Illicit Manufacturing Research Articles

Investigating the Illicit Manufacture of Pharmaceutical Drugs in Sri Lanka-A Case Study on the Underworld of Counterfeit Drugs

The pharmaceutical drug industry is engaged in the research, development, manufacture and marketing of drugs and medications, which plays a major role in the healthcare industry. The global demand for the pharmaceutical drugs is on the rise, and unfortunately there is a concurrent increase in the illicit production of these drugs worldwide. This surge can be attributed to factors such as high demand, potential for profit, weak regulatory oversight and desire to exploit gaps in the legal market. Despite pharmaceutical drugs are intended for the treatment of medical conditions and pain relief, there is growing trend of illicit drug abusers to misusing these substances. Reports indicate a significant number of unlicensed pharmacies in Sri Lanka, but fewer accounts of illicit manufacturing of pharmaceutical drugs. In April 2023, the Police Narcotic Bureau officers arrested a building in a densely populated area in Colombo, Sri Lanka, suspecting it to be a clandestine laboratory for the production of illicit drugs. Subsequently, the Government Analyst of Sri Lanka was tasked with investigating the suspected clandestine laboratory. A team of forensic analysts from Government Analyst’s Department (GAD) visited the site, scrutinized the location, examined the equipment and chemicals and collected samples for further analysis. Although the clandestine laboratory was abandoned at the time of visit, evidence of machinery used for filling capsules, various chemicals, chemical glassware and other equipment were observed. Preliminary tests for illicit drugs and handheld Raman Spectroscopy testing were conducted at the scene. Gas Chromatography – Mass Spectroscopy (GCMS) was performed on the collected samples in the GAD laboratory. The analysis revealed the samples collected from the clandestine laboratory contained the substances considered pharmaceutical drugs namely, Tramadol, Lidocaine, Niacinamide, Menthol and Chlorpheniramine.

Small Arms and Light Weapons Proliferation: Implications for Sahel Regional Security

The study examined small arms and light weapons proliferation and its implications for Sahel regional security. The study adopted institutional theory propounded by Meyer John and Rowen Brian. It adopted Ex-post facto research design, data for the study were sourced through secondary sources and analyzed using content analysis. The study discovered that the Sahel region's porous borders make it simple for illicit traffickers to smuggle small arms and light weapons because transnational criminal organisations and armed groups are very mobile in uncontrolled border regions. The study recommended among others that; states in the region should intensify efforts towards strict monitoring and management of local illicit manufacturing of firearms.

Creating an Assessment Indicator of Quality Culture Development in the Generic Pharmaceutical Industry in Japan.

In the past few years, there have been several instances of illicit pharmaceutical manufacturing in Japan, and there is a growing awareness of the importance of corporate compliance and pharmaceutical manufacturing and quality controls. One cause of illicit manufacturing is the inadequate development of quality culture. This study focuses on the degree of quality culture development in Japanese pharmaceutical companies manufacturing generic drugs. Because no evaluation index for Japan can visualize the degree of quality culture development in each company, this study sought to establish this index to utilize it as a tool for evaluating the degree of quality culture development that would enable each company to continuously monitor and improve its own. We conducted a questionnaire survey among Japan Generic Medicines Association members to evaluate the degree of their quality culture development. The questionnaire contained 28 questions in five evaluation categories. Potential indicators of quality culture development included "Employee growth and satisfaction"; "Management commitment"; "Improvement activities"; "Communication"; and "Environment, health, and safety." We obtained 294 responses from 37 Marketing Authorization Holder (MAH) and 61 manufacturing sites. Respondents were classified by roles of management, manager, and nonmanager. The results confirmed the current status of quality culture development efforts, showing that important messages such as the corporate philosophy as communicated by the management is well known, awareness of quality culture development level differs by role, and appropriate resources are not adequately allocated to employees or facilities. Based on the results, use of the index of quality culture development helped to make relative comparisons and visualize the areas to be addressed for quality culture development. This study established and visualized the index for the degree of quality culture development in domestic generic drug manufacturing companies and we hope this indicator becomes a useful tool for evaluating a company's quality culture development level.

Quality culture and knowledge management in the Japanese pharmaceutical industry - A cross-sectional study and case report.

Illicit pharmaceutical manufacturing, affecting the quality of drug products, has been frequently reported in Japan. Insufficient good manufacturing practice compliance and lack of quality culture in some pharmaceutical companies have been suggested as the underlying reasons for such cases. We aimed to focus on knowledge management and fostering of quality culture in pharmaceutical companies in Japan to understand their current situation and find a strategy for the availability of high-quality reliable pharmaceutical products. A wide-ranging questionnaire survey was conducted to understand the issues related to knowledge management and fostering of quality culture across pharmaceutical companies in Japan. A published investigation report on an illicit manufacturing case was closely examined by organizing the available facts using the diagram. Based on 395 responses to the questionnaire survey, we found that although pharmaceutical companies understand the importance of knowledge management and quality culture, issues exist in their operational methods. A total of 94% of the respondents agreed that they mentioned ″knowledge management″ as an enabler of the Pharmaceutical Quality System of ICH Q10, and 98% of the respondents accepted that insufficient fostering of quality culture leads to corporate risk. However, the survey revealed that many companies are struggling with this approach. Based on a report on an illicit manufacturing case, we analyzed the direct causes of misconduct and prepared a systematic summary that can be easily comprehended. Comparison of the illicit manufacturing case report with our questionnaire results suggests that many pharmaceutical companies do not regard the misconduct case as a situation that could occur in their company. With the revision of the Pharmaceuticals and Medical Devices Act and good manufacturing practice Ministerial Ordinance, we advocate the need for all employees of pharmaceutical companies to reconsider the priorities of their companies from the patient perspective.

Authenticity in Criminal Law, Criminalistics and Forensic Science

The authenticity of products, documents and some other objects is of paramount importance in all areas of human activity. Illicit manufacturing of the counterfeit goods, documents, money, and a number of other objects entails legal liability, including criminal. The questions about authenticity are commonly put before experts when appointing several forensic examinations: handwriting, traceological, commodity, materials, substances and products analysis. The techniques for forensic expert authenticity verification of a significant part of the objects require further improvement. The article reviews the objects, the forgery or falsification of which entails criminal liability, as well as the methods to establish the authenticity in criminalistics and forensic science. The authors also analyze the features of scientific substantiation of conclusions about authenticity in forensic examinations, and the questions of the evaluation of the expert opinions that resolved the issue in criminal cases. The article provides some examples of unique authenticity studies from the history of forensic science, as well as data on some contemporary studies of rare cultural objects. The authors highlight the need to further develop forensic methods that have become relevant concerning new objects known to contain deliberately false information.

Compliance of the Criminal Legislation of Ukraine with the UN Protocol on Firearms

Problems with regulating the trafficking of weapons and ammunition emerged in Ukraine after the collapse of the Soviet Union. The Soviet military left behind a large number of small arms, light weapons and ammunition, much of which did not have proper (in some cases any whatsoever) inventory control and accounting. The purpose of the study is to find the best models of criminal liability for illicit manufacturing and trafficking of firearms in Ukraine, its parts and components and ammunition, taking into account international experience. The study investigates the issue of compliance of the criminal legislation of Ukraine with the United Nations Protocol against the Illicit Manufacturing of and Trafficking in Firearms, Their Parts and Components and Ammunition, supplementing the United Nations Convention against Transnational Organised Crime, and proposes for harmonisation of national legislation with this Protocol. It is concluded that Ukraine needs to adopt the Law "On Arms Trafficking", which, among other things, must clearly define such concepts as "firearms", "parts and components", "ammunition", "illicit manufacturing", "illicit trafficking", etc. which would also be relevant for the criminal legislation of Ukraine.

Protocol against the Illicit Manufacturing of and Trafficking in Firearms, Their Parts and Components and Ammunition

Abstract This article gives an overview of the thrust and core provisions of the Protocol against the Illicit Manufacturing of and Trafficking in Firearms, Their Parts and Components and Ammunition 20 years after its adoption. It examines the interlinkages between illicit firearms trafficking and other crimes and the ability of the Firearms Protocol to address these threats, as well as its ties to other international instruments in this area and existing challenges and responses in its implementation.

ВИКОНАННЯ УКРАЇНОЮ МІЖНАРОДНО- ПРАВОВИХ ЗОБОВ’ЯЗАНЬ У СФЕРІ КРИМІНАЛІЗАЦІЇ НЕЗАКОННОГО ПОВОДЖЕННЯ З ВОГНЕПАЛЬНОЮ ЗБРОЄЮ В КОНТЕКСТІ РЕФОРМУВАННЯ КРИМІНАЛЬНОГО ЗАКОНОДАВСТВА

The article analyzes the compliance of the current criminal legislation of Ukraine with the provisions of international regulations in the field of illicit handling of firearms, in particular the Protocol against the Illicit Manufacturing of and Trafficking in Firearms, Their Components and Ammunition, as amended by the UN Convention against transnational organized crime. Based on the analysis, it is concluded that the current criminal legislation of Ukraine does not fully comply with the provisions of these acts and needs to be amended. In particular, it is pointed out that criminal acts involving illegal handling of smooth-bore hunting weapons, criminalization of illegal handling of the main parts of firearms, etc. are referred to as criminal offenses. It is noted that in terms of its properties and level of public danger, smooth-bore hunting weapons are not inferior to rifles, and the lack of criminal liability for illegal handling of such weapons is a tribute to the times when it was in free circulation.Attention is drawn to the fact that international law requires the criminalization of illicit trafficking in firearms components, but national law provides for criminal liability only for the smuggling of firearms. It is expedient to criminalize the circulation of only the main parts of firearms, as they are necessary for its operation, handling of non-essential parts that are designed to improve the appearance of firearms, their ergonomics, comfort, adaptation to anatomical features of the owner, adaptation to certain tasks. does not pose a significant public danger, and therefore does not require criminalization. It is believed that the objective aspect of the criminal offense under Article 263-1 of the Criminal Code of Ukraine does not cover the destruction of firearms markings, as required by international law, although such an act is socially dangerous because it does not allow the identification of weapons. It is concluded that in order to bring the national legislation in line with the said protocol, it is necessary to: criminalize the illegal handling of smooth-bore hunting weapons, the main parts of firearms; to envisage as a separate act in Article 263-1 of the Criminal Code of Ukraine the destruction of the marking of firearms.

Improved detection of 2C-x and Dox amphetamines – an analytical tool mitigating the environmental impact of their illicit manufacturing, consumption and disposal

Numerous studies made worldwide have indicated that treated and untreated wastewater entering surface waters contains illicit drugs, as a result of human consumption and excretion, illicit manufacturing processes and improper disposal. The results indicate that these wastes, and hence the drugs of abuse exposure, influences the plants and animals and the associated health of streams. The hallucinogenic 2C-x and DOx amphetamines are synthetic psychotropic drugs that have been increasingly reported in seizures, especially in Europe and the US. This paper presents a new combination of artificial intelligence techniques that improves the celerity of the detection of these illicit drugs based on their ATR-FTIR spectra, while decreasing the required computational resources.

Characterization of One Pot methamphetamine laboratories using GC-MS and LC-MS/MS

Following the first discovery in 2007, One Pot methamphetamine laboratories have quickly grown to become the number one method of production across the United States. While One Pot laboratories accounted for over 85% of all clandestine methamphetamine laboratories in the United States from 2012 to 2016, the byproducts formed during these syntheses have remained uncharacterized. This research sought to help assess the public health impacts of these clandestine laboratories and assist in criminal investigations by characterizing One Pot methamphetamine laboratories and identifying byproducts produced during illicit manufacturing. Using gas chromatography mass spectrometry, byproducts were identified in the solid and liquid waste materials, as well as the product salts of One Pot reactions. Once identified, liquid chromatography tandem mass spectrometry was used to quantitate the concentration of these byproducts in all aspects of a completed One Pot methamphetamine reaction. Results demonstrated that designated byproducts could be found in solid waste, liquid waste, and product salts of a One Pot methamphetamine reaction. Two commonly used solvents in One Pot methamphetamine laboratories, diethyl ether and camp fuel, were compared, and results determined that the quantity of byproducts produced during One Pot methamphetamine syntheses were affected by which solvent was used during the reaction. This was the first thorough characterization of the One Pot methamphetamine reaction, and the identification of byproducts in the reaction waste and product salts provides analytical targets to monitor and detect clandestine laboratories.

Criminal Liability for Illicit Trafficking of Radioactive Materials

The nuclear energy use progressively becomes part of the life of every modern person, who more and more faces radioactive materials in medical institutions, in industry. Half of all electricity generated in Ukraine is generated by nuclear power plants. The peculiarities of the nuclear energy use generate appropriate rules for people dealing with radioactive materials. The article analyzes the standards of the Criminal Code of Ukraine, which provides for liability for acts related to the illegal handling of radioactive materials, for violation of the nuclear and radiation safety rules, violation of radiation safety requirements, the threat of theft of radioactive materials, the illicit manufacturing of a nuclear explosive device, abduction or capture of radioactive materials, attack on radioactive materials transportation means. The grounds and peculiarities for bringing to criminal liability have been reviewed, the range of persons who can be prosecuted has been defined. Conditions and grounds for exemption from criminal liability in the absence of a person's criminal intent to use radioactive material are considered. It has been demonstrated that the Criminal Code of Ukraine, by prohibiting certain actions on the illegal radioactive materials handling, ensures protection of the most important social relations and social benefits.

Characterization of a heroin manufacturing process based on acidic extracts by combining complementary information from two-dimensional gas chromatography and high resolution mass spectrometry

A comprehensive two-dimensional gas chromatography mass spectrometric approach (GC×GC-TOFMS) supported by one-dimensional gas chromatography high resolution mass spectrometers (GC-HRTOFMS, GC-FTICRMS) were used to track and confirm characteristic chemical impurities through an authentic illicit heroin production process. Minor and trace compounds present in illicit heroin that result from the used opium and the manufacturing process generate a specific impurity profile of each batch. Based on that, comparative analysis of heroin samples is possible, which can contribute amongst others to the uncovering of links between seized samples. The illicit manufacturing processes are thereby only vaguely described in the literature. Neutral and acidic compounds of the unadulterated impurity profiles at different stages during an authentic manufacturing process of heroin were analyzed by comprehensive two-dimensional gas chromatography – time-of-flight mass spectrometry (GC×GC-TOFMS). The focus was set on 44 compounds, mostly acetylation products, found in the heroin base including four unaltered opium alkaloids and 18 target compounds used within the German Heroin Analysis Program (HAP) at the Bundeskriminalamt (Federal Criminal Police Office; BKA). 12 compounds were found to be preserved unaltered through the manufacturing process. In case of 21 acetylated compounds the original alkaloid is known or could be assigned, i.a. by analysis of separately acetylated standards.Using GC coupled to high resolution time-of-flight mass spectrometry (GC-HRTOFMS), major fragments caused by electron impact ionization (EI) were determined. The corresponding molecular weight was obtained by GC hyphenated to Fourier transform mass spectrometry mass spectrometer (FTICRMS) via atmospheric pressure chemical ionization (APCI) as soft ionization interface.

Introduction: Illicit Firearms Market in Europe and Beyond

Introduction: Illicit Firearms Market in Europe and Beyond

Clinical and criminological characteristics of patients with organic mental disorders who had repeatedly committed socially dangerous acts

Aim. To perform the comparative analysis of clinical and criminological characteristics of patients with organic mental disorders who had repeatedly committed socially dangerous acts. Methods. 79 patients with diagnosed organic mental disorders who had committed socially dangerous acts, declared insane by the court and underwent compulsory treatment determined by the court as out-patients or in general or specialized mental hospital. Patients who had repeated socially dangerous acts after treatment, were included in the group A (19 patients), patients who had not committed any socially dangerous act after treatment, were included in the group B (60 patients). Results. Patients with organic delusional disorder (21 vs 11.6%) and non-psychotic organic disorders (10.5 vs 5%) were more commonly seen in group A compared to group B. The share of patients with dementia was higher in group B (23.3 vs 5.2%). 8 (42.1%) patients of group A were never prosecuted before, compared to 40 (66.7%) patients from group B. Some crimes were registered only in patients who repeatedly committed crimes: sexual crimes - 1 (5.2%), crimes against administrative order - 2 (10.5%), crimes against public security 5.2% (patient was convicted in illicit firearms manufacturing). Psychopathy-like syndrome was the leading syndrome in patients who committed a socially dangerous act in both A and B groups: 11 (57.9%) and 33 (55%) cases respectively. Hallucinatory delusion was diagnosed in 7 (36.8%) of group A patients and in 17 (28.3%) of group B patients. Majority of the group A patients had further committed only one crime after treatment - 11 (57.9%), 5 (26.3%) committed 2-3 crimes, 3 (15.8%) patients - over 3 crimes. The time gap between the first and further compulsory treatment was between 1 and 3 years in most of the cases (11 patients, 57.9%). 4 (21%) patients were readmitted for repeated compulsory treatment within 1 year, 3 (15.8%) were readmitted from 3 to 5 years and 1 (5.3%) from 5 to 8 years after the initial treatment. Conclusion. There are a number of factors influencing the criminal behavior and re-committing socially dangerous acts in future. Despite the small sample size, it should be noted that patients with dementia do not repeat socially dangerous acts.

Drogas potenciadoras para la búsqueda de la perfección

The emerging threat to public health posed by the use of human enhancement drugs has remained largely unrecognised. In attempts to become stronger, happier or smarter, or to look thinner, younger or more beautiful, people are turning to a diverse range of pharmaceuticals. The widespread availability of drugs with the potential to improve human attributes, appearance and abilities has generated a new and growing audience of users. Unlike users of drugs such as heroin, cocaine etc, users of human enhancement drugs do not necessarily perceive themselves as 'drug users'. Those attracted to these drugs may have little or no knowledge or understanding of the physical or psychological harm associated with these substances or their potential for addiction. In addition to the potent effects of many human enhancement drugs, there are considerable risks associated to the clandestine nature of the market. The growing number of untested, banned or adulterated drugs and the lack of safeguards and quality assurance in the illicit manufacturing process has resulted in serious harms and fatalities. The ease with which pharmaceuticals can be manufactured and distributed, combined with the significant profits that can be made from the illicit market, has resulted in a growing challenge for policy makers and health systems in many countries. This editorial aims to raise awareness of this emerging drugs situation and provide a brief overview of some of the drugs and their associated risks.

Lead Encephalopathy in an Infant Mimicking a Neurometabolic Disorder

We report the case of a 7-month-old child who presented with regression of milestones, seizures, altered sensorium, and vomiting. An elder sibling had died of similar complaints. Lead encephalopathy was considered because of presence of microcytic hypochromic anemia and dense metaphyseal bands on wrist radiogram. Magnetic resonance imaging (MRI) of the brain revealed diffuse dysmyelination involving both periventricular and subcortical white matter. Such diffuse changes have not been described previously. The child's father was operating an illicit lead-acid battery manufacturing unit at home. The child was subjected to chelation therapy, which was accompanied by environmental exposure source modification. He showed significant improvement. Our case highlights the importance of taking a detailed occupational history and considering lead poisoning in the differential diagnosis of encephalopathy of unidentifiable cause.

Evaluation of Children Removed From a Clandestine Methamphetamine Laboratory

The illicit manufacturing and use of methamphetamine continues to be a significant and growing problem in the United States. Children are often found in homes where this activity is occurring and are affected by it on many levels. This article will provide background information on the manufacturing of methamphetamine, including classes of chemicals involved; hazards inherent to the manufacturing process and its effects on those living in a clandestine laboratory; and the approach to children found in these homes and their medical care. The focus will be on care in the acute settings with the introduction of a protocol for evaluation and follow-up of these patients.

Evaluation of Children Removed From a Clandestine Methamphetamine Laboratory

The illicit manufacturing and use of methamphetamine continues to be a significant and growing problem in the United States. Children are often found in homes where this activity is occurring and are affected by it on many levels. This article will provide background information on the manufacturing of methamphetamine, including classes of chemicals involved; hazards inherent to the manufacturing process and its effects on those living in a clandestine laboratory; and the approach to children found in these homes and their medical care. The focus will be on care in the acute settings with the introduction of a protocol for evaluation and follow-up of these patients.

Isotopic Fractionation of Carbon and Nitrogen During the Illicit Processing of Cocaine and Heroin in South America

The forensic application of stable isotope analysis to cocaine and heroin for geolocation of exhibits must take into account the possible enrichment and/or depletion of 13C and 15N during the illicit manufacturing process. Continuous-flow elemental analysis-isotope ratio mass spectrometry was utilized to measure changes in the stable isotope ratios of carbon and nitrogen for both cocaine (N = 92) and heroin/morphine (N = 81) exhibits derived from illicit manufacturing processes utilized by South American clandestine chemists. In controlled settings in South America, there was no siginficiant carbon isotope fractionation during the conversion of cocaine base to cocaine HCI using current illict methodologies. In contrast, nitrogen isotope fractionation for this conversion was 1 per thousand. There was a kinetic carbon isotope ratio fractionation during the acetylation of Colombian morphine to heroin and as a result heroin exhibits will almost always have more negative delta13C values than the original morphine. There was an isotopic fractionation against 15N during the acetylation of morphine base to heroin base, but this effect was not expressed since all of the heroin base was precipitated during the manufacturing process. However, the clandestine process of converting a single batch of heroin base usually involved two consecutive crops of heroin HCl and the latter crop was isotopically depleted as expected from a Rayleigh distillation process. When heroin was deacetylated to morphine, the morphine produced resulted in delta13C values that were indistinguishable from the original morphine. The kinetic carbon isotope fractionation factor for the South American process of morphine acetylation was -1.8 per thousand, allowing calculation of the delta13C values of the acetic anhydride from deacetylated heroin delta13C values.

Designer Androgens in Sport: When Too Much Is Never Enough

The recent identification of tetrahydrogestrinone (THG), the first true "designer androgen," as a sports doping agent reflects both an alarmingly sophisticated illicit manufacturing facility and an underground network of androgen abusers in elite sports, as well as the still untapped potential for designer androgens in medicine. Never marketed, THG was apparently developed as a potent androgen that was undetectable by conventional International Olympic Committee-mandated urinary sports doping tests. As a potent androgen and progestin with unspecified contaminants, its distribution for use at high doses without any prior biological or toxicological evaluation poses significant health risks. Yet this diversion of science also highlights the prospect of designer androgens for use in human medicine. Designer androgens also offer the possibility of tissue-specific effects enhancing the beneficial effects of androgens while mitigating the undesirable ones. Further developments require better understanding of the postreceptor tissue selectivity of androgens, comparable to the mechanism underlying that of partial estrogen agonists (SERMs). This experience highlights the ongoing need for vigilance to detect novel drug doping strategies in order to maintain fairness and safety in elite sports. This will require the deployment of generic catch-all tests, such as sensitive and specific in vitro androgen bioassays, coupled with the development of mass spectrometry-based tests for specific doping agents.