REGULATIONS OF ORPHAN DRUGS IN USA, EU AND INDIA-A COMPARATIVE STUDY
Journal Title: International Journal of Drug Regulatory Affairs - Year 2016, Vol 4, Issue 3
Abstract
Orphan drugs are the drugs and natural products used in treatment, diagnosis, or prevention of rare disease. The orphan drug regulation varies in different countries. Initially a guideline (Orphan Drug Act) for orphan drugs has been made in the USA. Exemption from application filing fees, tax credits for clinical research, marketing exclusivity for definite period of time and grant for phase I/II clinical trials are among the benefits given to the manufacturer of orphan drugs. As a result of these benefits number of drugs for the treatment of rare disease has been increased significantly in the last few decades. The orphan drug program can help the pharmaceutical companies in earning profit and recovering their investment even with small patient population in the developed countries. In 2001 a conference was held by the Indian Drugs Manufactures Association (IDMA) where a group of pharmacologists requested the Indian Government to establish the Orphan Drug Act in India. Indian rare disease population depends on developed countries approved orphan drugs because regulation for the orphan drugs has not been made by the Indian government. Developing countries are also feeling they should do something to promote the research and manufacturing of orphan drugs. The scarcity of regulation of orphan drugs adversely affects the economic growth of Indian medicinal industries. The present study reviews the orphan drug regulations in US, EU and India and raises some of the recent issues concerned to their regulation. .
Authors and Affiliations
Budhwar Vikaas, Singh Ajay K, Choudhary Manjusha
Keywords
Related Articles
- EP ID EP337030
- DOI 10.22270/ijdra.v4i3.187
- Views 90
- Downloads 0
FACTS ON DRUG REGULATIONS
The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable und...
COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES
Timely Product registration is a challenge in today’s scenario. Regulatory agencies are keen in assessing CTD sections like redefining starting material of Drug substance manufacturing, Pharmaceutical development, impuri...
TECHNOLOGY DVELOPMENT FOR POLYMER MODIFICATION TO ENHANCE SOLUBILITY OF POORLY SOLUBLE DRUG
Solubilization of poorly soluble drugs is a frequently encountered challenge in screening studies of new chemical entities as well as in formulation design and development. Solubility of some drugs is very less; these dr...
A Comprehensive and Comparative study of qualification process for Drug Development tools in US, Europe, Japan and India
Drug Development Tools are methods, materials, or measures that have the potential to facilitate drug development. USFDA has specified three major drug development tools and has also given the guidelines recommending the...
QUALITY BY DESIGN- A NEW APPROACH TO DRUG DEVELOPMENT
Quality by design is an essential part of the modern approach to pharmaceutical quality. A new approach to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important busi...