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Acinetobacter baumannii (A. baumannii) is a remarkable opportunistic pathogen responsible for a great proportion of hospital-associated infections and the high prevalence of resistance towards many classes of antibiotics makes the treatment challenging. The present cross-sectional study was conducted in the Department of Microbiology, IMCHRC, Indore. The study was approved by IEC and conducted from October 2019 to September 2021. A total number of 168 Acinetobacter species including 143 A. baumannii were isolated from the various clinical specimens, the majority of the isolates were obtained from the respiratory system (66%), followed by urine, pus/wound swab, blood, fluids and other samples. The majority of the patients who had underlying/diagnosed with a disease such as aspiration pneumonia/pneumonia (35%), cerebrovascular accident/haemorrhagic shock (30.7%), respiratory failure (24%), accelerated HTN/HTN(18%), and less common were septicemia (8.4), acute kidney injury/ chronic kidney diseases (7.7%) and trauma/burns (5.5%). The antibiotic susceptibility testing showed higher antibiotic resistance to cefotaxime (94%), ceftazidime (93%), cefepime (92%), imipenem (92%), meropenem (90%) and the resistance was low to doxycycline (39%) Polymyxin B (8%). The association between antibiotic resistance and the clinical profile of patients was found significant (p-value < 0.05). In our study, a remarkably high antibiotic resistance pattern was observed in the classes of antibiotics in A. baumannii isolates, mostly MDR and XDR. To address infection caused by antibiotic-resistant A. baumannii, appropriate antibiotic administration in a clinical setting is essential. Moreover, local and national surveillance data, stringent infection control, and antimicrobial stewardship are required. [ABSTRACT FROM AUTHOR]

Background: Diabetes is prevalent globally; India stands amongst the first two countries with the highest percentage of adults aged 20–79 years with diabetes in 2021. Anti-diabetic agents and insulin offer profound side effects. Phytoconstituents regulate blood sugar, improve health status and reduce dependency on anti-diabetic medications. This research aims to generate clinical evidence of Diabetic Support Product (GP/PROD/2021/001) in the treatment of type 2 diabetes. Trial design: A randomized, double-blind, placebo-controlled clinical trial was conducted on 150 individuals with type 2 diabetes mellitus. Subjects were divided into two parallel groups and given either GP/PROD/2021/001 or a placebo tablet; 2 tablets twice a day after meals for 90 days. Methods: Interventions were adjuvant to the standard medication. The research objectives were to evaluate changes in fasting and post-meal plasma glucose and HbA1c in patients with type 2 diabetes. Results: In 90 days, GP/PROD/2021/001 group showed a substantial improvement in all key biochemical markers-HbA1c, FBS, and PPBS when compared to the placebo group. A reduced HOMA-IR score suggests reduced insulin resistance. Quality of life improved in GP/PROD/2021/001 group than placebo. On day 90, there was a significant decrease in HbA1c levels in GP/PROD/2021/001 (23.51%) group than placebo (6.21%). The test group reduced their dependency on conventional antidiabetic medication and insulin. Conclusion: It can be concluded from the study that the advanced diabetic support formula (GP/PROD/2021/001) is a safer and more effective option as an adjuvant in the management of diabetes from newly diagnosed to chronic diabetic patients. Trial registration: CTRI/2022/01/039179 [Registered on: 05/01/2022] Trial Registered Prospectively. [ABSTRACT FROM AUTHOR]

The article focuses on the present options for patent litigations on medicines in India. It mentions that the regulations in the Patents Act, 1970 are denied through the litigations effecting the Indian pharma Small Medium Enterprise sector. It also mentions the options for improving access to lifesaving medicines in the present Indian patent legal system. It also adds information on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.

India is of great interest to the world of pharmaceuticals. The domestic market ($13b) is growing at almost 10% compound annual growth rate (CAGR). The exports of pharmaceuticals from India ($15b) is growing at 12% CAGR. All the well-known names in the global sphere are now present in the Indian pharma market, and many are having formulation manufacturing units here. It is widely believed that companies in India can soon become the biggest suppliers of generic drugs to the world. Apart from affordable cost, the emphasis is now shifting to Current Good Manufacturing Practices (cGMP)/Current Good Manufacturing/Clinical/Lab/etc Practices (cGXP). What should a pharma manufacturer know about the present status of issues in India which will reflect on the future performance of this country. Can India really be the pharmacy of the world? Only time will tell, but the conditions of the road will more or less be understood through this article. [ABSTRACT FROM PUBLISHER]

The prognosis of patients with chronic myeloid leukemia (CML) has changed radically since the advent of imatinib mesylate, a selective inhibitor of BCR-ABL tyrosine kinase. Shortly thereafter, more potent BCR-ABL inhibitors (dasatinib and nilotinib) were introduced for use in patients resistant to or intolerant of imatinib. All three drugs are now approved for initial therapy for chronic phase CML. Response to tyrosine kinase inhibitor (TKI) treatment is assessed with standardized quantitative reverse transcriptase polymerase chain reaction (Q-RTPCR) and/or cytogenetics at 3, 6 and 12 months. Clinical trials have clearly demonstrated that early and deeper cytogenetic and molecular response to TKI therapy is associated with lower rate of disease progression and improved long-term outcomes. In recent times, molecular response as determined by BCR-ABL transcript levels at defined time points is rapidly gaining popularity as a predictive marker for subsequent outcomes in CML. Optimal response is defined as BCR-ABL transcript levels of = 10% at 3 months, < 1% at 6 months, and = 0.1% from 12 months onward while > 10% at 6 months and > 1% from 12 months onward define failure. Patients who do not achieve molecular milestones at 3 or 6 months with 3 months being highly predictive are less likely to achieve cytogenetic responses eventually; early identification of such patients who have a low probability of achieving an adequate response are thus candidates for alternative treatment. Review of literature by electronic search of MEDline, Google Scholar was done using keywords and data was identified and systematically evaluated. [ABSTRACT FROM AUTHOR]

Genetic variants influencing the pharmacokinetics and/or pharmacodynamics of the chemotherapeutic drugs used in Acute Lymphoblastic Leukemia (ALL) therapy often contribute to the occurrence of treatment related toxicity (TRT). In this study, we explored the association of candidate genetic variants with early hematological TRT (grade 3–4) occurring within the first 100 days of low-dose methotrexate and 6-mercaptopurine based maintenance therapy (n = 73). Fourteen variants in the following candidate genes were genotyped using allele discrimination assay by real-time PCR: ABCB1, DHFR, GGH, FPGS, MTHFR, RFC1, SLCO1B1, TPMT, and NUDT15. Methotrexate polyglutamate (MTXPG3-5) levels in red blood cells were measured by LC-MS/MS. Early hematological TRT (grade 3–4) was seen in 54.9% of patients. The NUDT15c.415T allele was associated with early TRT occurrence [HR: 3.04 (95% CI: 1.5–6.1); p = 0.007]. Sensitivity of early TRT prediction improved (from 30.7% to 89.7%) by considering FPGS variant (rs1544105'T') carrier status along with NUDT15c.415T allele [HR = 2.7 (1.5–4.7, p = 0.008)]. None of the considered genetic variants were associated with MTXPG3-5 levels, which in turn were not associated with early TRT. NUDT15c.415T allele carrier status could be used as a stratifying marker for Indian ALL patients to distinguish patients at high or low risk of developing early hematological TRT. [ABSTRACT FROM AUTHOR]

Aim: To report our experience of the use of dasatinib in various phases of chronic myeloid leukemia (CML)., Methods: Ten patients in various phases of CML, not responding to imatinib and started on dasatinib, were included and analyzed. The baseline characteristics of the patients and their salient features including the duration and response to initial therapy as well as to dasatinib, were noted., Results: Before starting dasatinib three patients were in chronic phase of CML while seven others were in the progressive phase (accelerated and blast phase) of CML. Half the patients developed transient grade 3 and 4 toxicities to dasatinib. Overall, the tolerability of the drug in all 10 patients was acceptable and none discontinued treatment. Three patients died due to progressive disease while the remaining seven are continuing the drug with the disease still under cytogenetic or hematological remission. Of the 10 patients, seven achieved complete hematological response and two of the accelerated phase/blast crisis patients achieved complete cytogenetic response. Overall, dasatinib was able to control disease for a median of 20.6 months., Conclusion: Despite small sample size and insufficient information on mutational analysis, dasatinib is effective in CML in India. Cost limits the use of second-generation tyrosine kinase inhibitors in India. Our observation is not suitable for survival analysis but the difference made by dasatinib in progressive disease and its tolerability needs to be acknowledged., (© 2012 Wiley Publishing Asia Pty Ltd.)