Implementation of Orphan Drug Regulation in India: the Need of the Time

Dr. Papiya Bigoniya

The pharmaceuticals and biotechnological products used to treat life-threatening or chronically debilitating rare diseases are designated as Orphan Drugs. Drugs, vaccines, hormones, biotechnological and bioengineered products come under this category depending on their indications. Recognizing the need to boost up the development of adequate drugs for rare disorders United States was the first to implement law in 1983 named Orphan Drug Act (ODA). In the year 2000 European Union also established the Committee on Orphan Medicinal Products (COMP) to oversee the development of orphan drugs. Both these regulations are providing grants, tax credits, fee waiver, monopoly on sales for a specified period, protocol assistance and fast track approval to encourage research and development in the field of orphan drug discovery along with guaranteed commercial viability of the manufacturers. Other countries like Japan, Australia, Taiwan, South Korea, Hong Kong and Singapore are adopting the USFDA/MHRA regulations or developing their own guidelines to support activities related to orphan products with sophisticated health delivery systems.
Indian drug regulatory system still now had not implanted formed regulation to encourage growth in the sector of research, drug development and prise control of orphan drugs. Drugs for rare diseases are expensive, difficult to access, not covered by the National Health Insurance, with a shortage in genetic specialists (pharmacogenomics), and little information is available on rare diseases. It’s the call of the time that Indian drug regulation should impose price regulation, subsidy paybacks for profitability of orphan drugs and establish a National Orphan Drug Directive to strengthen the health infrastructure.


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