We here at Total Orphan Drugs, as part of this months focus on emerging markets for the orphan drug industry, have been speaking to Harsha K Rajasimha of the newly formed Organization for Rare Diseases India (ORDI).
With a rare disease population estimated to be around 72,611,605 (more than the US and EU rare disease populations combined) the need for orphan treatments is huge, and with little in place so far, India represents a lucrative market to developers and pharma looking to expand their orphan operations.Rajasimha, one of the seven founders of the organisation, sat down with us to tell us a bit more about the current state of the orphan drug industry in India and the opportunities it holds: So, Dr Rajasimha, how many rare disease treatments are currently available in India?
In theory, close to 400 US FDA approved orphan drugs and about 80 EMA approved orphan drugs are available in India and world-wide. However, in practice, most of them are either not accessible to most patients in India or are unaffordable. It is ORDI?s mission and hope to make these and new approved orphan drugs easily accessible and affordable to patients with rare diseases in India.
Are there any financial incentives available to orphan drug developers looking to develop a treatment in India?
Currently, drug developers in India are receiving no formal incentives from the Government and hence are more focused on developing affordable drugs for more common diseases such as oral insulin, statins for preventing or slowing the progression of cardiovascular disease, vaccines and antibiotics for a number of preventable infectious diseases, etc.
Hence, patients with rare diseases in India have to rely on imported drugs from western countries which makes these treatments (even when available) unaffordable. ORDI aims to work between the Government of India and the Pharma/Biotech/Diagnostic industry to enact an Orphan Drugs Act (ODA) that will create incentives for orphan drug developers. We also need the Government to create a framework that is conducive to enabling the manufacturing of orphan drugs in India.
What financial assistance can rare disease patients expect in order to cover the high cost of orphan drugs?
The healthcare system in India is mostly self-funded by the patients. This restricts the affordability threshold for drugs and diagnostic tests to around 25 thousand rupees (~400-500 USD) per instance or about a lac rupee (~1600-2000 USD) per year on recurring expenses for most patients. The costs of most available