Mr. Masoom Reza Khan (M.Pharm. Quality Assurance First Year student) secured BEST ORAL PRESENTATION AWARD at 63rd Indian Pharmaceutical Congress, Bengaluru
Mr. Masoom Reza Khan, (M.Pharm Quality Assurance, First Year Student) have secured Best Oral Presentation Award in Drug Regulatory Affairs section at 63rd Indian Pharmaceutical Congress, Bengaluru (16 – 18 Dec. 2011). He has presented a paper entitled “Need of Orphan Drug Act to Counter Growing Threats of Rare Diseases in India”. Co-authored & Guided by Dr. Anil M. Pethe, HOD Quality Assurance, SPTM, NMIMS Shirpur Campus.
Summary:
The present study deals with Need of Orphan Drug Act to Counter Growing Threats of Rare Diseases in India. The term “Orphan Drugs” refers to a product that treats a rare disease or conditions. The rare diseases (RD) are a spectrum of diseases (and disorders) with very different etiologies, the common denominator being the frequency of their occurrence in population, with most diseases having no defined diagnostic or treatment protocols available.
According to the India’s population census 2011, the India`s population is above 1.21 billion. World population census states that 17% of world population is Indian. India is second in the world population.
In India there are many common diseases but the occurrences of rare diseases are increasing rapidly with increasing population.
The United States, Japan, Australia and Europe has the Orphan Drug Act, the intent is to stimulate the research, development, and approval of products that treat rare diseases. India has not having such an Orphan Drug Act. Experts estimate suggests that there are over 3.3 crore patients in India suffering from rare diseases. There are about 6000-8000 rare diseases in India. Thus, it is important to establish an Orphan Drug Act in India.