What are orphan drugs? Policy framework for such drugs in a country like India.

QuestionWhat are orphan drugs? Examine the importance of establishing a policy framework for such drugs in a developing country like India. – 20 December 2021

Answer – Orphan drugs are medicinal products used to diagnose, prevent or treat rare diseases like hemophilia, thalassemia, etc. These drugs are called “orphans” because drug companies do not show much interest in developing and marketing these products due to fewer patients under the general market. As a result, it becomes very expensive and the expected profit from its sale is also less.

In developed countries such as the United States, Japan, Australia and the European Union, laws exist that encourage research into the treatment of diseases commonly neglected by the pharmaceutical industry. They offer incentives such as shorter clinical trials, extended exclusivity, tax breaks, and higher rates of regulatory success. This makes it commercially attractive for pharmaceutical companies to invest in R&D.

However, such incentives are still not provided in developing countries. Genetic disorders are treated as pre-existing conditions and excluded from coverage by private insurance companies in India. Therefore, it is important to have a sound policy framework due to the extremely poor population, high burden of rare diseases, low level health care infrastructure and limited investment in R&D etc.

In this context, the steps taken:

  • Formulation of a national policy for the treatment of rare diseases, including measures to control the price of orphan drugs and provisions for drug development. Exemption of local clinical trials for approval of new drugs, which have already been permitted outside India. Seminars are organized regularly by the Pharmaceutical Export Promotion Council and it promotes awareness about opportunities related to off-ings in India.
  • Indian Council of Medical Research (ICMR) is inviting R&D projects for Orphan Drugs. Various projects are also being run by academic institutions like AIIMS, CMC VELLORE etc.
  • The National Health Policy, 2017 also underlines the need for management of rare/orphan diseases.

Future steps to be taken:

  • Sponsoring treatments for rare diseases in the form of public-private partnerships in R&D and Corporate Social Responsibility (CSR).
  • Enacting legislation to allow tax concessions, financing and exclusive marketing rights as incentives for off-drug discovery.
  • Rare diseases covered under insurance cover at reasonable premium.

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