Whereas trade in medicinal products within the Community is hindered by disparities between certain national provisions, in particular between provisions relating to medicinal products (excluding substances or combinations of substances which are foods, animal feeding stuffs or toilet preparations) and whereas such disparities, directly affect the establishment and functioning of the common market ... 

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]. 

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