Local Pharmaceutical Industry Research Articles

Medicines development and regulation in Africa

Africa is one of the world’s fastest-growing economic regions, with a rise in its pharmaceutical industry value from $4.7 billion in 2003 to $20.8 billion in 2013. Multinational pharmaceutical companies are becoming more active in drug production and clinical trials across Africa, and there is an increase in the number of local companies engaged in medicines development and marketing. Such expansion of the local pharmaceutical industry requires trained pharmaceutical specialists to support it. The current situation and future requirements for local medicines development, regulation, education and training needs are discussed.

Current status and vision of local pharmaceutical industries in Saudi Arabia: The focus on nanomedicines

BackgroundPharmaceutical nanomedicine products are expected to impact the global pharmaceutical market and healthcare system significantly. Since 2000, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have approved over 80 nanomedicine products for marketing; an additional double that number is currently being tested in clinical trials. The nanomedicine market is expected to reach USD 350.8 billion by 2025 from USD 138.8 billion in 2016. This demonstrates the importance of nanotechnology to the delivery of pharmaceuticals. The main benefits of employing nanotechnology to distribute therapeutic agents include reducing the undesired toxicity from non-specific distribution and increasing patient adherence, which can indirectly minimize the burden on the country's healthcare system. Such products are expected to gain a significant economic impact on Saudi Arabia’s pharmaceutical drugs market once they get developed locally. MethodA descriptive and cross-sectional study, including a web-based questionnaire and a complete categorization of pharmaceutical products formed by the national industries in Saudi Arabia, was utilized to investigate the current and future direction of pharmaceutical manufacturing exploiting nanotechnology in the Kingdom. ResultsThe survey showed an apparent lack of willingness within the national pharmaceutical industries, as the majority (≈ 86%) of the leading Saudi companies cannot enable nanotechnology-based medicines in their manufacturing. However, more than 93% of the national pharmaceutical industries, upon the basis of the responses, agreed that the development of pharmaceutical products with nanotechnology is an important step toward solving various complications associated with conventional forms of the available medicine. ConclusionNational pharmaceutical industries in Saudi Arabia will need to get closer to manufacturing nanomedicines by partnering with international pioneer companies. In addition, empowering the local research and development (R&D) centers in nano delivery systems could facilitate translating their R&D outcomes into novel advanced and commercialized products. This could imitate the direction of the global pharmaceutical market and share its revenue which will positively reflect on the Kingdom's economy.

The impact of the increase in import verification fees on local production capacity of selected medicines in Uganda

BackgroundThe local manufacture of pharmaceuticals is an opportunity to develop a broader manufacturing and knowledge-based economy and reduce over dependence on imports. To promote local production, the Ugandan government introduced Buy Uganda Build Uganda policy geared towards promoting use of locally manufactured goods. It also increased import verification fees in 2017 for 37 selected locally manufactured essential medicines from 2 to 12% to discourage importation of these medicines. This study assessed the impact of the increase in verification fees on local production capacity of the medicines.MethodsThis was a mixed methods study looking at production capacity before and after introduction of the 12% import verification fees. It was conducted among six (6) local pharmaceutical industries in Uganda and seven (7) key informant interviews with experts in the pharmaceutical sector between February and September 2021.ResultsThe overall increase in local production capacity of the selected medicines was 8.2% from 2017 to 2020. The most significant increases were in the production of capsules (100.6%, P = 0.03) and oral liquids (170.8%, P = 0.0001). All the industries registered an increase in number of employees between 2017 and 2020 with an average percentage increase of 42%. There was a 14.7% (95% CI 2.76–17.6%) change in installed capacity of the compression machine (P = 0.033) and 27.7% (95% CI 24.6–33.9%) change in installed capacity of the Blow–Fill–Seal (BFS) filling machines (P = 0.011). There was also an increase in the number and capacity of installed utilities such as the heating ventilation and air conditioning (968%) and standby generators (131%). Only two (2) industries registered an increase in critical quality control equipment and one had all the critical equipment available by 2020. Most of the key informants reported positive impact of the increment of import verification on local manufacturing capacity.ConclusionsLocal pharmaceutical production capacity increased with the increase in import verification fees with significant increases in production of oral liquids and capsules. Successful implementation of policies supporting local production will promote the development of local pharmaceutical industries. Governments should consider increasing the list of medicines to benefit from the import verification fees increase by adding all essential generic medicines for which there is adequate domestic production capacity and technical skills.

Current and future prospective of pharmaceutical manufacturing in Saudi Arabia

This observational descriptive study that was carried out with the objective of exploring the contribution of the local pharmaceutical industry to the Saudi drug security. Using a drug formulary provided from the Saudi Food and Drug Authority, containing all registered pharmaceutical products available in Saudi Arabia, we extracted information about drug class, drug type, country and place of manufacturing, shelf-life and price. Results showed that the majority of drugs in the market are manufactured in Europe (43.86%), followed by Saudi Arabia (22.55%), China and India (20.47%), Americas (10.24%), and other nations (2.61%). Most of the manufactured drugs were prescription drugs (90.62%). In this work, the local pharmaceutical industry with the highest percentage of contribution to local drug security was Pharmaceutical Solution Industries (PSI), representing the 5% of the items available in the Saudi market. The second highest percentage was 4% by TABUK Pharmaceutical Manufacturing CO., followed by SPIMACO (3%), JAMJOOM pharmaceutical company (2%), Riyadh pharma (2%), and Jazeera pharmaceutical industries (2%). In addition, results from this study provide information about the most essential pharmaceutical products that needs to be nationally manufactured or increased in production in order to rise the contribution of local pharmaceutical industries in Saudi drug security. Unfortunately, the small contribution of the Saudi pharmaceutical industry in local drug security increases the burden on the Kingdom's annual budget due to the over-reliance on international pharmaceuticals.

Local pharmaceutical research and development capacity in a developing country: a qualitative exploration of perspectives from key stakeholders in Ethiopia

PurposeDespite its importance in ensuring sustainable healthcare, there are huge challenges with pharmaceutical research and development (R&D) especially for developing countries mainly due to the high investment costs naturally associated with such activities. In this regard, the pharmaceutical sector in Ethiopia, the most populous nation in East Africa, faces numerous challenges. The current study aimed at assessing the R&D capacity of the local pharmaceutical manufacturers from the perspectives of key informants working in the companies and supporting government offices and education institutions.MethodsA qualitative study design employing in-depth interviews using semi-structured interview guides with flexible probing techniques was used for data collection. The study involved purposively selected participants who represented major stakeholders such as managers in the R&D departments of pharmaceutical manufacturers, officers and leaders in concerned government agencies and researchers in a local university. All transcribed interviews were subjected to thematic analysis and the Qualitative Data Analysis software in family R (RQDA) was used for data analysis.ResultsA total of 14 participants were involved in the study and three major themes were identified from the interviews. Current R&D capacity, opportunities and challenges for involvement in R&D were the major themes. Under current R&D capacity, the weak R&D status of local pharmaceutical plants and minimal university–industry linkage were identified. The challenges of pharmaceutical R&D in Ethiopia included weak governmental and managerial support; difficult procurement processes for R&D input; and the high cost of R&D. Availability of trainable human power and planned government incentives were identified as the opportunities.ConclusionOverall, there is a low level of R&D capacity in local pharmaceutical industries and timely interventional strategies should be implemented through collaboration of academia, research institutions and pharmaceutical industries.

Determining Factors for Pharmaceutical Innovation and the Health Industrial Complex in Brazil and the BRICS

The development of a local pharmaceutical research and development industry is essential to meet the demands of a large country with a large population such as Brazil. This work aims to explore the existing data on the ecosystem of the pharmaceutical industry in this group of countries, and through parameters based on the precursor literature, to identify the innovation factors and the position of Brazil in relation to the other representatives of the BRICS (the leading developing countries in the world). Since the mid-1940s, Brazil has received pharmaceutical multinationals and through government initiatives it has locally reproduced medicines developed abroad when the patents have ended. The BRICS represent the group of emerging countries considered “the big five”, with population capacity and economic growth that tend to boost the global economy in the coming years. The comparative analysis showed that Brazil has a certain lag in fundamental parameters for the existence of a national pharmaceutical R&D industry, having placed behind Russia, India and China, even symbolically by not producing a national vaccine in response to COVID-19.

Quality by Design: A Suitable Methodology in Industrial Pharmacy for Costa Rican Universities

This review aims to present the Quality by Design (QbD) model as a suitable methodology to perform research in the academic Costa Rican institutions that teach Pharmacy. Pubmed, Science Direct, and Google Scholar databases were screened for original research papers and review papers published not more than ten years ago. Institutional repositories from the different universities were reviewed as well. The QbD model stands out as a great methodology for carrying out research projects regarding Pharmaceutical Sciences, but especially for Industrial Pharmacy, where it has contributed in terms of formulation development, manufacturing, and quality control. Academic research based on this model enables the training and development of practical, scientific, and leadership skills in Industrial Pharmacy students. The generated knowledge can be shared in classrooms, which represents an ideal environment to communicate research results and to foster collaborative work between researchers, professors, and students. Moreover, research performed through a QbD approach increases the confidence shown by the industrial sector and health regulatory authorities in the quality of the research, products, and knowledge that are developed and created in an Academy. As a result, the implementation of the model has allowed the creation, transfer, and materialization of knowledge from the Costa Rican Academy to different local pharmaceutical industries.

Implications of national tax policy on local pharmaceutical production in a southwestern state nigeria \u2013 qualitative research for the intersection of national pharmaceutical policy on health systems development

BackgroundUniversal access to quality and affordable medicines is one of the targets of the Sustainable Development Goals (SDGs). Access to essential medicines is defined as the availability of medicine at an affordable price in public and private health institutions including retail pharmacies in the proximity of less than an hour from the home of the population. The dependence on importation to meet the drug needs of an expanding population has implications on the growth of the local pharmaceutical industry, availability, and affordability of essential medicines in the country. This study aims to understand the dynamics of tariffs and tax policy on local drug production in the pharmaceutical industry in Nigeria.MethodsThis was a qualitative study involving the use of Key Informant Interviews (KIIs). A total of 15 stakeholders were interviewed. Interviews conducted were analysed thematically. The data generated were analysed using Atlas.Ti version 8.2.ResultsAssessment of the pharmaceutical industry sub-sector underscores myriads of challenges facing the industry and explains why the pharmaceutical industries in Nigeria are performing sub-optimally. Key stakeholders in the sector expressed concern about the fact that substantial percentage of drugs consumed in Nigeria are imported. Local manufacturers are underperforming due to several factors. Some highlighted factors were unfriendly tax environment, high cost of production, infrastructural deficit, low patronage from the government, and lack of access to low-interest rate loans. However, tax incentives and tax cuts are proven strategies to encourage and facilitate the growth of entrepreneurs in the pharmaceutical industry.ConclusionsStakeholders’ perspective of implications of the tax environment on the pharmaceutical sector of Nigeria revealed the unfriendliness of the government policy to local manufacturers. Although the checklist for availability and prices of essential medicines in Osun state, Nigeria revealed that the pre-selected drugs were available in the facilities, the observed prices further affirmed the relative difficulty that is experienced by local manufacturers to compete with imported brands of the same drugs.

Features of intellectual property protection mechanisms on the example of orphan drugs circulation

Objective: to study features of intellectual property protection mechanisms on the example of drugs for the treatment of rare (orphan) diseases.Material and methods. Analysis of pharmaceutical market data was performed with the DSM Group analytical database. The approach proposed by the Russian Federal Industrial Property Service was used for creating patent landscape. The method supposes conducting a patent search and analysis of the documents found for date of filing, office (country) of filing, applicant, as well as analysis of the patent activity (dynamics) for the subject, in this case, for orphan drugs having a defined structure.Results. We proposed the complex conclusions to increase national drug safety. Intellectual property limitations for importing countries such as data exclusivity, do not allow to reproduce clinical trials, which leads to non-disclosure of medical data to all parties – medical society and patients, all other market participants, including local pharmaceutical producers. Current intellectual property restrictions conceal crucial data from medical and patient society and other market players and affect accuracy of diagnosis and treatment. Along with outstanding cost of new therapies it causes enormous budget burden for the healthcare system and prevents the introduction of objective criteria in the appointment and use of medicines. Prior to the approval and submission of the registration certificate by the regulatory authority, it is necessary to establish reasonable marginal prices, to form a sufficient set and volume of clinical guidelines and to determine in advance the sources of financing and mechanisms of integration into the national system of drug provision.Conclusion. The introduction of drugs for the treatment of rare diseases into circulation leads to a sharp increase in the burden on the budgets of the healthcare system at all levels. Current restrictions and obligations in the field of intellectual property rights protection, the degree of disclosure of medical data in the process of registration and admission to the market require significant changes to the traditional system of drug provision and the system of placing state orders, as well as the introduction of new regulatory mechanisms (for example, compulsory licensing or producing individual dosage forms in pharmacy organizations), contributing to the development of the local pharmaceutical industry and providing the national health system with the necessary volume of drugs with a sufficient level of quality and safety.

Utilization of Pectin from Okra as Binding Agent in Immediate Release Tablets.

Polymeric materials from plants continue to be of interest to pharmaceutical scientists as potential binders in immediate release tablets due to availability, sustainability, and constant supply to feed local pharmaceutical industries. Paracetamol tablet formulations were utilized in investigating the potential binding characteristics of pectin harnessed from various okra genotypes (PC1-PC5) in Ghana. The pectin yields from the different genotypes ranged from 6.12 to 18.84%w/w. The pH of extracted pectin ranged from 6.39 to 6.92, and it had good swelling indices and a low moisture content. Pectin extracted from all genotypes were evaluated as binders (10, 15, and 20%w/v) and compared to tragacanth BP. All formulated tablets (F1-F18) passed the weight uniformity, drug content, hardness, and friability tests. Based on their crushing strength, tablets prepared with pectin from the various genotypes were relatively harder (P ≤ 0.05) than tablets prepared with tragacanth BP. Tablets prepared with pectins as binders at 10%w/v and 15%w/v passed the disintegration and dissolution tests with the exception of PC4 at 15%w/v. Incorporation of pectin from all genotypes (excluding PC5) as a binder at concentrations above 15%w/v (F13, F16, F14, and F15) produced tablets which failed the disintegration test and showed poor dissolution profiles. Thus, pectin from these genotypes can be industrially commodified as binders in immediate release tablets using varying concentrations.

Accessing Affordable Medicines in a Post-TRIPS Environment: The Case of Bangladesh

The cost of medicines in Bangladesh is among the lowest in the world. Over the last forty years, Bangladesh, a Least Developed Country (LDC), has nurtured a local industry based on strong industrial policy and a pharmaceutical patent-free system. Of the 46 LDCs in the world, it is the only one to have a thriving industry of this kind. In this paper, we explore how a relatively poor LDC managed to take on the dominance of MNCs in the global production of pharmaceuticals. We focus on the 1982 National Drug Policy (NDP) which transformed the pharmaceutical sector in Bangladesh from one in which three-quarters of drugs were supplied by just eight MNCs to one where almost all domestic demand is met by local industry. The thriving local pharmaceutical industry also exports generic medicines to 147 different countries. In 2026, Bangladesh is due to graduate to ‘Developing Country’ status, at which time, as a member of the WTO, Bangladesh will have to abide by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Under TRIPS it will have to change its patent regime to allow for the registration of pharmaceutical patents by 2029. Using interview data with key Bangladeshi experts, we argue that TRIPS compliance could potentially wipe out this flourishing local pharmaceutical industry, leading to steep increases in the cost of essential medicines, with dire implications for the right to health. We explore policy options open to the Bangladesh government to protect affordable drugs in the country, in particular protection for the production of domestic generics in a post-TRIPS environment. We also argue that there are ways in which Bangladesh and India could co-operate to protect the affordability of high-quality medicines for domestic and international markets.

Paving New Roads Towards Biodiversity-Based Drug Development in Brazil: Lessons from the Past and Future Perspectives.

Although Brazil gathers two fundamental features to occupy a leading position on the development of biodiversity-based medicines, the largest flora on earth and a broad tradition on the use of medicinal plants, the number of products derived from the national genetic heritage is so far modest, either as single drugs or as herbal medicines. This article highlights some aspects that may have contributed to the low rates of success and proposes new insights for innovation. We initially approach the use of medicinal plants in Brazil, molded by its ethnic diversity, and the development of the local pharmaceutical industry. A discussion of some governmental initiatives to support plant-based drug development is then presented. Employing the economic concept of “middle-income trap,” we further propose that Brazil is stuck in a “middle-level science trap,” since the increase in the number of scientific publications that launched the country to an intermediate publishing position has not been translated into drug development. Two new approaches to escape from this trap are presented, which may result in innovative drug development. The first is based on the exploitation of the antifragility properties of herbal products aiming to investigate non-canonical pharmacodynamics mechanisms of action, aligned with the concepts of system biology. The second is the manufacture of herbal products based on the circular economy principles, including the use of byproducts for the development of new therapeutical agents. The adoption of these strategies may result in innovative phytomedicines, with global competitiveness.Graphical abstract

Covid-19 and Semi-Periphery

The SARS-CoV-2 pandemic has disturbed the order of the world-system. While central countries—through their pharmaceutical multinationals—focused on the development of vaccines, semi-peripheral and peripheral countries fulfill another role, either by offering an environment for trials, or by inserting themselves in the hierarchical global order as a hub for research, development, or production of the candidate vaccines. This paper focuses on the analysis of the geopolitics of the world-system regarding production and participation in the clinical trials of vaccines for SARS-CoV-2 of Oxford University-AstraZeneca, BioNTech-Pfizer, and Sinopharm in Argentina. This is a case analysis of the Argentine semi-peripheral context, the local and global pharmaceutical industry, and the geopolitical order. We conclude that Argentina, which has scientific and industrial capabilities to manufacture vaccines, has joined in global value chains on the dependence side, deepening the scientific and technological gap vis-à-vis the central countries.

Legal status of pharmaceutical industry secrecy In the UAE legal system

Facing the problem of matching growth and status, starting work, starting work, starting work, starting work, starting work, starting work, starting work, and the United Arab Emirates. This harmonization - by approving a set of exceptions of this nature has some of the effects and the secret idea behind it.
 As we see him, he relied on the idea of ​​public order in order to set some exceptions related to the inventions themselves by excluding some of them from the requirement to obtain a patent certificate, which is stipulated in Article 6 of the Law on the Organization and Protection of Industrial Property, and he also made exceptions related to the rights established for the inventor, which are It gives him the power to monopolize and dominate the invention if the inventor has what is in conflict with the objectives of scientific research, which is stipulated in Article 19 of the aforementioned law, and we see that the UAE legislator has organized the idea of ​​compulsory licensing contracts for pharmaceutical products in accordance with the interests of both the licensee and the licensee. Both.
 Research problem: considering that the pharmaceutical industry in the UAE is a strategic industry, and because of the fluctuation of drug prices in the global and local market. Therefore, the problem of this research will focus not on the extent to which the pharmaceutical industry in the Emirates can activate its role in the UAE national economy in light of the UAE pharmaceutical legislation, and whether these legislations were able to create a balance between secrecy in the pharmaceutical industry and scientific progress in this industry.
 research assumes:
 1- There is no relationship between advances in the pharmaceutical industry in the UAE and the confidentiality imposed by the TRIPS Agreement.
 2- The UAE’s accession to the TRIPS Agreement had a negative impact on the pharmaceutical industry.
 3- The Emirati legislator was able to create a consensus between commitment to confidentiality and the manufacture of medicines.
 research aims:
 1- Introducing confidentiality in the pharmaceutical industry.
 2- Identifying the main obstacles to the pharmaceutical industry in the UAE.
 3- Developing proposals to activate the role of local legislation to create a balance between confidentiality and the pharmaceutical industry.
 research importance:
 The importance of the research lies in focusing on the balance between confidentiality and the local pharmaceutical industry to have a developmental role. Thus, we will try to reveal the state of the pharmaceutical industry in the UAE. And how to stimulate the pharmaceutical industry through national legislation
 Research methodology: The researcher will rely on a descriptive approach to analyze and characterize the special industrial reality in medicine in the UAE and analyze private legislation
 Based on the foregoing, and in order to understand the position of the Emirati legislator on the idea of ​​secrecy in the pharmaceutical industries more, this requirement must be divided into two studies. In the first, we review the concept of confidentiality in the pharmaceutical industries. Second: the concerted attempts to mitigate the negative effects of confidentiality in the pharmaceutical industries.

VALIDATION OF HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF PSEUDOEPHEDRINE HCl, GUAIFENESIN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBr

Objectives: Pseudoephedrine HCl, Guaifenesin, Chlorpheniramine Maleate and Dextromethorphan HBr combination is a common combination cough syrup. Many validated methods are available for the determination of each compound alone and in combination with other drugs. The local pharmaceutical industry used to analyze such combination in individual assessment which is efforts and time consuming. The objective of this study is to validate a method for simultaneous determinations of the four compounds in one single injection.
 Methods: HPLC method had been develop using detector at 210 nm, column C18 4.6 mm × 250 mm, 3µm and mobile phase of Potassium dihydrogen orthophosphate, acetonitrile, orthophosphoric acid, triethanolamine and water. The column oven temperature is 400C, flow rate 0.8 ml/min and 60 minutes run time. The method had been validated according to the ICH guidelines with respect to method specificity, linearity and range, precision, accuracy and robustness. Limit of detection, quantitation limit and solution stability had been assessed.
 Results: The average retention times the 4 compounds are 5.5, 12.63, 15.85, 50.44 minutes. The RSD% is less than 1%, the theoretical plates is more than 2000, the tailing factor is not more than 2 and the resolution between the peaks was found to be above 20. The Method showed an appropriate linearity having correlation coefficient r2 0.9996 – 0.9998. The RSD% of results for two analysts in two different apparatus in two days was less than 2. The test solution is stable for 48 hours.
 Conclusion: The method is simple and fulfilled all acceptable criteria for all validation parameters. The method is qualified enough to be used for routine analysis of products containing the four components.
 Peer Review History: 
 Received: 2 September 2020; Revised: 12 October; Accepted: 23 October, Available online: 15 November 2020
 UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency.
 Received file 
 
 Average Peer review marks at initial stage: 5.0/10
 Average Peer review marks at publication stage: 7.0/10
 Reviewer(s) detail:
 Dr. Vijay Kumar Singh, Institute of Pharmacy, Bundelkhand University, Jhansi, India
 vijayquantum@gmail.com
 Dr. Showkat Ahmad Bhawani, UNIMAS Sarawak Malaysia, sabhawani@gmail.com 
 Comments of reviewer(s): 
 
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Stakeholders’ Perspective of Role of Policy and Legislation in Achieving Medicines’ Security

Background: The role of the pharmaceutical industry in a country such as Nigeria in the provision of safe, high quality and efficacious pharmaceutical products to meet the healthcare need of the populace, cannot be over-emphasized. This study was undertaken to critically look at the issues affecting Medicines’ Security in Nigeria. Methods: A self-completion questionnaire was used for data collection. The questionnaire was administered to participants of an Industry event in September 2017. Data collected were analyzed using Statistical Package for Social Science. Results: A total number of 800 questionnaires were administered to the participants and 529 of the questionnaires were included for analysis. Male participants (58.6%) were more than female participants, all age groups were well represented and more than a third of the respondents had first degree as their minimum qualification. Majority of the respondents (91.3%) indicated that Ministry of Health and its agencies were key to protecting the pharmaceutical sector, while slightly less of that proportion (79.1%) indicated that they patronized Nigeria pharmaceutical products. Almost all the participants (91.7%) supported the need for the local pharmaceutical industry to have access to sustainable funding and other incentives. A similar proportion (89.6%) of the respondents indicated that the local pharmaceutical industry should be prioritized in policy making and implementation. A significant proportion of the study participants (82.3%) indicated that access to medicines in Nigeria is a security issue. Conclusion: To ensure Medicines’ Security and attain medicines self-sufficiency in Nigeria, radical policies must therefore be put in place, together with enabling good business and industrial environment by the government in order to protect, promote and grow the local pharmaceutical industry in Nigeria.

Physico-chemical Properties of Starches from Two Varieties of Sweet Potato and Yam Tubers Available in Nigeria

The research sought to investigate the functional properties of starches obtained from four Nigerian root and tubers, yam and sweet potato varieties, in order to facilitate their exploitation as substitute raw material for the local food and pharmaceutical manufacturing industry. The varieties, namely: white yam (Dioscorea rotundata), water yam (Dioscorea alorta), orange flesh sweet potato (Ipomoea batatas) and cream flesh sweet potato (Ipomoea batatas), their respective starches were obtained by wet separation techniques and were analyzed for their pasting properties, physic-chemical properties, starch yield on dry and wet basis, functional, starch purity, amylase and amylo-pectin were undertaken in order to determine their suitability for food and other uses. The peak time, pasting temperature, peak viscosity, holding strength, breakdown, set from peak and set back from through ranged from 7.3 – 8.3 mins, 65.4 – 71.3°C, 511.5 – 1001.2 BU, 860.8 – 871.3 BU, 300.1 – 306.9 BU, 240.8 – 248.1 BU and 400.4 – 510.9 BU respectively. There were significant differences (p<0.05) in the pasting properties. The crude protein, crude fat, crude fibre, ash, moisture and carbohydrate ranged from 1.55 – 1.85%, 0.09 – 0.12%, 0.12 – 0.22%, 1.32 – 2.05%, 10.72 – 11.09% and 85.59 – 86.20% respectively. There were significant differences (p<0.05) in the proximate composition of the starches. The starch yield on dry weight basis, starch weight on fresh weight basis, starch yield from tubers and percentage dry matter ranged from 56.84 – 85.88%, 22.75 – 36.07%, 18.02 – 26.00% and 40.02 – 44.01% respectively. There were significant differences (p<0.05) in the all the parameters. The bulk density, water absorption capacity, oil absorption capacity, gelatinization temperature, starch purity, amylase, amylo-pectin and pH ranged from 0.56 – 0.61g/cm3, 86.8 – 99.4%, 103.2 – 125.4%, 59.78 – 60.42°C, 95.28 – 96.55%, 27.25 – 29.37%, 70.63 – 72.63% and 6.82 – 6.91 respectively. There were significant differences (p<0.05) in all the parameters but no significant difference (p>0.05) in the pH. The starches from yam and sweet potato varieties starches can be exploited for diverse uses based on their different characteristics.

A Review on Revolution of Pharmaceutical Sector in Bangladesh after Liberation War and Future Prospects and Challenges

Pharmaceutical is the core of Bangladesh’s Healthcare sector with an annual average growth rate consistently in the double digits. The real growth of local pharmaceutical industries started after the “Drug Control Ordinance-1982’'. This research is based on Primary and secondary data. Presently, the industry meets 97% of local demand and exports to more than 80 countries. Generic drugs in Bangladesh estimates to reach BDT 30,300 core by 2024. A local industry supporting drug policy and effective regulatory framework, along with trade related aspects of intellectual property rights relaxations are the key reasons for success of the industry. Prime Minister Sheikh Hasina has named pharmaceuticals the Product of the Year for 2018. Prospect of the sector depends largely on the interactions among the proprietors, regulatory bodies and the government, whether they can meet up the requisites to continue growth of the sector while facing the challenge.

Preliminary evaluation of probiotic potential of yeasts isolated from bovine milk and curd of Sri Lanka

There has been mounting interest in the health benefits associated with live microorganisms commonly known as probiotics. Many probiotic bacterial species have been identified. However, the potential of yeasts as a source of probiotics has not been well explored. The present study was carried out to screen and identify potential probiotic yeasts from selected dairy sources available in Sri Lanka. Yeasts from raw bovine milk and curd were isolated, purified, selected and phenotypically characterized by performing morphological, physiological and biochemical tests. Isolates were assessed for their ability to survive under simulated gastro-intestinal conditions to explore their probiotic potential. Approximately, 190 colonies similar to yeast were isolated and 45 isolates of the division Ascomycota were selected and coded for convenience (SLDY_001-SLDY_045). Most promising probiotic isolates (20) were genotypically identified to be species of Pichia (55%), Candida (30%), and Kluyveromyces (15%) of the family: Saccharomycetaceae. Considering a threshold of >95% similarity to the type strain, eight different yeast species were identified. Isolates (SLDY_005, SLDY_006 and SLDY_039) of Kluyveromyces marxianus species showed the highest probiotic potential from the pool. The strain confirmation and in-vitro/in-vivo safety assessment of these isolates will further verify their suitability as probiotic starter cultures to be used in local food and pharmaceutical industries.

Traditional medicine, modern science and the upgrading of the local pharmaceutical industry: endogenous development of the phytomedicine innovation system in Korea

ABSTRACT This study examines the opportunities to upgrade the Korean pharmaceutical industry from imitation to innovation through the development of phytomedicine. Phytomedicines are modern drugs developed by scientifying traditional medicines which have been an overlooked source of knowledge for innovation in studies on latecomers’ industrial development. This study illustrates the emergence of phytomedicine in Korea in view of the sectoral innovation system and the global value chain. It determines the technological and socio-economic conditions for the development of the new phytomedicine sector and discusses its role in upgrading the local pharmaceutical industry. The findings highlight that phytomedicine development provides an alternative path for continuing incremental innovation, which is still a common practice of most latecomers’ industrial development. For latecomers’ pharmaceutical industries, incremental innovation has been regarded as being increasingly difficult to adopt due to the large technological and marketing gap between generic drugs and innovative patented drugs.