Indian Pharmacopoeia Commission Research Articles

The Indian Pharmacopoeia Commission: Challenges, Compliance of Pharmaceutical Industries

The Indian Pharmacopoeia Commission: Challenges, Compliance of Pharmaceutical Industries

Ensuring Medication Safety in India: The Crucial Role of the Pharmacovigilance Programme of India (PvPI) in Adverse Drug Event Monitoring

With the establishment of 12 regional centers, India implemented a comprehensive system for monitoring drug reactions in 1986. In 1997, India became a member of the Uppsala Monitoring Centre in Sweden, which oversees the World Health Organization's Programme for International Drug Surveillance. Beginning at the outset, six regional centers were created in Chandigarh, New Delhi, Mumbai, Kolkata, Lucknow, and Pondicherry. ADR is being watched throughout the nation. Advocating for safe drug use may become a top focus for the Indian Pharmacopoeia Commission, which also functions as the National Coordination Centre for India's Pharmacovigilance Program. We currently have 179 adverse drug reactions under observation. At the moment, the National Coordination Centre receives adverse event reports from centers in India.Reporting Form; Phocomelia; Vigiflow; UMC; Death; Thalidomide

The exploring role and responsibility of Indian pharmacopoeia commission: An introduction

: This article emphasise on the Journey of Indian Pharmacopoeia and its parent organisation, the Indian Pharmacopoeia Commission (IPC) as setting up standards for maintaining the efficacy and quality of drugs used for the treatment of diseases prevailing in India. This study attempts to explore Indian Pharmacopoeial growth and general awareness among the scientists, research scholars, drug manufacturers, testing laboratories, healthcare professionals and other stakeholders for their compliance and usage. This article describe the functions of IP Commission such as revision and publication of the Indian Pharmacopoeia, addendum, National formulary of India on a regular basis also providing IP Reference Substances and professional training to the stakeholders on pertaining the Pharmacopoeial work. The objectives of the study are as follows:i. To increase awareness about the Indian Pharmacopoeia (IP) and National Formulary of India (NFI) among the stakeholders; ii. To highlight the Pharmacopoeial importance in India; iii. To discuss landscape for safety and efficacy of the medicines; iv. To explore the journey of the Indian Pharmacopoeia (IP) and National Formulary of India (NFI).This article has been brought out on the basis of evaluation of pharmacopoeial publications and recent literature published online relevant to the drug and pharmaceuticals and it is a kind of descriptive study. There is a shortage of previous similar studies observed on Pharmacopoeial importance and its compliance. It is an attempt being made to understand the drug standardization for rational use of medicine in India.

Pattern of central nervous system related adverse drug reactions (ADRs) due to anti-retroviral therapy in HIV infected patients in tertiary care hospitals in North India

Background: Anti-retroviral therapy is associated with myriads of side-effects. Central nervous system related side effects are troublesome and mostly self limiting. Working knowledge of these side effects can improve the prescription habits of physicians. The study aimed pattern of central system related adverse drug reactions (ADRs) due to anti-retroviral therapy in HIV infected patients in tertiary care hospitals in North India. Materials and methods: A prospective observational study was conducted and all HIV positive patients, previously registered and new; attending OPD who encountered ADRs were enrolled in our study irrespective of their age and sex. Data was collected using ADR reporting form issued by Indian Pharmacopoeia Commission. Causality assessment was done by using Naranjo’s Probability Scale. Modified Hartwig severity scale was used to evaluate severity, WHO criteria for seriousness and guidelines of council for international organizations of medical sciences to decide the predictability of ADRs. Results: A total of 250 patients encountered various types of ADRs during the study period. Total number of ADRs recorded was 452. Out of total ADRs (n=452) recorded, 20.35% (n=92) were central system related ADRs. Most common central nervous system related ADR was dizziness. Most central nervous system related ADRs were of moderate type and possible in nature on causality assessment. Conclusion: Relatively overweight, older age and baseline CD4 absolute count below 250 cells/mm3, were predictors for central nervous system related side effects due to anti-retroviral therapy in HIV patients. We suggest that more stringent evaluation and monitoring should be carefully done in all HIV/AIDS patients who will receive and on efavirenz based anti-retroviral therapy, especially if they have the above predictors.

Pattern of adverse drug reactions to commonly prescribed antibiotics in a tertiary care hospital

Background: Antibiotics have been one of the most significant discoveries in the history of medicine, as they saved countless lives and prevented many serious complications from bacterial infections. Antibiotics are usually safe and effective in treating bacterial infections but can result in adverse drug reactions (ADRs) in some patients. Antibiotics are the most common class of drugs which implicate a greater number of ADRs, because of overuse and misuse of antibiotics, antibiotic resistance, and decreased efficacy. Aims and Objectives: The aims and objectives of the study are to determine clinical symptoms, causality, and severity of antibiotic-associated ADRs. Materials and Methods: A retrospective study was carried out from January 2021 to June 2022; data were collected from Adverse Drug Monitoring Center, GMC/Government General Hospital, Guntur. Prior Institutional Ethics Committee Approval and Permission from Indian Pharmacopoeia Commission, Ghaziabad, were taken. The collected reports were analyzed for ADR pattern, drug groups, causality, and severity. Descriptive statistics were used. Results: Out of 847 ADRs reported, 119 (14%) ADRs were related to antibiotics. The majority of ADRs (65%) were reported in males. A greater number of ADRs were reported in mean age group 31–40 years. Anti-tubercular drugs (27%) were the most commonly implicated antibiotics followed by cephalosporins (22%). Most commonly affected system was cutaneous system (45%) followed by gastrointestinal system (21%). Most common ADRs reported were pruritus (20%), followed by rash (14%). 93% of ADRs were possible and 7% were probable. 87% of ADRs were mild, 12% were moderate, and 2% were severe ADRs. Conclusion: ADRs can be prevented by taking proper action at an early stage. Implementation of antibiotic guideline policy for the hospital and strict adherence to it should be ensured to promote their rational and safe use.

Insights into Mefenamic Acid-Induced Allergic Reactions: A Comprehensive Clinical and Research Review

This study investigates the incidence of Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome associated with the over-the-counter non-steroidal anti-inflammatory drug (NSAID) mefenamic acid. Approximately 10% of individuals exposed to mefenamic acid experience DRESS syndrome, a severe and potentially fatal allergic reaction characterized by fever, skin rash, lymphadenopathy, hematological abnormalities, and internal organ involvement. Leukocytosis with eosinophilia (90%) and mononucleosis (40%) has been linked to certain cases, emphasizing the diversity of clinical presentations. The causative medication must be promptly discontinued upon identification of DRESS syndrome, with documented evidence indicating improved prognosis with early drug removal. Despite the severity of these reactions, the study sheds light on the alarming accessibility of mefenamic acid and other banned medications in developing nations, particularly exemplified by the Indian Pharmacopoeia Commission’s alert on mefenamic acid issued on December 7, 2023. The lack of effective law enforcement and medical awareness poses significant challenges, allowing banned drugs, including Nimesulide and Rofecoxib, to persist in the market despite being banned by the USFDA. This research underscores the critical need for global collaboration to address regulatory gaps, enhance medical awareness, and enforce stringent measures to restrict the availability of harmful medications in developing nations. Urgent attention to these issues is imperative to safeguard public health and ensure the effective implementation of drug regulations on a global scale.

Development of Pharmacovigilance System in India and Paradigm of Pharmacovigilance Research: An Overview.

The drugs are projected to cure, prevent and treat diseases; however, there are also chances of mild or severe adverse drug reactions (ADRs) in the patients. Pharmacovigilance (PV) enhances the approach to safe medicines and healthcare, but integration into public healthcare remains a challenge in many countries. The Pharmacovigilance Programme of India (PvPI) is a nationwide programme launched by the Ministry of Health and Family Welfare (MoHFW), Government of India, on 14 July 2010. It is currently run by the Indian Pharmacopoeia Commission (IPC). Presently, 567 ADR Monitoring Centres (AMC) are functioning under PvPI across India. The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), and the Ministry of Health, Family & Welfare (MoHFW) Government of India is the National Regulatory Authority (NRA) of India. This review aims to trace the development of PV in India and its status among the top ADR reporting countries, with a focus on the current status of the studied ADR in different regions in India. Among the top 20 countries enthusiastic about sending ICSR per million population between 2015 and 2020, India shares 2% of the total ICSRs in VigiBase. India is now being recognized as a hub of global clinical trials and clinical research studies. Hence, it is the need of the hour in India to have a dynamic PV network system with an efficient and prudent operation method. Nevertheless, in India, PV programs are at an early stage on par with other countries, and only because of underreporting of ADRs. However, in the future, PvPI may appear as a big dashboard for ADR reporting culture in India as it continuously works hard to improve patients and drug safety.

Challenges encountered by health care professionals in monitoring adverse events due to medical devices: A review

Materiovigilance is the term used to characterize any negative outcomes brought on by a medical device. The "Materiovigilance Programme of India" is a plan that has been launched in India to track the unfavorable outcomes of the use of medical devices and to take the necessary action to resolve those unfavorable outcomes. On July 6, 2015, DCGI adopted MvPI at the Indian Pharmacopoeia Commission in Ghaziabad. Factors contributing to underreporting of MDAE are Health care system capacity related, Organizational related barriers, and Industry responsiveness. Challenges faced by healthcare professionals in reporting MDAE are administration, healthcare professionals, self-implementation of devices, counter-fit devices, and poor awareness. This approach might offer helpful data for purchasing decisions, and support quality and safety management in hospitals. The present evidence base is of low quality, and there isn't a framework to report error-causing elements, which limits the possibility of learning from mistakes.

Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report

Humane Society International India (HSI India) organized and facilitated a workshop on the ‘Future of Target Animal Batch Safety Test (TABST) and Laboratory Animal Batch Safety Test (LABST) in the Indian Pharmacopoeia (IP) Monographs’. The workshop hosted key Indian regulators from the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO), industry representatives from the Indian Federation of Animal Health Companies (INFAH), Asian Animal Health Association (AAHA), and international experts representing the European Directorate for the Quality of Medicines (EDQM), the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), and multinational veterinary products manufacturers. The workshop was organized to encourage a bidirectional flow of information and to discuss the deletion of TABST and LABST from the veterinary vaccine monographs in the IP. This workshop was built from the symposium held by Humane Society International on the ‘Global Harmonization of Vaccine Testing Requirements’ held in 2019. This report details the outcomes of the workshop with proposed activities to be taken up as part of the next steps for the elimination or waiving of these tests.

Investigating the Pharmacognostic and Pharmacological Activities of Azadirachta indica L. through Biochemical Assays

Pharmacognosy Research,2023,15,2,242-254.DOI:10.5530/pres.15.2.026Published:February 2023Type:Original Article Authors:Mamta Yadav, Smita Mishra, Ritu Tiwari, Bhavna Kumari, Mayank Shukla, Meenakshi Dahiya, Anil Teotia, Varsha Mehra, Vivekanandan Kalaiselvan, and Rajeev Singh Raghuvanshi Author(s) affiliations:Mamta Yadav, Smita Mishra*, Ritu Tiwari, Bhavna Kumari, Mayank Shukla, Meenakshi Dahiya, Anil Teotia, Varsha Mehra, Vivekanandan Kalaiselvan, Rajeev Singh Raghuvanshi Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh, INDIA. Abstract:Background: Azadirachta indica L., commonly known as ‘neem’ is a member of the Mahagony family, widely available in Indian sub-continents. Neem tree is popularly known for its vast therapeutic properties such as antimicrobial, antiparasitic, antidiabetic, insecticides and pesticides. The plant leaves are commonly used in several Ayurvedic formulations such as ‘kwath’ and ‘churna.’ Due to its high therapeutic value, it is important to standardize and document the quality parameters of the plant leaves. The A. indica leaves were collected, shade dried and pharmacognostic parameters were performed using techniques such as microscopy, physicochemical tests, viz., extractive values, total ash, acid insoluble ash. Apart from this, pharmacological assays for antioxidant, antidiabetic and antimicrobial activities were performed. Based on the assays and preliminary phytochemical analysis, best extract was selected for further compound(s) detection by HPLC and HPTLC. Results: Neem methanolic extract was found to possess various phytochemicals compared to hexane extract, the methanolic extract of neem leaves also exhibited excellent antioxidant and antidiabetic activity along with good antimicrobial against gram-positive bacteria and fungi. Through HPLC and HPTLC analysis, presence of rutin hydrate, ellagic acid, and quercetin was observed in the neem leaf methanolic extract. The pharmacognostic tests values were found similar to that of stated in IP-2022. Conclusion: This is one of the first kind of research to provide a comprehensive pharmacognostic profile of leaves of A. indica L. as well as its pharmacological evaluation along with compounds detection by high throughput analysis. Keywords:Antioxidant assay, Azadirachta indica, HPLC, HPTLC., Physicochemical analysis, α-amylase enzyme inhibition assayView:PDF (733.75 KB)

Materiovigilance in Intensive Care Units: An Active Surveillance.

Background: Medical devices are the vital part of healthcare system. The use of medical devices is higher in the intensive care units leading to increased exposure rendering the exponential rise in incidence of medical device associated adverse events (MDAEs). Timely detection and reporting of MDAEs can help reduce the disease and associated liabilities. Objective: To determine the rate, patterns, and predictors of MDAEs. Methods: An active surveillance was carried out in the intensive care units (ICUs) of a tertiary care teaching hospital located in southern India. The patients were monitored for MDAEs which were reported based on MvPI guidance document 1.2. The predictors were calculated using an odds ratio at 95% confidence interval. Results: A total of 185 MDAEs were reported amongst 116 patients, of which the majority [74 (63.7%)] were males. Most of the MDAEs were attributed to urethral-catheters [42 (22.7%)] among which a high majority of 34 were associated with urinary tract infections (UTI), followed by ventilators [35 (18.9%)] with all events causing pneumonia. Urethral catheters and ventilators are both classified as categories B and C respectively based on device risk classification provided by the Indian Pharmacopoeia Commission (IPC). Over 58% of MDAEs were reported among the elderly. The causality assessment was possible for 90 (48.6%) MDAEs whereas 86 (46.4%) were probable. The majority of the MDAEs reported were serious [165 (89.2%)] and only [20 (10.8%)] were found to be non-serious on the severity scale. Most [104 (56.2%)] of the devices attributed to MDAEs were single-use devices, of which [103 (55.6%)] were destroyed and only [81 (43.7%)] were retained in healthcare facilities. Conclusions: Despite the best possible care in the intensive care units (ICUs), MDAEs are inevitable, adding to the burden of patients in terms of suffering, disease, extended hospital stay, and increased costs. MDAEs require rigorous monitoring of patients, especially in the elderly population and patients with increased exposure to multiple devices.

Pharmacovigilance Activities in Maulana Azad Medical College and Associated Hospitals

Introduction: Pharmacovigilance plays an important role in patient safety and rationalizing the use of medicines. It helps in identifying the frequency of adverse drug reactions (ADRs), their causes, and the associated risk factors. Pharmacovigilance activities are facilitated through adverse drug reactions monitoring centers (AMCs) in most of the institutions. Aim: The objective of this paper is to provide an overview to the health care professionals regarding ADRs reported from the associated hospitals of Maulana Azad Medical College (MAMC) and the pharmacovigilance activities undertaken. Observations: Maulana Azad Medical College, Department of Pharmacology was recognized as an AMC in 2014 under the Pharmacovigilance Program of India (PvPI). The AMC established a way for reporting ADRs both by spontaneously and through active monitoring of ADRs from different wards. The causality assessment of all ADR reports collected is done. The program was informed by a college pharmacovigilance committee, emails, and by putting posters in the hospital nursing stations. Fourteen training workshops for doctors and pharmacists and two training workshops exclusively for nurses have been conducted so far on pharmacovigilance. In 2017, a program to sensitize doctors working in the Delhi government hospital was started. A total of 854 healthcare workers have been sensitized. The center has reported a total of 2572 ADRs to the National Coordination Centre (NCC) at Indian Pharmacopoeia Commission until December 2021. ADRs reported were highest in the age group of 20 to 59 years. Most of the reports were from the department of T.B. and Chest (n = 589, 23.8%). The most common class of medicines implicated in causing ADRs was antimicrobials (n = 1100, 44%). Among the ADRs reported, the majority were mild (n = 1451, 81.1%) with 346 (18.8%) reported as serious. Conclusion: A system for reporting ADRs on campus has been established. The pattern of ADRs reported to this ADR monitoring center is comparable to the national and global data. Hospital-based ADR monitoring and reporting programs are very crucial to identify and quantify the risks associated with the use of medicines. The pharmacovigilance program at MAMC is a commitment and a small step towards patient safety.

Adverse Drug Reactions in the Pediatric Population: Findings From the Adverse Drug Reaction Monitoring Center of a Teaching Hospital in Odisha (2015-2020).

Background and objectiveThe incidence of adverse drug reactions (ADRs) in hospitalized children varies from 0.6-16.8%. There is a lack of uniformity and an absence of quality reporting with respect to the collection of data on ADRs worldwide, resulting in a scarcity of data regarding ADRs in children. In light of this, we aimed to analyze various factors related to ADRs in the pediatric population in the ADR Monitoring Center (AMC) of a teaching hospital in Odisha, India.MethodsThis was a record-based study conducted by the department of pharmacology in collaboration with the department of pediatrics. Detailed information regarding all ADR cases in children (<14 years of age) was collected in a format designed by the Indian Pharmacopoeia Commission (IPC). A total of 105 ADRs reported during a five-year period (2015-20) were subjected to analysis.ResultsThe largest number of ADRs were reported in the age group zero to five years (41%). Males were affected more compared to females (1.7:1). Cutaneous ADRs were the most common type (86.5%) followed by the involvement of the gastrointestinal system (10%); 21% of cases were serious in nature, i.e., they required either hospitalization or led to a prolonged hospital stay. Antibiotics were the major drug category involved in causing drug reactions (66%) and among them, ceftriaxone (24.6%) was the most common causative agent.ConclusionsOne-fifth of the pediatric cases of ADRs were serious in nature. The most common causative agent was antibiotics, especially beta-lactams. There is an urgent need to raise awareness among healthcare professionals by conducting training programs to encourage the spontaneous reporting of ADRs, which will help to ensure drug safety in the pediatric population.

ANALYSIS OF QTC PROLONGATION DUE TO BEDAQUILINE IN TUBERCULOSIS PATIENTS – A RETROSPECTIVE STUDY.

Introduction: Bedaquiline should is administered under direct observation along with standard MDR-TB regimen. Recommended dose is 400 mg once daily for 2 weeks followed by 200 mg thrice weekly for 22 weeks. After 24 weeks of Bedaquiline therapy, MDR-TB regimen should be continued as per national TB treatment guidelines. The observed prolongation of the QT interval and potentially fatal cardiac arrhythmia may or may not be related to interference with membrane associated cation transports.&#x0D; Aims and objective: To analyze QTc Prolongation in patients who received Bedaquiline in District tuberculosis center at Rajkot.&#x0D; Material and method: All the patient who received and actively followed and developed QTc prolongation as Adverse Drug Reaction were included in the study. Demographic parameter and detailed information about ECG changes due to QTc Prolongation was noted from patient treatment sheet. Interim analysis was done in this study. Adverse drug reactions data was collected in Adverse Drug Reaction(ADR) form (version 1.3) by Indian Pharmacopoeia Commission. The ADR related data can be accessed through - https://vigiflow-in.who-umc.org.&#x0D; Result: Total 30 patient who received Tablet Bedaquiline were included in the study. Out of which 18 (60%) were males and 12 (40%) were females, Mean age of patient was 28.3 (years) ± 11.6 SD, Mean weight of patient was 48.2 (kg) ± 5.6 SD and 2 patient died due to cardiac arrest.&#x0D; Statistical analysis: Descriptive analysis like mean, standard deviation and percentage was done using excel office version 2016.&#x0D; Conclusion: Long QTc prolongation was noted more among male patients weighing 41 to 50 kg. Among all the participant, majority were having QTc prolongation and two death were observed during treatment of Bedaquiline. The patients will be further followed up for outcome analysis.&#x0D; Keywords: Bedaquiline, QTc interval, adverse effect.

Comprehensive Data of Spontaneous Adverse Drug Reactions Reporting

Underreporting is a matter of concern for Pharmacovigilance Programme of India. Since multiple interventions are needed to improve ADR reporting. In 37 studies performed in 12 countries, the median under reporting was 94%. Even for the drug combinations it was as high as 85%. Even in general practice, the concern was underreporting of the spontaneous reporting systems. The spontaneous reporting initiative is often passive which relies on the healthcare professionals to detect and take the initiative to report an ADR. Spontaneous reports play a major role in the identification of safety signals once a drug is marketed. In many instances, a Marketing authorization holder can be alerted to rare adverse events that were not detected in earlier clinical trials or other pre-marketing studies. In India, Indian Pharmacopoeia Commission (IPC) and National Coordination Committee (NCC) along with the Central Drug Standard Control Organization (CDSCO) together regulate the PV activity. The Spontaneous ADR reporting form can be downloaded from CDSCO website. It captures all features essential for reporting a ADR This is similar to Yellow card of UK, Australian Blue Card and in US as Med watch.

PHYTO-PHARMACEUTICAL DEFINITION UNDER DRUG REGULATIONS, INDIA NEEDS AN URGENT REVIEW

Dear Reader, An Amendment to the Drugs and Cosmetics Regulations to permit scientifically developed plant based leads as drugs named “phytopharmaceuticals”, was notified for the first time in November 2015. This regulation has now been further amended and revised to put it under new drug definitions and provided more provisions for greater clarity in 2019. However, having championed these regulations (as part of the Indian Pharmacopoeia Commission’s Expert Committee on Herbals) for nearly a decade a greater number of drugs should have come out through this route given the scientific capability of the Indian drug sector and academia. However, the only information in the public domain as on date is the approval for conducting human clinical trials of a plant based lead for testing the protective or curative potency of Coculous hirsutus against SARS – CoV-2 given by the Drugs Controller General of India. A purified fraction of the stem of this plant commonly called broom creeper has been tested for sinnococculine markers as the lead drug candidate.

A Comparative Study of Pharmacopoeial Quality Standards and Regulations of Radiopharmaceuticals.

Radiopharmaceutical preparations are the important pharmaceutical dosage forms used for the diagnosis and therapeutic purposes. Various pharmacopoeias are having methods for the quality control of these preparations in the form of monographs. Indian Pharmacopoeia (IP) also included these monographs in IP 2014 first time with the help of an experts' group on radiopharmaceutical, drawing expertise from elite stakeholder institutions and the core team of Indian Pharmacopoeia Commission. Since then, these standards are regularly updated through the IP addendum and bringing out new edition of IP. IP is a book of official methods as per Drugs and Cosmetic Act, 1940. These standards can be used in government laboratories, private laboratories, or academia in India and abroad. This review provides an overview of the journey of radiopharmaceuticals' standard setting in IP. A comprehensive comparative information of regulatory perspectives of radiopharmaceuticals in different jurisdictions such as the US, EU, and India is also presented.

Present era of drug safety in India: An overview

Introduction: Common Adverse Drug Reactions (ADR), evaluated by drug clinical trial studies, whereas an individual or specific population might suffer reactions after prolonged dormancy. Pharmacovigilance (PV) is a scientific investigation dealing with and keeping regular vigil on the drugs being used. Methods: The Indian Pharmacopoeia Commission (IPC) and other regulatory authorities like a National Coordination Committee (NCC) via the Central Drug Standard Control Organization (CDSCO) manage PV activity in synchronicity. Indian Pharmacovigilance (PV) system requires carving, therefore the Pharmacovigilance Program of India (PvPI) was enforced by the government in the year 2010, relying on exact ADR detection, evaluation, and reporting. Results: Thus, several regional, zonal and peripheral centers are developed for ADR reporting. Clinicians, Nurses, laypersons, pharmacists, and other healthcare professionals can fill ADR reporting forms online or offline at the nearest centers in suitable languages. Additionally, a toll-free number and mobile app could be used for reporting ADR. Every reported ADR gets collected and processed at the centers through Vigi-flow software, which detects and assesses the signal strength reported at CDSCO and World Health Organisation (WHO) for the required regulatory action. Conclusions: The final decision of CDSCO-WHO is passed by a suitable media source for the advancement of society's health.

Commentary - A comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars and Intended Copy Biologics in treating chemotherapy associated febrile neutropenia

Filgrastim, human white cell growth factor, Granulocyte colony-stimulating factor (G-CSF), is a core medicine in the WHO list of Essential Medicines. For this reason, recent reporting of statistically significant safety and efficacy differences between reference and Biosimilar brands of filgrastim by Rastogi and the Indian Pharmacopoeia Commission in Toxicology and Applied Pharmacology in 2020 is of great concern [Shruti Rastogi et al. Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data. Toxicology and Applied Pharmacology Volume 395, 15 May 2020, 114,976. https://doi.org/10.1016/j.taap.2020.114976]. This commentary shows that the alarming report is a result of incorrect statistical tests misapplied to inappropriate data sets compounded by a further problem relating to the strict regulatory definition of a Biosimilar Medicine as opposed that of an Intended Copy Biologic. In contrast, the body of evidence from more than seven and a half thousand participants in Confirmatory Clinical Studies and Post Approval Clinical Studies as well as the Periodic Safety Update Reports confirms that European approved filgrastim Biosimilars show no meaningful difference in quality, safety or efficacy compared to the reference brand.

Materiovigilance: Concept, Structure and Emerging Perspective for Patient’s Safety in India

There has been an escalation in the number, diversity, and complexity of medical devices. Regulation of these devices has also advanced due to the requirement of better regulatory perspective induced due to elevation in the number of adverse events associated with medical devices. All over the globe, various measures are undertaken to provide better safety to the patients along with attempts to improve the standard of medical devices. The initial and ultimate objective of the concept happens to be unfailingly to ensure patient safety as well as impart required guidance for both manufacturers and adept authorities enabling them to superintend cases coherently and appropriately. Materiovigilance programme of India (MvPI) was launched by the Drug Controller General of India at the Indian Pharmacopoeia commission (IPC) in Ghaziabad in 2015. The main purpose of this initiative is to monitor adverse events associated with medical devices in order to generate safety data, create awareness among the various stakeholders, and prescribe best practices for patient safety. Whilst the reforms in regulations have proposed policies and designs to elucidate, consolidate and accelerate the processes involved in manufacturing and importing medical devices to India, they consistently carry their challenges and limitations. To eliminate such complications the guidelines and regulations are anticipated to be implemented appropriately with the efficacious conclusion. India has been evident in matching with advancements in the World Medical Device regulation scenario, the current review at hand takes upon the question of 'how successful has it been so far'?