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.

Synthesis, Analytical Characterization and Spectroscopic Investigation of Chloramphenicol Impurity A for the Quality Control of Chloramphenicol and its Formulation as Per International Compendium.

Objective: The main aim of the present work is to synthesize chloramphenicol impurity A (CLRMIMP- A) in the purest form and its subsequent characterization by using a panel of sophisticated analytical techniques (LC-MS, DSC, TGA, NMR, FTIR, HPLC, and CHNS) to provide as a reference standard mentioned in most of the international compendiums, including IP, BP, USP, and EP. The present synthetic procedure has not been disclosed anywhere in the prior art.

Methods: A simple, cheaper, and new synthesis method was described for the preparation of CLRM-IMP-A.

Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data.

Filgrastim, a biopharmaceutical listed on WHO model list of essential medicines, was approved in USA in 1991 for patients with non-myeloid malignancies associated with severe neutropenia and fever. Several filgrastim biosimilars have now been approved in USA, Europe and elsewhere since 2008, based on the reference product which has lost patent exclusivity; however their immunogenicity and safety is controversial. We conducted a retrospective, post market study between 1991 and May 2018 using VigiBase®.

Implementation of adverse event reporting for medical devices, India.

Problem: Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India.

Approach: Implementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users.

"ADR PvPI" Android mobile app: Report adverse drug reaction at any time anywhere in India.

Background: To improve the public health and promote instant adverse drug reaction (ADR) reporting, a need to develop an ADR Pharmacovigilance Programme of India (PvPI) mobile app was identified by the National Coordination CentrePvPI (NCCPvPI) to serve the Pan India ADR reporting. The objective of this study was to develop an indigenous Googlebased Android mobile application known as "ADR PvPI" and to analyze the ADRrelated data reported through this mobile application on pilot basis.

Materials And Methods: The ADR PvPI mobile application was indigenously developed by NCCPvPI officials within 6 months.

The Unprecedented Role of Gold Nanomaterial in Diabetes Management.

Gold nanoparticles possess unique mechanical, chemical, photo-optical and biological properties and have been an interesting field of research on life sciences. The research studies produced new nanodevices and nanotechnology-based biosensing, diagnostics therapeutics, and targeted drug delivery systems. In this review, the unique potential aspects of gold nanoparticles/ nanoformulations/ or devices related to diabetes management have been discussed together with the recent patent on the gold nanoparticles developed for diabetes management.

Peptide-based therapeutics: quality specifications, regulatory considerations, and prospects.

Exquisite selectivity, remarkable efficacy, and minimal toxicity are key attributes inherently assigned to peptides, resulting in increased research interest from the pharmaceutical industry in peptide-based therapeutics (PbTs). Pharmacopoeias develop authoritative standards for PbT by providing standard specifications and test methods. Nevertheless, a lack of harmonization in test procedures adopted for PbT in the latest editions of Pharmacopoeias has been observed.

Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India.

Background: The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission works under the aegis of Ministry of Health and Family Welfare, Government of India. It promotes patient safety in India and also supports postmarketing surveillance programs. Currently, almost hundred thousand case reports are submitted to NCC-PvPI each year through its 250 ADR Monitoring Centers (AMCs) located across India, and India is the one of the top ten contributor countries under WHO-Uppsala Monitoring Centre since 2012 and start issuing drug safety alerts from March 2016.

Current Status of Herbal Drug Standards in the Indian Pharmacopoeia.

The benefits of herbal drugs were well understood way back. They have been used for the promotion of health and medical purposes - in disease conditions. It is a conventional belief that herbal drugs have no side effects, are cheaper and locally available.

Pharmacovigilance Programme of India: Recent developments and future perspectives.

Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.

Risk of Intussusception with Rotavirus Vaccine.

Objective: To study the case series for intussusception associated with the vaccination of rotavirus vaccine in children.

Methods: The study of spontaneous adverse event monitoring such as intussusception due to rotavirus vaccine was carried out from the year 2011 through 2015. The individual case safety reports (ICSRs) of this event were collated, assessed and recorded as per the requirement of Suspected Adverse Drug Reactions Reporting form of Pharmacovigilance Programme of India (PvPI).

Pharmacovigilance in radiopharmaceuticals.

Indian Pharmacopoeia Commission is Committed for maintaining the standards of drugs including Radiopharmaceuticals (RPs) by publishing Indian Pharmacopoeia. These RPs are being used in India for diagnostic or therapeutic purpose. RPs though contain relatively small quantities of active ingredient and administered in small volumes could cause some adverse reactions to the patients.

Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India.

Background: The Pharmacovigilance Programme of India (PvPI) is responsible for collecting reports of adverse drug reactions (ADRs) to assess the association between particular drugs and ADRs. The aim of the present study was to apply statistical tools to determine associations between drugs and ADRs for signal detection in the PvPI.

Methods: Four methods were proposed for quantitative signal detection: one was based on Bayesian inference and others on classical inference procedures.

Veterinary herbal medicines in India.

India has a rich and diversified flora. It is seen that synthetic drugs could pose serious problems, are toxic and costly. In contrast to this, herbal medicines are relatively nontoxic, cheaper and are eco-friendly.

Adverse reactions to contrast media: an analysis of spontaneous reports in the database of the pharmacovigilance programme of India.

Background: Contrast media are used widely to improve medical imaging. Like all other pharmaceuticals, these agents are not completely devoid of risk, and continuous monitoring of adverse reactions with these agents is important. Spontaneous reporting is the simplest method for understanding the safety profile of pharmaceutical products after their approval.

Unilateral supernumerary kidney with contra lateral hydronephrosis-a rare case report.

Supernumerary kidney is the rarest of all renal anomalies; fewer than 80 cases have been reported in the literature over the years. Supernumerary kidneys are most commonly located on the left side of the abdomen. Different pathologic conditions are reported to affect supernumerary kidneys and they may be associated with malformations of the upper urinary tract and genital tract.

Quality Standards and Current Status of Ophthalmic Formulations in Indian Pharmacopoeia and National Formulary of India.

The global ophthalmic formulations (OFs) market is expanding dramatically with the approval of new drug formulations for a variety of ophthalmic indications by competent authorities in various countries. In India, the Central Drug Standards Control Organization (CDSCO) and Indian Pharmacopoeia Commission (IPC) are making efforts for approval and setting the standards for OFs, respectively. In fulfillment of the requirements of the Drugs and Cosmetics Act of 1940, the IPC is publishing an official book of standards for drugs known as the Indian Pharmacopoeia (IP).

3-Acetyl-11-keto-beta-boswellic acid loaded-polymeric nanomicelles for topical anti-inflammatory and anti-arthritic activity.

Objectives: The aim of this study was to develop 3-acetyl-11-keto-beta-boswellic acid (AKBA)-loaded polymeric nanomicelles for topical anti-inflammatory and anti-arthritic activity.

Methods: Polymeric nanomicelles of AKBA were developed by a radical polymerization method using N-isopropylacrylamide, vinylpyrrolidone and acrylic acid. The polymeric nanomicelles obtained were characterized by Fourier transform infrared (FTIR), transmission electron microscopy (TEM) and dynamic light scattering (DLS).