Explanation:

Orphan Drug- A biological product or medicine that is intended to treat diseases so rare that sponsors are reluctant to develop them under usual marketing conditions.
In 1983, the US government passed the Orphan Drugs Act to stimulate research in the treatment of diseases that have been largely ignored by the pharmaceutical industry. Similar laws have been enacted in Japan, Australia and the European Union. All these laws offer incentives such as shorter clinical trials, extended exclusivity, tax breaks and high rates of regulatory success. They have made it commercially attractive for pharmaceutical companies to invest in the research and development (R&D) required to find a cure for these diseases. India does not have a nationwide Orphan Drug policy.
In 2016 Karnataka became the first state to release a Rare Diseases and Orphan Drugs Policy. It recommended the implementation of preventive and carrier testing as a means of reducing morbidity and mortality. Given that over 80% of rare diseases have a genetic basis, it suggested the use genetic testing to accelerate the identification of the critical genes involved in rare diseases.
Do you know?
The court made many suggestions to the government. It pointed to the corporate social responsibility (CSR) provisions under the Companies Act, 2013 and confirmed that the act of sponsoring the treatment of rare diseases would qualify as a CSR activity.
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• Living Drugs
• Gene therapy.