The governmentlaunched the National Policy for Rare Diseases (NPRD), 2021, in March 2021 for the treatment of rare disease patients. The salient features of NPRD, 2021, are as follows:
The rare diseases have been identified and categorized into 3 groups, namely Group 1, Group 2, and Group 3.
Group 1: Disorders amenable to one-time curative treatment.
Group 2: Diseases requiring long-term/lifelong treatment having relatively lower cost of treatment and benefit have been documented in literature, and annual or more frequent surveillance is required.
Group 3: Diseases for which definitive treatment is available but challenges are to make optimal patient selection for benefit, very high cost, and lifelong therapy.
Provision for financial support of up to Rs. 50 lakhs to the patients suffering from any category of the rare diseases and for treatment in any of the Centers of Excellence (CoE) mentioned in NPRD-2021, outside the Umbrella Scheme of Rashtriya Arogaya Nidhi.
In order to receive financial assistance for treatment of a rare disease, the patient of the nearby area may approach the nearest Center of Excellence to get him assessed and avail the benefits.
Eight (08) Centers of Excellence (CoEs) have been identified for diagnosis, prevention, and treatment of rare diseases.
Five Nidan Kendras have been set up for genetic testing and counseling services.
The NPRD, 2021, has provisions for promotion of research and development for diagnosis and treatment of rare diseases; promotion of local development and manufacture of drugs; and creation of a conducive environment for indigenous manufacturing of drugs for rare diseases at affordable prices.
The Department of Pharmaceuticals has initiated the implementation of the Production Linked Incentive Scheme for Pharmaceuticals. The scheme provides for financial incentives to manufacturers selected under the scheme for domestic manufacturing of various product categories, which also include orphan drugs.
The Department of Revenue, Ministry of Finance, vide their Notification No. 46/2021-Customs dated 30.09.2021, gives a full waiver of Basic Customs Duty (BCD) and Integrated Goods and Services Tax (IGST) to drugs imported (personal use only) for the treatment of Spinal Muscular Atrophy (SMA), a rare disease, thereby making the medicines for SMA more affordable.
In addition, the Department of Revenue, Ministry of Finance, vide their Notification No. 02/2022-Customs dated 01.02.2022, has given exemption from Basic Customs Duty to drugs or medicines that are used in the treatment of rare diseases when imported by Centers of Excellence (CoEs) as specified in NPRD, 2021, or any person or institution on the recommendation of any Center of Excellence listed in NPRD, 2021, certifying that the person (by name) for whom the drugs or medicines are imported is suffering from a rare disease (to be specified by name) and requires the drugs or medicines for the treatment of said rare disease.
The Union Minister of State for Health and Family Welfare, Dr. Bharati Pravin Pawar, stated this in a written reply in the Lok Sabha today.
