Recent court orders in patent suits on limits of Bolar exemption: Shrinking space for pharmaceutical generic companies in India?

Author(s):  
Sandeep K Rathod ◽  
Priyam Lizmary Cherian ◽  
Ketki P Jha

The generic pharmaceutical sector in India transformed over the last few decades. However, certain recent judicial developments may impact the flexibility that generic companies have for development of future generics. This article looks at some of these developments. The developments covered are: a) interpretation and application of the Bolar flexibilities and b) hurdles in claiming use under S.107 A.

2006 ◽  
Author(s):  
Chris S. O'Sullivan ◽  
Lori A. King ◽  
Kyla Levin-Russell ◽  
Emily Horowitz

Author(s):  
G. N. Singh

India has emerged as a global player for pharmaceuticals. The pharmaceutical revolution of 1970-90 of Indian Pharma Industry had demonstrated that India could be self-sufficient in the manufacture of essential drugs at affordable prices. The turnover of Indian Pharmaceutical is over $30 billion in 2015 including $15 billion in exports.  It was a great honor to preside the 67th Indian pharmaceutical congress held in Mysore. The topic of Pharmacists for a Healthy India is close to my heart and being a regulator myself, I feel that the Pharmacy fraternity can play a much larger role in contributing to the healthcare system in India. Pharmacist as such are involved in a big way in the regulation of drugs, be it manufacture, be it sale or research and development. A contribution of the Pharmacists is there at every stage till the drug reaches the consumer safely. For this purpose, the society needs a pool of well qualified and experienced pharmacists, which requires regular updating of their knowledge to keep pace with the developments taking place in the pharmaceutical sector. The advancements in technology and the emerging challenges in the health sector require pharmacists to shoulder the responsibilities towards the utilization of scientific knowledge in the use of modern medicines and the protection of the public against dangers of wrong use of drugs. The Pharmacy Council of India on its part will have to ensure that the courses offered for creating a high technology based are calibrated in such a way that the education and skills developed suit to the requirements of the Pharmaceutical Industry as well as needs to the patients


2017 ◽  
Vol 6 (2) ◽  
pp. 1
Author(s):  
Albert Naiem Naguib ◽  
Eahab Elsaid ◽  
Abdel Moneim Elsaid

This study examines the relationship between dynamic capabilities (experience, routine, skills, firm characteristics, knowledge and technology) and competitive advantage sustainability in the Egyptian pharmaceutical sector. The data was collected using primary and secondary data sources. Primary data was collected from questionnaires distributed to 160 top managers in 20 pharmaceutical firms. The secondary data about pharmaceutical firms like rankings, revenues and market share was collected from external sources such as Intercontinental Marketing Service (IMS). The questionnaires examine six independent variables based on a five-scale Likert scale. The methodology used in the study is non-probability sampling (judgmental sampling), Cronbach’s alpha reliability coefficient and Chi-square tests. The results support the notion that there is a significant relationship between four of the six dynamic capabilities (experience, skills, firm characteristics and knowledge) and the competitive advantage sustainability for pharmaceutical firms in Egypt. Designing the questionnaire and formulating the questions to target the required field was challenging, given that the topic is dynamic and the business scene in Egypt has witnessed drastic political changes since January 2011. The study should assist pharmaceutical companies in Egypt in directing their investments properly and in determining the weaknesses in their dynamic capabilities that need to be addressed.


2021 ◽  
Vol 13 (12) ◽  
pp. 6525
Author(s):  
Diana Marieta Mihaiu ◽  
Radu-Alexandru Șerban ◽  
Alin Opreana ◽  
Mihai Țichindelean ◽  
Vasile Brătian ◽  
...  

The primary goal of this study was to determine the impact of mergers and acquisitions (M&A) and the environmental, social, and governance (ESG) sustainability scores of companies. In this regard, efforts to measure and analyze the evolution of a company’s performance, taking into account financial and non-financial measures using a score function, are adapted to the pharmaceutical sector. The sample consisted of 100 leading pharmaceutical companies, ranked by stock market capitalization, who registered 30% (n = 492) of the total M&A transactions over the study period (2010–2020). There was a direct and positive link between the M&A process and the evolution of company performance. The ESG score, as an indicator for measuring sustainability, has a positive and direct impact on company performance, indicating that a high ESG score determines an increase in company performance. A similar impact is identified for companies involved in M&A processes, meaning that companies in the pharmaceutical sector tend to register a performance improvement.


2012 ◽  
Vol 37 (2) ◽  
pp. 69-75 ◽  
Author(s):  
Patricia Hansen

This article reports on a study of Children's Court files relating to completed applications for variation of care orders (section 90 applications) in three specialised Children's Courts in New South Wales. All files that could be located for completed applications were reviewed and nonidentifying data was recorded. The study attempted to examine the type of applications, the characteristics of applicants and the outcomes of the applications. One hundred and seventeen applications were reviewed: almost half of these were made by the then Department of Community Services (DoCS), and about the same proportion of applications were made by parents. After the section 90 applications were determined there was an increase in care orders allocating parental responsibility to the Minister for Community Services with 73% of the children placed under the care of the minister to age 18.


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