Ancient wisdom of ayurveda vis-à-vis contemporary aspect of materiovigilance.

Materiovigilance is regulatory system to study and follow incidents that might result from using medical devices. To trail the occurrence of untoward effects associated with medical devices as well as to document and prevent their recurrence; the Indian Pharmacopeia Commission initiated Materiovigilance program in India (MvPI) in 2015. Classical texts of Ayurveda include substantial description of devices intended for various therapeutic purposes such as Panchakarm (penta-bio purification procedures), Surgeries and for management of gynecological conditions etc. The implemented program of Materiovigilance does not include Ayurveda devices and thus there is need for documentation, systematic classification of Ayurveda devices and development of Ayurveda Materiovigilance (AMv). In this review, relevant information from classical texts of Ayurveda, latest published information related to Materiovigilance and information of medical devices from classical texts of Ayurveda has been scrutinized along with systematic correlation and applied interpretation of the collected data. It is observed that Materiovigilance has been well documented in Ayurveda in context of twenty six surgical and diagnostic devices; eleven mostly utilized pharmaceutical instruments five Panchakarma instruments and five home devices. For regulation of quality of Ayurveda medical devices, their manufacturing, standard utilization, reporting and prevention of medical device associated errors; it is the need of hour to create and implement regulation in the form of AMv. The Ayurveda literature highlights that the ancient seers of Ayurveda were well aware regarding Materiovigilance in their own way. However in view of modern era and mainstreaming of Ayurveda heritage, critical revision, updating, systematically categorization of Ayurveda devices, development and implementation of AMv regulation is the need of hour.

Ethambutol toxicity: Expert panel consensus for the primary prevention, diagnosis and management of ethambutol-induced optic neuropathy.

Ethambutol use may lead to permanent vision loss by inducing a dose- and duration-dependent optic neuropathy. This has been of concern to ophthalmologists and physicians both; however, ethambutol continues to be used because of its anti-mycobacterial action with relative systemic safety. Recently, the guidelines of the Revised National Tuberculosis Control Programme of India have been revised to allow for fixed dose and longer duration of ethambutol use; this is likely to result in an increase in vision-threatening adverse effects. Taking cognizance of this, neuro-ophthalmologists, infectious disease specialists, and scientists met under the aegis of the Indian Neuro-Ophthalmology Society to deliberate on prevention, early diagnosis, and management of ethambutol-related toxic optic neuropathy. The recommendations made by the expert group focus on early suspicion of ethambutol toxicity through screening at the physician's office and opportunistic screening by the ophthalmologist. Further, they focus on an early diagnosis through identification of specific clinical biomarkers and on management in way of early stoppage of the drug and supportive therapy. This statement also describes the mechanism of reporting a case of toxic optic neuropathy through the Pharmacovigilance Programme of India and emphasizes the need for spreading awareness regarding vision-threatening adverse effects among patients and healthcare workers.

Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance.

The Materiovigilance Programme of India (MvPI) has been implemented to ensure the safety of medical devices including cardiovascular devices (MD-CVD). This article describes the role of MvPI surveillance system that comprehensively collects, collates and analyses the adverse events associated with MD-CVD and also its supplementing role to the Central Drugs Standard Control Organization for taking regulatory decision to reduce the health burden on account of adverse events due to medical devices to the patients based on the evidence based data. This article is expected to stimulate ethical reporting of adverse events due to MD-CVD at MvPI.

Effectiveness and safety of bedaquiline under conditional access program for treatment of drug-resistant tuberculosis in India: An interim analysis.

BACKGROUND: India accounts for a quarter of the world's multidrug-resistant tuberculosis (MDR-TB); with less than 50% having successful treatment outcomes. Bedaquiline (BDQ) was approved for use under conditional access program in India in 2015. OBJECTIVE: We evaluate the effectiveness, safety, and tolerability of a BDQ containing regimen used under field settings in India. METHOD: Interim analysis of a prospective cohort of MDR-TB patients on a BDQ containing regimen at six sites in the country. RESULTS: Six hundred and twenty MDR-TB patients [349 (56%) males; 554 (89%) between 18 and 50 years and 240 (39%) severely malnourished] were started on BDQ containing regimen between June 2016 and August 2017. There 354 (57%) patients had MDR-TB with additional drug resistance to fluoroquinolone (MDRFQ); 31 (5%) with additional resistance to second-line injectable (MDRSLI) and 101 (16%) extensively drug-resistant TB. After 6 months of treatment, culture conversion was achieved in 513 of 620 (83%) patients. The median time to culture conversion was 60 days. Higher body mass index was the only factor associated with faster culture conversion (HR 1.97; 95% CI 1.24-2.9). Around 100 patients (16.3%) experienced a ≥60-ms increase in QTc interval during the treatment. Seventy-three (12%) deaths were reported, the majority of them (56%) occurring within the first 6 months of treatment. CONCLUSIONS: BDQ with a background regimen has the potential to achieve higher and faster culture conversion rates with a lower toxicity profile among DR-TB patients. Use of BDQ with additional monitoring may be safe and effective even in the field settings.

Pharmacovigilance in India: Present Scenario and Future Challenges.

Pharmacovigilance in India was initiated way back in 1986 with a formal adverse drug reaction (ADR) monitoring system, under supervision of the drug controller of India. India joined the World Health Organization (WHO) Programme for International Drug Monitoring in 1998, but was not successful. Later, the National Programme of Pharmacovigilance was launched in 2005, and was renamed as the Pharmacovigilance Programme of India (PvPI) in 2010. In consideration of having a robust pharmacovigilance system in India, steps were taken. The National Coordination Centre was shifted from New Delhi to the Indian Pharmacopoeia Commission (IPC) in Ghaziabad. The PvPI works to safeguard the health of the Indian population by ensuring that the benefit of medicines outweighs the risks associated with their use. The culture of reporting of ADRs has achieved remarkable success, with 250 PvPI-established adverse drug monitoring centres all over India and provision of training to healthcare professionals. The programme is striving hard to build trust between the physician and the patient, thereby increasing patient safety and the confidence of people in the country's health system, in addition to the detection of substandard medicines and prescribing, dispensing and administration errors. The IPC-PvPI has now become a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services. In spite of these achievements, several challenges are faced by the PvPI, like the monitoring of generic drugs, biosimilars, and disease-specific ADRs of antidiabetic, cardiovascular and antipsychotic drugs and, above all, creating awareness, which is a continual process. At the same time, the PvPI is trying to address other challenges like counterfeit drugs, antimicrobial resistance, and surveillance during mass vaccinations and other national programmes.

Indian College of Physicians (ICP) Position Statement on Pharmacovigilance.

Pharmacovigilance is the art and science of detection, understanding and prevention of adverse drug reactions and not merely a critical analysis of prescriptions and errors. This field starts with reporting by clinicians of a suspected adverse drug reaction (ADR) to the pharmacologist followed by joint causality analysis and ends at the application of new information by a clinician for benefit of patients. There are a number of ways, which can be utilised for reporting adverse effects using pen and paper format to software applications for smart phones. Varied types of activities spreading from systematic reviews to the mechanistic evaluation of ADR can be performed under the umbrella of pharmacovigilance. It is of utmost importance for clinicians to understand how to identify, communicate and understand adverse effects of drugs with an aim to prevent harm to patients.

Indian College of Physicians Position Statement: Addictive Disorders Among Persons with Diabetes Mellitus.

OBJECTIVES: Migraine, a common primary headache disorder which can be severely disabling, associated with poor health-related quality of life (HRQoL) amongst affected patients. The present study was performed to provide adequate clinical data on migraine and the management practices in India. MATERIAL AND METHODS: A cross-sectional study was designed to assess disease burden, HRQoL, symptom profile, management trends and comorbidities associated with migraine patients across ten centres in India. This study assessed HRQoL using Migraine Specific Quality of life (MSQ) and Migraine Disability Assessment Scores (MIDAS) questionnaire. Categorical variables were summarized as frequency, and percentage and continuous variables as mean and standard deviation respectively. RESULTS: A total of 705 patients were enrolled with a mean age of 35.2 years. Hypertension (7.0%) was the highest co-morbid illness associated with migraine. A higher MSQ score was observed in females as compared to males (39.3±12.4 and 37.4±11.6) while MIDAS showed a comparable score (27.7±47.6 and 27.2±35.4). Majority of migraine patients were unemployed (61.6%) and in profession, females had poor HRQoL than males by MIDAS and MSQ. Majority of patients had pulsating, bilateral attacks for the duration of 4h to 72 h. Paracetamol (47.1%) and propranolol (50.9%) was most commonly prescribed drugs for acute attack and prophylaxis, respectively. CONCLUSION: The quality of life was superior in males as compared to females amongst migraine patients in India. Hypertension was the commonest comorbidity associated with migraine. KEY MESSAGES: Migraine is associated with substantial disability with higher prevalence in females and older people (age >40 years). NSAIDs and propanol was widely prescribed drug in acute attacks and prophylaxis of migraine respectively. Cardiovascular diseases, diabetes mellitus and anxiety were common comorbidities associated with migraine.

Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.

A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs.

Quality assessment of different marketed brands of Dasamoolaristam, an Ayurvedic formulation.

Arista is a classical Ayurvedic preparation that is typically used as a digestive and cardiotonic. The present Investigation evaluated five different brands of Dasamoolaristam available in the market as per WHO and Indian Pharmacopoeial specifications. Various physicochemical parameters such as alcohol-soluble extractive, water-soluble extractive, total ash, acid-insoluble ash, total solid, and alcohol content were determined. The present investigation reveals that all the preparations contain acceptable levels of alcohol (less than 12% v/v). However, the preparations were found to contain unacceptable limits of microbial load although all showed the absence of Escherichia coli, Salmonella species, and Staphylococcus aureus.

Evaluation of anticataract potential of Triphala in selenite-induced cataract: In vitro and in vivo studies.

Triphala (TP) is composed of Emblica officinalis, Terminalia chebula, and Terminalia belerica. The present study was undertaken to evaluate its anticataract potential in vitro and in vivo in a selenite-induced experimental model of cataract. In vitro enucleated rat lenses were maintained in organ culture containing Dulbecco's Modified Eagles Medium alone or with the addition of 100µM selenite. These served as the normal and control groups, respectively. In the test group, the medium was supplemented with selenite and different concentrations of TP aqueous extract. The lenses were incubated for 24 h at 37°C. After incubation, the lenses were processed to estimate reduced glutathione (GSH), lipid peroxidation product, and antioxidant enzymes. In vivo selenite cataract was induced in 9-day-old rat pups by subcutaneous injection of sodium selenite (25 µmole/kg body weight). The test groups received 25, 50, and 75 mg/kg of TP intraperitoneally 4 h before the selenite challenge. At the end of the study period, the rats' eyes were examined by slit-lamp. TP significantly (P < 0.01) restored GSH and decreased malondialdehyde levels. A significant restoration in the activities of antioxidant enzymes such as superoxide dismutase (P < 0.05), catalase (P < 0.05), glutathione peroxidase (P < 0.05), and glutathione-s-transferase (P < 0.005) was observed in the TP-supplemented group compared to controls. In vivo TF 25mg/kg developed only 20% nuclear cataract as compared to 100% in control. TP prevents or retards experimental selenite-induced cataract. This effect may be due to antioxidant activity. Further studies are warranted to explore its role in human cataract.

Current knowledge and future direction of research on soy isoflavones as a therapeutic agents.

Isoflavones, the most abundant phytoestrogens in Soy beans, are structurally similar to 17beta-estradiol. The antioxidant property of the soy isoflavones, namely, genistein and daidzein is well established in different experimental models and also in clinical studies. The compounds have been found effective in the management of diabetes by acting on peroxisome proliferator-activated receptors. It reduces the risk of coronary heart disease by reducing the level of low-density lipoprotein and triglycerides. Soy isoflavones have the potential in the treatment of osteoporosis to act on osteoclasts further to inhibit tyrosine kinase. Among the soy isoflavones, genistein is the potential compound found effective in the treatment of cancer by acting on androgen receptor further to inhibit tyrosine kinases. In this article, various aspects of the diverse biological activities of soy isoflavones and their potential clinical implications with mechanism of action, especially in the treatment and prevention of diabetes, cardiovascular diseases, cancer, osteoporosis, neuroprotection, and also future area of research on soy isoflavones are reviewed and discussed.