ABSTRACT
Abstract Intellectual Property is a powerful legal and economic instrument. In our "knowledge economy", patents are the preferred IP tool with special emphasis in the pharma - agro biotech industry. However, the growth of patents in the bio sector such as the pharma and agro fields, encounters many challenges. Life itself has not been defined yet. So, how can it be determined exactly when a living being, or a biological entity has been modified by itself or by human intervention, and thus address issues of patentability? Therefore, a researcher in the bio field cannot be alien to Intellectual Property, being the main actor in the revolution of the bio-pharma-agro sectors.
Resumen La propiedad intelectual es un poderoso instrumento legal y económico. En nuestra "economía del conocimiento", las patentes son la herramienta de propiedad intelectual preferida, con mayor énfasis en la industria farmacéutica - agrícola - biotecnológica. Sin embargo, el crecimiento de patentes en el sector biológico, tales como el campo farmacéutico y el agro, encuentra muchos desafíos. La vida misma aún no ha sido definida. Entonces, ¿cómo podría determinarse exactamente cuándo un ser vivo o una entidad biológica ha sido modificado por sí mismo o por la intervención humana? Por lo tanto, un investigador del sector bio, no puede ser ajeno a la Propiedad Intelectual, siendo el actor principal en la revolución del sector biofarmacéutico y agrario.
ABSTRACT
This study embraces the Generic Drug User Fee Act (GDUFA) implication on the Indian generic pharmaceuticalindustry based on the primary analysis. A sample size of randomly selected 250 employees from the generic industryof India, were the study participants and were provided with a close-ended questionnaire. The survey response issubjected to both descriptive and inferential analyses using the SPSS version 21.0 package. The benefits of GDUFAwere greater than the challenges to the Indian pharmaceutical industry are the key findings noted in this study. It wasfurther found that the different challenges faced due to the GDUFA did not alter the attention of the Indian genericindustry to the other market significantly. Correspondingly, the statistical outcomes of the respondent’s viewpointsimplied that the overall impact of the GDUFA on the return on investments for the Indian pharmaceutical industry wasincreased. It is inferred that the GDUFA has compelled the pharmaceutical industry of India to be in compliance withthe United States Food and Drug Administration all the time. Nevertheless, India remains one of the key exporters ofgeneric drugs for the United States. Fundamentally, the GDUFA has displayed an encouraging influence on the Indianpharma sector.
ABSTRACT
Background: AIDS is one of the most prevalent causes of death due to infectious origin which requires a lifelong therapy. There is variation in prices of antiretroviral drugs available in Indian market. Thus, a study was planned to find out variation in prices of antiretroviral drugs either as a single drug or in combination and to evaluate the difference in cost of various brands of the same antiretroviral drugs by calculating percentage variation in cost in Indian rupees. Methods: Cost of antiretroviral drugs manufactured by different pharmaceutical companies, in the same strength and dosage forms was obtained from “Current Index of Medical Specialties” July-October 2014 and “Indian Drug Review” Vol. XXI, Issue No. 4, 2014. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and percentage variation in cost was calculated. Results: Percentage variation in cost for antiretroviral drugs marketed in India was found to be zidovudine (100 mg) - 436%, lamivudine (100 mg) - 268%, tenofovir (300 mg) - 149.5%, didanosine (250 mg) - 73.75%, indinavir (400 mg) - 35.26%. Among the combination therapy, price variation was lamivudine + zidovudine (150 + 300 mg) - 314%, lamivudine + stavudine (150 + 40 mg) - 105%, lopinavir + ritonavir (133.3 + 33 mg) - 25%. Conclusion: There is wide variation in the prices of antiretroviral agents available in the market. Regulatory authorities, pharma companies, physicians should maximize their efforts to reduce the cost of drugs.