World Journal of Pharmaceutical Sciences

Address for Correspondence: Mrs. V R Teja Sruthi Pagadala, Mail: tejam.pharmacy@gmail.com How to Cite this Article: Mrs. V R Teja Sruthi Pagadala, ONE MEDICINE, MANY RULES: GLOBAL HARMONIZATION AND REGULATORY FRAGMENTATION IN DRUG APPROVALS, World J Pharm

Mrs. V R Teja Sruthi Pagadala, — 2026-03-17

The globalization of pharmaceutical markets has intensified the need for a unified regulatory approach to facilitate timely access to safe, effective, and affordable generic medicines. Despite advances in international regulatory harmonization, significant fragmentation persists among global drug approval systems, creating challenges for pharmaceutical development, post-approval management, and lifecycle optimization. This research critically examines the current regulatory landscape governing generic drug approvals across major global regions, highlighting both convergence and divergence in regulatory expectations. The study is structured into five analytical chapters covering regulatory frameworks in ASEAN countries, post-approval change management practices in the United States and European Union, regulatory submission requirements in Australia, and comparative bridging strategies across Australia, Canada, Europe, Russia, and ASEAN nations. Special emphasis is placed on post-approval variation procedures, regulatory timelines, documentation requirements, and risk-based classification systems adopted by different authorities. Industry-based case studies are incorporated to evaluate practical challenges and strategic solutions for global product development. Findings indicate that while harmonization initiatives such as ICH guidelines have improved regulatory consistency, region-specific procedural requirements, data expectations, and approval pathways continue to hinder the development of a single globally acceptable drug product. The research underscores the importance of proactive regulatory planning, reliance-based submissions, and strategic bridging approaches to minimize duplication, reduce development costs, and accelerate global market access. This study contributes to regulatory science by proposing integrated regulatory strategies aimed at balancing global harmonization with regional regulatory autonomy, ultimately supporting efficient generic drug development and improved patient access worldwide

A Review Article on Nanodiamonds Discussing Their Properties and Applications

Rushika Jaiswal — 2026-03-17

With the rapid development of Nano science and nanotechnology, a wide variety of nanomaterial have been synthesized and discovered. Diamond nanoparticles, or Nanodiamonds, have the most disparate origins. Diamond nanoparticles are another form of carbon nanomaterial’s with unique properties and applications They are found in crude oil at concentrations up to thousands of parts per million, in meteorites, interstellar dust, and protoplanetary nebulae, as well as in certain sediment layers on Earth. They can also be produced in the laboratory by chemical vapor deposition or by detonating high explosive materials [27]. Nano diamonds have excellent mechanical and optical properties, high surface areas and tunable surface structures. Diamond nanoparticles are another form of carbon nanomaterial with unique properties and applications. Here we review the synthesis, structure, properties, and applications of individual Nano diamonds and clusters of Nano diamonds and their biomedical applications.

RECENT TRENDS AND THERAPEUTIC APPROACHES OF THYROIDISM ON INFERTILITY

Undamatla Bhargavi — 2026-03-17

Thyroid disorders are the most common endocrine problems in women. In most of the cases, thyroid can lead to infertility or miscarriages. The etiology of infertility is multifactorial with thyroid disorders as the most common presenting factor, hypothyroidism in particular. Infertility in women can lead to emotional and psychological stress. The prevalence of hypothyroidism during pregnancy is estimated to be 0.3%–0.5%. Hypothyroidism and hyperthyroidism can result in menstrual irregularities and anovulatory cycles, thus affecting the fertility. There is a ) level in infertile women with hypothyroidism when compared to euthyroid patients, indicating the relation between hypothyroidism and hyperprolactinemia. The amount of thyrotropin releasing hormone (TRH) from the hypothalamus is markedly increased by inhibition of pyroglutamyl peptidase II, the enzyme catalyzing TRH. The increased TRH in hypothyroidism causes increased thyroid-stimulating hormone and PRL secretion by pituitary, leading to infertility and galactorrhea. In recent years, a neuropeptide called kisspeptin, encoded by Kiss1 gene, a potent stimulus for GnRH secretion, has been recognized, which suggests a future direction of treatment with kisspeptin and benefits the fertility induction among hyperprolactinemic infertile patients. Untreated hypothyroidism during pregnancy can lead to subfertility, fetal deaths, premature deliveries, and abortions. Therefore, women planning for pregnancy and infertile women should be assessed for thyroid hormones and serum PRL.

The Effect of Mobile Phone Use on Pregnant Women: A Comprehensive Review

Ganji Srujini — 2026-03-17

The ubiquity of mobile phone usage has sparked widespread interest in its potential health effects, especially among vulnerable populations such as pregnant women. Mobile phones emit radiofrequency electromagnetic fields (RF-EMFs) and are associated with behavioral and physiological changes due to prolonged screen exposure, sleep disruption, and thermal effects. This review examines current human and animal studies related to the effects of mobile phone exposure during pregnancy. Key concerns include increased risk of miscarriage, adverse fetal growth, altered biochemical markers, and potential neurodevelopmental impacts on offspring. While conclusive causal links remain elusive, emerging evidence justifies a precautionary approach, especially during critical windows of fetal development. This article discusses mechanisms, limitations of current research, and practical recommendations for risk reduction.

The Coldrif Cough Syrup Tragedy: A Review of Diethylene Glycol Contamination and Pediatric Safety Failures in India

Mora Vyshnavi — 2026-03-17

In October 2025, India experienced a tragic outbreak of paediatric deaths linked to consumption of the cough-and-cold liquid formulation Coldrif Syrup, manufactured by Sresan Pharmaceuticals. The present review examines the event in the wider context of paediatric cough-syrup usage, regulatory vulnerabilities, formulation factors and pharmacology, adverse toxicology, public-health response and future prevention. The review first outlines the history of paediatric cough syrups and regulatory frameworks in India, then analyses the composition of Coldrif, its pharmacological rationale, and evidence of usage in children aged 2-8 years. Next, we summarise clinical and epidemiological evidence of efficacy and safety, followed by detailed discussion of the toxic contamination event: detection of diethylene glycol (DEG) in the batch, mechanisms of DEG toxicity, mortality outcomes (at least 20–24 children under five died), and key lapses in manufacturing and oversight. We then review regulatory and public-health responses: immediate product recalls, manufacturing shutdowns, arrests, revision of testing norms (incorporation of DEG/EG testing in monograph), and advisory-against use in very young children. The article closes with recommendations for clinicians, pharmacists and caregivers around rational prescribing of cough-cold syrups in children, safer alternative strategies, and calls for strengthened pharmacovigilance, manufacturing oversight and supply-chain traceability. Although cough and cold remain common in children, this calamity emphasises that benefit-risk balance demands rigorous manufacturing quality and regulatory vigilance. Keywords: paediatric cough syrup, Coldrif, diethylene glycol, contamination, drug safety, India.

Review on Tissue Engineering: Recent Advances and Future Prospects

Kosuri Avinash Goud — 2026-03-17

Tissue engineering is fast developing out of both a conceptual framework to a transitional field encompassing biomaterials, stem cells, bioprinting technologies, and regenerative therapies. In the past several years, impressive innovations in scaffolding structure, new biofabrication techniques, vascularisation approaches, and exosome-based approaches have challenged the limits to what can be manufactured and regenerated. This review article is a thorough review of the current developments in tissue engineering in the recent past, the challenges and future aspects of tissue engineering. Understanding biomaterials, 3D bioprinting advancements, stem cell uses, vascularization, and innervation plans, regulatory, and commercialization are discussed. Last but not least, it gives realistic predictions to the field within the coming decade, which is scalable manufacturing, immune-instructive materials, and harmonizing regulation.

A Review on Solvent Use in HPLC

Sha Shake Farid Uddin — 2026-03-17

High-Performance Liquid Chromatography (HPLC) is one of the newest and accurate analytical techniques used for the various things like separation, identification, and quantification of complex mixtures in pharmaceuticals, biotechnology, and environmental sciences. The efficiency and reproducibility of HPLC highly depend on the solvent system employed in the mobile phase. Solvents play a main role in determining the selectivity, resolution, retention time, and peak symmetry of analytes. The choice of solvents is influenced by some factors such as polarity, viscosity, UV transparency, miscibility, and pH stability. The classification of HPLC solvents can broadly be divided into aqueous and organic components. Aqueous solvents, including pure or buffered water, provide stability and polarity control, while organic modifiers like methanol, acetonitrile, and tetrahydrofuran enhance elution strength and selectivity. One of the most sophisticated and accurate analytical methods for the separation, identification, and measurement of complex mixtures in the fields of environmental sciences, biotechnology, and pharmaceuticals is High-Performance Liquid Chromatography (HPLC). The solvent system used in the mobile phase has a significant impact on HPLC's efficiency and repeatability. The selectivity, resolution, retention time, and peak symmetry of analytes are all significantly influenced by solvents. Numerous factors, including polarity, viscosity, UV transparency, miscibility, and pH stability, affect the choice of solvents. Aqueous and organic components make up the two main categories into which HPLC solvents are classified. Organic modifiers such as methanol, acetonitrile, and tetrahydrofuran improve elution strength and selectivity, while aqueous solvents, such as pure or buffered water, offer stability and polarity control.

A Review on Impact of Junk Food on Health

Oinam Indikas Singh — 2026-03-17

Premature aging and degradative processes are mainly generated by unhealthy habits and an unbalanced diet. Quality of food and lifestyle are important factors in sano-genesis. Many imbalances and ailments have their origin in the adoption of an unbalanced diet and a disordered lifestyle. With the help of a transversal study carried out on the basis of a questionnaire, the consumption of junk food products among the population of Romania was evaluated; at the same time, an evaluation of the characteristics of the associated diet, as well as a series of lifestyle components (quality of rest, physical activity, evaluation of the state of health) was carried out. The data collected and processed indicate an increased tendency to consume junk food products in the 18–23 age group, and especially among obese respondents. Female respondents show a lower tendency toward an increased consumption of junk food products (OR = 0.703, 95% CI)—0.19–0.95, p = 0.011) compared to male respondents. The most consumed junk food products are fried potatoes (46.2%) and pastries (41.4%). Junk food products that show an increased tendency toward consumption addiction are fried potatoes (13.8%), sweets (12.4%), pastry products (11.1%), and sweetened drinks (11.2%). The poor quality of food from a nutritional point of view, and reduced physical activity, are reflected in the varied range of problems faced by the respondents: states of fatigue (62.4%), nervousness (37.5%), depression, anxiety, emotional eating, etc

Effect of Dietary Supplements In Women's Health Across the Life Cycle: A Nutraceutical Perspective

Sujata Sasmal — 2026-03-17

Women health is dynamic and it is affected by the changes in hormones, metabolism and lifestyles in the life cycle life cycle such as adolescence, reproductive years, menopause, and old age. Nutraceuticals/ Dietary supplements are assuming a highly essential role in closing nutritional gaps that might exist as a result of physiological requirements, inadequacy in nutritional habits, or constant stress. Adolescents are prone to iron, calcium, vitamin D, and folate deficiency that may also have an impact on growth and reproductive well-being. At the reproductive age, omega-3 fatty acids, probiotics, and antioxidants aid fertility, hormonal equilibrium, and immunity. Pregnancy raises the need of micronutrients like folic acid, iron, Iodine and DHA in the growth of the fetus and in the health of the mother. Menopause Menopause has been shown to respond to calcium and vitamin D, as well as phytoestrogens and herbal adaptogens, which help to determine hormonal changes and bone density.
Nevertheless, over-supplementation, low quality, or self-medication complicate this situation and cause toxicity, metabolic disorders, and interactions between drugs and nutrients. Misinformation and socioeconomic barriers are also other conditions that contribute to the improper usage. Clinically directed nutraceutical interventions, in combination with a personalized nutritional assessment, have the potential to lead to a major improvement of the quality of life, decrease the risk of chronic diseases, and healthy aging. The evidence-based review of the use of supplements in the maintenance of women health at all stages of life has been identified and viable points given to be used safely and effectively in nutraceuticals with professional advice.

A Review on Disadvantages of Artificial Intelligence in the Pharmacy Field

Jampani Venkata Ravindra Kumar — 2026-03-17

Pharmacy is being transformed by the use of Artificial Intelligence (AI) through automation, data analytics and predictive modeling. However, its use poses ethical, technical and operational issues. This review addresses the varieties of drawbacks of AI in the pharmacy field, such as data privacy breaches, algorithm bias, legal ambiguity, cost, and work dislocation. It also points to losing human empathy in attending to patients telling the necessity of the balanced integration. The analysis finds that the responsible governance, explainable models of AI, and continuous learning are essential in reducing the risk.

LEUKEMIA: TARGETED THERAPEUTIC FORMULATION CONTAINING MANNOSE-COATED CHITOSAN PHYTO-NANOPARTICLES

B. Sasidhar — 2026-03-17

Leukemia is a life-threatening blood cancer. It happens when abnormal white blood cells grow out of control. Chemotherapy is the usual treatment. But it has big limits. It is not selective, cause’s systemic toxicity, and tumors can become drug resistant. Plants may help. Phytochemicals from Moringa oleifera and Nyctanthes arbor-tristis show anticancer activity and tend to have fewer side effects. Tiny drug carriers help too. Nanoparticles let compounds get into cells better and aim them where needed. This study set out to make and test mannose-coated chitosan phyto-nanoparticles that hold hydroalcoholic extracts of Moringa oleifera and Nyctanthes arbor-tristis for targeted leukemia therapy in vitro using human chronic myeloid leukemia K562 cells (ATCC® CCL-243™). We made the mannose-coated chitosan phyto-nanoparticles by ionic gelation using sodium tripolyphosphate (TPP) as the cross-linker. Then we measured particle size, polydispersity index (PDI), and zeta potential by dynamic light scattering. Encapsulation efficiency and in vitro drug release were checked. Cytotoxicity was tested on leukemia cell lines with the MTT assay. The particles averaged 180–250 nm. PDI was 0.21–0.28, so sizes were fairly uniform. Zeta potential ranged from +22 to +30 mV, which shows good colloidal stability. Encapsulation efficiency was 84.6 ± 3.2% for the combined extracts. Drug release in vitro followed a two-phase pattern: a mild burst first, then sustained release over 72 h at pH 7.4. The nanoformulation killed K562 cells in a dose-dependent way on the MTT assay, with an IC₅₀ of 58.3 ± 4.7 μg/mL, significantly lower than crude extracts (IC₅₀ ≈ 142 μg/mL) and uncoated nanoparticles (IC₅₀ > 200 μg/mL) (p < 0.001).ase-3 upregulation confirmed apoptosis induction. Overall, mannose-coated chitosan phyto-nanoparticles improved the therapeutic effect of these plant phytochemicals and could be a promising targeted delivery system for leukemia treatment.