Orphan regulations for orphan drug development in india

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Saikiran Reddy.D and T.M. Pramod Kumar

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Through this paper an attempt has been made to put forward the challenges faced by rare disease drug development and the current scenario of orphan drugs legislations in India. An orphan drug is a pharmaceutical agent that is used to treat a rare medical condition (viz., Huntington?s disease, myoclonus disease, Tourette syndrome etc.). Developed countries like US, EU, Japan; Australia has laid down legal framework for combating rare diseases. A path breaking legislation was formulated by the U.S government way back in 1983, known as ?Orphan Drugs Act (ODA)'. The key purpose of ODA was to incentivize R&D initiatives for such drugs to treat millions of population suffering from ?Orphan Diseases?. Though the percentage of patients suffering from ?Rare Diseases? in India is reportedly higher than the world average, unfortunately even today such cases get little help from our government. By considering the importance of ODA, Indian government should also encourage its domestic pharmaceutical industry to get engaged in research to discover drugs for rare diseases by putting an ?Orphan Drugs Act? in place and extending financial support, and regulatory concessions like smaller and shorter clinical trials, without further delay. Thus India could well demonstrate that the concept of Orphan Drugs for Orphan Diseases is really not Orphan in India.

Biography :

I am saikiran reddy pursuing 1st M.Pharm in pharmaceutical regulatory affairs from JSS College of Pharmacy, JSS University, Mysore. I actively took part in various seminars and presented papers in national level symposiums.