Diseases which manifest in patient populations representing at the maximum 6-8% of the world population are defined as rare diseases. An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. Due to the small number of patients suffering, and the resultant lack of revenue they provide, pharmaceutical companies do not have any incentives to develop drugs and treatments for rare diseases. Therefore the pharmaceutical company may have the ability to supply orphan drugs, even when there is a demand, but this demand is not significant enough to manufacture the needed product. This is also partially due to the lack of sponsorship, or no one to “adopt” the orphan drug, to conduct the necessary testing to obtain the necessary approval from the Food and Drug Administration. Orphan Drug Act’ was passed by the US Congress in 1982 and signed into a law in January 1983. The objectives of this legislation were to stimulate the development of drugs for the treatment of rare diseases. The need for such an act is thus evident and it need from initiative from the Indian Pharmacists and the Government to implement such Laws which would strengthen the health infrastructure and provide relief to the numerous rare disease sufferers throughout the country.
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