Mankind Pharma (India)

Background: Hypertension and dyslipidemia frequently coexist and significantly elevate the risk of cardiovascular disease (CVD) through shared mechanisms. Despite clear evidence supporting integrated management, real-world gaps persist in diagnosis, monitoring, and patient adherence. Methods: This nationwide cross-sectional survey was conducted among 842 healthcare professionals (HCPs) across India to evaluate current clinical practices, challenges, and educational needs in managing this dual comorbidity. A structured 20-item questionnaire captured insights on comorbidity prevalence, diagnostic approaches, therapeutic practices, and barriers to optimal care. Results: The survey revealed substantial coexistence of hypertension and dyslipidemia, with 40.2% of HCPs reporting dyslipidemia in 10-20% of hypertensive patients and 38.8% observing hypertension in 20-30% of dyslipidemic cases. Comorbidity was most prevalent in adults aged 45-60 years (51.9%). Lifestyle factors were the leading contributors (38.3%), followed by age-related factors (25.4%). Despite routine lipid panel use, early diagnosis was hindered by poor follow-up (24.6%), asymptomatic presentation (23.3%), and inadequate screening guidelines (23.0%). Poor patient adherence was identified as the major treatment challenge (54.7%), while guideline sufficiency was divided, with 45.5% rating them adequate and a similar proportion finding them only somewhat sufficient. Conclusions: Overall, the findings highlight substantial unmet needs in the real-world management of hypertension with dyslipidemia. Strengthened patient education, structured lifestyle support programs, regular lipid testing, and enhanced clinician training may improve early detection and long-term outcomes. A more unified, patient-centered approach is essential to reducing the growing cardiometabolic burden in India.

Staphylococcal nuclease and tudor domain-containing protein 1 (SND1) is an oncoprotein that is overexpressed in various types of cancer, including breast, prostate, lung, colorectal and hepatocellular carcinomas, as well as malignant gliomas, especially in cases of advanced and metastatic cancer. SND1 has a significant role in tumour development via its interactions with RNA and partner proteins. SND1 functions as a nuclease within the RNA-induced silencing complex, where small RNAs (such as siRNAs or miRNAs) bind to ribonucleoproteins to mediate RNA interference and silencing of tumour suppressor genes. Metadherin (MTDH) has been identified as an important protein partner of SND1, and the SND1-MTDH interaction has been reported to drive tumour initiation, metastasis and immune evasion in various types of cancer. Therefore, SND1 is considered as a crucial target for cancer therapy, and multiple approaches have been explored to inhibit its nuclease activity or disrupt its interaction with MTDH. In the present review, both the oncogenic functions of SND1 and therapeutic strategies that target either its binding to RNA or its interaction with MTDH are investigated.

Soil-transmitted helminth (STH) infections are endemic in India despite considerable improvements in hygiene conditions and regular deworming. This multicentric, double-blind, randomized controlled trial(Efficacy and Safety of Albendazole Versus AlbenDazole and IVERmectin in Reduction of Soil-Transmitted HelMINth Infections in School-Age Children (DVERMIN)) was conducted to evaluate the efficacy and safety of albendazole versus albendazole + ivermectin in the treatment of STH infections and to evaluate the prevalence of stool-positivity for STH in school-going children from 12 schools of Lucknow and Kolkata. This was a randomized controlled trial conducted from March 2022 to February 2023. The included children aged 6-15 years were administered single-dose oral suspension of albendazole (400 mg) or albendazole (400 mg) + ivermectin (3/6/12 mg based on body weight). The primary endpoint was the microbiological cure rate (proportion of infected children having egg-free stool samples post single-dose treatment) on Day 7. The secondary endpoints were egg reduction rate and clinical cure rate (proportion of children with symptom resolution) on Day 7, and the proportion of children in the regions of study conduct with stool positivity for STH at baseline. Safety was assessed based on adverse events (AEs). Among the 1233 eligible children, stool samples from 1067 were evaluable at baseline. A total of 416 (38.99%) of these 1067 samples were egg-positive. Ascaris lumbricoides was the most prevalent STH (99.52% samples). Of the 416 samples, 304 were evaluable for post-dose analysis (albendazole, 146; albendazole + ivermectin, 158). In these samples, the microbiological cure rate achieved with albendazole (61.64%) was comparable to that achieved with albendazole + ivermectin (62.03%; p=0.95). The egg reduction rate obtained with albendazole was 90.61% compared to 93.22% achieved with albendazole + ivermectin. The rate of complete clinical cure on Day 7 was 66.95% with albendazole and 71.31% with albendazole + ivermectin (p=0.47). A moderate AE unrelated to antihelminthic medication was observed with albendazole; no AE was observed with albendazole + ivermectin. Overall, both treatments were found to be effective and safe in school-age children. The rates of microbiological cure, egg reduction, and clinical cure were not significantly different between the groups; however, a clinical advantage was demonstrated in the albendazole + ivermectin group with respect to egg reduction and clinical cure.

Abnormal uterine bleeding (AUB) is an acute/chronic variation in the normal menstrual cycle that affects adolescents, women of reproductive age and perimenopausal women. AUB affects approximately 3–30% of reproductive-aged women worldwide, and reduces their quality of life and productivity whilst increasing the overall healthcare burden. Its management requires thorough medical evaluation and individualized treatment. Depending on the severity and cause of AUB, its treatment ranges from lifestyle modifications and hormonal therapies to more invasive procedures or surgery. Although hormonal therapy is the preferred first-line measure in AUB, the available pharmacological options have various adverse effects. There exists a need for safer and more efficient treatment regimens with high patient compliance to effectively treat AUB. Norethisterone, also known as norethindrone, is a widely used synthetic analogue of progestogen. Controlled release formulations of norethisterone/ norethisterone acetate help maintain constant drug levels in the blood and exert minimal side-effects; therefore, they are promising therapeutic agents for effective AUB management. The present review summarizes the epidemiology and diagnosis of AUB, with a focus on the safety, efficacy and tolerability of norethisterone/ norethisterone acetate in AUB management. We also report a case of AUB in a 40-year-old woman, who was treated with NETA tablets. The treatment resulted in favourable outcomes, and patient satisfaction.

Objective: To evaluate the efficacy and safety of the multivitamin tablet “Health OK” (phytochemical formulation of nutrients and super-nutrients like Taurine and Ginseng Extract) in healthy male subjects. Material and methods: This was a multicentric, double-blind, randomized, placebo-controlled clinical study of Health OK Tablet (Multivitamin, Multimineral, Amino Acids with Taurine & Ginseng Extract) (test product:control= 2:1). Efficacy parameter evaluation was carried out at randomization, and follow-ups (2, 4, 8 and 12th weeks). Primary endpoint was to assess general well-being. Secondary endpoints were mean changes in laboratory parameters, immune/inflammatory response, oxidative stress markers, energy and fatigue, mental alertness, and memory. Results: 56.67% of the 60 test subjects showed clinical improvement in general well-being compared to 30% in control. The test group showed notable improvement in the Energy and Fatigue scores by day 14, than control group. Similar differences between the two groups were also observed in mental alertness and memory scores. In terms of the immune/inflammatory response, the test group (2.58 pg/ml) showed a major reduction in IFN-γ from baseline to the end of the study (EOS) than the control group (1.5 pg/ml). Significant reductions were seen in levels of malondialdehyde (p=0.0001), superoxide dismutase (p=0.0261), and glutathione (p=0.0058) in the test group than control. None of the subjects were withdrawn from the study owing to adverse events. Conclusion: Our results showed that the test product was effective in improving the general well-being, energy, memory and mental alertness parameters, immune and inflammatory responses and oxidative stress markers compared to placebo in healthy male subjects, with improvement in energy scores evident within 14 days.

Background Low back pain (LBP) is a global health concern. Management of LBP aims at pain relief facilitating improvement of functional ability. Non-steroidal anti-inflammatory drugs (NSAIDs) are the first line of therapy. However, the selection of NSAIDs is challenging given the range of underlying etiologies and severity. The current study aimed to compare the efficacy and safety of two available fixed-dose combinations (FDCs), namely, a dual FDC (DFC) of etoricoxib (60 mg) and thiocolchicoside (4 mg) versus a triple FDC (TFC) of chlorzoxazone (500 mg), diclofenac (50 mg), and paracetamol (325 mg). Methodology A total of 200 eligible adult subjects aged 18-70 years with a history of LBP and muscle spasm for ≤14 days and Wong-Baker Faces Pain score >4 were enrolled after obtaining written informed consent and randomized in a 1:1 allocation ratio to be treated with either DFC or TFC for 28 days. Efficacy was assessed based on the change in score from baseline (before treatment) to day 28 on the Wong-Baker Faces Pain Scale and the Oswestry Disability Index (ODI) questionnaire, as well as the proportion of subjects who improved upon treatment. Safety was assessed based on adverse events and clinical laboratory test results. Results A significant decrease in pain intensity (p < 0.001) and significant improvement in functional ability (p < 0.001) was observed after treatment with either DFC or TFC. The decrease in Wong-Baker Faces Pain score and ODI, from baseline, was comparable between the treatment groups. However, more subjects with very severe pain at baseline showed ≥30% improvement upon treatment with DFC than with TFC (~25% versus ~12%; p = 0.172). Also, significantly more crippled subjects with very severe functional disability showed improvement in the DFC group compared to the TFC group (~26% versus ~4%; p = 0.008). No adverse events or clinically relevant laboratory test results were evident. Conclusions Both DFC and TFC were comparable in efficacy and safety for the management of recent-onset LBP. However, significantly more subjects with very severe pain or functional disability showed improvement after 28 days when treated with DFC compared to TFC.

Abstract: Introduction: Generic Drug User Fee Act (GDUFA) was introduced in 2012 to bring more and more generic drugs into the market in a short time through an effective review process. In the present study, the impact of the GDUFA on prices of the generic drugs has been evaluated. Materials and Methods: Various research reports related to drug costs and competition such as (i) reasons for high drug prices, (ii) FDA’s research on drug prices pre- and post- GDUFA, and (iii) the current status of generic drugs in the USA produced by different agencies including the Congressional Budget Office (CBO), FDA’s Center for Drug Evaluation and Research (CDER), and the Federal Trade Commission (FTC) to understand the challenges of high drug costs have been critically evaluated. Results and Discussion: The analysis of research reports generated over some time concludes that the fall in generic drug prices has been accelerated further in recent years, with increased competition. The data analysis also reflects that during the GDUFA period, the Agency has been able to proactively address the challenges posed by brand-product companies. However, some issues remain to be addressed. Conclusion: The scope of this evaluation was limited to focus on FDA-related aspects where generic competition can be enhanced by making the generic drug approval process more efficient, continue to facilitate industry on complex products regulation to bring generic equivalents of complex products where patents expired long-time back, help resolve shortages faster and help expedite resolution of site compliance matters more quickly to assist in resuming supplies. Keywords: Congressional Budget Office (CBO), Federal Trade Commission (FTC), Generic Drug User Fee Act (GDUFA), USFDA, Drug Prices.

A proficient GC-HS method was developed for quantification of THIRTEEN residual solvents in Atorvastatin Calcium drugs substance with flame ionization detector (FID) using column Rtx-624, (60m length X 0.25mm diameter) 1.4µm film thickness, Part No.: 10969, Make: Restek. Nitrogen is used as Carrier gas with Linear velocity of 27.7cm/se on Shimadzu /GC-2010 Plus/HS-20 instrument. The proposed method was validated for System suitability, Specificity, Linearity, LOD and LOQ determination, Recovery, Precision, Range and Robustness. All the parameters were found within the acceptable limits. Linearity of all thirteen residual solvents are in the range of LOQ to 150%. The established methodology was commercially useful, specific, accurate, precise and suitable for the analysis of Residual solvents in Atorvastatin Calcium drug substance.