Local Pharmaceutical Industry Research Articles

THE EX SITU COMPARISON OF TWO IMPROVED ST. JOHN'S WORT (HYPERICUM PERFORATUM) CULTIVARS WITH AN IRANIAN WILD POPULATION

This research is part of an ongoing selection and breeding effort to target Iranian genotypes of Hypericum perforatum with the potential to produce higher amounts of desired secondary metabolites and greater resistance to fungal pathogens. There is a significant interest in the development of such cultivars to supply materials to the local pharmaceutical industries. For this reason, two improved cultivars of H. perforatum ("Gold" and "Veperikon") were compared with a wild Iranian population (Ardabile population) under common garden conditions in Iran. Plants were cultivated from seed in a greenhouse and seedlings were transplanted after one month to the field plots. The statistical design of this study was a Randomized Complete Block Design with three replications. During the period of full flowering, selected phenological (number of days to flowering), morphological (plant height, mean leaf area, number of black glands/leaf) and chemical (hypericin and pseudohypericin content) characteristics were assessed. Our observations were that the "Veperikon" cultivar is very sensitive to soil-borne diseases. All transplanted seedlings were infected by the plant pathogenic fungus Colletotrichum gloeosporioides, which caused necrosis of the whole plant. Both the "Gold" cultivar and plants from the wild population persisted despite mild infections with C. gloeosporioides and produced flowering shoots at both the first and second years after cultivation. The "Gold" cultivar was superior to the Ardabile population in terms of phenological and morphological characteristics. The average naphthodianthrone content (% dry weight of tissue) for the wild Iranian population was 0.04(±0.01)%, but for the "Gold" cultivar, 0.33(±0.43)%. These data indicate that selection and directed cultivation of Iranian H. perforatum plants can result in plants with improved morphological, phenological and chemical characteristics.

Sufficiency economy, the King’s philosophy: an application of Buddhist economics to develop Thai local pharmaceutical industries for sustainable well-being

This article is developed from a policy research carried out to study the impacts on local pharmaceutical industries in case that the Thai government decides to accept the free trade agreement (FTA) on pharmaceutical products proposed by the US government. Despite that the US-Thai FTA is unfair, the Thai government is likely to accept the agreement due to international political pressures and a globalized discourse claiming free trades. Therefore the research recommended applying “Sufficiency Economy”, the King’s Philosophy as a survival strategy for both local industries and Thai people. Sufficiency Economy, as a part of Buddhist Economics, comprises of three principles and two fundamental conditions. The principles are moderation, rationality and self-immunity to changes , while the two conditions include wisdom or abilities to understand things properly and morality or a moral commitment not to put burden on others. The article proposed that there are three levels of all kinds of development according to the application of the principle of moderation. If applied at the first level, it means that the local industries are supposed to build their own capabilities and put emphasis on internal potentials or resources rather than external ones. The second level concerns with the other companies’ survival. If applied, the local companies are supposed to support, not compete against each other. Then, it would lead to network building and increasing strength of local industry groups. However, the two levels may be perceived as concerning only on business benefits. The third level concerning with survival of all involved is therefore the most required approach, where the local companies would run business with a truthful devotion for real health needs of Thai people. That is, the third level is for the well-being of all people. However, this level is less likely to be implemented; most local industries still lack right understanding on sufferings of patients, and its relationship with their survival. As “suffering” was the central strategy proposed by the Buddha, the article proposes that the local industries should learn from patients’ sufferings. Sufferings from sickness are common burdens of life, it is morally wrong to increase any burdens to anyone, even ourselves. In case that the multinational pharmaceutical companies earn excess profits and put more burdens on poor patients, the local companies would contribute to minimise these sufferings. The approach concerning patients’ sufferings would help local companies gain more supports from Thai patients and it may call for more understanding from other people over the world. Sooner or later it may change the world a better place for everyone to live happily and healthy.

Kinetics of p-nitrophenol degradation by Pseudomonas pseudomallei wild and mutant strains

Pseudomonas pseudomallei EBN-10 strain, previously isolated from a local pharmaceutical industry's wastewater, was spontaneously adapted to higher p-nitrophenol (PNP) levels, which then was subjected to gamma ray-induced mutagenesis; the efficient isolates hence obtained were designated as EBN-11 and EBN-12, respectively. EBN-12 mutant strain could completely mineralize PNP (100 mg/L) on the minimal media in 24 h while, the parent strain utilized only 6% of it. Addition of glucose as co-substrate further increased the PNP degradation rate; however, phenol inclusion inhibited the degradation process. Ammonium sulphate was experienced as the best of the nitrogen sources used by EBN-12 mutant strain, while degrading PNP.

Rhetorics of Power and Development: Intellectual Property Rights and The Pharmaceutical Industry in Brazil

AbstractThis paper examines the rise of an intellectual property (IP) rights discourse and highlights how it has been translated into national IP regimes. Recently, IP has become a polarizing concept, and attention has focused on questions that are overly narrow in scope. The characterization of the issue in simplistic dichotomous terms has ignored complex realities of developing countries. The case of Brazil is to highlights the complex ways in which the local pharmaceutical industry has been shaped by and has responded to the regulatory framework that has been established since and including the passage of the 1996 Industrial Property Law.

Knowledge-based industry after market liberalisation: the case of the local pharmaceutical industry in Central and Eastern Europe

Research of the strategic aspects of the generic pharmaceutical industry in Central and Eastern Europe (CEE) suggests that generic pharmaceutical companies have neglected technological innovation capability, market orientation and performance and have underestimated the process of globalisation. This has resulted in deteriorated performance and lost competitiveness. A recommended approach to improve the situation is competence-based development cooperation in the form of horizontal networks of regional technological hubs, within the capabilities and limitations of each country. However, this approach departs from traditional production and R&D capacity building and is beyond the current political and economic considerations of individual companies and governments.

Issues with generic drugs in Saudi Arabia

- ing their own, newly developed drugs. Hence the ac - ceptance of these products by professionals, institutions, health authorities and consumers means the survival of the local pharmaceutical industry. in addition, regulat - ing the licensing of generic drugs represents a driving force for the local pharmaceutical industry to produce pharmaceuticals of high quality to justify their licensing by health authorities both locally and worldwide. 2

Existence of antimalarial formulations with low bioavailability in Tanzania

The main objective of this work was to assess the relative bioavailability of two tablet formulations containing sulfadoxine/pyrimethamine (SP) and marketed in Tanzania. Twelve healthy volunteers were randomized to receive a single oral dose of three SP tablets each containing 500 mg sulfadoxine (SDX) and 25 mg pyrimethamine (PYR) in a form of either A (a locally manufactured SP tablet formulation, manufactured by a local pharmaceutical industry in Tanzania) or B (Fansidar), Hoffmann La Roche, Basel, Switzerland, an innovator's SP) after an overnight fasting. Serial blood samples (100 microL) were collected from a finger prick in duplicate up to 10 days and dried on Whatman filter paper. The samples were assayed for SDX and PYR using high-performance liquid chromatographic methods. Pharmacokinetic parameters of SDX and PYR were estimated by single compartment method. The pharmacokinetics of formulation A--maximum plasma concentration, the areas under the plasma concentration--time curve and the relative bioavailability (A versus B) were significantly lower than those of formulation B (P < 0.1). These observed differences indicate bioinequivalence between the two products.

Influence of manufacturing practices on quality of pharmaceutical products manufactured in Kenya

To establish the quality of pharmaceutical products manufactured by the respective industries in Kenya and determine the effect of manufacturing practices on the quality of these products. Cross-sectional study. Industries examined are in Nairobi, Kenya. Laboratory analysis was carried out using available facilities at Kenya Medical Research Institute and University of Nairobi, Faculty of Pharmacy. Structured Questionnaires were administered to examine how the code of good manufacturing practices has been used in the production of each pharmaceutical product by respective companies. Questionnaires designed to evaluate the distribution and carry out limited post-market surveillance study were administered to community pharmacy outlets. Drugs were sampled and analyzed for their quality according to the respective monographs. The questionnaires administered to the industry included the source of raw materials, quarantine procedure before and after manufacture, manufacturing procedure, quality audit, quality assurance procedure, equipment, and staff. That administered to the pharmacy outlet included availability, affordability and acceptability of locally manufactured pharmaceutical products. Quality analysis of products involved the establishment of the chemical content, dissolution profile, friability, uniformity of weight and identity. For antibiotic suspensions the stability after reconstitution was also determined. There were 15 respondents and two non-respondents from the industry and six out of nine respondents from the pharmacy outlets. The ratio of qualified staff to product range produced seemed to influence product quality. Industries producing several products with only limited number of pharmaceutical staff had more products failing to comply with pharmacopoeia specifications compared to those producing only few products. Nevertheless, all companies are well equipped with quality control equipment, in accordance with type of product manufactured. Private pharmacies stocked few of the locally manufactured products. The reason, they said, was due to low doctor and/or patient acceptance. Compliance with quality specifications as set out in respective monographs was overall 76%. Although the local pharmaceutical industries have adopted good manufacturing practices leading to many good quality products currently in commerce, these manufacturing practices are not comprehensive and measures need to be taken to continue improving them.

Cuba: improving use of medicines

As a result of the US economic blockade and the loss of trading partners after the collapse of the Soviet Union, Cuba's economy has weakened. On some health indices Cuba had been performing very well, among the South and Central American and Caribbean nations, but the downturn in the economy has taken its toll in terms of, for example, infectious disease. Access to drugs and other medical supplies has become difficult. In 1991 a national medicines programme had been set up to ensure the availability of essential drugs. In 1994, as the economic situation worsened, the programme was retuned to cover 343 drugs in 29 pharmacological classes. Cuba's local pharmaceutical industry can manufacture 87% of the products on the basic list of medicines. Since 1993 the Ministry of Health (MINSAP) in Havana, PAHO/WHO, and the Catalan Institute of Pharmacology (ICF) in Barcelona, Spain, have been working together to try to improve drug use in primary care. This collaboration began with a workshop held at the Cuban drug regulatory authority (CECMED), the object being to review drug registration procedures and make them consistent with the national medicines programme. One outcome was a formulary, which has since been distributed to 25 000 family doctors in Cuba and to the country's medical schools. This was followed by a course on the clinical pharmacological basis for the rational use of medicines, and subsequently more than 400 primary care physicians have been taking par in three research projects on drug use by pregnant women and on the treatment of asthma and uncontrolled hypertension. In 1996 MINSAP began to set up a network of centres, one for each of the country's 169 municipalities. These centres, coordinated by the newly established Centre for the Development of Pharmacoepidemiology, are staffed by one family doctor and one pharmacist, who have the following tasks: •Updating the national formulary by review of published material•Revising printed information on drugs and common therapeutic problems•Advising primary health care centres and local associations with a view to setting up protocols on the treatment of common diseases•Promoting and coordinating drug utilisation and pharmacoepidemiological studies•Organising courses and seminars on therapeutics The family doctors who will be in charge of these local centres are being trained in the pharmacoepidemiological aspects of 30 common problems seen in primary care in Cuba. Several Cuban family doctors and pharmacologists are also being trained in Barcelona. MINSAP in Havana provides the manpower and the office space while funding and technical support and training for this project come from PAHO/WHO's Havana office and from ICF, Barcelona.