Hurdles in Mandatory Generic Medicine Prescription

Coronavirus pandemic has brought forth the urgency of providing affordable health care to everyone. Generic medicines are often one-fourth to one-tenth of the cost of the branded drugs, and so offer a remarkable opportunity to significantly lower the health-care expenditure. However, the argument for promoting generic medicines is indisputable, we have to think about the other enabling conditions which are necessary for a successful health policy on encouraging generics without causing unintended adverse repercussions. This paper attempts to answer such questions by considering the motivations of the various stakeholders of the broader health services ecosystem in India and undertaking a systematic analysis of the winners and losers from such a policy. We argue that generic prescription will not be successful without prior improvement in the state capacity for quality control of drug manufacturing; rise in awareness among the doctors, patients, and pharmacists; improved trust in the medical systems; and innovative demand-side interventions.

Effect of Non-Genetic Factors on Test-Day Milk Yields and First Lactation Milk Yields in Holstein Friesian × Sahiwal Cattle

The present study was carried out using first lactation monthly test-day milk yield records of 466 crossbred (HF × Sahiwal) cattle calved from 2000 to 2018 sired by 89 bulls maintained at Directorate of Livestock Farms, GADVASU, Ludhiana. Mixed model analysis was carried out by least-squares maximum likelihood programme to study the effects of non-genetic factors on first full lactation milk yield (FFLMY), first lactation 305-day milk yield (FL305MY) and monthly test-day (TD) milk yield records of crossbred cattle. The least squares means of different monthly TD milk yields (1st to 11th) were 12.05 ± 0.42, 15.65 ± 0.42, 15.38 ± 0.44, 14.44 ± 0.43, 13.79 ± 0.41, 12.88 ± 0.40, 12.27 ± 0.42, 11.83 ± 0.37, 10.85 ± 0.42, 10.64 ± 0.45 and 10.28 ± 0.50 kg, respectively. For FFLMY and FL305MY the means were 4979.60±184.45 and 3818.17±103.26 kg. The effects of different AFC groups were non-significant on TDs and FL305MYs, whereas it was significant (p≤0.01) for FFLMY. The season was significant (p≤0.01) for all the monthly TDs whereas it was non-significant for FFLMY and FL305MY. The sire was significant (p≤0.01) for most of the TDs and FL305MYs except the later TDs (9th, 10th and 11th TD) and FFLMYs. The present investigation revealed the importance of non-genetic factors in performance evaluation of crossbred cattle based on monthly test-day milk yield, FL305MY and FFLMY records

Metabolic Profiling of Normal and Lame Karan Fries Cows and its Association with Lameness during Transition Period

In high yielding dairy cows, one of the major cause of lameness during transition period is the altered nutritional status of pregnant animal. Concentrations of essential nutrients get varied and often decrease around calving due to physiological factors and thus extra-supplementation is recommended in these animals. Blood measures are frequently used in assessment of the vital nutrients for predicting the risk of lameness during this period. The objective of this study was to investigate the nutritional status of healthy and lame Karan Fries (KF) cows and their association with lameness score during transition period. For this fifteen high-yielding crossbreed (KF) healthy cows and fifteen high yielding crossbreed (KF) lame cows were randomly selected from the Livestock Research Centre (LRC) of National Diary Research Institute, Karnal for pooled blood sample collection. Samples were collected 60d, 15d pre-partum, on the day of calving, and 60d, 15d post-partum. The results revealed that the mean plasma biotin, zinc (below critical level) and calcium (within range) levels were significantly lower (P<0.05) in lame KF cows while β-hydroxybutyrate (BHBA) concentrations was significantly higher, however no significant difference in plasma copper, glucose and non-esterified fatty acids (NEFA) concentrations was found in lame cows as compared to normal KF cows during this period. There was also significant (P<0.05) variation of blood biochemical profiles (glucose, NEFA and BHBA) and plasma biotin concentration among different lameness scores (1-5) whereas no relation of mineral profiles (calcium, zinc and copper) was seen with lameness score

Differences in Hepatic Expression of Iron, Inflammation and Stress-Related Genes in Patients with Nonalcoholic Steatohepatitis

Abstract: Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide. We have previously shown that hepatic reticuloendothelial system (RES) iron deposition is associated with an advanced degree of nonalcoholic steatohepatitis (NASH) in humans. In this study, we aimed to determine differentially expressed genes related to iron overload, inflammation and oxidative stress pathways, with the goal of identifying factors associated with NASH progression. Seventy five patients with NAFLD were evaluated for their biochemical parameters and their liver tissue analyzed for NASH histological characteristics. Gene expression analysis of pathways related to iron homeostasis, inflammation and oxidative stress was performed using real-time PCR. Gene expression was compared between subjects based on disease status and presence of hepatic iron staining. We observed increased gene expression of hepcidin (HAMP) (2.3 fold, p = 0.027), transmembrane serine proteinase 6 (TMPRSS6) (8.4 fold, p = 0.003), signal transducer and activator of transcription 3 (STAT3) (5.5 fold, p = 0.004), proinflammatory cytokines; IL-1β (2.7 fold, p = 0.046) and TNF-α (3.8 fold, p = 0.001) in patients with NASH. TMPRSS6, a negative regulator of HAMP, is overexpressed in patients with NASH and HIF1α (hypoxia inducible factor-1) is downregulated. NAFLD patients with hepatic iron deposition exhibited higher hepcidin expression (3.1 fold, p = 0.04) but lower expression of cytokines. In conclusion, we observed elevated hepatic HAMP expression in patients with NASH and in NAFLD patients who had hepatic iron deposition, while proinflammatory cytokines displayed elevated expression only in patients with NASH, suggesting a regulatory role for hepcidin in NAFL to NASH transition and in mitigating inflammatory responses.

Spinocerebellar ataxia 7 (SCA7) in Indian population: predilection of ATXN7-CAG expansion mutation in an ethnic population.

Background & objectives: spinocerebellar ataxia 7 (SCA7) is a rare form of neurodegenerative disorder with the clinical manifestation of cerebellar ataxia and retinal degeneration. In this study we describe the clinico-genetic characteristics of nine SCA7 families of Indian origin and cross compare these with other available worldwide studies. Methods: Thirty five individuals from nine SCA7 families were clinico-genetically characterized and CAG repeat distribution analysis was carried out in 382 control DNA samples from healthy controls (derived from 21 diverse Indian populations based on ethnic and linguistic and geographical location). Results: Of the nine families studied, 22 affected individuals and one asymptomatic carrier were identified. The average age at disease onset was 23.4±12.6 yr. The length of expanded CAG ranged from 40-94 with mean value of 53.2±13.9. The main clinical findings in affecteds individuals included cerebellar ataxia, and retinal degeneration along with hyper-reflexia (95%), slow saccades (85%) and spasticity (45%). Analysis of the association of number of CAG repeats with disease onset revealed that <49 repeats were associated with earlier age at onset in South East Asians compared to European populations. Further analysis of CAG repeats from 21 diverse Indian populations showed pre-mutable repeats (28-34) alleles in the IE-N-LP2 population. Six of the nine families identified in this study belonged to the same ethnic population. Interpretations & conclusion: Our results show that presenece of SCA7 is relatively rare and confined to one ethnic group from Haryana region of India. We observed a homogeneous phenotypic expression of SCA7 mutation as described earlier and an earlier age of onset in our patients with CAG <49. The identification of pre-mutable allele in IE-N-LP2 suggests this population to be at the risk of SCA7.

A Review on Pharmaceutical Validation and Its Implications.

The process validation is establishing documented evidence which provides high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality characteristic. According to GMP validation studies are essential part of GMP these are required to be done as per predefined protocols. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Thus the validation is an essential part of the quality assurance.

Moyamoya disease--magnetic resonance imaging and magnetic resonance angiographic features.

A rare case of moyamoya disease in a 9-year-old female presented with behavioural disturbances and recurrent hemiparetic attacks is reported. Moyamoya disease is an uncommon form of arteritis which affects the cerebrovascular circulation. Magnetic resonance angiography is a non-invasive technique for evaluation of the carotid and vertebrobasilar circulation. The magnetic resonance angiography findings are typical and characteristic of this disease.