Lok Sabha Question No. 230 (UNSTARRED), answered on 2017-12-15
Subject: IGST on Life Saving Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: SHOBHA KARANDLAJE, PRATHAP SIMHA

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

## LOK SABHA UNSTARRED QUESTION NO. 230 TO BE ANSWERED ON   15 TH DECEMBER, 2017

## IGST ON LIFE SAVING MEDICINES

## 230. KUMARI SHOBHA KARANDLAJE: SHRI PRATHAP SIMHA:

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

- (a) whether life - saving medicines imported for personal use would attract 5- 12 per cent IGST, if so, the details thereof;
- (b) whether the impact of the 12 per cent IGST on patien ts will lead to inaccessibility of such crucial  medicines  to majority  of  patients  suffering  from  seven types  of  Lysosomal  Storage Disorder (LSDs), rare cancers, etc., if so, the reaction of the Government thereto;
- (c) whether it is a fact that LSDs treatments are not presently commercially available in India, if so, the details and reasons therefor;
- (d) whether Enzyme Replacement Therapy (ERT) drugs become costlier as a patient gets older and heavier as the dosage increases; and
- (e) the steps taken by the Government to make life saving medicines exempt from IGST for patients with rare genetic disorders?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a): Medicaments  in  general  attract 12%  IGST.  However,  some  specified  medicaments including their salts and esters and diagnostic test kits have been prescribed 5% IGST r implementation  of  GST,  representations  have  been  received  for  reduction  of  IGST  rates lifesaving medicines f rom 12% to 5% or Nil. The requests were examined by Department of Revenue and based on the recommendation of the GST Council, IGST has been exempted on imports of
- I. Medicines/drugs/vaccines  supplied  free  of  cost    by  United  Nations  Internatio Children's  Em ergency  Fund  (UNICEF),  Red  Cross  or  an  International  Organization subject to specified conditions.
- II. Lifesaving Medicines for personal use supplied free of cost by overseas supplier, s to specified conditions.
- (b): National Pharmaceuticals Pricing A uthority under the Department of Pharmaceuticals has made  an  impact  analysis  of  the  GST/IGST  implementation  on  the  prices  of  medicines  an noticed that there is no significant impact on the prices of medicines on implementatio GST/IGST.

(c): As the number of persons suffering from individual rare diseases is small, they d constitute a significant market for drug manufacturers to develop and bring to market dr them. At present very few pharmaceutical companies are manufacturing drugs f or rare diseases globally and there are no domestic manufacturers in India.

However, Central Drugs Standard Control Organisation (CDSCO) has approved certain drugs as enzyme replacement therapy for the treatment of certain types of Lysosomal St rage Disorders (LSD). Further, the following enzyme replacement therapy drugs and medicines LSDs  and  other  metabolic  disorders  are  being  donated  to  the  patients  by  international manufacturers under their CSR/International charitable access progra mme:

Cerezyme,  Velaglucerase,  Cerdelga,  Myozyme,  Aldurazyme,  Elaprase,  Replagalvipriv, Orfadin (NTBC), Fabrazyme, Vimzim & Eleyso.

(d): Yes.

(e): As at (a) above