DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE

2015 ◽  
Vol 3 (2) ◽  
pp. 1-7 ◽  
Author(s):  
Achin Jain ◽  
M P Venkatesh M P ◽  
Pramod T.M. Kumar
Keyword(s):  
Quality Control ◽  
Medical Devices ◽  
Emerging Market ◽  
Well Being ◽  
New Drugs ◽  
Regulatory Body ◽  
Herbal Drugs ◽  
Drug Products ◽  
Set Up

In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally 

Medical technology: A systematic review on medical devices utilized for epilepsy prediction and management

2021 ◽  
Vol 19 ◽  
Author(s):  
Jen Sze Ong ◽  
Shuet Nee Wong ◽  
Alina Arulsamy ◽  
Jessica L. Watterson ◽  
Mohd. Farooq Shaikh
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Medical Devices ◽  
Epileptic Seizures ◽  
Well Being ◽  
Sudden Unexpected Death ◽  
Unexpected Death ◽  
Long Time ◽  
Wearable Medical

: Epilepsy is a devastating neurological disorder that affects nearly 70 million people worldwide. Epilepsy causes uncontrollable, unprovoked and unpredictable seizures that reduces the quality of life of those afflicted, with 1-9 epileptic patient deaths per 1000 patient occurring annually due to sudden unexpected death in epilepsy (SUDEP). Predicting the onset of seizures and managing them may help patients from harming themselves and may improve their well-being. For a long time, electroencephalography (EEG) devices have been the mainstay for seizure detection and monitoring. This systematic review aimed to elucidate and critically evaluate the latest advancements of medical devices, besides EEG, that have been proposed for the management and prediction of epileptic seizures. A literature search was performed on three databases; PubMed, Scopus and EMBASE. Following title/abstract screening by two independent reviewers, 27 articles were selected for critical analysis in this review. These articles revealed ambulatory, non-invasive and wearable medical devices such as the in-ear EEG devices, the accelerometer-based devices and the subcutaneous implanted EEG devices might be more acceptable than traditional EEG systems. In addition, extracerebral signal-based devices may be more efficient than EEG-based systems, especially when combined with an intervention trigger. Although further studies may still be required to improve and validate these proposed systems before commercialization, these findings may give hope to epileptic patients, particularly those with refractory epilepsy, to predict and manage their seizures. The use of medical devices for epilepsy may improve patients' independence and quality of life and possibly prevent sudden unexpected death in epilepsy (SUDEP).

scholarly journals Quality control practices at BMC centre – A comparative study

2020 ◽  
Vol 13 (3) ◽  
pp. 69-72
Author(s):  
P. Sowmya ◽  
N. T. Krishna Kishore ◽  
N. Vani
Keyword(s):  
Quality Control ◽  
Andhra Pradesh ◽  
Raw Milk ◽  
Well Being ◽  
Preparation Time ◽  
Milk Products ◽  
End Products ◽  
Opening And Closing ◽  
Main Factor

Raw milk quality is one of the most important factor before processing of milk and milk products. It is the main factor which is responsible for deciding the quality of end products. The present study was carried out at the selected BMC centre of a FPO owned dairy unit in Chittoor district of Andhra Pradesh. The principal objective of the study was to draw a comparison between BMC standards of NDDB and standards of selected BMC centre. The findings of the study show that there are no major deviations except delay in opening and closing timings for milk collection. As a result preparation time is reduced hindering the efficiency of milk collection process. BMC unit is well-being running manually by operator and switch was being turned off once BMC centre milk temperature touches 40C and starts at 60C, due to this delay in manual cutoff the milk is being crystallized. As per NDDB standards auto mode is recommended so that the BMC switches off automatically once the milk temperature reaches 40C and restarts at 60C at BMC centre.

Board Quality and Earnings Management: Evidence from India

2019 ◽  
Vol 21 (5) ◽  
pp. 1302-1324 ◽  
Author(s):  
Chanchal Chatterjee
Keyword(s):  
Earnings Management ◽  
Emerging Market ◽  
Institutional Ownership ◽  
Board Independence ◽  
Management Behaviour ◽  
Foreign Institutional Investors ◽  
Independence Results ◽  
Set Up ◽  
Reported Earnings

This article examines whether board qualities influence the earnings management behaviour of firms in a large emerging market set-up by using panel data of 783 Indian private manufacturing firms over a period of 7 years (April 2009–March 2016). The study finds that it is board quality that helps in curbing earnings manipulation and not just board independence. Results reveal that diligent and busy boards help in reducing earnings management, CEO duality affects the quality of reported earnings and promoters’ influence on boards increases earnings management. Domestic or foreign institutional investors do not have any independent impact on earnings management. However, domestic institutional ownership reduces earnings management when promoters’ influence exists. The article contributes to the literature by focusing on whether corporate governance (CG) mechanisms are important in curbing earnings management in an emerging market context. The findings are expected to be helpful to policymakers and regulators while framing appropriate CG policies and regulations.

Comprehensive HPTLC Fingerprinting for Quality Control of an Herbal Drug – The Case of Angelica gigas Root

Planta Medica ◽  
2018 ◽  
Vol 84 (06/07) ◽  
pp. 465-474 ◽  
Author(s):  
Débora Frommenwiler ◽  
Jonghwan Kim ◽  
Chang-Soo Yook ◽  
Thi Tran ◽  
Salvador Cañigueral ◽  
...  
Keyword(s):  
Quality Control ◽  
Reference Material ◽  
Herbal Drugs ◽  
Proof Of Concept ◽  
Herbal Drug ◽  
Angelica Gigas ◽  
Decursinol Angelate ◽  
Suitable Reference ◽  
Hptlc Method

AbstractThe quality of herbal drugs is usually controlled using several tests recommended in a monograph. HPTLC is the method of choice for identification in many pharmacopoeias. If combined with a suitable reference material for comparison, HPTLC can provide information beyond identification and thus may simplify quality control. This paper describes, as a proof of concept, how HPTLC can be applied to define specifications for an herbal reference material and to control the quality of an herbal drug according to these specifications. Based on multiple batches of cultivated Angelica gigas root, a specific HPTLC method for identification was optimized. This method can distinguish 27 related species. It also can detect the presence of mixtures of A. gigas with two other Angelica species traded as “Dang gui” and is suitable as well for quantitative assessment of samples in a test for minimum content of the sum of decursin and decursinol angelate. The new concept of “comprehensive HPTLC fingerprinting” is proposed: HPTLC fingerprints (images), which are used for identification, are converted into peak profiles and the intensities of selected zones are quantitatively compared to those of the corresponding zones of the reference material. Following a collaborative trial involving three laboratories in three countries, the method was applied to check the quality of further candidates for establishing an appropriate reference material. In conclusion, this case demonstrates that a single HPTLC analysis can provide information about identity, purity, and minimum content of markers of an herbal drug.

scholarly journals ADROIT AQUACULTURE SURVEILLANCE SYSTEM

2021 ◽  
Vol 5 (12) ◽  
Author(s):  
Avinash Wilson J ◽  
Anusha P ◽  
Arun P
Keyword(s):  
Internet Of Things ◽  
Rapid Growth ◽  
Mobile Application ◽  
Surveillance System ◽  
Well Being ◽  
Internet Of Everything ◽  
Set Up ◽  
And Control ◽  
Growing Population

Aquaculture is one of the indispensable fields that helps in the chain of nourishment by feeding the world’s growing population, with 93.6 million metric tons to meet the world’s seafood needs by 2030. Internet of Things (IoT) or Internet of Everything is a blooming paradigm that changes the way of interaction with the environment, which has global attention of the industries in its rapid growth. Incorporating the IoT in the observation of seafood cultivating procedures can improve the productivity and supportability while upgrading the business with the next generation technologies. In Aquaculture, a handful of units are set-up in the deep seas, while the majority of the units are set inland. In inland offices, the ocean organisms are cultured in tanks that can change in volumes and materials. In such cases where profitable aquaculture is done, numerous endeavors are taken to augment the well-being of the sea creatures. Here, we are proposing an exceptionally beneficial aquaculture framework, designed for the aquafarming unit employments, for observing the quality of the water, controlling the system’s irregularity and providing real-time updates to the aqua-farmer. The Aqua-Farmer can surveille the units and control the water circulation remotely through a mobile application.

scholarly journals Review on Standardization Parameters of Churna

2017 ◽  
Vol 5 (5) ◽  
Author(s):  
Dipika R. Turankar ◽  
Sneha Kubde
Keyword(s):  
Quality Control ◽  
Plant Material ◽  
Analytical Techniques ◽  
Quality Assurance Program ◽  
Herbal Drugs ◽  
Control Test ◽  
Chemical Profile ◽  
Ayurvedic Drugs ◽  
Quality Control Test

Ayurved has a long and strong heritage use of  Polyherbal drugs and formulations to treat various diseases. Standardization of Ayurvedic formulations is an important step for the establishment of a consistent biological activity, a consistent chemical profile or simply a quality assurance program for production and manufacturing of herbal drugs. It is a burning topic in Ayurvedic drug industry nowadays. Tremendous work is going on for standardization of Ayurvedic drugs to prove its reproducibility, compatibility and safety on modern parameters.                    Concept of churna is well established in Ayurvedic pharmaceutics for therapeutic purposes as well as for production of other formulations. There is sound description of its various method of preparation along with shelf life period in Ayurveda. Implication of latest analytical techniques is the demand of time to standardize different churna. Plant material may vary in physiochemical content and therefore in its therapeutic effect; according to different places of collection, with different times in a year for collection, with collection at the same time and places but in different years and with a particular medicinal plant. Adding to this variability is the fact that in herbal medicine several plants may be used together in the same preparation. It is very important that a system of standardization is established for every medicine in the market because the scope for variation in different batches of medicine is enormous. This means that there should be a quality control test for the entire preparation to ensure quality of the product.

scholarly journals QUALITY OF BIM–GIS CONVERSION

2019 ◽  
Vol IV-4/W8 ◽  
pp. 35-42 ◽  
Author(s):  
F. Biljecki ◽  
H. Tauscher
Keyword(s):  
Quality Control ◽  
Systematic Errors ◽  
Discussion Paper ◽  
3D City Models ◽  
Empirical Results ◽  
Potential Impact ◽  
Set Up ◽  
City Models

<p><strong>Abstract.</strong> Much work has been done on quality of geoinformation and interoperability between BIM and GIS. However, the intersection of the two – quality control of the conversion between BIM and GIS – remains uncharted. This discussion paper, based on empirical results, is one of the first steps towards mapping out a framework on errors and quality control in the context of BIM–GIS interoperability. In our work we focus on the conversion from IFC to CityGML, identifying several systematic errors potentially common and/or exclusive to the context of BIM–GIS conversion. Besides exposing several faults pertaining to IFC-sourced 3D city models, we discuss their taxonomy and their potential impact when engaged in applications. This paper is also relevant with respect to the growing popularity of conversion between IFC and CityGML, potentially aiding others to avoid many of the errors that can occur in the process and establishing directions to set up a benchmark to assess the performance of the interoperability workflows.</p>

scholarly journals Pharmaceutical Quality of Antimalarial Drugs: Quinine Sulfate and Artemether/lumefantrine Tablets Sold on Bukavu Market 

2021 ◽  
Author(s):  
Aladin Ombeni Mahano ◽  
Aline Zawadi Mahano ◽  
Nelson Hendwa Cubaka ◽  
Félicien Mushagalusa Kasali ◽  
Benjamin Bavurhe Zirirane ◽  
...  
Keyword(s):  
Quality Control ◽  
Plasmodium Species ◽  
Antimalarial Drugs ◽  
Quinine Sulfate ◽  
Sub Saharan Africa ◽  
Pharmaceutical Quality ◽  
Pubmed Search ◽  
Sub Saharan ◽  
Set Up

Abstract Background: Malaria is a tropical parasitic disease caused by Plasmodium species, mainly falciparum, transmitted by the female Anopheles mosquito, strongly affecting sub-Saharan Africa and Indian areas. Generic antimalarial drugs sold in these regions require tighter quality control as counterfeiting has grown more and more out of control. The study aimed to analyze the pharmaceutical quality of Quinine sulfate and Artemether/Lumefantrine tablets marketed in Bukavu city compared to current trends in other African cities. Methods: We set up 13 simple TLC and UV spectrometric quality-control tests and applied them to analyze five Quinine brands divided into 12 batches and two Artemether/Lumefantrine brands divided into 12 batches. Quality scores were expressed as a percentage of compliance with each or the whole set of 13 tests. The samples were collected from community pharmacies and ambulatory street vendors. For comparison, available literature data related to the subject was retrieved from Google Scholar and PubMed search. Results: The analysis showed 16.6% of QS batches failed quality specifications concerning hardness, friability, and uniformity of mass; 66.6% failed the disintegration test; 33.3% did not contain quinine, and 8.33% had an active ingredient other than quinine. Only 3 batches exhibited a global score >90%. For Artemether/Lumefantrine, 93% of batches had an acceptable quality score >90%. Conclusion: The findings strongly support literature data from many countries. Simple TLC procedures may help to detect any low-quality generics to avoid microbial resistance and guarantee the health of the population. Pharmacists and regulatory authorities are alerted to the circulation of low-quality generic quinine preparations in the country.

scholarly journals Cohort profile: the SHoT-study, a national health and well-being survey of Norwegian university students

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025200 ◽  
Author(s):  
Børge Sivertsen ◽  
Hege Råkil ◽  
Espen Munkvik ◽  
Kari Jussie Lønning
Keyword(s):  
Mental Health Problems ◽  
Well Being ◽  
Related Information ◽  
Wide Range ◽  
Health Related ◽  
Health Quality ◽  
Set Up ◽  
Reported Data ◽  
Mental And Physical Health

PurposeThe SHoT study was set up as a national student health survey for higher education in Norway, conducted at 4-year intervals. The dataset comprises a wide range of self-reported data covering information on mental and physical health, quality of life, health-related behaviours as well as more specific study-related information.ParticipantsThe SHoT studies conducted so far in 2010, 2014 and 2018, included 6053, 13 525 and 50 054 fulltime students (aged 18–35), respectively.Findings to dateThe main results from the first two waves have been published in three comprehensive Norwegian reports, with the most important finding being an increase in mental health problems (HSCL-score ≥2.0) among Norwegian college students from 2010 (16%) to 2014 (21%) to 2018 (29%).Future plansThe next SHoT study will be conducted in 2022, 2026 and so on. Starting from 2018-study, the survey data can also be linked to several national registers.

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