scholarly journals Innovative Space Occupied By Indian Pharmaceutical Industry: Future Prospects

2020 ◽  
Vol 5 (1) ◽  
Keyword(s):  
Pharmaceutical Industry ◽  
Patient Outcomes ◽  
Price Competition ◽  
Patent Protection ◽  
Drug Product ◽  
Profit Margins ◽  
Patent Term ◽  
The Us ◽  
Generic Products ◽  
Indian Pharmaceutical Industry

Through the 1984 Drug Price Competition and Patent Term Restoration Act, the Indian Pharmaceutical Industry has thrived in the US market by selling generic products at competitive rates. However, the traditional and conservative model is no longer sustainable as we head past the “patent cliff”. An innovative business model characterized by the development of “super-generics”, an improved version of an original drug product which has lost patent protection, is the next logical step as it is relatively less time consuming and less expensive compared to the development of a new chemical entity, while affording higher profit margins and potentially, better patient outcomes compared to generics. This presentation will highlight the current space occupied by these super-generics, why the traditional Indian Pharmaceutical Industry should transition to become more innovative as well as the regulatory, infrastructure and personnel requirements that such a transition would entail.

The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Uruguay Round ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Patent Law ◽  
Patent Laws ◽  
The Impact ◽  
First Time ◽  
Indian Pharmaceutical Industry

The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various comities were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India’s patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.

What the patent dance of the Biosimilars Act means for biosimilars

2014 ◽  
Vol 20 (4) ◽  
Author(s):  
David A. Fazzolare ◽  
Joanna Brougher
Keyword(s):  
Price Competition ◽  
Market Entry ◽  
Patent Protection ◽  
Reference Product ◽  
Title Vii ◽  
President Obama ◽  
Biological Products ◽  
Related Information ◽  
The Us ◽  
Biologic Product

There are currently only two biosimilars on the market in the US in contrast to the 21 biosimilars have been approved in Europe since 2006. Part of the reason for the lack of biosimilars is that until recently, there has been no abbreviated pathway for a biosimilar to reach the market meaning that biosimilars had to undergo the long and costly process of obtaining approval just like an innovator biologic product. After years of negotiation, however, the Biologics Price Competition and Innovation Act (the “Biosimilars Act”) was signed into law on March 23, 2010, by President Obama as Title VII of the Patent Protection and Affordable Care Act. The Biosimilars Act established an abbreviated pathway by which the FDA could approve generic versions of previously licensed biological products. The Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information before the biosimilar can enter the market. In this article, we will explore what the Patent Dance is and what it means for biosimilars that are seeking market entry in the US. 

Generics and Biosimilars

2018 ◽  
Author(s):  
Stuart O. Schweitzer ◽  
Z. John Lu
Keyword(s):  
United States ◽  
Price Competition ◽  
Strategic Behavior ◽  
The United States ◽  
Approval Process ◽  
Biological Drugs ◽  
Patent Term ◽  
Important Player ◽  
Generic Products ◽  
Regulatory Significance

The generic pharmaceutical industry is arguably the most important player in the quest for affordable healthcare, especially in the United States. Since the inception of the industry following the enactment of the Drug Price Competition and Patent Term Restoration Act in 1984, generics have grown by leaps and bounds, and by 2015 they accounted for almost 90 percent of prescriptions filled in the United States. This chapter describes the history, industrial organization, regulatory approval process, price competition, and strategic behavior in this vitally important sector. It also provides an in-depth look at the issue of drug shortages, which affect older, generic products the most. The last part of the chapter examines the rising financial and regulatory significance of biosimilar drugs, which are analogous to generics for biological drugs, in the United States and Europe.

Innovation and Market Structure in Pharmaceuticals: An Econometric Analysis on Simulated Data

2014 ◽  
Vol 234 (2-3) ◽  
Author(s):  
Christian Garavaglia ◽  
Franco Malerba ◽  
Luigi Orsenigo ◽  
Michele Pezzoni
Keyword(s):  
Pharmaceutical Industry ◽  
Market Structure ◽  
Price Competition ◽  
Patent Protection ◽  
Simulated Data ◽  
Econometric Analysis ◽  
Emerging Leaders ◽  
Agent Based ◽  
First Mover Advantage ◽  
High Level

SummaryThe contribution of this paper is twofold. First, it presents the results of a “history-friendly” simulation model of evolution of the pharmaceutical industry. Second, it aims at contributing to a more general methodological discussion about agent-based models by proposing an econometric analysis of the results of the simulations. The case of the pharmaceutical industry has been studied extensively by scholars because, despite the high level of R&D intensity, the industry has been characterized by a relatively low levels of concentration. The model is able to reproduce the main stylized facts of the industry in an evolutionary perspective. In this paper we extend the analysis conducted in two previous works (Garavaglia et al. 2012, 2013) by further qualifying the findings with an extensive econometric investigation of the model outputs. The paper focuses the attention on the determinants of market structure, the innovative performance of the industry, the diversification in multiple submarkets and the level of prices. We find that the properties of the technological and demand regimes are key determinants of the patterns of industry evolution and that the main mechanisms driving the model are the random processes of search, the discovery of new submarkets as well as the interactions between patent protection, imitation and price competition. In addition, this paper emphasizes how the emerging leaders in the industry are those innovative early entrants which entered in large submarkets, showing the importance of the first mover advantage and of the size of the “prize” accruing to innovators when they discover a new rich submarket.

scholarly journals A study on working capital management of pharmaceutical industry in india

2015 ◽  
Vol 1 (3) ◽  
pp. 248-269
Author(s):  
Vijayalakshmia V ◽  
Srividya M
Keyword(s):  
Standard Deviation ◽  
Pharmaceutical Industry ◽  
Financial Performance ◽  
Chemical Industry ◽  
Price Competition ◽  
Working Capital ◽  
Working Capital Management ◽  
A Company ◽  
Indian Pharmaceutical Industry

The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered units. It has expended drastically in the last two decades. The pharmaceutical and chemical industry in India is an extremely fragmented market with severe price competition and government price control. The Pharmaceutical Industry in India meets around 705 of the country‟s demand for bulk drugs, drug intermediates, pharmaceutical formulation, chemicals,tablets, orals and injectibles. The Indian Pharmaceutical Industry is developing drastically every year. It is felt that there is the need to study the role of working capital on profitability of a Pharmaceutical company. Conventionally, it has been seen that if a company desires to take a greater risk for bigger profits and losses, it reduces the size of its working capital in relation to its sales. If it is interested in improving its liquidity, it increases the level of its working capital.Hence an attempt has been made to analyze the working capital position of the industry with the help of mean, standard deviation, co-efficient of variation, multiple regression, and analysis of variance. The increase in working capital will improve the financial performance in future.

scholarly journals Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products

2017 ◽  
Vol 20 ◽  
pp. 252
Author(s):  
Paramjeet Kaur ◽  
Xiaojian Jiang ◽  
Ethan Stier
Keyword(s):  
Coating Layer ◽  
Drug Product ◽  
Enteric Coating ◽  
Drug Products ◽  
New Drug ◽  
Delayed Release ◽  
The Us ◽  
Generic Products ◽  
The Impact

The US FDA’s rule on “Requirements for Submission of Bioequivalence Data” requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January 2009. With the publication of this rule, we evaluated the impact of data from non-pivotal BE studies in assessing BE and identified the reasons for failed in vivo BE studies for generic oral delayed-release (DR) drug products only. We searched the Agency databases from January 2009 toDecember 2016 to identify Abbreviated New Drug Applications (ANDAs) submitted for DR drug products containing non-pivotal BE studies. Out of 202 ANDAs, 43 ANDAs contained 102 non-pivotal BE studies. Forty-nine non-pivotal BE studies were conducted on the to-be-marketed (TBM) formulation and 53 were conducted on formulations different from the TBM formulation. These experimental formulations primarily differed in the ratio of components of the enteric coating layer and/or amount (i.e., %w/w) of enteric coating layer. Of the 49 non-pivotal BE studies conducted on the TBM formulation, 41 failed to meet the BE acceptance criteria. The majority of failed non-pivotal BE studies on the TBM DR generic products had insufficient power, which was expected as these studies are exploratory in nature and not designed to have adequate power to pass the BE statistical criteria. In addition, among the failed non-pivotal BE studies on the TBM DR generic products, the most commonly failing pharmacokinetic parameter was Cmax. The data from these non-pivotal BE studies indicate that inadequate BE study design can lead to failure of the BE on the same formulation. Also, the non-pivotal BE studies on formulations different from the TBM formulation help us link the formulation design to the product performance in vivo. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals High prices for generics in Australia — more competition might help

2009 ◽  
Vol 33 (2) ◽  
pp. 200 ◽  
Author(s):  
Liliana Bulfone
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
Developed Countries ◽  
Dominant Strategy ◽  
Generic Product ◽  
The Us ◽  
Generic Products ◽  
The Government ◽  
The Individual ◽  
Pharmaceutical Benefits Scheme

It is commonly believed that dispensed prices of medicines in Australia are substantially lower than those in other developed countries, particularly the US. This article reports the results of an analysis comparing dispensed prices for the most commonly prescribed and the highest cost items in Australia with dispensed prices in the US. Although a large majority of items are less expensive in Australia than in the US, Australian prices are higher for a substantial number of products, particularly generic drugs. This article examines various policies affecting the pricing of generics in Australia. It is postulated that the main cause for higher prices for a substantial number of generic products is the lack of price competition. This results from government policy which ensures that a price reduction by one company is communicated immediately to all competitors in that market along with an invitation to match the reduced price. The dominant strategy for all suppliers is to only reduce their price in response to a reduction in price by a competitor. The result is a lack of differentiation in pricing across brands of a medicine on the Schedule of Pharmaceutical Benefits. The government could improve the structure of the generics market and encourage greater competition by ceasing to disclose competitor firms? offers to other competitors. The government could conduct pricing reviews of each generic product relatively infrequently (eg, only once annually or every 18 months). At the time of the pricing review, the government would request confidential offers on price for a generic from all players in the market. Brands should then all be listed under the Pharmaceutical Benefits Scheme (PBS) at the offered price. Prices offered by the individual supplier would apply until the next pricing review. The PBS would continue to subsidise up to the price of the lowest priced brand, with brand premiums applying to all brands priced higher than the benchmark price. Such an approach would provide opportunity for players in the market to capture market share by being the lowest priced brand.

scholarly journals A study on financial performance of pharmaceutical industry in india

2014 ◽  
Vol 1 (3) ◽  
pp. 191-209
Author(s):  
Vijayalakshmi V ◽  
Srividya M
Keyword(s):  
Standard Deviation ◽  
Public Sector ◽  
Pharmaceutical Industry ◽  
Financial Performance ◽  
Analysis Of Variance ◽  
Chemical Industry ◽  
Price Competition ◽  
Small Scale ◽  
The Core ◽  
Indian Pharmaceutical Industry

The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered units. It has expended drastically in the last two decades. The pharmaceutical and chemical industry in India is an extremely fragmented market with severe price competition and government price control. The Pharmaceutical Industry in India meets around 705 of the country‟s demand for bulk drugs, drug intermediates, pharmaceutical formulation, chemicals,tablets, orals and injectibles. There are approximately 250 large units and about 8000 small-scale units, which form the core of the Pharmaceutical Industry in India (including 5 central public sector units) Looking ahead, the worldwide pharma market is estimated to more than double to $1.3 billion by the year 2020.The Indian Pharmaceutical Industry is developing drastically every year. Hence an attempt has been made to analyze the profitability position of the industry withthe help of mean, standard deviation, co-efficient of variation, multiple regression, and analysis of variance. The increase in profitability will not only yield greater efficiency but also improve financial performance in future.

scholarly journals A study on the present market situation of Nanoparticles (Liposomes and Niosomes) and its regulatory environment in us, Eu and Indian Pharmaceutical Industry

2020 ◽  
Vol 11 (4) ◽  
pp. 7241-7246
Author(s):  
Daka Nagarjuna Reddy ◽  
Mahaveer Singh ◽  
Birendra Shrivastava ◽  
Ravi Kumar Konda
Keyword(s):  
Pharmaceutical Industry ◽  
Present Situation ◽  
Research Process ◽  
Regulatory Environment ◽  
Indian Market ◽  
Regulatory Affairs ◽  
The Us ◽  
Market Situation ◽  
Market Strategies ◽  
Indian Pharmaceutical Industry

The knowledge of regulatory affairs is continuously improving in the pharmaceutical industry. The quality, safety and efficacy of the drug are related to various factors. Still, one of the vital system needed for marketing is that company should have a proper regulatory department. Our research process focuses on the regulatory department in the pharmaceutical industry and also the present situation of Nanoparticles across US, EU and India. The Nanotechnology in the Indian pharmaceutical industry is taking an excellent path. Still, when compared to USFDA and EU, there are some steps to be taken for the development of Nanotechnology. This study is mainly focused on Nanoparticles (Liposomes & Niosomes). By comparing the US and EU regulatory markets, we can build a strong regulation in the Indian market on Liposomes and Niosomes. The aim of this study is also focused on present regulations on Liposomes and Niosomes in the three market regions, i.e. in the US, EU and India and present market strategies. By this study, we can gain knowledge on marketing developments of Nanoparticles (LIPOSOMES&NIOSOMES).

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