Minimizing the risk of ethylene glycol and diethylene glycol poisoning in medications: A regulatory and pharmacopoeial response.

Pharmaceutical and personal care products, including syrups and toothpastes, extensively use glycerin, sorbitol, and propylene glycol. However, past incidents of ethylene glycol (EG) and diethylene glycol (DEG) contamination in these products have raised serious health concerns. Recently, several child deaths linked to contaminated cough syrup consumption have heightened concerns regarding the safety of Indian pharmaceuticals.

Ossifying Fibroma of Mandible - A Case Report.

Introduction: Ossifying fibromas are rare, non-aggressive benign tumours of the bone, commonly involving the posterior mandible in middle-aged individuals with a female predilection.

Findings: Clinical manifestations include asymptomatic expansion of the mandible with infrequent maxillary lesions, pain, malocclusion, and compromised quality of life including aesthetic perception. Owing to multiplicity of features, tendency of recurrence, and possibility of malignant transformation, the diagnosis, treatment, and post-operative management of ossifying fibroma are always a challenge.

Efficacy of Oral Colchicine and Intralesional Hyaluronidase with and without Ultrasound Therapy in the Management of Oral Submucous Fibrosis-A Comparative Study.

Aim: To determine the therapeutic effect and efficacy of oral colchicine tablet and intralesional injection of hyaluronidase with and without ultrasound therapy in the clinical course of oral submucous fibrosis.

Materials And Methods: This comparative study involving 45 human participants was divided into three equal groups. The participants in group 1 received oral colchicine and intralesional hyaluronidase.

Prevalence of Anemia: A Hospital-Based Diagnostic Study.

Objectives: To determine the prevalence of anemia in female patients and its association with age, nutritional status, body mass index, number of children, intra-oral and extra-oral clinical finding.

Materials And Methods: A total of 1000 participants in various age groups were taken as sample, and a pro forma was used to collect data. Hemoglobin was recorded using Sahli's method and categorized according to WHO.

Report of a collaborative study to establish the first Indian Pharmacopoeia reference standard for teriparatide.

A collaborative study was conducted to establish the first Indian Pharmacopoeia Reference Standard (IPRS) for teriparatide to be used in quality control testing of marketed products in compliance with the Indian Pharmacopoeia (IP) monograph. The study objective was to evaluate the candidate standard in terms of the WHO International Standard (IS) to assign its content in mg per vial terms. This study involved four laboratories from India and the candidate standard was calibrated against the WHO IS by each participant laboratory using high-performance liquid chromatography (HPLC) assay method per IP monograph.

Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia.

India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying high-quality and affordable medicines across the globe. Ensuring the quality and safety of the marketed medicinal products is one of the most important components of the drug regulatory framework and assessment of the quality of medicines is usually achieved by referring to the public standards of the official Pharmacopoeia. In India, the Indian Pharmacopoeia (IP) is published at regular intervals to fulfill the requirements of the Drugs and Cosmetics Act, 1940 to ensure the quality of medicines being manufactured and/or marketed in India.

Sialolithiasis: An Unusually Large Submandibular Salivary Stone.

Salivary stones are termed as sialoliths, and the condition is referred to as sialolithiasis. Pain and swelling in the affected area, especially after eating, occur often. Small, easily accessible stones may be managed with conservative methods, such as milking of ducts, along with palliative care, whereas bigger, more difficult-to-reach stones need surgical removal.

Rapidly expanding chondromyxoid fibroma of the mandible: A case report of rare entity.

Chondromyxoid fibroma is an unusual, benign bone tumour that is usually sited in the metaphyseal region of the long bones. It accounts for less than 1% of all bone tumours. It manifests predominantly in males in their second and third decades of life.

Pharmacopoeia roles and responses: A systemic resilience approach to COVID-19 pandemic.

The Coronavirus Disease (COVID-19) is sweeping around the world at a rapid pace resulting in severe health crises across the globe. The pandemic condition has forced the government, regulatory authorities, bio/pharmaceutical industry, and healthcare system to take novel measures to address the crisis. The race for development of medicines and vaccines for treatment of COVID-19 is well under way and regulatory authorities are making efforts to safely deliver it into hands of public.

Global testing of a consensus solubility assessment to enhance robustness of the WHO biopharmaceutical classification system.

The WHO Biopharmaceutical Classification System (BCS) is a practical tool to identify active pharmaceutical ingredients (APIs) that scientifically qualify for a waiver of in vivo bioequivalence studies. The focus of this study was to engage a global network of laboratories to experimentally quantify the pH-dependent solubility of the highest therapeutic dose of 16 APIs using a harmonized protocol. Intra-laboratory variability was ≤5 %, and no apparent association of inter-laboratory variability with API solubility was discovered.

Traumatic Bone Cyst of Mandible: A Case Report of Rare Entity and Review of Literature.

The traumatic bone cyst was first described by Lucas in 1929 and later by Rushton. A solitary bone cyst (SBC) is a nonneoplastic osseous lesion affecting ≥95% of the metaphyses of long bones such as the proximal humerus and femur. The incidence of cyst affecting the jaws is 1% of all the cyst.

Establishment of the First National Reference Standard for Insulin Lispro: Report of a collaborative study.

The present study was aimed to establish the First National Reference Standard (NRS) for Insulin lispro to allow stakeholders including manufacturer's laboratories, drug testing laboratories, drug regulatory authorities and academic institutions to demonstrate accuracy of the test results and to enable comparison and validation of analytical methods. The candidate standard for Insulin lispro was evaluated in a collaborative study to assign the vial content in order to serve it as NRS to support the Indian Pharmacopoeia (IP) monograph. The candidate standard was calibrated against the Ph.

Is screening in dental office an effective method of detecting undiagnosed hypertension?

Background: Hypertension is an important worldwide public health challenge because of its high frequency and risk of cardiovascular and renal disease.

Objective: The objective of this study was to investigate the prevalence of undiagnosed hypertension as well as inadequately controlled hypertension among general population who sought tooth extraction at Army College of Dental Sciences, Secunderabad.

Materials And Methods: Only 1200 patients in the age group of 20-60 years who sought tooth extraction were included in the study.

Monitoring Quality of Biotherapeutic Products Using Multivariate Data Analysis.

Monitoring the quality of pharmaceutical products is a global challenge, heightened by the implications of letting subquality drugs come to the market on public safety. Regulatory agencies do their due diligence at the time of approval as per their prescribed regulations. However, product quality needs to be monitored post-approval as well to ensure patient safety throughout the product life cycle.

Effect of efflux pump inhibitors on drug susceptibility of ofloxacin resistant Mycobacterium tuberculosis isolates.

Background & Objectives: In drug resistant, especially multi-drug resistant (MDR) tuberculosis, fluoroquinolones (FQs) are used as second line drugs. However, the incidence of FQ-resistant Mycobacterium tuberculosis is rapidly increasing which may be due to extensive use of FQs in the treatment of various other diseases. The most important known mechanism i.

Role of embCAB gene mutations in ethambutol resistance in Mycobacterium tuberculosis isolates from India.

In the present study, ethambutol (EMB) resistance-associated mutations were characterised in the embCAB genes of clinical isolates of Mycobacterium tuberculosis (MTB) collected in India. Thirty MTB isolates were tested for their susceptibility to first-line antitubercular drugs using the Löwenstein-Jensen proportion method, and EMB minimum inhibitory concentrations of MTB isolates were determined by the resazurin microtitre assay. Sequencing of various regions of the embCAB genes was performed to identify EMB resistance-associated mutations.

Determination of ethambutol MICs for Mycobacterium tuberculosis and Mycobacterium avium isolates by resazurin microtitre assay.

Objectives: To test susceptibilities of Mycobacterium tuberculosis (MTB) isolates to ethambutol by the Löwenstein-Jensen (LJ) proportion method and resazurin microtitre assay (REMA) and to evaluate REMA for the determination of ethambutol MICs for MTB and Mycobacterium avium isolates.

Methods: A total of 50 MTB and 20 M. avium isolates were tested to determine the MICs of ethambutol by REMA and agar dilution method.

Simultaneous use of two PCR systems targeting IS6110 and MPB64 for confirmation of diagnosis of tuberculous lymphadenitis.

PCR has emerged as a powerful technique for detection of various pathogens including Mycobacterium tuberculosis. In present study, eighty one samples of lymph node biopsies from clinically suspected cases of tuberculous lymphadenitis were examined for AFB, culture on Löwenstein Jensen medium and simultaneous use of two PCRs targeting IS6110 and MPB64. Positivity with M.

Simultaneous ethambutol & isoniazid resistance in clinical isolates of Mycobacterium tuberculosis.

Background & Objective: There is a need to understand the nature of drug resistance patterns and predictors of emergence of drug resistance in Mycobacterium tuberculosis. There could be common factors/mechanisms for resistance to the drugs, isoniazid and ethambutol, both acting on cell wall. The present study was conducted to analyze the antimycobacterial susceptibility patterns of M.