scholarly journals A comprehensive synopsis on cognizance of Regulatory Affairs in different sectors of Pharmacy

2021 ◽  
Vol 9 (4) ◽  
pp. 20-32
Author(s):  
Sukanya Paricharak ◽  
Atul Baravkar ◽  
Apeksha Masal ◽  
Sushma Chougule ◽  
Pooja Deshmane ◽  
...  
Keyword(s):  
Online Survey ◽  
Drug Product ◽  
Drug Application ◽  
Regulatory System ◽  
Industrial Area ◽  
Pharmaceutical Products ◽  
Systematic Analysis ◽  
Regulatory Affairs ◽  
Pharmaceutical Industries ◽  
High Benefit

A pharmaceutical drug regulatory Affairs is mainly involved in registration process parameters of different pharmaceutical products and new drug application. Regulatory affairs (RA) professionals play vital roles in a pharmaceutical field as, it is related to healthcare products. It provides strategic, operational direction and support for working within regulations to expedite the development of pharmaceutical, biological and medical devices. Also, it is principally concern with safety and efficacy, low risk/high benefit and quality assessment of healthcare drug products throughout the world. Regulatory system of each and every country has different regulatory agencies which govern certification and good manufacturing practices. Regulatory Affairs also has a very specific importance within the formulation and marketing of drug product in pharmaceutical industries. Current abstract reports for the first time and emphasizes on studies concerning awareness and knowledge testing in regulatory affair field by the various pharma professionals. This is completely certified online survey of quiz questionnaire based on important concepts in RA and circulated via google form to different social medias to more than 1000 pharma professionals (Academics, Students, Industrials area). The systematic analysis of received responses reveals awareness and knowledge of the participants about RA in selected pharma professionals. It shows that, participants form industrial area having more knowledge than academics and students. This survey comes out with conclusion that, there is more need to raise RA information sources by the inclusion of this subject in syllabus for academics via various courses to fulfill more RA professional demands in future.

DEVELOPMENT AND VALIDATION OF ESOMEPRAZOLE RESIDUE IN DOMESTIC WATER BY USING REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (10) ◽  
pp. 63-66
Author(s):  
Lakshmi Tulasi S. ◽  
Swamy V. V. S. A. ◽  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Drug Product ◽  
Pharmaceutical Products ◽  
Uv Detector ◽  
Domestic Water ◽  
Accurate Analysis ◽  
Rp Hplc ◽  
Pharmaceutical Industries

As more concern arises day by day for the environmental pollution due to pharmaceutical products and their toxic nature, analytical methods require characterizing drug substances and drug product composition during all phases of environmental habitats, mainly in water habitats. A simple, sensitive, and accurate analysis has been developed to estimate esomeprazole in pharmaceutical effluents, which are released from the pharmaceutical industries into the aquatic environment, by using RP-HPLC with UV detection. The developed method is highly reproducible and sensitive to determine the esomeprazole at less than 10 ppm level. A reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of esomeprazole in effluents or pharmaceutical industry washouts. The separation was achieved on the C18 Gemini NX column (150 mm × 4.6 mm id., 5.0 μm). Detection was carried out using a UV detector at 302 nm. The total chromatographic analysis time per sample was about 10.0 min with esomeprazole eluting at a retention time of about 5.0 min. The method was validated for accuracy, precision, specificity, linearity and sensitivity.

Pharmaceutical Polymers - A Review

2019 ◽  
Vol 9 (01) ◽  
pp. 27-33
Author(s):  
Naveen Kumar ◽  
Sonia Pahuja ◽  
Ranjit Sharma
Keyword(s):  
Drug Release ◽  
Industrial Revolution ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Products ◽  
Water Soluble ◽  
Taste Masking ◽  
Natural Polymers ◽  
Pharmaceutical Dosage Forms ◽  
Pharmaceutical Applications ◽  
Pharmaceutical Industries

Humans have taken advantage of the adaptability of polymers for centuries in the form of resins, gums tars, and oils. However, it was not until the industrial revolution that the modern polymer industry began to develop. Polymers represent an important constituent of pharmaceutical dosage forms. Polymers have played vital roles in the formulation of pharmaceutical products. Polymers have been used as a major tool to manage the drug release rate from the formulations. Synthetic and natural-based polymers have found their way into the biomedical and pharmaceutical industries. Synthetic and Natural polymers can be produced with a broad range of strength, heat resistance, density, stiffness and even price. By constant research into the science and applications of polymers, they are playing an ever-increasing role in society. Diverse applications of polymers in the present pharmaceutical field are for controlled drug release. Based on solubility pharmaceutical polymers can be classified as water-soluble and water-insoluble. In general, the desirable polymer properties in pharmaceutical applications are film forming, adhesion, gelling, thickening, pH-dependent solubility and taste masking. General pharmaceutical applications of polymers in various pharmaceutical formulations are also discussed

Indian Pharmaceutical Industries Current Status and Togetherness to Overcome Speed Breakers in Term of Quality Issues to Make India as a Global Pharma Destination

2020 ◽  
Vol 07 ◽  
Author(s):  
Vikas Rathee ◽  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
...  
Keyword(s):  
Generic Drugs ◽  
Regulatory Compliance ◽  
Pharmaceutical Products ◽  
Current Status ◽  
Family Welfare ◽  
United States Dollar ◽  
Doing Business ◽  
Pharmaceutical Industries ◽  
Governmental Control ◽  
Future Plans

: Regulatory is the heart of the Pharmaceutical Industries which acts as an interface between the industries and government authorities for the growth and development of pharmaceutical industry system of their respective country. In 2017, India was a pharmaceutical country valued at USD (United States Dollar) 13 billion and accounting for 20 percent of worldwide exports, making the country the main supplier of generic drugs worldwide. Ministry of Chemicals and Fertilizers, the Department of Pharmaceutical Products said that the national pharmaceutical market's gross revenue reached approximately US $ 18.12 billion in 2018 (Rs 129,015), growing 9.4% year-on-year and export retention in 2018 was US $ 17.88 billion. 19.14 billion US$ in 2019. The Union Ministry of Health and Family Welfare has increased by 13.1 percent to Rs 61,398 crore (US $ 8.98 billion) in the Union Budget 2019-20. The Indian pharmaceutical market is facing many difficulties such as central and state regulatory compliance, data integrity, ethics committee in clinical trials, governmental control over the price of medicine, lack of research and so on. We are discussing in our article that top 10 pharmaceutical companies are doing business, their turnover in 2020 and challenge in today's era. We discuss future plans and solutions to problems, so that they can be ranked first in the world.

scholarly journals Online survey into developing a model for a legal cannabis market in the United Kingdom

2021 ◽  
Vol 7 ◽  
pp. 205032452110349
Author(s):  
Edward James ◽  
Thomas L Robertshaw ◽  
Michael J Pascoe ◽  
Fiona M Chapman ◽  
Andrew D Westwell ◽  
...  
Keyword(s):  
United Kingdom ◽  
Online Survey ◽  
Medical Condition ◽  
Population Sample ◽  
Regulatory System ◽  
Supporting Evidence ◽  
Medical Conditions ◽  
Medical Cannabis ◽  
Individual Liberty ◽  
The United Kingdom

Background Despite rescheduling of cannabis to Schedule 2 and amendments to the law permitting legal availability of cannabis for the treatment of medical conditions, access to cannabis for medical use remains challenging for patients in the United Kingdom (UK). Recreational use is widespread despite laws stating users can be sentenced to prison for up to 5 years for possession. Objective The aim of the study was to develop a model for a legal cannabis market in the UK building upon the results of a preceding study in which a UK population sample determined that pharmacies are the most suitable primary legal vendor of cannabis as opposed to regulated shops or the black market. Methods An online survey was developed using Qualtrics software and advertised via the Multidisciplinary Association for Psychedelic Studies’ Facebook, Twitter and Instagram social media accounts and monthly newsletter. Results Three hundred and ninety seven individuals, a majority having used cannabis at least once, consented to participate in the study. The participants concluded that there is enough evidence for cannabis to be prescribed to treat a range of medical conditions. In addition to pharmacies providing cannabis to patients with a prescription, a majority of participants supported cannabis being sold in pharmacies for harm reduction purposes and allowing access to medicinal cannabis in cases where supporting evidence is insufficient to merit a prescription. Participants supported greater integration between dispensing pharmacies and mental health services. Overall, the participants did not oppose a consultation or screening for potential cannabis users prior to obtaining access from licensed vendors. UK participants were supportive of the concept of a cannabis card, which users can present to licensed vendors such as pharmacies, with specific recommendations (such as strains relevant to a patient’s medical condition) being coded into the card. A majority of participants supported the existence of shisha-type bars for the purchase and onsite consumption of cannabis and determined that such vendors should not be part of a pharmacy chain of stores or regulated by pharmacy regulators. The participants generally preferred that laws regarding public consumption are in line with existing smoking legislation. Participants determined that it should be legally permitted to grow cannabis at home for personal medical and non-medical purposes but not to sell for profit. Conclusion The results are suggestive of a regulatory system that medical and non-medical cannabis users can use which aims to maximise therapeutic applications, minimise harms and respect individual liberty.

Tissue-specific peptide pools. Generation and function

2000 ◽  
Vol 72 (3) ◽  
pp. 355-363 ◽  
Author(s):  
Vadim T. Ivanov ◽  
Oleg N. Yatskin ◽  
Olga A. Kalinina ◽  
Marina M. Philippova ◽  
Andrei A. Karelin ◽  
...  
Keyword(s):  
Surrounding Medium ◽  
Regulatory System ◽  
Systematic Analysis ◽  
Tissue Specific ◽  
Tissue Extracts ◽  
Normal Ratio ◽  
And Function ◽  
Dying Cells ◽  
Specific Peptide

Systematic analysis of several tissue extracts for peptide components followed by bioactivity studies leads to formulation of the concept of "tissue-specific peptide pools". According to that concept the endogenous proteolysis of proteins with well-established functions, such as hemoglobin, actin, and cellular enzymes in tissues leads to formation of the sets (or pools) of bioactive peptides. The sets are tissue-specific on one hand and conservative in a given tissue at normal conditions on the other. The content and the composition of pool components are sensitive both to pathologies linked with alterations of tissue metabolism and to prolonged physiological changes. In vivo formation of fragments of functional proteins includes several consecutive proteolytic stages inside the cells and further release of bioactive compounds into the surrounding medium. The effects of pool components take place predominantly at tissue and cellular levels, their effects being related to stimulation or inhibition of cell growth, induction of cell differentiation, and death. The above-mentioned features lead to the proposal that the main in vivo function of components of tissue-specific peptides is maintenance of tissue homeostasis, i.e., the normal ratio of functional, dividing, differentiating, and dying cells of tissues. Components of tissue-specific peptide pools display several features distinguishing them from "classical" peptide hormones and neuromediators. Summarizing, a novel peptidergic regulatory system is considered.

scholarly journals An Assessment of the Quality of Groundwater in a Textile Dyeing Industrial Area in Erode City, Tamilnadu, India

2010 ◽  
Vol 7 (3) ◽  
pp. 1033-1039 ◽  
Author(s):  
P. N. Palanisamy ◽  
S. K. Kavitha
Keyword(s):  
Physicochemical Parameters ◽  
Industrial Area ◽  
Total Hardness ◽  
Systematic Analysis ◽  
Adverse Impacts ◽  
Groundwater Samples ◽  
Textile Dyeing ◽  
Calcium Magnesium ◽  
Standard Values

Groundwater samples were collected in Erode city, Tamilnadu, from an area having large number of textile dyeing units. Though people residing in this area use river water supplied by local bodies as their major source for drinking, groundwater is also used as complementary source. The samples collected were subjected to systematic analysis using the standard methods and procedures. The values obtained for different physicochemical parameters were compared with the standard values given by ISI/ WHO. Variations in many physicochemical parameters were observed for most of the samples when compared to the standard values. More than half of the samples collected had their EC, TDS, total hardness, calcium, magnesium, sulphate and chloride exceeding their acceptable limits. This attempt has been made to determine the quality of groundwater in the study area confirms the deterioration of groundwater quality in the area and calls for some effective measures to be taken urgently to minimize the adverse impacts that may occur due to the contamination of groundwater.

scholarly journals A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

2017 ◽  
Vol 1 (04) ◽  
pp. 133-146
Author(s):  
Krishna Madagoni ◽  
Uppunuri Saidireddy ◽  
Himaja .
Keyword(s):  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Technical Documentation ◽  
Regulatory Requirements ◽  
Regulatory Decision ◽  
New Drug ◽  
Regulatory Affairs ◽  
Regulatory Approach ◽  
Drug Approval Process

Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (RandD) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy. CTD was developed with the aim to provide a common format for the technical documentation that would significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and would ease the preparation of electronic submissions. Bioavailability and bioequivalence testing are essential in the drug development process as they create the foundation for regulatory decision making when evaluating formulation changes and lot-to-lot consistency in innovator products. They also serve as the primary components to demonstrate therapeutic equivalence between generic products and the reference innovator product. This article will focus the similarities and differences in drug approval process and requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India also focuses on submission and work flow related to bioavailability and bioequivalence studies.

scholarly journals FDA relations during drug development

2000 ◽  
Vol 2 (3) ◽  
pp. 213-217
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
Legal Aspects ◽  
Development Programs ◽  
New Drug ◽  
Regulatory Affairs ◽  
New Drug Application ◽  
Drug Development Program

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.

scholarly journals Regulatory requirement for the approval of Generic Drug in Cambodia as per ASEAN Common Technical Dossier (ACTD)

2018 ◽  
Vol 6 (2) ◽  
pp. 67-71 ◽  
Author(s):  
Ravish Patel ◽  
Amit Patel ◽  
Tejasvini Gohil
Keyword(s):  
Generic Drug ◽  
Drug Product ◽  
Regulatory System ◽  
Drug Approval ◽  
Oral Dosage ◽  
Market Regulation ◽  
Product Analysis ◽  
Regulatory Requirement ◽  
Generic Drug Product ◽  
Asean Countries

Drug approval process differs from one country to another country. In some countries only single body regulates the drug as well as responsible for all regulatory work which is a challenging task for the pharmaceutical companies to prepare single dossier that can be simultaneously submitted in many countries for approval. In all countries there is a similar characteristic in regulatory environment but there is a difference in their registration requirements. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Malaysia. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.

Technological Maturity and Systematic Review of Medicinal Plants with Pharmacological Activity in the Central Nervous System

2021 ◽  
Vol 15 ◽  
Author(s):  
Eduardo Muniz Santana Bastos ◽  
Victor Diogenes Amaral da Silva ◽  
Silvia Lima Costa ◽  
Samira Abdallah Hanna
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Medicinal Plants ◽  
Pharmacological Activity ◽  
Pharmaceutical Products ◽  
Technology Readiness ◽  
Industrial Property ◽  
Scientific Exploration ◽  
The Central Nervous System ◽  
Pharmaceutical Industries

Background: Medicinal plants present activities against neurodegenerative diseases with potential for the pharmaceutical industries. Therefore, the objective of this study was to investigate the current panorama of patents and articles of Brazilian medicinal plants with pharmacological activities in the Central Nervous System (CNS), regarding such aspects as: the number of patents by countries, areas of knowledge and technological maturity. Method: We carry out a technological exploration on the Questel Orbit® platform with the descriptors: Agave sisalana P., Amburana cearenses A., Dimorphandra mollis B., Jatropha curcas L, Poincianella pyramidalis T. and Prosopis juliflora (Sw.) DC. with pharmacological activity, and a scientific exploration in PubMed and Science Direct associated with the CNS in the title, abstract and methodology. Results: A total of 642 patents were identified between the years 1999-2019. India, China and Brazil are highlighted, 6th place, out of a total of 48 countries. Of these, 30 patents were not in the National Institute of Industrial Property and 10% are Brazilian in biotechnology and pharmaceutical products. Eleven articles were used in PubMed and Science Direct with scientific domains (anticancer, neuroprotection and anti-inflammatory). The Federal University of Bahia is highlighted, showing Technology Readiness Levels (TRL4), basic skills of pre-clinical research. Conclusion: Brazilian public universities have a significant role in the scientific, technological and innovative development of therapeutic assets for CNS.

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