A call for revamping the policy on import process of anticancer drugs in Pakistan

2021 ◽  
Vol 71 (10) ◽  
pp. 2483-2486
Author(s):  
Ehsan Elahi ◽  
Adeel Siddiqui
Keyword(s):  
Anticancer Drugs ◽  
Generic Drugs ◽  
Raw Material ◽  
Multiple Sources ◽  
Drug Regulatory Authority ◽  
Pharmaceutical Ingredients ◽  
Cancer Care Facilities ◽  
Costly Treatment ◽  
Price Hike ◽  
Costs Of Treatment

Madam, cancer therapy in Pakistan is a costly treatment financially exhausting patients and their caregivers. Due to the sky high costs of treatment, there is a lack of cancer care facilities in the country. The sale and regulation of anticancer drugs and biologics is controlled by the Drug Regulatory Authority Pakistan (DRAP). DRAP is responsible for granting No Objection Certificate (NOC) to import unregistered drugs either for the patient or the institutional use of a hospital, both subject to renewal. This process can take up from a minimum of 10 days to a maximum of 30 days, for an individual patient it may take up to 1 to 3 days. This was a task almost unachievable before the formation of DRAP. (1,2) In Pakistan, there have been challenges such as price hike in local medicines (3), anticancer drug shortages due to unavailability of active pharmaceutical ingredients (4) as well as COVID19 related raw material and drug availability (5). The average time for importing an unregistered drug from outside the country is about 4-6 weeks, which may be further delayed for months. Our discourse aims to bring attention to this issue, as delay in initiation or continuation of treatment significantly reduces the chances of the patient’s survival with time, which is something they do not have much of We propose the following steps as part of making this process easier for the stakeholders and patients alike: Reduce the time of import of unregistered drugs to 1 week (revamp import process/fast-track) Decentralize authority to provincial DRAP to reduce the burden Once an unregistered drug is imported, it should be registered in the list of special status drugs to fasten future process Facilitate the cancer centers on procurement of import medicines. Hospitals who face inventory challenges- should be able to easily borrow an imported medicine item from a nearby hospital where it is available. Exempt custom duties and taxes on import of such medicines Encourage local manufacturing of generic drugs Abolish regularity duties on import of raw material of said medicines for the manufacturer of such generic drugs Allow multiple sources of drug import Trainee program for DRAP officials dealing with biologics Derive an online process/portal to communicate and update patients and hospitals for delays and implement procedures to deal with such issues (6). Continuous...

scholarly journals Production of Unsaturated Fatty Acids Concentrate Tablets from Sardinella sp. Oil

2020 ◽  
Vol 147 ◽  
pp. 03008
Author(s):  
Rodiah Nurbaya Sari ◽  
Hari Eko Irianto ◽  
Ema Hastarini
Keyword(s):  
Fatty Acids ◽  
Flow Rate ◽  
Unsaturated Fatty Acids ◽  
Dosage Forms ◽  
Raw Material ◽  
Solid Dosage Forms ◽  
Fixed Angle ◽  
Pharmaceutical Ingredients ◽  
Solid Dosage ◽  
Size Uniformity

Tablets are medicinal ingredients in solid dosage forms which are usually prepared with suitable pharmaceutical ingredients. In this study, unsaturated fatty acids concentrate from Sardinella sp. oil was used as raw material and then it was microencapsulated. The microcapsule was formulated into a tablet with proportion of 250 mg concentrated unsaturated fatty acids for each 450 mg tablet. Tablet granules were analyzed for compressibility, flow rate, and fixed angle. While, the tablets were determined for weight uniformity, released time, hardness, and tablet size uniformity. The results showed that compressibility, flow rate and fixed angle of the tablet granules were 5.6%; 10.36 g/sec; and 32.4° respectively. Tablets had 447.85 mg weight uniformity; 48’12” released time; and 0.775 kg hardness. In addition, the tablet size uniformity with diameter 10 mm and thickness 4 mm was 2.5. Based on the pharmacopoeia, the tablets of unsaturated fatty acids concentrate from Sardinella sp. oil had met these requirements, but optimization was still needed for improving the released time and hardness of the tablet.

scholarly journals Generic Drugs Not as Safe as FDA Wants You to Believe

2019 ◽  
Vol 54 (3) ◽  
pp. 283-286 ◽  
Author(s):  
C. Michael White
Keyword(s):  
United States ◽  
Prescription Drugs ◽  
Generic Drugs ◽  
The United States ◽  
Drug Supply ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Time Horizons ◽  
Long Time ◽  
Generic Products

Food and Drug Administration (FDA) rules for the production of prescription drugs are very rigorous and, if followed, guarantees a safe drug supply. For many years, foreign manufacturers have produced substandard generic products and active pharmaceutical ingredients and shipped them into the United States. If the FDA had inspected them with the same rigor as they do domestic manufacturers, they would have found many of these egregious deviations from ethical manufacturing much earlier. Although the FDA is finally stepping up the number of inspections, their current processes still rely on preannounced inspections with long time horizons, so quality issues can be temporarily corrected and documents altered or destroyed.

scholarly journals Evaluation of Ionic Liquids and Ionic Liquids Active Pharmaceutical Ingredients Inhibition in Elastase Enzyme Activity

Molecules ◽  
2021 ◽  
Vol 26 (1) ◽  
pp. 200
Author(s):  
Fátima A. R. Mota ◽  
Sarah A. P. Pereira ◽  
André R. T. S. Araujo ◽  
M. Lúcia M. F. S. Saraiva
Keyword(s):  
Enzyme Activity ◽  
Ionic Liquids ◽  
Sodium Salicylate ◽  
Raw Material ◽  
Human Neutrophil Elastase ◽  
Active Pharmaceutical Ingredients ◽  
Diagnostic Biomarker ◽  
Significant Information ◽  
Pharmaceutical Ingredients

Human neutrophil elastase (HNE) is used as diagnostic biomarker for inflammation/infection. In this work, 10 ionic liquids (ILs) and 11 ionic liquids active pharmaceutical ingredients (ILs-APIs) were tested to evaluate the inhibition effect on the activity of porcine pancreatic elastase enzyme, frequently employed as a model for HNE. The insertion of ionic liquids in some drugs is useful, as the insertion of ILs with inhibitory capacity will also slow down all processes in which this enzyme is involved. Therefore, a spectrophotometric method was performed to the determination of EC50 values of the compounds tested. EC50 values of 124 ± 4 mM to 289 ± 11 mM were obtained, with the most toxic IL for elastase being tetrabutylammonium acetate and the least toxic 1-butyl-3-methylimidazolium acetate. Moreover, sodium salicylate (raw material) presented the lower and benzethonium bistriflimide the higher EC50 when compared with all the IL-APIs tested. This work provides significant information about the effect of the studied IL and IL-APIs in elastase enzyme activity.

scholarly journals The way of the pharmaceutical ingredients to the finished pharmaceutical form

2018 ◽  
Vol 12 (2) ◽  
pp. 24-31
Author(s):  
Bence Rafael ◽  
Nóra Kuruczleki ◽  
József Gál
Keyword(s):  
Material Handling ◽  
Raw Materials ◽  
Good Manufacturing Practice ◽  
Raw Material ◽  
No Production ◽  
Pharmaceutical Ingredients ◽  
Correct Execution ◽  
Pharmaceutical Form ◽  
Pharmaceutical Manufacture ◽  
Logistics Activity

The modern pharmaceutical industry is a strictly controlled area. Both national and international rules apply, but none of these deals with logistical issues arising from the manufacture of the product. Following the path of a drug, it is possible to get acquainted with the problems that arise and their solution. The drug is much more than a common product. The drug is a product of confidence, which is provided with information. It defines its quality as well, to comply with the relevant directives and standards in the manufacture of, and that the enclosed information is sent to the user. This requires the manufacturer, the distributor and the user to comply with it. There is no production without material handling, but GMP (Good Manufacturing Practice) does not yet have a chapter on logistics. References to handling raw materials and finished products can be found in the corresponding GMP chapters, the responsibility of the correct execution are borne by the manufacturer. In this case, the effect of the common sense prevails exponentially, keep the medicine in mind and it has to be done, that no loss, no quality deterioration is not caused by the transport, handling of such loads, storage. It is typical that the raw material and the finished product are going through the entire site during the pharmaceutical manufacture. Starting from the warehouse, it runs through the manufacturing facilities, on the packaging, and some units go to the lab, so that eventually, in medicine form returns to the warehouse, from where it goes further in the supply chain through the pharmacies to the patients. In our study we examine the logistics activity and problems of a small pharmaceutical company and tasks to be solved presented in the light of the theory.

Methodology to screen and evaluate cost/survival of anticancer drugs in advanced/metastatic gastrointestinal cancers.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 196-196
Author(s):  
Helmy M. Guirgis
Keyword(s):  
Quality Of Life ◽  
Anticancer Drugs ◽  
Generic Drugs ◽  
Progression Free Survival ◽  
Gastrointestinal Cancers ◽  
Free Survival ◽  
Colon Cancers ◽  
Pancreatic Cancers ◽  
Gi Cancers

196 Background: There is a paucity of methods to screen cost/survival of anticancer drugs in 1st-line advanced/metastatic (adv/met) gastrointestinal (GI) cancers. Methods: Average whole prices (AWP) in United States dollars (US $) of evaluated drugs for the entire course were divided by previously reported median survival gain in days. Generic drugs were given flat total costs of up to $750. A 100% crude score was assigned to cost/survival/day < $25 and 0% to cost/survival/day $750. Results were expressed as % scores of cost/progression-free-survival (cost/PFS) or cost/overall survival (cost/OS). Guidelines were suggested for corrections; lack of OS - 10%, adverse effects (AEs) - 0 -15%, Quality of life (QoL) - 0-10% and administration and preparation (A and P) - 0-10%. Results: Generic drugs scored 80%-90% in pancreatic and biliary followed by Trastuzumam 60% in gastric and Bevacizumab 0-40% in colon cancers (Table 1). Conclusions: Methodology based on limits on cost/survival/day was developed to screen anticancer drugs in GI cancers. Generic drugs in bilary and pancreatic cancers scored the highest. [Table: see text]

scholarly journals In-Depth Understanding of Granule Compression Behavior under Variable Raw Material and Processing Conditions

Pharmaceutics ◽  
2022 ◽  
Vol 14 (1) ◽  
pp. 177
Author(s):  
Tibor Casian ◽  
Sonia Iurian ◽  
Alexandru Gâvan ◽  
Alina Porfire ◽  
Anca Lucia Pop ◽  
...  
Keyword(s):  
Microcrystalline Cellulose ◽  
Raw Materials ◽  
Binding Capacity ◽  
Raw Material ◽  
Sensitivity Index ◽  
Processing Conditions ◽  
Water Binding ◽  
Pharmaceutical Ingredients ◽  
Compression Properties ◽  
Addition Rate

Tablet manufacturing involves the processing of raw materials through several unit operations. Thus, the mitigation of input-induced variability should also consider the downstream processability of intermediary products. The objective of the present work was to study the effect of variable raw materials and processing conditions on the compression properties of granules containing two active pharmaceutical ingredients (APIs) and microcrystalline cellulose. Differences in compressibility and tabletability of granules were highlighted in function of the initial particle size of the first API, granule polydispersity and fragmentation. Moreover, interactions were underlined with the atomizing pressure. Changing the supplier of the second API was efficiently controlled by adapting the binder addition rate and atomizing pressure during granulation, considering the starting crystal size. By fitting mathematical models on the available compression data, the influence of diluent source on granule compactibility and tabletability was identified. These differences resumed to the ease of compaction, tableting capacity and pressure sensitivity index due to variable water binding capacity of microcrystalline cellulose. Building the design space enabled the identification of suitable API types and the appropriate processing conditions (spray rate, atomizing pressure, compression force) required to ensure the desired tableting performance.

scholarly journals Acceptability and barriers to implementation of N-of-1 tests in Ethiopia - a qualitative study

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Chalachew Alemayehu ◽  
Geoff Mitchell ◽  
Jane Nikles ◽  
Abraham Aseffa ◽  
Alexandra Clavarino
Keyword(s):  
Qualitative Study ◽  
Regulatory Authority ◽  
Generic Drugs ◽  
Clinical Care ◽  
Cost Effective ◽  
Analysis Data ◽  
Institutional Review Board ◽  
Therapeutic Equivalence ◽  
Drug Regulatory Authority ◽  
Institutional Review

Abstract Background Locally produced generic drugs offer a cost–effective alternative to imported drugs to treat patients in Ethiopia. However, due to a lack of bioequivalence testing, additional assurance tests are needed to build trust in cheaper, locally made drugs. By testing bioequivalence of local drugs to gold standard, N-of-1 tests have the potential to promote patient centred quality use of medicines. Method We sought to assess the acceptability of, and explore barriers to, conducting N-of-1 tests to evaluate local medicines in a resource limited clinical setting. We conducted a descriptive qualitative study, analysing four focus group discussions and five key informant interviews. Participants were senior drug regulatory authority members, institutional review board members, physicians and patients. All interviews were audio taped and transcribed verbatim. Patient interviews were conducted in Amharic and translated to English prior to analysis. Data analysis used an inductive, thematic process. Results Five major themes were identified; (1) Appropriateness of N-of-1 tests to determine the therapeutic equivalence of local drugs, (2) N-of-1 therapeutic equivalence tests: clinical care or research? (3) Ethical and regulatory requirements (IRB), (4) Potential barriers to implementing N-of-1 tests and (5) Possible solutions to identified challenges. The study demonstrated considerable support for using N-of-1 tests for clinical equivalence studies between local and imported medicines, but important impediments were very likely to impact the feasibility of conducting N-of-1 tests in Ethiopia. Key informants from the regulatory authority did not support additional tests of local drugs. There were also mixed opinions regarding ethical requirements for conducting N-of-1 tests. The Institutional Review Board (IRB) members believed that IRB approval was sufficient to conduct N-of-1 tests, however, the regulatory authority members considered that N-of-1 tests constituted a clinical trial, and required approval at the regulatory level. Conclusion This study showed that there were key uncertainties that could impact the feasiblity of using N-of-1 testing local drugs in Ethiopia. Therefore, a number of protocol amendments to address contextual threats and regulatory challenges, would be needed before progressing to conducting these tests.

scholarly journals Archaeometric studies on early medieval silver jewellery from Central and Eastern Europe

2019 ◽  
Vol 11 (12) ◽  
pp. 6705-6723
Author(s):  
Ewelina Miśta-Jakubowska ◽  
Renata Czech Błońska ◽  
Władysław Duczko ◽  
Aneta M. Gójska ◽  
Paweł Kalbarczyk ◽  
...  
Keyword(s):  
Inductively Coupled Plasma ◽  
Raw Material ◽  
Isotopic Ratios ◽  
Multiple Sources ◽  
Linear Discriminant ◽  
Inductively Coupled ◽  
Cu Content ◽  
Plasma Mass Spectrometry ◽  
Technological Study ◽  
Lead Isotopic Ratios

Abstract Scanning electron microscopy with X-ray microanalyses (SEM-EDX) was used for a technological study of silver jewellery from three hoards found in Poland. The assemblage consists of 26 artefacts from the period of formation of the first Polish state (900–1039 AD) and can be divided into three groups: West Slavic, post-Moravian and Scandinavian. Research results provide information concerning techniques used for granulation ornament and the provenance of raw silver. Elemental composition changes are manifested mainly by different Cu contents. A higher Cu content was found in solder. The higher Cu content in relation to the morphology of the joining region with visibly spilled granulation demonstrates that the West Slavic beads were produced with the use of metallic soldering. On the other hand, other studied jewelleries are characterised by Cu, Sn, Sb and Zn enrichments in oxidised soldering regions, which implies that they were manufactured with the use of non-metallic soldering. In addition, studies on the provenance of the raw material were made based on the analysis of lead isotopic ratios. For this purpose, laser ablation inductively coupled plasma mass spectrometry (LA-ICP-MS) was used, and the obtained lead isotopic ratios were processed using linear discriminant analysis (LDA). The isotope study demonstrates that all examined artefacts were made using re-melted metal from multiple sources. The most probable sources of silver were ores from Uzbekistan, Afghanistan and Freiberg (Germany).

scholarly journals Kimberley points of Western Australia: Pressure flaking, projections and prestige

2020 ◽  
Vol 7 (1) ◽  
pp. 1-26
Author(s):  
Tim Ryan Maloney
Keyword(s):  
Western Australia ◽  
Social Values ◽  
Raw Material ◽  
Stone Tool ◽  
Multiple Sources ◽  
Archaeological Data ◽  
Social Prestige ◽  
The Social ◽  
Trade And Exchange ◽  
North Western

Kimberley points are pressure flaked bifaces with marginal projections, produced within the last millennium, in north Western Australia. These points were hafted for hunting and fighting in recent times, although there is some suggestion that smaller points tended to be hafted for use in favour of larger points, which were reserved for trade and exchange. Kimberley Points are imbued with strong social signalling and prestige qualities, known from Historic times. This paper examines whether these qualities are reflected archaeologically in their marginal projections produced with pressure flaking; and their morphology and production. Multiple sources of Kimberley Point archaeology, ethnography, and production are critically reviewed. As prestige items, the marginal projections are found to very likely relate to their social value, rather than functional drive, which this study investigates using morphological approaches. Samples from both ethnographic collections and archaeological surface assemblages are analysed. The study finds that biface elongation, length and perimeter length each greatly influenced the number of and size of marginal projections, regardless of raw material. This aspect of production probably reflects the value and social prestige for large serrated points, likely produced by the knapper before an audience in virtuoso displays of pressure flaking. It is conceivable that these complex social practices emerged around 1,000 years ago. This study provides a rare glimpse into the social values of stone tool produces, and links archaeological data to social values in the past.

Shortage of generic neurologic therapeutics

Neurology ◽  
2017 ◽  
Vol 89 (24) ◽  
pp. 2431-2437
Author(s):  
Jacklyn O. Omorodion ◽  
Rami M. Algahtani ◽  
Mark S. Zocchi ◽  
Erin R. Fox ◽  
Jesse M. Pines ◽  
...  
Keyword(s):  
Generic Drugs ◽  
Information Service ◽  
The United States ◽  
Median Number ◽  
Raw Material ◽  
Professional Organizations ◽  
Drug Shortage ◽  
Business Decisions ◽  
University Of Utah ◽  
The Government

Objective:To assess longitudinal trends in shortages of generic drugs used for neurologic conditions over a 15-year period in the United States.Methods:Drug shortage data from the University of Utah Drug Information Service (UUDIS) from 2001 to 2015 were analyzed. Medications were included that were likely to be prescribed by a neurologist to treat a primary neurologic condition or critical for care of a patient with a neurologic condition. Trends in shortage length were assessed using standard descriptive statistics.Results:A total of 2,081 shortages were reported by UUDIS and 311 (15%) involved medications for neurologic conditions. After excluding discontinued products, 291 shortages were analyzed. The median number of neurologic drugs in shortage was 21 per month with a median duration of 7.4 months. During the three 5-year periods of 2001–2005, 2006–2010, and 2011–2015, a median of 12.5, 14, and 45 drugs were in shortage, respectively. A maximum of 50 drugs in shortage was reached in December 2012 and December 2014. By the end of the study period, 30 neurologic drugs remained in shortage. In over half of the shortages, manufacturers did not provide a reason for the shortage. When reported, manufacturing delays, followed by supply/demand issues, raw material shortages, regulatory issues, and business decisions were cited.Conclusions:Continued drug shortages may compromise the care of patients with neurologic conditions. Manufacturers, together with professional organizations, patient advocacy groups, and the government, need to continue to address this issue, which may escalate with a growing burden of neurologic disease.

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