The Delhi High Court has passed landmark orders for the Indian government regarding rare disease treatment, focusing on funding, regulatory reforms, and price controls. The court has ordered the establishment of a National Fund for Rare Diseases (NFRD), with an initial allocation over $110 million USD for the next two fiscal years – aimed at improving accessibility to life-saving therapies. This new fund is expected to help bridge the gap in financial support and provide critical treatments to those afflicted with rare diseases.
In addition, the court has directed the Drugs Controller General of India (DCGI) and the Central Drugs Standard Control Organization (CDSCO) to establish a fast-track approval system for rare disease drugs. This fast-tracking program will expedite approvals, with the goal of processing applications within 90 days of submission.
In addition, the court raised the issue of price controls. Should orphan drugs be excluded from India’s Drug Prices Control Order (DPCO)? While rare disease drugs have been previously excluded from price controls, the court noted that they need to reassess this policy to ensure affordability because many such medicines remain inaccessible due to their high costs. The government has already begun discussions with pharmaceutical companies, including Sarepta, Roche, and others, to secure discounted pricing for rare disease treatments.
These steps will hopefully reduce the burden on patients and facilitate better access to lifesaving medicines for Indian citizens.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.