Lok Sabha Question No. 3447 (UNSTARRED), answered on 2021-12-17
Subject: High cost of drugs for the Treatment of Spinal Muscular Atrophy
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Feroze Varun Gandhi, Hanuman Beniwal

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

## LOK SABHA UNSTARRED QUESTION No.3447

## TO BE ANSWERED ON 17 th  DECEMBER 2021

## HIGH COST OF DRUGS FOR THE TREATMENT OF SPINAL MUSCULAR ATROPHY

## 3447.  SHRI FEROZE VARUN GANDHI:

## SHRI HANUMAN BENIWAL:

Will the Minister of HEALTH AND FAMILY WELFARE

be pleased to state:

- (a) the total number of reported cases of spinal muscular atrophy in the country, State/UT-wise;
- (b)  whether  the  Government  is  aware  of  the  high  cost  of  drugs  for  the  treatment  of  spinal
- muscular atrophy particularly the injections used in its treatment and if so, the details thereof;
- (c) the customs duty, GST and other taxes levied on such drugs;
- (d) whether the Government has taken any steps to control the prices of SMA drugs, and if so,
- the details thereof; and
- (e) if not, whether the Government proposes to undertake such steps to make the medicine/injection more affordable or proposes to bear the high expenditure on medicine/injection for treatment of patients including children?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

## (DR. BHARATI PRAVIN PAWAR)

- (a) ICMR has initiated a National Registry wherein epidemiological data is collected for Rare diseases  and  other  inherited  disorders.  Data  of  a  total  of  4001  rare  disease  cases  (storage disorders,  small  molecular  inborn  errors  of  metabolism,  primary  immune  deficiency disorders,  skeletal  dysplasia,  neuromuscular  disorders,  haemoglobinopathies  and  bleeding disorders)  have  been  collected  till  31 st October,  2021.  The  number  of  patients  of  Spinal Muscular  Atrophy  enrolled  in  the  registry  portal  is  295.  Information  specific  to  each State/UT is not maintained centrally.
- (b) & (c) As informed by the Department of Revenue, Ministry of Finance, for general imports, medicines used in the treatment of Spinal Muscular Atrophy attract  Basic  Custom  Duty  of  10%  and  IGST  of  12%.  However,  individuals  are  allowed to  import  medicine  for  Spinal  Muscular  Atrophy  without  payment  of  Customs  Duty and IGST (Nil Custom Duty and Nil IGST) if the following conditions are satisfied:
- (i) the goods are imported by an individual for personal use;
- (ii)  it  is  certified  in  the  Form  as  applicable,  by  the  Director  General  or  Deputy Director General  or  Assistant  Director  General,  Health  Services,  New  Delhi, Director  of  Health  Services  of  the  State  Government  or  the  District  Medical Officer/Civil Surgeon of the district, in each individual case
- (iii)  the  importer  produces  the  said  certificate  to  the  Deputy  Commissioner  of Customs  or  the  Assistant  Commissioner  of  Customs,  as  the  case  may  be,  at  the time of clearance or gives an undertaking to furnish the said certificate.
- (d) &(e)  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  manufactures 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'.