仿制药,对公众的需求:美国和印度-政府计划降低简化新药申请的价格和2018年批准的仿制药清单

Russell Martin, K. Bahmani
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引用次数: 3

摘要

健康是每个人的主要组成部分,在世界上,有不同的传统,有自己的治疗和治愈疾病的方法。药物的剂量形式可能看起来不同,但从医学上讲,非专利药物在体内的作用机制与昂贵的名牌药物相同。它们获得相同的有效成分,具有相同的质量,并且必须在药品制造和包装方面通过相同的令人满意的标准。受美国食品药品监督管理局监管的仿制药必须具有与品牌药同等的质量和性能。美国食品和药物管理局表示:“仿制药与品牌标识药具有相同的质量。”当一种仿制药被批准时,它已经达到了食品和药物管理局在识别、强度、质量、纯度和效力方面制定的严格标准。印度启动了Jan Aushadhi计划,以可承受的价格为购物者提供优质药品。鉴于该国的社会经济条件和无知和文盲的程度以及巨大的收入差距,只有在制订适当的多媒体宣传方案以教育社会各阶层的消费者时,消费者才能利用该计划的优势,或者应该使消费者特别是穷人和有需要的人受益。印度仍然是一个发展中国家,高质量和廉价的药物仍然是主要问题。
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Generic drugs, a need to the public: USA and India – Government plans to reduce the price of abbreviated new drug application and list of generic drugs approved in year 2018
Health is the prime component for every person, and in the world, there are different traditions that have their own approaches to treat and cure illness. The dosage form of the drug may appear different but medically, however, a generic medicament has the same mechanism in the body as that of the costlier brand-name drugs. They acquire the equal active ingredient an have the identical quality asd must pass the same satisfactory standards with respect to manufacturing and packaging of medicaments. The generic medicinal drug beneath the regulation of U.S. Food and Drug Administration must have the equal quality and performance as that of the brand-name drugs. The Food and Drug Administration states: ‘Generics have the identical quality as brand identify drugs’. When a generic drug product is approved, it has met rigorous standards established via the Food and Drug Administration with respect to identity, strength, quality, purity and potency. India started Jan Aushadhi scheme to make quality medicines handy to the shoppers at affordable prices. Given the socio-economic conditions and the level of ignorance and illiteracy with vast disparities of income in the country, the advantage of the scheme can be taken by the consumers or should reach the consumers particularly the poor and the needy, only when a proper multimedia publicity programmed is mounted to educate the consumers of all strata of society. India is still a developing country where quality and inexpensive remedy are still major issues.
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