Pharmaceutical Regulation Research Articles

Do No Harm? Unintended Consequences of Pharmaceutical Price Regulation in India

The Drugs (Prices Control) Order of 2013 in India regulated the prices of certain essential and life-saving drugs to ensure their affordability and availability, expecting an increase in sales of those drugs. The authors study the effects of the regulation on sales volumes of each regulated drug using a synthetic control approach with sales data from a comparable country that did not experience a regulatory change. They assess the robustness of the results via multiple empirical approaches to triangulate the findings. Contrary to the order's objectives, they find that sales volumes declined for regulated drugs. Since the order placed restrictions on production levels and on drugs exiting the market, the lowered margins of regulated drugs could have pushed pharmaceutical firms to reduce their marketing expenditures on them. The authors provide evidence of such a reduction using detailing data from a large pharmaceutical firm. The findings illustrate that this shift in detailing adversely affected prescriptions from physicians without formal medical degrees who treat poor and disadvantaged people in India—patients that the order was intended to help the most. A survey the authors conducted shows that these physicians rely on detailing more than medically trained doctors. Taken together, the results provide insights into the strategic actions of firms when faced with regulations, and highlight their unintended consequences. The generalizable nature of the study's findings across a broad set of medications has implications for governmental agencies in terms of the need to account for the entire ecosystem when implementing such regulations.

Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA)

N-Nitrosamine impurities, including nitrosamine drug substance-related impurities (NDSRIs), have challenged pharmaceutical industry and regulators alike and affected the global drug supply over the past 5 years. Nitrosamines are a class of known carcinogens, but NDSRIs have posed additional challenges as many lack empirical data to establish acceptable intake (AI) limits. Read-across analysis from surrogates has been used to identify AI limits in some cases; however, this approach is limited by the availability of robustly-tested surrogates matching the structural features of NDSRIs, which usually contain a diverse array of functional groups. Furthermore, the absence of a surrogate has resulted in conservative AI limits in some cases, posing practical challenges for impurity control. Therefore, a new framework for determining recommended AI limits was urgently needed. Here, the Carcinogenic Potency Categorization Approach (CPCA) and its supporting scientific rationale are presented. The CPCA is a rapidly-applied structure-activity relationship-based method that assigns a nitrosamine to 1 of 5 categories, each with a corresponding AI limit, reflecting predicted carcinogenic potency. The CPCA considers the number and distribution of α-hydrogens at the N-nitroso center and other activating and deactivating structural features of a nitrosamine that affect the α-hydroxylation metabolic activation pathway of carcinogenesis. The CPCA has been adopted internationally by several drug regulatory authorities as a simplified approach and a starting point to determine recommended AI limits for nitrosamines without the need for compound-specific empirical data.

Exploring regulatory flexibility to create novel incentives to optimize drug discovery.

Efforts by governments, firms, and patients to deliver pioneering drugs for critical health needs face a challenge of diminishing efficiency in developing those medicines. While multi-sectoral collaborations involving firms, researchers, patients, and policymakers are widely recognized as crucial for countering this decline, existing incentives to engage in drug development predominantly target drug manufacturers and thereby do little to stimulate collaborative innovation. In this mini review, we consider the unexplored potential within pharmaceutical regulations to create novel incentives to encourage a diverse set of actors from the public and private spheres to engage in the kind of collaborative knowledge exchange requisite for fostering enhanced innovation in early drug development.

Perspectives on systematic capacity building in pharmaceutical regulation for regulators of medical products.

Having a robust, integrated regulatory system is important for ensuring the availability of safe and efficacious medical products of good quality and for protecting public health. However, less than 30% of countries globally have reached the required regulatory maturity level three, with low- and middle-income countries facing challenges in attracting and retaining qualified staff. World Health Organization (WHO) advocates for systematic workforce development, including competency-based education, to address these gaps. We provide perspectives on a systematic approach to capacity building of medicine regulators based on the experience and lessons learnt in developing and piloting the WHO global competency framework for medicine regulators through three scenarios. A systematic approach to capacity building, such as the human performance technology model, can be used to implement the WHO competency framework as part of organizational performance improvement while ensuring that initiatives are well-defined, targeted, and aligned with organizational goals. The competency framework can be used in different contexts, such as improving organization performance for individual regulatory authorities, strengthening regional collaborations, harmonization and reliance on medical products assessment and joint good manufacturing practices inspections of pharmaceutical manufacturers, and developing learning programs for medicine regulators. A competency-based learning approach for regulatory professionals ensures the transfer of learning to the workplace by integrating real-world practices in learning activities and assessments. Further work is required to develop and validate the assessment instruments, apply the competency framework in other contexts, expanding the learning programmes while continuously providing feedback for further refinement of the competency framework and implementation support tools.

Identifying and costing common gaps in Central and West Africa pharmaceutical regulation.

Regulatory systems strengthening is crucial for catalyzing access to safe and effective medical products and health technologies (MPHT) for all. Identifying and addressing common regulatory gaps through regional approaches could be instrumental for the newly incepted African Medicine Agency. This original study sheds light on common gaps among 10 national regulatory authorities (NRAs) and ways to address them regionally. The study used NRA self-assessment outcomes to identify common gaps in four critical regulatory pillars and estimate the cost of addressing them from regional perspectives that aimed at raising the maturity level of regulatory institutions. A cross-sectional study, using the WHO Global Benchmarking Tool (GBT), was conducted between 2020 and 2021 with five NRAs from ECCAS and ECOWAS member states that use French and Spanish as lingua franca. The 10 NRAs operated in a non-formal-to-reactive approach (ML1-2), which hinders their ability to ensure the quality of MPHT and respond appropriately to public health emergencies. Common gaps were identified in four critical regulatory pillars-good regulatory practices, preparedness for public health emergencies, quality management systems, and substandard and falsified medical products-with overall cost to address gaps estimated at US$3.3 million. We elaborated a reproducible method to strengthen regulatory systems at a regional level to improve equitable access to assured-quality MPHT. Our bottom-up approach could be utilized by RECs to address common gaps through common efforts.

Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing.

Medication administration via enteral feeding tubes (EFT) is a necessary practice for patients unable to swallow oral dosage forms due to a medical condition or treatment that affects the ability to swallow or the function of the gastrointestinal tract. Off-label administration of oral drug products via EFT raises concerns for pharmaceutical sponsors, regulators, and healthcare practitioners (HCPs) because of the potential risks this practice introduces to both the patient and the caregiver. These risks can be mitigated by generating data-supported instructions that patients and HCPs can use to ensure safe and accurate administration of oral drug products via EFT. This commentary presents an industry perspective on the testing that should be conducted to enable development of product-specific instructions in the labeling to support or advise against administration of oral drug products via enteral feeding tube. The proposal outlined in this commentary takes a risk-based approach, addressing recommendations from both regulatory agencies as well as considerations for expanding this testing to address needs specific to neonatal and pediatric populations.

Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union.

Pharmaceutical regulation on a global scale is a complex process, with regulatory bodies overseeing various aspects, including licensing, registration, manufacturing, marketing, and labeling. Among these, the USFDA plays a crucial role in upholding public health. The pharmaceutical industry contributes significantly to well-being by developing and distributing therapeutic agents. The journey of evaluating new pharmaceuticals involves meticulous examination through several phases, from safety and efficacy assessments to toxicity evaluation. Drug approval involves submitting New Drug Applications (NDAs) to regulatory agencies like the USFDA and EMA. However, disparities in durations contribute to the phenomenon known as "drug lag." This lag refers to delays in a pharmaceutical product's availability in one market compared to another. Addressing this issue is crucial, given its impact on patient access to treatments. This study aims to analyze the extent of drug lag, focusing on newly approved oncology targeted therapies in Saudi Arabia, the United States, and the European Union. Data for cancer treatments authorized by the USFDA, EMA, and SFDA from January 1, 1997, to December 31, 2022, were collected from regulatory agency websites. The data sources included authorization letters, prescription information, and evaluation documents. We conducted a comparative assessment of drug lag for approved oncology targeted therapies between Saudi Arabia, the US, and the EU. Our analysis identified 135 newly approved oncology-targeted drugs within the specified timeframe. Of these, 71 received approval in all three regions, while disparities were evident in others. The USFDA consistently had the highest number of approved drugs, with 98.5% of drugs initially approved there. In contrast, Saudi Arabia had the lowest number of approved drugs and a significantly longer median drug lag, indicating substantial delays in drug availability. This study highlights the significance of mitigating drug lag to enhance global healthcare outcomes and patient access to innovative therapies. Further research and collaborative efforts are essential to bridging these disparities and promoting equitable healthcare worldwide.

UPLC-TQD-MS/MS Method Validation for Quality Control of Alkaloid Content in Lepidium meyenii (Maca)-Containing Food and Dietary Supplements.

Lepidium meyenii Walp. (Brassicaceae), also known as Maca or Peruvian ginseng, is a common ingredient in food supplements with many claimed health benefits, such as improved endurance, increased energy level, and enhanced sexual properties. Due to potential toxicity of its chemicals, including alkaloids, some regulatory authorities, e.g., in Belgium, Germany, the United States, expressed concerns about the safe consumption of Maca root. However, due to the lack of commercial standards, no established analytical method currently exists for this purpose. The current project focuses on the quantitative determination of potentially toxic alkaloids from Maca. The current study presents the first analytical method for quality control of alkaloid content in Maca-containing food and dietary supplements, assessing the presence of 11 major compounds belonging to three different classes, i.e., imidazole, β-carboline, and pyrrole alkaloids. An accurate, rapid, and sensitive UPLC-TQD-MS/MS method is reported, which was fully validated according to the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and SANTE/11312/2021 guidelines. To ensure the method's applicability and practicability in the absence of primary standards, validation of secondary standards (SSs) alongside primary standards (PSs) was also conducted for imidazole alkaloids. As a result, in Maca raw powder, total alkaloid content was found to vary from 418 to 554 ppm (mg/kg). Furthermore, all quantified imidazole alkaloids were ascertained to be the major alkaloids with the total content from 323 to 470 ppm in Maca raw powder, followed by the β-carboline and pyrrole alkaloids. It was also observed that the commercial preparation of finished products affects the total alkaloid content, evidenced by the large variation from 56 to 598 ppm. Ultimately, from a regulatory point of view, it seems advisible not to request the complete absence of the alkaloids but to impose a maximum level based on safety considerations. In addition to the analytical method, a low-cost, simple, and scalable synthetic scheme of macapyrrolins A, C, and G was reported for the first time.

The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities.

Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product. The objective of this article is to describe the recommendations from participating Bioequivalence Working Group for Generics (BEWGG) members of the International Pharmaceutical Regulators Programme (IPRP) regarding the conduct and acceptance criteria for BE studies of immediate release solid oral dosage forms. A survey was conducted among BEWGG members regarding their BE recommendations and requirements related to study subjects, study design, sample size, single or multiple dose administration, study conditions (fasting or fed), analyte to be measured, selection of product strength, drug content, handling of endogenous substances, BE acceptance criteria, and additional design aspects. All members prefer conducting single dose cross-over designed studies in healthy subjects with a minimum of 12 subjects and utilizing the parent drug data to assess BE. However, differences emerged among the members when the drug's pharmacokinetics and pharmacodynamics become more complex, such that the study design (e.g., fasting versus fed conditions) and BE acceptance criteria (e.g., highly variable drugs, narrow therapeutic index drugs) may be affected. The survey results and discussions were shared with the ICH M13 Expert Working Group (EWG) and played an important role in identifying and analyzing gaps during the harmonization process. The draft ICH M13A guideline developed by the M13 EWG was endorsed by ICH on 20 December 2022, under Step 2.

Method validation and characterization of stress degradation products of azelastine hydrochloride using LC-UV/PDA and LC-Q/TOF-MS studies.

Azelastine HCl is a second-generation H1 -receptor antagonist approved by the US Food and Drug Administration (US FDA) for treating seasonal allergic rhinitis and non-allergic vasomotor rhinitis. This study encompasses the validation of a liquid chromatography-ultra violet photo diode array (LC-UV/PDA) method for the drug and its extension to liquid chromatography/quadrupole time-of-flightmassspectrometry (LC-Q/TOF-MS) studies for identification and characterization of various stress degradation products of the drug. Stress degradation of azelastine HCl was undertaken under the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) prescribed conditions of hydrolytic, photolytic, oxidative, and thermal stress. The degraded drug solutions were analyzed using Ultra Performance Liquid Chromatography (UPLC) employing a C18 (100 × 4.6mm; 2.6μ, Kinetex) column by isocratic elution. Detection wavelength was 241 nm. The degradation products were identified and characterized using UPLC-MS/TOF studies, and an attempt was made to isolate one of the degradation products by solvent extraction. The drug was found to significantly degrade under acidic/alkaline/neutral photolytic, oxidative, and alkaline hydrolytic conditions. Six degradation products (I-VI) were identified through LC-Q/TOF-MS studies that were adequately resolved from the drug with the developed UPLC method. All degradation products (I-VI) were ionized in the total ion chromatogram (TIC) in the LC-MS studies, and these were identified and characterized, and the degradation pathway of the drug was postulated. One of the oxidation products isolated from the degraded drug solution was characterized through differential scanning calorimetry, Fourier-transform infrared spectroscopy, and nuclear magnetic resonance spectral data. Six degradation products generated from stress degradation studies on azelastine HCl were adequately resolved through LC-UV/PDA studies followed by method validation. These were successfully identified and characterized through LC-Q/TOF-MS studies, and the degradation pathways for the generation of these products from the drug have been postulated.

Emergency Regulatory Procedures, Pharmaceutical Regulatory Politics, and the Political Economy of Vaccine Regulation in the COVID-19 Pandemic

Context: Regulatory approaches to COVID-19 vaccine authorizations varied substantially across countries. Facing a common public health threat, what accounts for regulatory variation? This study focuses on emergency pharmaceutical and vaccine regulatory procedures and whether and how regulators' emergency pharmaceutical regulatory procedures going into the pandemic shaped regulatory processes and decisions during the pandemic. Methods: The authors conducted an analysis of seven high-impact national and international pharmaceutical regulators with case studies from Brazil, China, India, Russia, the United Kingdom, the United States, and the European Medicines Agency. The authors analyzed evidence from primary source executive and legislative branch regulations and statutes as well as national and international scientific and general press reporting; they also drew on the secondary analysis of scholars, practitioners, and international organizations. Findings: Inherited emergency pharmaceutical and vaccine regulatory procedures substantially shaped COVID-19 vaccine regulation during the pandemic. Variation in the presence and content of emergency regulatory procedures affected the quality of pandemic regulatory processes, outcomes, and procedural updates and differentially empowered policy-making experts and elected politicians. Conclusions: Emergency regulatory procedures affect key features of regulatory political economy and public health practices during crises. To improve future public health crisis responses, the authors provide policy recommendations for (1) establishing clear emergency pharmaceutical regulatory procedures, and (2) international collaboration.

A Multi-Objective Approach Optimizing Pharmacy Industry Decisions through MOORA Method

The pharmacy industry, a crucial pillar of the healthcare sector, encompasses the discovery, development, production, distribution, and sale of pharmaceutical drugs and medications. With an intricate interplay of scientific innovation, medical expertise, and commercial activities, this industry plays an indispensable role in safeguarding and improving human health. From the inception of groundbreaking drugs to their widespread distribution, the pharmacy industry integrates various stakeholders, including pharmaceutical companies, researchers, healthcare professionals, regulators, and consumers. It strives to address a wide spectrum of health conditions, from acute ailments to chronic diseases, by developing innovative treatments, generic medicines, and over-the-counter drugs. The pharmacy industry's evolution has been marked by technological advancements, research breakthroughs, and regulatory frameworks to ensure drug safety and efficacy. As the global population continues to grow and age, the industry faces the challenges of maintaining affordability, accessibility, and quality of medications. Furthermore, the pharmacy industry is a catalyst for economic growth, creating jobs, fostering research collaborations, and contributing to national and international healthcare systems. Its multifaceted nature, ranging from drug research to patient care, underscores its significance in the broader landscape of healthcare and public well-being. Research within the pharmacy industry holds immense significance due to its pivotal role in advancing medical knowledge and improving patient outcomes. Pharmaceutical research drives the development of new medications, innovative therapies, and treatment protocols, enhancing the efficacy and safety of drugs. It also uncovers insights into disease mechanisms, fostering a deeper understanding of health conditions. Furthermore, research guides regulatory decisions, ensuring drugs' quality, and promotes evidence-based medical practices. Through ongoing investigation, the pharmacy industry continually evolves, addressing emerging health challenges, optimizing drug utilization, and ultimately contributing to the overall enhancement of global healthcare standards. MOORA (Multi-Objective Optimization by Ratio Analysis) is a decision-making method used to evaluate and prioritize alternatives based on multiple conflicting criteria. It involves comparing alternatives' performance ratios against reference alternatives, considering both benefits and drawbacks. By assigning weights to criteria, MOORA quantifies their importance and ranks alternatives accordingly. This technique assists in complex decision scenarios where various factors must be balanced. MOORA's systematic approach aids in reaching well-informed decisions by quantifying trade-offs and providing a structured framework for considering multiple objectives simultaneously. Product Innovation, Market Share (%), Research Investment ($ billion), Patient Satisfaction, Drug Efficacy (%), Global Reach (countries). Pfizer, Johnson & Johnson, Roche, Novartis, GlaxoSmithKline, CVS Health, Walgreens Boots Alliance, Rite Aid.From the result it is seen that Novartisis got the first rank where as is the Rite Aidis having the lowest rank.

Pharmacy education 2.0 with special reference to digital India

Indian pharmacy education has grown and changed, producing trained individuals needed in the pharmaceutical and healthcare industries. Pharmacy education in India is reviewed here, noting its merits, weaknesses, and future possibilities. India has many pharmacy schools, with a concentration in Maharashtra, Karnataka, and Andhra Pradesh. The Pharmacy Council of India (PCI) regulates curriculum and infrastructure. Diploma, undergraduate (B. Pharm), postgraduate (M. Pharm), and doctoral (Ph.D.) pharmacy programs serve students with varied professional goals. Students learn basic pharmaceutical sciences, technology, medication interactions, clinical pharmacy, and regulation to prepare for healthcare careers. Through experiential learning, creative methods, and digital resources, the teaching methods integrate academic knowledge with practical applications. Students' critical thinking and involvement improve with collaborative learning. Quality pharmacy education is ensured by qualified instructors, research culture, and industry exposure. Faculty development programs improve teaching and research skills. Along with academic guidance, student research projects create a research mindset. Industry-academia partnership enhances students' experiences and employability through internships, cooperative research, guest lectures, and technology transfer. Specialization and transdisciplinary programs can help Indian pharmaceutical education meet industrial needs. Focusing on research-oriented learning and sponsoring research projects will boost innovation and science. The merger of AI and precision medicine will prepare graduates for the future of healthcare. Faculty development programs will keep academics current, and industry-government-academia collaboration will solve healthcare problems. Growth requires filling skill gaps, responding to the changing healthcare market, and assuring quality and consistency. Transparency, accountability, and global recognition depend on accreditation. Pharmacy education in India can produce skilled pharmacists that promote healthcare and science by addressing obstacles and embracing the future. Pharmacy education will become a cornerstone of healthcare excellence and innovation in India with ongoing stakeholder initiatives.

Could the Norms for International Radiation Protection Be a Model for Pharmaceuticals?

There is no international norm-setting mechanism for pharmaceutical registration. By contrast, the International Commission on Radiological Protection (ICRP) has been recommending widely respected norms for X-rays and radioactive isotopes in medical and other uses for almost a century. It does so with no legal authority on the basis of collaborative deliberations by a self-selected group that includes experts concerned about both health effects and the benefits of ionizing radiation. Such an “epistemic group” has advantages over the more usual adversarial processes. It can evaluate the scientific evidence more objectively, it can adapt more rapidly to technological progress, and it can judge benefits as well as risks. Forming such normative epistemic groups for at least some of the rapidly growing number of new pharmaceuticals would avoid duplication and contribute to harmonizing pharmaceutical registration worldwide.

Regulatory Gaps in Pharmaceutical Waste Management: A Case Study of Malaysia

Recent scientific studies emphasise the detrimental effects of pharmaceutical residues, such as antibiotics and endocrine disruptors, on aquatic ecosystems, biodiversity, and human health. Improper disposal of pharmaceutical waste poses several risks, including the development of antimicrobial resistance and hormonal imbalances. This paper reviews Malaysia’s federal regulations on pollution and waste management to identify gaps in addressing pharmaceutical pollutants. A content analysis approach was employed, involving transcribing, reading, coding, categorizing, and identifying themes within the textual data. Recurring themes were then used to highlight gaps and opportunities for improving pharmaceutical waste management within the existing legal framework. The study discovered that while the current legal framework effectively manages pharmaceutical waste from point sources like healthcare facilities and manufacturing sites, there is a significant regulatory gap concerning household pharmaceutical waste. Such waste is neither regulated under environmental pollution laws nor included in hazardous or solid waste management regimes, posing a considerable risk to the country’s environment. The study recommends adopting extended producer responsibility to improve household pharmaceutical waste management and highlights the potential role of solid waste legislation in achieving this goal. By prioritizing pharmaceutical waste regulation and adopting proactive environmental protection measures, Malaysia can safeguard public health, ensure a cleaner ecosystem, and strengthen its commitment to sustainable environmental management. The study also noted that many developed nations have already integrated pharmaceutical markers into their water quality monitoring standards. Therefore, Malaysia should begin monitoring emerging pharmaceutical pollutants as well. Updating the National Water Quality Index to include pharmaceutical residues will further enhance efforts to protect the environment.

Suicides, drug poisonings, and alcohol-related deaths cluster with health and social disadvantage in 4.1 million citizens from two nations.

Deaths from suicides, drug poisonings, and alcohol-related diseases ('deaths of despair') are well-documented among working-age Americans, and have been hypothesized to be largely specific to the U.S. However, support for this assertion-and associated policies to reduce premature mortality-requires tests concerning these deaths in other industrialized countries, with different institutional contexts. We tested whether the concentration and accumulation of health and social disadvantage forecasts deaths of despair, in New Zealand and Denmark. We used nationwide administrative data. Our observation period was 10 years (NZ = July 2006-June 2016, Denmark = January 2007-December 2016). We identified all NZ-born and Danish-born individuals aged 25-64 in the last observation year (NZ = 1 555 902, Denmark = 2 541 758). We ascertained measures of disadvantage (public-hospital stays for physical- and mental-health difficulties, social-welfare benefit-use, and criminal convictions) across the first nine years. We ascertained deaths from suicide, drugs, alcohol, and all other causes in the last year. Deaths of despair clustered within a population segment that disproportionately experienced multiple disadvantages. In both countries, individuals in the top 5% of the population in multiple health- and social-service sectors were at elevated risk for deaths from suicide, drugs, and alcohol, and deaths from other causes. Associations were evident across sex and age. Deaths of despair are a marker of inequalities in countries beyond the U.S. with robust social-safety nets, nationwide healthcare, and strong pharmaceutical regulations. These deaths cluster within a highly disadvantaged population segment identifiable within health- and social-service systems.

Navigating the Regulatory Landscape: Key Trends Shaping Today's Regulatory Affairs Environment

Regulatory Science, positioned at the intersection of Science, policy, and law, is essential for safeguarding public health and ensuring the safety and effectiveness of products and practices. It spans various sectors, including pharmaceuticals, medical devices, food and agriculture, environmental protection, and emerging technologies. It faces challenges and opportunities such as rapid technological advancements, global market globalization, and complex scientific discoveries.
 This review paper examines current trends and future directions in Regulatory Aspects within the Pharmaceutical World. It explores how regulatory authorities address challenges and delves into the historical development of pharmaceutical regulation globally. The paper also explores innovative approaches and technologies influencing the regulatory processes, investigates future directions in regulation, and proposes recommendations for the future of pharmaceutical regulations.
 In conclusion, regulatory Science, with its rich history, holds promise for a bright future. Adapting to technological advancements, embracing collaborative approaches, and investing in research and education are crucial for navigating the complexities of the modern world. Regulatory Science will continue to play a vital role in safeguarding public health and fostering innovation.

”What’s up with price controls?” Stakeholders’ views on the regulation of pharmaceutical pricing in Malaysia

Escalating costs have made the accessibility of drugs one of the biggest challenges faced by the Malaysian government. The government agreed to regulate drug prices by means of external reference pricing, but its proposed policy had a setback owing to much opposition from the pharmaceutical industry. The policy did gain support from the public and from non-governmental organisations because it ensured easy access to affordable medicines. Comments from public consultations with key stakeholders were used to explore stakeholders’ perceptions of the external reference pricing policy. A total of 140 comments were analysed for this study. Stakeholders’ views were classified as being from the Socioeconomic, industrial, and government sectors. To summarise, the government must carefully manage and consider stakeholders’ views to ensure a sound policy. Using Mendelow’s stakeholder mapping, this study mapped out stakeholders’ views in a systematic approach. The classification of different stakeholders’ views and recommendations led to suggestions for reviewing current practices in pharmaceutical pricing regulations in the Malaysian healthcare system. The analyses can be extended to other countries that face similar concerns.

Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations.

Since the awareness of adverse effects associated with pharmaceutical excipients in drug formulations, these excipients are no longer considered inert substances. Numerous countries have recognized the potential risks that they pose to patients and have implemented diverse regulations to evaluate their safety, compatibility, toxicity, and quality. Regulatory authorities have proactively implemented measures to evaluate excipients and have formulated comprehensive guidelines that manufacturers are obligated to follow. This review primarily highlights the different provisions governing the utilization of excipients in drug formulation by regulatory authorities worldwide. Nonetheless, it is worth noting that there are still many countries that do not perceive excipients as posing a potential threat.

Identifikasi hidroquinon dalam lotion pemutih dengan metode kromatografi lapis tipis

Background: Cosmetics have been widely used to enhance the appearance and make it look more attractive. One of the most commonly used cosmetics is lotion. As science and technology progress, many lotions are introduced to the market. As pharmaceutical regulations require, not all lotion products are safe, effective, and of high quality. However, many losses are caused by whitening lotion products in circulation, one of which is the addition of hydroquinone, a whitening substance that can cause damage to the skin.Objectives: This study aims to identify the hydroquinone content contained in whitening lotion.Methods: Experimental research using the Thin Layer Chromatography (KLT) method to test lotions for hazardous ingredients. It was conducted at the Chemistry Laboratory of Poltekkes Kemenkes Aceh in June 2022. Materials are whitening hand body lotion available online and not branded as many as five samples—determination of criteria, namely, low prices, high demand, and instant results. The single variable used in this study determines the presence or absence of hydroquinone in lotion samples.Results: This study has shown that five whitening lotion samples are positive. Sample S4 contains hydroquinone with an Rf value of 0,55 (< 0,05). Meanwhile, samples S1, S2, S3, and S5 were negative for hydroquinone.Conclusion: Some lotions tested have met the requirements of BPOM regulations and are safe to use, but one lotion is unsafe to use because it contains high hydroquinone.