Lok Sabha Question No. 246 (UNSTARRED), answered on 2021-07-20
Subject: API Import
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Parvesh Sahib Singh

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

LOK SABHA UNSTARRED QUESTION No. 246 TO BE ANSWERED ON THE 20 th  July, 2021

## API Import

## 246. SHRI PARVESH SAHIB SINGH VERMA:

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

- (a)  whether  the  country  is  dependent  on  China  for  most  of  crucial  Active  Pharmaceutical Ingredients (API) required to manufacture drugs and medicines;
- (b) the list of APIs which are imported from foreign countries; and
- (c) the steps taken by the Government to ensure indigenous production of crucial API in the country and reduce the import dependency?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI MANSUKH MANDAVIYA)

- (a): Many  Active  Pharmaceutical  Ingredients  (APIs)  are  imported  from  China,  for manufacturing  of  medicine.  As  per  Directorate  General  of  Commercial  Intelligence  and Statistics (DGCIS), the details of the percentage of APIs imported from China are as under: -
- (b): As per the data available from port offices of CDSCO more than 700 APIs of various therapeutic categories such as Antibiotics, Vitamins, Hormones, Antiviral, Anti-TB, Anticonvulsant, Analgesic, Antipyretic, Antidiabetic, Cardiovascular etc. have been imported into country.
- (c): The  Department  of  Pharmaceuticals  has  launched  following  three  schemes  for promoting domestic manufacturing of Pharmaceutical drugs including APIs by attracting large investments in the sector to ensure their sustainable domestic supply and thereby reduce India's import dependence on other countries: -
- (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: The scheme provides for financial incentives will be provided to manufacturers selected under the scheme for manufacturing of 41 Key Starting Materials (KSMs)/ Drug Intermediates (DIs) and Active Pharmaceutical Ingredients

| Year    | Percentage of Total imports (in terms of value)   |
|---------|---------------------------------------------------|
| 2018-19 | 67.56%                                            |
| 2019-20 | 68.04%                                            |
| 2020-21 | 68.02%                                            |

(APIs).The scheme provides for incentives on incremental sales to selected participants for a period of 6 years. The total financial outlay of the scheme is Rs. 6,940 crore and the tenure of the scheme is from FY 2020-2021 to 2029-30.

- (II) Scheme for Promotion of Bulk Drug Parks: This scheme provides for grant-in-aid to 3 Bulk Drug Parks for creation of Common Infrastructure Facilities (CIF) with a maximum limit of Rs.1000 crore per park or 70% of the project cost of CIF, whichever is less. In case of North Eastern States  and Hilly States (Himachal Pradesh,  Uttarakhand,  Union Territory  of Jammu & Kashmir and Union Territory of Ladakh) financial assistance would be 90% of the project cost. The total financial outlay of the Scheme is Rs. 3000 crore and the tenure of the Scheme is from FY 2020-21 to 2024-25.
- (III) Production Linked Incentive Scheme for Pharmaceuticals :  The objective of the scheme  is  to  enhance  India's  manufacturing  capabilities  by  increasing  investment  and production in the sector and contributing to product diversification to high value goods in the pharmaceutical sector. One of the further objectives of the scheme is to create global champions out of India who have the potential to grow in size and scale using cutting edge technology and thereby  penetrate  the  global  value  chains.  Under  this  scheme,  financial  incentives  will  be provided to participants selected under the scheme for their incremental sales of eligible drugs manufactured  in  India.  Eligible  drugs  under  the  scheme  include  Active  Pharmaceutical Ingredients  among  other  categories  of  pharmaceutical  products.  The  scheme  provides  for incentives  on  incremental  sales  to  selected  participants  for  a  period  of  6  years.  The  total financial outlay of the scheme is Rs. 15,000 crore and the tenure of the scheme is from FY 2020-2021 to 2028-29.

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