Lok Sabha Question No. 2194 (UNSTARRED), answered on 2022-07-29
Subject: National Policy for Rare Diseases, 2021
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Beesetti  Venkata Satyavathi

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 2194 TO BE ANSWERED ON 29 th July, 2022

## NATIONAL POLICY FOR RARE DISEASES, 2021

## 2194. DR. BEESETTI VENKATA SATYAVATHI:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) the salient features of National Policy for Rare Diseases, 2021;
- (b) whether the policy states the need for promotion of affordability and indigenous manufacturing of drugs for Rare Diseases;
- (c) if so, the details thereof; and
- (d) the steps being taken by the Government in this regard?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

(a): The Government has launched 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 under:

-  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  has  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 upto Rs. 50 lakhs to the patients suffering from any category of the Rare Diseases and for treatment in any of the Centre of Excellence (CoE) mentioned in NPRD-2021, outside the Umbrella Scheme of Rashtriya Arogaya Nidhi.
-  In order to receive financial assistance for treatment of rare disease, the patient of the nearby area  may  approach  the  nearest  Centre  of  Excellence  to  get  him  assessed  and  avail  the benefits.
-  Eight (08) Centres 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 counselling services.

(b) & (c): 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  conducive  environment  for  indigenous  manufacturing  of  drugs  for  rare  diseases  at affordable prices.

(d): Department  of  Pharmaceuticals  has  initiated  the  implementation  of  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.

Department  of  Revenue,  Ministry  of  Finance  vide  their  Notification  No.  46/2021-Customs dated  30.09.2021  gives  full  waiver  of  Basic  Customs  Duty  (BCD)  and  Integrated  Goods  and Services  Tax  (IGST)  to  drugs  imported  (personal  use  only)  for  treatment  of  Spinal  Muscular Atrophy (SMA) rare disease, thereby making the medicines for SMA rare disease more affordable.

In addition, Department of Revenue, Ministry of Finance vide their Notification No. 02/2022Customs dated 01.02.2022 has given exemption from Basic Customs Duty to drugs or medicines, which are used in the treatment of Rare Diseases when imported by Centres of Excellence (CoEs) as specified  in  NPRD,  2021  or  any  person  or  institution  on  recommendation  of  any  Centre  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.