What is an orphan drug? How the absence of regulations for Orphan Drugs in India acting as a gaping lacuna in the health-care services?

Orphan drug is a medicinal products which is intended for diagnosis, prevention or treatment of life threatening serious diseases or disorder. This drug are called “orphan” because under the normal market conditions the pharmaceutical industry has little industry in developing and marketing products intended for only a small number of patient.  The prices of exorbitantly saving medicines, which is used to treat rare diseases have increased by 12%, with implementation of Goods and Services Tax, and this has resulted in skyrocketing bills and leaving many patients in the danger. This high value orphan drug is used in bone marrow transplant, crohn’s disease and melanoma which is prescribed for life long. This type of treatment is very costly and now they have been burdened with 12 % additional levy to be paid.
Impact of Absence of Regulations
The absence of regulation for orphan drugs in India has resulted in gaping lacuna in the health care services. While no specific details are available regarding this and the market size is estimated between Rs 50 – 60 crore with this type of drug which is imported to treat rare diseases mainly genetic disorders, that affect a small percentage of population.
The patients has to import these lifesaving medicines from the other country as this not approved in India, by applying for an import they are required to get the permission and custom duty exemption. They are required to pay 12% levy of tax as this regulation is not been approved in India. With regard to these treatment the patients has to pay a huge amount of money for lifelong. Earlier, the no tax has been leived in this drug, but after the GST enanctment 12% rate is levied.


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