the Indian Journal of Pharmacy最新文献

{"title":"Pharmacovigilance of paracetamol-induced Stevens-Johnson Syndrome and toxic epidermal necrolysis in the Indian population.","authors":"R S Ray, Ayushi Yadav, Shashi Bhushan, Jai Prakash, Rajeev Singh Raghuvanshi","doi":"10.4103/ijp.ijp_495_23","DOIUrl":"10.4103/ijp.ijp_495_23","url":null,"abstract":"<p><strong>Aims: </strong>Despite decades of proven safety of paracetamol, serious and rare reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) often occur in the Indian population. The current study aimed to understand the safety profile of this relatively safer drug, paracetamol, with respect to rare and serious adverse events, SJS/TEN, based on data collected from the Indian population through the Pharmacovigilance Programme of India.</p><p><strong>Methods: </strong>The collected, collated and analyzed all Individual Case Safety Reports with the use of paracetamol from the Indian population for the period January 1, 2010, to December 31, 2021, were reported to VigiBase and analyzed using the WHO database, VigiLyze.</p><p><strong>Results: </strong>Analysis of the reported data showed that 313 SJS/TEN adverse events were associated with the use of paracetamol. Disproportionality analysis of paracetamol-induced SJS/TEN reactions in the Indian population using the Proportional Reporting Ratio (PRR), reporting odds ratio, and the information component indicated higher risk of paracetamol in the Indian population.</p><p><strong>Conclusions: </strong>The findings provide crucial insights into the extent of rare and infrequent SJS/TEN associated with the use of paracetamol in the Indian population. Owing to the seriousness of reaction and the widespread use of paracetamol for fever-like illness, the prescribing physicians, pharmacists, and other healthcare professionals should closely monitor patients administered paracetamol for this potential rare reaction, SJS/TEN.</p>","PeriodicalId":49189,"journal":{"name":"the Indian Journal of Pharmacy","volume":"58 3","pages":"250-258"},"PeriodicalIF":1.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13258291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147822751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"After the green light: Evaluating drugs in Phase IV studies.","authors":"Bikash Ranjan Meher, Archana Mishra","doi":"10.4103/ijp.ijp_427_25","DOIUrl":"10.4103/ijp.ijp_427_25","url":null,"abstract":"<p><strong>Abstract: </strong>The drug development process is lengthy and complex and Phase IV is a crucial phase within it. Phase IV studies are conducted after a drug has been approved by regulatory agencies to further evaluate its safety, efficacy, usefulness in special populations, new indications, and new formulations. There are many examples of Phase IV studies; not all Phase IV studies are postmarketing surveillance (PMS) studies, but every PMS study is an example of a Phase IV study. Phase IV studies are imperative as they evaluate the drug's effectiveness and performance in real-world clinical practice and premarketing trials have some inherent limitations. Phase IV studies can be observational or interventional studies, depending on the objectives of such studies. A drug utilization study is a Phase IV study; similarly, a registry is also an example of a Phase IV study.</p>","PeriodicalId":49189,"journal":{"name":"the Indian Journal of Pharmacy","volume":"58 3","pages":"189-195"},"PeriodicalIF":1.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13258280/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147822783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Emerging patterns, impact, and collaborative networks of global scientific output on carrageenan and digestive problems: A bibliometric analysis.","authors":"Fran Espinoza-Carhuancho, Miguel Cabanillas-Lazo, Lucia Quispe-Tasayco, Cesar Mauricio-Vilchez, Arnaldo Munive Degregori, Frank Mayta-Tovalino","doi":"10.4103/ijp.ijp_457_25","DOIUrl":"10.4103/ijp.ijp_457_25","url":null,"abstract":"<p><strong>Background: </strong>The study aimed to analyze the current trends and spatiotemporal dynamics of research on carrageenan and digestive problems through a bibliometric study from 2019 to 2024.</p><p><strong>Materials and methods: </strong>The literature published on carrageenan and digestive issues from the period of January 2019 until July 2024 was examined using an observational and descriptive approach. The use of a quantitative approach was made in relation to authorship distribution and collaboration, country collaboration, and the evolution of themes. A search of the Scopus database was conducted with different keywords of \"Carrageenan\" and \"Digestive problems.\" Analysis and visualization of the data were done with the use of SciVal and RStudio software.</p><p><strong>Results: </strong>Between 2019 and 2024, a significant increase in publication activity occurred, with associated variations in publication types and pronounced growth in international collaboration. In regard to scientific production, there was an average year-on-year increase of 18.98%, with an average age of the papers of 3.2 years and an average of 15.72 citations per article. A total of 889 authors produced the articles, with an average of 6.71 co-authors per paper and 21.33% international collaborations. Notable institutions producing articles include the Ocean University of China, which produced seven articles, and Jimei University, which produced five articles. The scientific production was highest in China (40), followed by Brazil and Japan, and while most authors contributed a single article, there was a lack of equal scientific productivity accumulated in the articles.</p><p><strong>Conclusions: </strong>The results highlight both the importance and the need to investigate carrageenan and its impact on digestive issues that might yield exciting avenues of research. The number of publications being produced regarding this foundational aspect of research continues to be relevant. The examination of literature also illustrated the key role of international collaborations and changing research agendas in dealing with the challenges related to digestive problems.</p>","PeriodicalId":49189,"journal":{"name":"the Indian Journal of Pharmacy","volume":"58 3","pages":"205-214"},"PeriodicalIF":1.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13258293/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147822770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nutraceutical market in India: Thoughts on a right-based regulatory approach.","authors":"G Haripriya, P C Harigovind, Uma V Sankar","doi":"10.4103/ijp.ijp_862_25","DOIUrl":"10.4103/ijp.ijp_862_25","url":null,"abstract":"<p><strong>Abstract: </strong>The nutraceuticals industry in India has witnessed strong growth, expanding at a CAGR of ~12%-15% in recent years (2020-2023), driven by rising health awareness, increasing disposable incomes, and demand for preventive healthcare. The market, valued at $8-10 billion in 2023, is expected to reach $18-20 billion by 2027, fueled by trends like immunity-boosting supplements, functional foods, and e-commerce penetration. However, the regulatory framework governing this sector remains complex. Nutraceuticals, which fall between food and pharmaceuticals, pose unique challenges regarding their quality, safety and effectiveness. In India, nutraceutical products are categorized as foods and are regulated by the Food Safety and Standards (FSS) Act, 2006. The FSS Authority of India is the primary regulatory body responsible for monitoring the manufacturing and marketing of nutraceuticals in India. Regardless of these efforts, there exists an uncertainty regarding the categorization of nutraceuticals. The main reason is with respect to their therapeutic effect and the form in which they are sold in the market. It closely resembles pharmaceutical products. With the global expansion of these products, it is imperative to ensure their quality and safety. This article critically analyses the current regulatory framework for nutraceuticals in India and also makes a comparative analysis of the regulation of nutraceuticals in various countries. The article also emphasizes the necessity for more rigorous regulation for the manufacturing and marketing of nutraceuticals to ensure the quality and safety of the products, thereby protecting public health.</p>","PeriodicalId":49189,"journal":{"name":"the Indian Journal of Pharmacy","volume":"58 3","pages":"196-204"},"PeriodicalIF":1.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13258191/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147822789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bleomycin-induced Sweet's syndrome.","authors":"Anuja Yadav, Vishal Gaurav, Deepika Yadav, Sonika Garg","doi":"10.4103/ijp.ijp_134_25","DOIUrl":"10.4103/ijp.ijp_134_25","url":null,"abstract":"<p><p>Sweet's syndrome is also called as acute febrile neutrophilic dermatosis. Drug-induced Sweet's syndrome was first reported in association with trimethoprim-sulfamethoxazole. It is very rare. To the best of our knowledge, bleomycin-induced Sweet's syndrome has not been reported previously.</p>","PeriodicalId":49189,"journal":{"name":"the Indian Journal of Pharmacy","volume":"57 5","pages":"356-358"},"PeriodicalIF":1.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12419575/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144975980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of the timing of antibiotic prophylaxis on the surgical site infections in patients undergoing elective general surgery.","authors":"Aayush Lakkanna, Guguloth Rajender, Yashwant Raj Sakaray, Cherring Tandup, Siddhant Khare, Ajay Savlania, Kamal Kajal, Prerna Varma, Ashish Gupta, Lileswar Kaman","doi":"10.4103/ijp.ijp_797_24","DOIUrl":"10.4103/ijp.ijp_797_24","url":null,"abstract":"<p><strong>Introduction: </strong>Surgical site infections are one of the major challenges in surgical practice. The antibiotic prophylaxis, though scientific, still lacks clarity on the timing of the administration of the drugs.</p><p><strong>Methods: </strong>An interventional study was planned in the Department of General Surgery at PGIMER, Chandigarh. One hundred twenty-seven patients who met the inclusion and exclusion criteria were enrolled. They were divided into two groups using a table of random numbers into Group A (n = 67) where the drug was administered 0-30 min before incision, and Group B (n = 60) where the drug was injected 30-60 min before incision. Both the surgical team and the investigator for the SSI were blinded.</p><p><strong>Results: </strong>The distribution of sex ratio, comorbidities, and the hematological parameters was equal among groups. The mean blood loss, operative times, and the type of surgical procedures were also distributed equally. There was significantly low SSI in Group A (n = 2) versus Group B (n = 8) (P = 0.03). Drains were placed in 41 patients; 9 out of the 10 patients who reported SSI had an intraoperative drain placed. The placement of the drain was significantly associated with SSI (P < 0.001).</p><p><strong>Conclusions: </strong>Administering prophylactic antibiotics within 30 min before the surgical incision is effective. Placement of the Drain must be avoided to prevent SSI.</p>","PeriodicalId":49189,"journal":{"name":"the Indian Journal of Pharmacy","volume":"57 5","pages":"334-337"},"PeriodicalIF":1.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12419558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144975948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reporting negative Ames test results for Indian Acorus calamus L., rhizome, extracts, and beta asarone.","authors":"D B Anantha Narayana, Alka Mukne","doi":"10.4103/ijp.ijp_391_24","DOIUrl":"10.4103/ijp.ijp_391_24","url":null,"abstract":"<p><strong>Objective: </strong>Acorus calamus L. (Sweet Flag), known in India as \"Vacha,\" is widely used in traditional medicine, particularly for cognitive enhancement in infants. While traditionally considered safe, β-asarone - a key constituent - has shown potential genotoxicity in some in vitro studies. This study aimed to evaluate the mutagenic potential of Indian A. calamus rhizome, its extracts, and pure β-asarone using the Ames test in accordance with Organization for Economic Co-operation and Development guidelines.</p><p><strong>Materials and methods: </strong>Samples tested included pure β-asarone, dried rhizome powder, and extracts prepared in acidic and alkaline aqueous media. Marker compounds (β-asarone, α-asarone, and shyobunone) were quantified. The Ames test was conducted under GLP using Salmonella typhimurium strains TA97a, TA98, TA100, TA102, and TA1535 (Moltox Inc., USA). Each strain was tested with and without metabolic activation using Aroclor 1254-induced rat liver S9 homogenate. Positive controls included 2-aminoanthracene, sodium azide, mitomycin C, 9-aminoacridine, and 4-nitro-o-phenylenediamine. The vehicle was used as a negative control. Doses tested ranged from 39.06 to 5000 µg/plate.</p><p><strong>Results: </strong>No mutagenic response was observed in any of the tested samples across all five strains under either condition (±S9). Positive controls showed expected increases in revertant colonies. Revertant counts for test samples did not reach the threshold for a positive response (≥3 × control for TA1535, TA97a; ≥2× for TA98, TA100, and TA102).</p><p><strong>Conclusions: </strong>Under the test conditions, A. calamus rhizome and β-asarone did not exhibit mutagenicity. Further studies, including chronic toxicity and carcinogenicity evaluations, are recommended to confirm safety across formulations.</p>","PeriodicalId":49189,"journal":{"name":"the Indian Journal of Pharmacy","volume":"57 5","pages":"302-307"},"PeriodicalIF":1.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12419574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144975959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety assessment of dexmedetomidine: Real-world adverse event analysis from the Food and Drug Administration Adverse Events Reporting System public dashboard.","authors":"Yi Yin, Jie Jiang, Youpeng Jin","doi":"10.4103/ijp.ijp_688_24","DOIUrl":"10.4103/ijp.ijp_688_24","url":null,"abstract":"<p><p>Dexmedetomidine (DEX), as a widely used medication for sedation, its usage has increased significantly. The concerns about its side effects remain, making a thorough safety evaluation necessary. Data on adverse drug events related to DEX from the first quarter of 2004 to the fourth quarter of 2023 were collected from the US Food and Drug Administration. Signal quantification techniques were used for the analysis, including reporting odds ratios (RORs), proportional reporting ratios, Bayesian confidence propagation neural network and empirical Bayes geometric mean. An analysis of 20,629,811 adverse event (AE) reports identified 1977 cases of DEX-related AEs, covering 24 system organ classes and 344 preferred terms (PTs). The most common PTs were bradycardia (n = 263), cardiac arrest (n = 150), and hypotension (n = 141). Based on the ROR algorithm, the top three were: transcranial electrical motor evoked potential monitoring abnorma, acute motor axonal neuropathy, and trigemino-cardiac reflex. In addition, this study identified the adverse effects such as diabetes insipidus, coronary arteriospasm, and intestinal pseudo-obstruction, which were not previously mentioned in the instructions. It is essential to monitor, identify, and address these adverse reactions effectively.</p>","PeriodicalId":49189,"journal":{"name":"the Indian Journal of Pharmacy","volume":"57 5","pages":"344-349"},"PeriodicalIF":1.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12419569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144976022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sodium glucose co-transporter 2 inhibitors safety depending on their adverse drug reactions and glucose monitoring parameters in type 2 diabetes mellitus.","authors":"Dhanush Bellapu, Ronald Darwin","doi":"10.4103/ijp.ijp_924_24","DOIUrl":"10.4103/ijp.ijp_924_24","url":null,"abstract":"<p><strong>Introduction: </strong>SGLT2 inhibitors have a wide extent of restorative movement and higher chance of hypoglycemia because of their affront autonomous action in treating type 2 diabetes. SGLT2 inhibitors have great security and resistance when utilized as monotherapy or in conjunction with other oral hypoglycemic medicines. Since SGLT2 inhibitors can cause hyperglycemia, which results in vaginal and urinary tract infection contaminations. When compared, dapagliflozin had higher contaminations. The key issue displayed is that ketoacidosis and that it may take a little time to analyze it.</p><p><strong>Objectives: </strong>To compare the security of canagliflozin and dapagliflozin by watching the long-term impacts on the urinary volume, changes in renal status, and metabolic changes.</p><p><strong>Research methodology: </strong>A Planned Interventional Comparative Ponder conducted among 1726 patients who were conceded to in the General Medicine and Endocrine Departments, Anu Group of hospitals, Vijayawada over 12 months from December 2021 to December 2022. By alluding to the patient's fasting blood sugar and postprandial blood sugar, renal function test, glycated hemoglobin, blood pressure, and the finding seriousness score of adverse drug reaction (ADR) utilizing Naranjo scale.</p><p><strong>Results: </strong>Patients had most common ADRs after utilizing Canagliflozin and Dapagliflozin, were hypotension and dehydration, respectively.</p><p><strong>Conclusion: </strong>We concluded that in patients had ADRs after utilizing Canagliflozin versus Dapagliflozin where hypotension and dehydration were more common, respectively. ADRs in the control population was weight pick up had the negative impact and hypoglycemia was found to be more in the control population compared to canagliflozin and dapagliflozin endorsed bunches. Weight loss had a positive impact on canagliflozin and dapagliflozin-endorsed groups.</p>","PeriodicalId":49189,"journal":{"name":"the Indian Journal of Pharmacy","volume":"57 5","pages":"329-333"},"PeriodicalIF":1.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12419563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144975977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Undergraduate medical students as future prescribers: Enhancing their participation in adverse drug reaction reporting in India by revising the curriculum.","authors":"Bikash Ranjan Meher, Ajaya Kumar Sahoo, Monalisa Jena","doi":"10.4103/ijp.ijp_251_25","DOIUrl":"10.4103/ijp.ijp_251_25","url":null,"abstract":"","PeriodicalId":49189,"journal":{"name":"the Indian Journal of Pharmacy","volume":"57 5","pages":"359-360"},"PeriodicalIF":1.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12419568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144975470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}