Lok Sabha Question No. 251 (UNSTARRED), answered on 2020-09-15
Subject: Import of APIs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Dhanush M Kumar, C.N. Annadurai, Gautham Sigamani Pon, Pradeep Kumar Singh

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION No. 251

TO BE ANSWERED ON THE 15 th  September, 2020

## Import of APIs

## 251.   SHRI DHANUSH M.KUMAR:

SHRI C.N. ANNADURAI:

SHRI GAUTHAM SIGAMANI PON:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether Indian Pharmaceutical companies imported more than 70% of the Active Pharmaceutical Ingredients (APIs) used for manufacturing medicines in the country;
- (b)  if  so,  the  details  of  the  countries  from  which  India  imports  APIs  along  with  the reasons for high import of APIs;
- (c) whether the Government has taken steps to ensure regular supply of APIs in view of Covid-19 by enhancing domestic production and if so, the details thereof;
- (d) whether the Government has taken any steps for setting up Bulk Drug Parks in the country especially in Tamil Nadu and if so, the details thereof, State/UT-wise;
- (e) whether Private Sector will also be involved in setting up Bulk Drug Parks, if so, the details thereof and the steps taken in this direction; and
- (f) the other steps taken by the Government to create a self-reliant ecosystem in the Pharmaceuticals and Health and Hygiene sector by ramping up domestic production which will help in building an Atma Nirbhar Bharat?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

- (a)  &  (b):  Bulk drugs accounted for 63% of the total pharmaceutical imports in the country during 2019-20. India imports bulk drugs largely for economic considerations.  The  following  are  major  countries  from  which  India  imported  APIs during 2019-20.

|   S. No. | Country    |   Percentage share of import |
|----------|------------|------------------------------|
|        1 | CHINA P RP |                        68.04 |
|        2 | U S A      |                         3.53 |
|        3 | ITALY      |                         3.02 |
|        4 | SINGAPORE  |                         2.88 |
|        5 | SPAIN      |                         2.17 |
|        6 | GERMANY    |                         1.85 |
|        7 | FRANCE     |                         1.56 |
|        8 | JAPAN      |                         1.53 |
|        9 | DENMARK    |                         1.26 |
|       10 | HONG KONG  |                         1.25 |

Source: DGCIS, Kolkata

(c) & (f) : With a view to attain self-reliance and reduce import dependence in APIs/ Bulk  drugs,  the  department  of  pharmaceuticals  has  rolled  two  schemes  viz.  (i) 'Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of  critical  Key  Starting  Materials  (KSMs)/  Drug  Intermediates  (DIs)  and  Active Pharmaceutical Ingredients (APIs) In India' and (ii) "Promotion of Bulk Drug Parks". The guidelines of both the schemes were released on 27th July, 2020.

(d) & (e):  Under the scheme 'Promotion of Bulk Drug Parks' financial assistance will be provided to the State implementing agencies for creation of common infrastructure facilities  in  Bulk  Drug  Parks to  be  developed by State Governments. Three Bulk Drug parks will be financed under the scheme. States will be selected on the  basis  of  scores  obtained  by  the  proposals  submitted  by  the  states  on  a predefined  selection  criteria  (  given  in  the  scheme  guidelines  available  on  the website  of  the  department  under  the  tab  titled  'schemes').  A  State  Implementing Agency has to be a legal entity set up for the purpose of developing the Bulk Drug Park  and  having  minimum  51%  equity  of  the  State  government. No  proposal  has been submitted by the state government of Tamil Nadu. States can submit proposals under  this  scheme  within  a  period  of  60  days  from  the  date  of  issuance  of  the scheme guidelines (guidelines were issued on 27th July, 2020).

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