ORPHAN DRUG - THE CURRENT GLOBAL AND INDIAN SCENARIO

Vanam Manisree*, K. Sandhya Rani, P. Krishna, N. Rachana Kumari, B. V. P. Deepthi, Dr. J. V. C. Sharma

ABSTRACT

It was not until a few decades ago that orphan drugs, still „enjoyed‟ the status of pharmaceutical touch-me-not entities. However, the past two decades have witnessed a radical shift in the approach of global pharmaceutical industry towards orphan drug. They are usually not studied for their pathophysiology or for newer therapeutic options, as they are not economically viable. In previous decades, rare diseases were nearly invisible in national health care systems. Due to lack of knowledge on these very rare and complex diseases, patients, families and careers were in the dark and faced extreme difficulties in accessing a diagnosis, appropriate care and treatment. Then a guideline (orphan drug act-1983) for orphan drugs has been made in the USA. In 2001 a conference was held by the Indian drugs Manufactures association (IDMA), where a group of pharmacologist requested the Indian government to establish the Orphan drug act in India. The percentage of patients suffering “rare diseases” in India is reportedly higher than the world range but the production of orphan drugs are low as compared to that of developed countries like US, Europe. The present studies review the current global and Indian scenario of orphan drugs.

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