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Compassionate drug use: Current status in India

The World Health Organization defines compassionate use (CU) as a “program that is intended to provide potentially life-saving experimental treatments to patients suffering from a disease for which no satisfactory authorized therapy exists and/or who cannot enter a clinical trial. For many patients,...

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Detalles Bibliográficos
Autores principales: Shetty, Yashashri C., Brahma, Smita, Manjesh, P. S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034137/
https://www.ncbi.nlm.nih.gov/pubmed/32154142
http://dx.doi.org/10.4103/picr.PICR_119_18
Descripción
Sumario:The World Health Organization defines compassionate use (CU) as a “program that is intended to provide potentially life-saving experimental treatments to patients suffering from a disease for which no satisfactory authorized therapy exists and/or who cannot enter a clinical trial. For many patients, these programs represent their last hope.” Over the years, an increasing number of requests and isolated cases have paved the way for more robust CU programs by pharmaceutical companies and guidelines by eminent regulatory bodies globally. In India, although there is no formal mention of the term “Compassionate Use” by the Central Drugs Standard Control Organization, there are provisions in the Drugs and Cosmetics Act 1940 and Rules 1945 to allow drugs to be imported as and when necessary. Such applications can be submitted to the Drug Controller General of India by a hospital, patient, or a pharmaceutical company. The evidence of such use of drugs is underlined by the availability of bedaquiline and delamanid for extensively drug-resistant tuberculosis (TB) and multidrug-resistant TB patients, respectively. CU is in its nascent stage in India owing to the lack of policies and laws needed to govern it. There is a need for regulatory bodies and pharmaceutical companies to work together to extend the spectrum of CU of drugs for the betterment of needy patients.