scholarly journals Intellectual Property Right in India- A Review

2019 ◽  
Vol 7 (3) ◽  
pp. 8-13
Author(s):  
Zakir Hussain Shaik Md. ◽  
Jennai Shiva ◽  
Goli Venkateswarlu ◽  
R. Suthakaran ◽  
Syed Ghouse

The CDSCO prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, diagnostics, cosmetics and devices in the country. Pharmaceutical research and development is an expensive, time consuming and uncertain process that may take 8-10 years to complete. Patent clock starts much before a new drug is approved for marketing and significant amount of time may be lost in the review and approval process by regulatory bodies. So in order to recoup the considerable time and resources invested in the drug development and approval process, the pharmaceutical companies depend on exclusivity provisions granted by the regulatory bodies. Patent strategy provides a check list for developing comprehensive patent strategies for the company.

Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.


The article examines the transition of Ukraine from the periphery of the modern world-economy to the semi-periphery. Several global variants of such a transition have been analysed and a hybrid version has been proposed. Based on the analysis of Ukrainian export-import operations, the conclusion of our previous work of Ukraine being one of the periphery states has been confirmed. According to the global practice, for such states, there are two options for the transition to the semi-periphery. The first of them is the implementation of such systemic reforms that will allow for a considerable time to redistribute profits from international operations in their favour. This option is implemented in two forms. The first is authoritarian modernization (examples – Singapore, China). The second is reforms carried out with the broad support of the countries of the centre (an example is the European and Euro-Atlantic integration of the Central Europe countries). The second option is cooperation with the hegemonic state (USA) in the field of security and maintenance of order, for which such a state receives various support and access to the American sales market (examples - South Korea, Japan and the FRG, partly Turkey and Chile). It was concluded that the above options are unacceptable in a difficult Ukrainian case (chronic under-reforming, low quality of the Ukrainian elite, internal problems in the EU and the United States, a protracted conflict with the Russian Federation, etc.), thus there is a need for such an option that would combine the elements of all of the above – that is, a hybrid one. The proposed option assumes, firstly, the introduction of qualitatively new representatives into the Ukrainian elite, capable for systemic reforms, secondly, the continuation of European integration efforts, thirdly, strengthening cooperation with the United States in the security sphere, and fourthly, the activation of regional integration projects (primarily with Turkey and Poland). If efforts in one of the designated areas fail, then resources can be redirected to activate others without wasting precious time. As a conclusion, it was stated that the proposed hybrid version of Ukraine’s transition from the periphery to the semi-periphery looks like the only realistic way for Ukraine.


2021 ◽  
Author(s):  
◽  
Amy Hill

<p>This paper explores one very important issue in the regulatory regime for medicines in New Zealand and around the world- the deficit of information about medicines available to doctors, patients and independent researchers. Much of the information about safety, efficacy and quality of drugs is held and controlled by pharmaceutical companies and regulators. The public is entitled to this information in full.</p>


Author(s):  
Л.В. Кузнецова ◽  
Л.Ю. Бахтина ◽  
И.Ю. Малышев

В кратком обзоре обсуждаются задачи фармацевтических компаний, и вопросы о наиболее рациональном соотношении скорости, стоимости и качества процесса разработки лекарств и технологий (DDD). Делается заключение, что экспериментальный дизайн и методы медико-фармакологических исследований должны разрабатываться на основании современных принципов и представлений о содержании этапов DDD, с особым акцентом на высокое качество научных исследований на этапе открытия. This brief review discusses challenges of pharmaceutical companies and issues of the most rational relationship between the speed, cost, and quality of the process for drug and technology development (DTD). It was concluded that the experimental design and methods of medical and pharmacological research should be developed on the basis of modern principles and ideas about the essence of DTD stages with a particular emphasis on the high quality of scientific research at the stage of discovery.


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