|
ORDI asks Karnataka govt to frame an Orphan Drug Policy to provide access to existing drugs
|
|
Nandita Vijay, Bengaluru
August 17 , 2022
|
|
|
The Organisation of Rare Diseases India (ORDI) has stressed on the need for an Orphan Drug Policy for Karnataka to provide access to existing drugs that could save children from further disease progression, rather than trying to find a new drug.
In this regard, the Organisation has submitted a request to the Minister for IT, BT and ST Dr Ashwath Narayana who said it would be looked into.
Prasanna Shirol, co-founder and executive director, ORDI and Rare Disease Patient Advocate, said that an attempt to devise a State Orphan Drug Policy by the IT BT department in 2015 did not come through. But there is an urgent need for this now in Karnataka.
The state’s leadership in biotechnology, strong capability of the pharma industry, access to scientific expertise and presence of leading research institutes augur well for the policy to be announced, he said.
The focus of the Karnataka Orphan Drug Policy should be directed towards a separate allocation of funds for research, single window clearance infrastructure, land subsidy, global pharma to set up units to manufacture, incentives for production of off-patent generic drugs, GST waiver for the research for 5-8 years, dedicated research lab/incubation centre for scientist-entrepreneurs, easy access to treatment at government hospitals, Shirol told Pharmabiz.
The state can look at constituting a committee for the drafting the rare disease policy. The biotech leadership status will enable Karnataka to be a torch bearer in this area for the country, he added.
The US passed the Orphan Drug Act (ODA) in 1983 to propel the drug development for rare diseases. It brought in 7-year marketing exclusivity, tax credit of 50 per cent of the human clinical testing cost, research grants and exclusive marketing rights to limit competition The global orphan drugs market is projected to be US$ 4,35,686.3 million by 2030 and will register a CAGR of 11.8 between 2021 to 2030.
.
The National Rare Disease Policy for India (NRDPI-2021) could have included scope for drug development by supporting the industry, instead it is more focused on direct patients benefit to enable early and accurate diagnosis, faster access to treatment and long-term supportive care rehabilitation, besides procedures for interventions and training, said Shirol.
Orphan drug development requires huge investment, long gestation for R&D and human studies. There is limited knowledge on these rare disease conditions. This has led fewer physicians because of fewer patients across India and globally. The research needs to address multi gene and multi-organ aspects which make it challenging for scientists and less lucrative for the pharma industry, he noted.
Some countries in Asia, including China and Taiwan, have already taken a lead. In Australia, the Orphan Drugs Policy was introduced in 1997 with regulatory fee waivers, 5-year market exclusivity, etc. Japan offers financial subsidies of up to 50% expenses for clinical and non-clinical research, 10 years’ exclusive marketing rights, 15% tax credits, user fee waivers, etc.
With the Bengaluru-based Indira Gandhi Institute of Children Health being the first centre in the country to have a dedicated centre to treat rare diseases, already in existence and with the Research and Training Unit within the Centre for Human Genetics campus to come up with a Rs. 20 crore grant from the state government, there is a need to speed up the policy, said Shirol.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|