Lok Sabha Question No. 5022 (UNSTARRED), answered on 2023-03-31
Subject: Lifestyle and Genetic Diseases
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Sumalatha Ambareesh

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

## LOK SABHA UNSTARRED QUESTION No. 5022 TO BE ANSWERED ON 31 st  March, 2023

## LIFESTYLE AND GENETIC DISEASES

## 5022. SHRIMATI SUMALATHA AMBAREESH:

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

- (a)   whether the Government has noticed the rise in lifestyle and rare genetic diseases in the country;
- (b)   if so, the details regarding the steps and measures taken for spreading awareness on the same;
- (c)   the steps taken to prevent rare genetic disorders;
- (d)  whether the Government has observed that medicines for rare genetic diseases are very costly; and
- (e)   if so, the details of steps taken to decrease the price?

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

(a) As per the data available with Indian Council of Medical Research (ICMR) National Registry for Rare and Other Inherited Disorders (NRROID), a total of 9076 patients suffering from rare diseases have been enrolled since November, 2019.

(b) & (c) The Government has launched National Policy for Rare Diseases (NPRD), 2021 in March, 2021.  The  policy  aims  at  lowering  the  incidence  and  prevalence  of  rare  diseases  based  on  an integrated and comprehensive preventive strategy  encompassing awareness  generation, premarital, post-marital,  pre-conception  and  post-conception  and  post-conception  screening  and  counselling programmes to prevent births of children with rare diseases, and within the constraints on resources and  competing  health  care  priorities,  enable  access  to  affordable  health  care  to  Patients  of  rare diseases.  Eleven  (11)  Centres  of  Excellence  (CoEs)  have  been  identified,  which  are  premier Government tertiary hospitals with facilities for diagnosis, prevention and treatment of rare diseases.

(d) & (e) Specific treatments like gene therapy and antisense molecules etc. are quite expensive. In order  to  help  the  patients  in  terms  of  affordable  medicines,  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. The Guidelines for the  Scheme  are  available  on  the  website  of  the  Department  of  Pharmaceuticals  under  the  tab 'Schemes'

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.  Subsequently, 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, 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.

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