Pub Date : 2023-02-02DOI: 10.1177/17411343231154751
B. Tempest
{"title":"The Journal of Generic Medicines – Editorial March 2023","authors":"B. Tempest","doi":"10.1177/17411343231154751","DOIUrl":"https://doi.org/10.1177/17411343231154751","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"8 1","pages":"3 - 3"},"PeriodicalIF":0.0,"publicationDate":"2023-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89231310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-30DOI: 10.1177/17411343221144876
Joseph Darmoe, K. Ofori‐Boateng
Prescription brand substitution also known as generic substitution (GS)is a worldwide phenomenon. In the pharmaceutical industry, growth of the generic drug market implies growth in the number and types of substitutes for ethical (innovator) pharmaceutical products. This threat is relevant mainly due to the comparatively lower prices of these substitutes. Ultimately, prescription brand substitution renders the various marketing efforts and investments of the affected pharmaceutical companies fruitless. The efforts in the literature have focused more on cost as the reason but there seems to be more reasons than cost in developing countries like Ghana. The study examined the marketing-related impacts of prescription brand substitution at community pharmacies in Ghana. Utilizing the ideas of Porter’s five competitive forces model, specifically the threat of substitute products and services, the study which is cross-sectional, deductive and descriptive survey in nature, used a mix of cluster sampling and purposive sampling to arrive at a final sample size of 50 pharmacies and 9 pharmaceutical companies,. Data collected were analysed using simple linear regression and descriptive statistics. Weak but statistically significant relationship between frequency of pharmacy calls and nature of drug substitution was observed. Also, prescription brand substitution is prevalent at community pharmacies in Ghana, and that ethical companies are the most affected. Pharmacy front line staff and patients played contributory roles in this phenomenon. It is recommended that Ethical pharmaceutical companies should acknowledge, plan and act in order to minimize the competitive effects of prescription brand substitution
{"title":"What drug to buy? generic brand substitution in base of the pyramid markets: Evidence from Ghana","authors":"Joseph Darmoe, K. Ofori‐Boateng","doi":"10.1177/17411343221144876","DOIUrl":"https://doi.org/10.1177/17411343221144876","url":null,"abstract":"Prescription brand substitution also known as generic substitution (GS)is a worldwide phenomenon. In the pharmaceutical industry, growth of the generic drug market implies growth in the number and types of substitutes for ethical (innovator) pharmaceutical products. This threat is relevant mainly due to the comparatively lower prices of these substitutes. Ultimately, prescription brand substitution renders the various marketing efforts and investments of the affected pharmaceutical companies fruitless. The efforts in the literature have focused more on cost as the reason but there seems to be more reasons than cost in developing countries like Ghana. The study examined the marketing-related impacts of prescription brand substitution at community pharmacies in Ghana. Utilizing the ideas of Porter’s five competitive forces model, specifically the threat of substitute products and services, the study which is cross-sectional, deductive and descriptive survey in nature, used a mix of cluster sampling and purposive sampling to arrive at a final sample size of 50 pharmacies and 9 pharmaceutical companies,. Data collected were analysed using simple linear regression and descriptive statistics. Weak but statistically significant relationship between frequency of pharmacy calls and nature of drug substitution was observed. Also, prescription brand substitution is prevalent at community pharmacies in Ghana, and that ethical companies are the most affected. Pharmacy front line staff and patients played contributory roles in this phenomenon. It is recommended that Ethical pharmaceutical companies should acknowledge, plan and act in order to minimize the competitive effects of prescription brand substitution","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"86 1","pages":"33 - 45"},"PeriodicalIF":0.0,"publicationDate":"2022-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80984235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-12DOI: 10.1177/17411343221145488
Salman Ahmed, P. Musyuni, G. Aggarwal
Drug recalls are essential to maintaining the safety process because the medical industry’s top objective is primarily to deliver higher-quality goods to a larger population. They do this by eliminating subpar products from the market. Drug recalls are increasing quickly as a result of increased investigation rates, the emergence of industrialization and the online era into the sector, and regulatory authorities and health experts are now focusing on more stringent regulations to prevent further recalls of faulty pharmaceutical drugs. The purpose of the present write-up is to give an overview of how drug recalls work with the help pf examples of recalls due to presence of undesired solvents and mineral residue, how they affect the pharmaceutical business, and what can be done to stop them.
{"title":"A retrospective analysis on the product recall due to solvent and mineral residue issues","authors":"Salman Ahmed, P. Musyuni, G. Aggarwal","doi":"10.1177/17411343221145488","DOIUrl":"https://doi.org/10.1177/17411343221145488","url":null,"abstract":"Drug recalls are essential to maintaining the safety process because the medical industry’s top objective is primarily to deliver higher-quality goods to a larger population. They do this by eliminating subpar products from the market. Drug recalls are increasing quickly as a result of increased investigation rates, the emergence of industrialization and the online era into the sector, and regulatory authorities and health experts are now focusing on more stringent regulations to prevent further recalls of faulty pharmaceutical drugs. The purpose of the present write-up is to give an overview of how drug recalls work with the help pf examples of recalls due to presence of undesired solvents and mineral residue, how they affect the pharmaceutical business, and what can be done to stop them.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"126 1","pages":"10 - 22"},"PeriodicalIF":0.0,"publicationDate":"2022-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85364595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01DOI: 10.1177/17411343221137936
B. Tempest
{"title":"Journal of Generic Medicine –Editorial December 2022","authors":"B. Tempest","doi":"10.1177/17411343221137936","DOIUrl":"https://doi.org/10.1177/17411343221137936","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"15 1","pages":"203 - 204"},"PeriodicalIF":0.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78320791","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-11-03DOI: 10.1177/17411343221137189
Dimple D Marathe, Shaikh Md Shahzeb
There is different procedure used to submit drug product for marketing authorization process. Mutual recognition procedure (MRP) is one of them. The European commission had published the procedure in consultation with competent authorities of member state. Using MRP, the applicant can apply for marketing authorization in one or more European Union nations. (MAH) who already holds authorization for a medical product in a EUROPEAN UNION (EU) member state can use the mutual recognition method to get authorization in additional EU member states. Directive 2004/27/EC established the decentralized procedure. Because the mutual recognition mechanism is also reliant on national authorities recognizing a first assessment done by one-member state, the distinction is that it only applies to pharmaceutical products that do not yet have a marketing authorization at the time of application.
{"title":"Review on: Dossier submission in the European countries by using mutual recognition procedure and decentralized procedure","authors":"Dimple D Marathe, Shaikh Md Shahzeb","doi":"10.1177/17411343221137189","DOIUrl":"https://doi.org/10.1177/17411343221137189","url":null,"abstract":"There is different procedure used to submit drug product for marketing authorization process. Mutual recognition procedure (MRP) is one of them. The European commission had published the procedure in consultation with competent authorities of member state. Using MRP, the applicant can apply for marketing authorization in one or more European Union nations. (MAH) who already holds authorization for a medical product in a EUROPEAN UNION (EU) member state can use the mutual recognition method to get authorization in additional EU member states. Directive 2004/27/EC established the decentralized procedure. Because the mutual recognition mechanism is also reliant on national authorities recognizing a first assessment done by one-member state, the distinction is that it only applies to pharmaceutical products that do not yet have a marketing authorization at the time of application.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"11 1","pages":"4 - 9"},"PeriodicalIF":0.0,"publicationDate":"2022-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82018404","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-10-20DOI: 10.1177/17411343221135317
S. Charbonnel, R. Milchior
Herald Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies.
{"title":"EU legal and regulatory update October 2022","authors":"S. Charbonnel, R. Milchior","doi":"10.1177/17411343221135317","DOIUrl":"https://doi.org/10.1177/17411343221135317","url":null,"abstract":"Herald Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"4 1","pages":"240 - 249"},"PeriodicalIF":0.0,"publicationDate":"2022-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77848970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-08-14DOI: 10.1177/17411343221116291
{"title":"EU Legal and Regulatory Update July 2022","authors":"","doi":"10.1177/17411343221116291","DOIUrl":"https://doi.org/10.1177/17411343221116291","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"50 1","pages":"187 - 193"},"PeriodicalIF":0.0,"publicationDate":"2022-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74226807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-08-05DOI: 10.1177/17411343221120335
{"title":"Journal of Generic Medicine – Editorial September 2022","authors":"","doi":"10.1177/17411343221120335","DOIUrl":"https://doi.org/10.1177/17411343221120335","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"45 1","pages":"135 - 135"},"PeriodicalIF":0.0,"publicationDate":"2022-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86916916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-08-03DOI: 10.1177/17411343221115807
Ashutosh Sareen, Gurvinder Singh, Sheetu Wadhwa, N. Khurana, Rajesh Kumar
Background Increased healthcare charges remain a prime subject worldwide, especially in underdeveloped and developing countries like India, where economic conditions are on the lower side. To control this, the Government of India (GoI) launched Jan Aushadhi scheme in April 2008 for providing low-cost generic medicines, however, the scheme has not been able to reach an extent. Moreover, the patients rely on branded prescribed medicines due to a lack of awareness. India is the world’s largest maker of generic medicines since its pharmaceutical sector fulfils over 50% of the global demand, still, Indians are spending their 10–20% of total income as health expenses. Aim and Objective This cross-sectional study was designed to have insight into the awareness of generic and ethical medicines among youth studying in different institutes. The main objective was to collect the responses from the students studying in various undergraduate and post-graduate professional programs. We aimed to collect 300 responses from students enrolled in various institutes located in Doaba region of Punjab. Materials and Methods A self-made questionnaire comprising basic questions based on generic and ethical medicines and Jan Aushadhi Kendra was randomly distributed amongst respondents through Google form. Conclusion According to the study’s findings, respondents had average understanding of the Jan Aushadhi Kendra. The study’s findings revealed a modest relationship between knowledge and attitude towards the Jan Aushadhi initiative. Despite the fact that the Jan Aushadhi plan was started many years ago, it has yet to gain limelight in the country.
{"title":"Awareness regarding generic and ethical medicines, and Jan Aushadhi Kendra: A survey-based study","authors":"Ashutosh Sareen, Gurvinder Singh, Sheetu Wadhwa, N. Khurana, Rajesh Kumar","doi":"10.1177/17411343221115807","DOIUrl":"https://doi.org/10.1177/17411343221115807","url":null,"abstract":"Background Increased healthcare charges remain a prime subject worldwide, especially in underdeveloped and developing countries like India, where economic conditions are on the lower side. To control this, the Government of India (GoI) launched Jan Aushadhi scheme in April 2008 for providing low-cost generic medicines, however, the scheme has not been able to reach an extent. Moreover, the patients rely on branded prescribed medicines due to a lack of awareness. India is the world’s largest maker of generic medicines since its pharmaceutical sector fulfils over 50% of the global demand, still, Indians are spending their 10–20% of total income as health expenses. Aim and Objective This cross-sectional study was designed to have insight into the awareness of generic and ethical medicines among youth studying in different institutes. The main objective was to collect the responses from the students studying in various undergraduate and post-graduate professional programs. We aimed to collect 300 responses from students enrolled in various institutes located in Doaba region of Punjab. Materials and Methods A self-made questionnaire comprising basic questions based on generic and ethical medicines and Jan Aushadhi Kendra was randomly distributed amongst respondents through Google form. Conclusion According to the study’s findings, respondents had average understanding of the Jan Aushadhi Kendra. The study’s findings revealed a modest relationship between knowledge and attitude towards the Jan Aushadhi initiative. Despite the fact that the Jan Aushadhi plan was started many years ago, it has yet to gain limelight in the country.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"54 1","pages":"233 - 239"},"PeriodicalIF":0.0,"publicationDate":"2022-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90924602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-18DOI: 10.1177/17411343221116086
Paul A. Braier
CompiledandwrittenbyGreenblum&BernsteinPLC A US intellectual property law firm which provides a full range of services in IP-related matters across all industries, including the biotech and pharmaceutical industries, including: Inter partes Review (IPR) and Post Grant Review (PGR) Abbreviated new drug applications (ANDAs) and Notice Letters Patent and trademark litigation Patent drafting and prosecution Patent infringement and validity opinions Patent reexamination proceedings and interferences New drug strategies Market entry strategies Joint venture strategies Licensing This section is intended to be a synopsis of recent developments and is not intended to be exhaustive. If any issue referred to in this section is to be relied upon, specific advice should be sought. Please contact: Paul A. Braier, PhD, Esq. Greenblum & Bernstein PLC 1950 Roland Clarke Place Reston, VA 20191 USA Tel: +1 703 716 1191 Fax: +1 703 716 1180 Email: pbraier@gbpatent.com Web: www.gbpatent.com
greenblum&bernsteinplc是一家美国知识产权律师事务所，为包括生物技术和制药行业在内的所有行业提供全方位的知识产权相关服务，包括:专利和商标诉讼专利起草和审查专利侵权和有效性意见专利复审程序和干扰新药战略市场进入战略合资企业战略许可本节旨在概述最近的发展，但并非详尽。如果要依赖本节中提到的任何问题，应寻求具体的建议。请联系:Paul A. Braier, PhD, Esq。Greenblum & Bernstein PLC 1950 Roland Clarke Place Reston, VA 20191 USA电话:+1 703 716 1191传真:+1 703 716 1180邮箱:pbraier@gbpatent.com网址:www.gbpatent.com
{"title":"A catalyst for change? Orphan drugs and the case of Catalyst v. Becerra","authors":"Paul A. Braier","doi":"10.1177/17411343221116086","DOIUrl":"https://doi.org/10.1177/17411343221116086","url":null,"abstract":"CompiledandwrittenbyGreenblum&BernsteinPLC A US intellectual property law firm which provides a full range of services in IP-related matters across all industries, including the biotech and pharmaceutical industries, including: Inter partes Review (IPR) and Post Grant Review (PGR) Abbreviated new drug applications (ANDAs) and Notice Letters Patent and trademark litigation Patent drafting and prosecution Patent infringement and validity opinions Patent reexamination proceedings and interferences New drug strategies Market entry strategies Joint venture strategies Licensing This section is intended to be a synopsis of recent developments and is not intended to be exhaustive. If any issue referred to in this section is to be relied upon, specific advice should be sought. Please contact: Paul A. Braier, PhD, Esq. Greenblum & Bernstein PLC 1950 Roland Clarke Place Reston, VA 20191 USA Tel: +1 703 716 1191 Fax: +1 703 716 1180 Email: pbraier@gbpatent.com Web: www.gbpatent.com","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"70 1","pages":"194 - 197"},"PeriodicalIF":0.0,"publicationDate":"2022-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73829352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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