Lok Sabha Question No. 304 (UNSTARRED), answered on 2023-02-03
Subject: Supply of Active Pharmaceuticals Ingredients
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Ramya  Haridas, Uday Pratap Singh, Brijendra Singh

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

LOK SABHA UNSTARRED QUESTION No. 304 TO BE ANSWERED ON THE 3 rd  February, 2023

## Supply of Active Pharmaceuticals Ingredients

## 304. MS. RAMYA HARIDAS: SHRI UDAY PRATAP SINGH: SHRI BRIJENDRA SINGH:

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

- (a)  whether  it  is  a  fact  that  Government  is  depended  on  China  for  the  supply  of  Active Pharmaceuticals Ingredients (API) for drug manufacturing;
- (b)  if  so,  the  details  thereof  along  with  the  ratio  of  API  import  from  China  and  domestic production, in terms of value and quantity;
- (c) whether the Government has any contingency plan in case of sudden dip in the supply of APIsalong with the quality check put in place for API imported into the country;
- (d) the measures taken/proposed to be taken to avoid such dependency on China for supply of APIs;
- (e) the details of API imported by India, country-wise; and
- (f) whether the Government is taking steps to expand the volume of 'Made in India' APIs to reduce reliance on imports, especially from China and if so, the details thereof?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI BHAGWANTH KHUBA)

(a) to (b) and (e):   The Indian pharmaceutical industry is the world's 3 rd largest by volume and 14 th largest in terms of value . Over the last 30 years, the Indian Pharmaceutical Industry has  become  a  leader  in  the  manufacture  of  high  quality  generic  drugs  at  competitive prices.  India exported pharmaceuticals worth Rs. 1,75,040 crore in the financial year 2021-22, including Bulk Drugs/ Drug Intermediates.

Also, India is one of the major producers of Active Pharma Ingredients (API) or bulk drugs in the world . India exported Bulk Drugs/ Drug Intermediates worth Rs. 33,320 crore in financial  year  2021-22.   However,  the  country  also  imports  various  Bulk  Drugs/  APIs  for producing medicines from various countries including China, because of economic considerations.

Department does not maintain the details of domestic production of the APIs. However, the details of APIs (Bulk Drug and Drug Intermediates) imported from China & from other countries from 2019-20 to 2022-23 (upto November, 2022) and details of Imports (by value) of APIs  (Bulk  Drug  and  Drug  Intermediates) from 25 countries in FY 21-22 is given at Annexure .

(c):      As  per  the  information  received  from  the  CDSCO  under  DoHFW,  the  Indian pharmaceutical producers make an assessment of the imports needs and keeps adequate stocks of APIs in emergencies as has been observed during the times of COVID. Further, the import of drugs is regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Rules made  there  under.  For  import  of  any  drug,  including  bulk  drug  (API),  the  overseas manufacturing sites and the drugs are required to be registered and import license is required to be obtained in accordance with provisions of the said Act and Rules. All the imported drugs are  required  to  comply  with  standards  mentioned  under  Second  Schedule  of  the  Drugs  & Cosmetics Act 1940. Further, for quality check of drugs, sampling is carried out based on defined risk based criteria for imported consignments, at Port offices of Central Drugs Standard Control  Organization  (CDSCO)  under  Directorate  General  of  Health  Services,  Ministry  of Health & Family Welfare. As and when issue regarding quality of imported drug is received, action is taken by CDSCO in accordance with the provisions of said Act and Rules.

(d)  &  (f):     In  order  to  make  the  country  Atmanirbhar  in  the  manufacturing  of  APIs,  the Department of Pharmaceuticals has taken several measures. The Programmatic interventions which are under implementation to support the industry for domestic manufacturing of APIs are as follows:

- i. Under  the  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, with a financial outlay of Rs. 6,940 crores and the tenure from FY 2020-2021 to FY 2029-30, the financial incentives are to be provided for 41 identified products. Out of these, 21 projects have already been commissioned.
- ii. Production Linked Incentive Scheme for Pharmaceuticals, with a financial outlay Rs. 15,000 crores and the tenure from FY 2020- 2021 to FY 2028-29, provides for financial incentives to 55 selected applicants for manufacturing of identified products under three categories for a period of six years. The eligible drugs under this scheme include APIs among other categories of pharmaceutical products.
- iii. Scheme for Promotion of Bulk Drug Parks, with a financial outlay of Rs. 3,000 crores and the tenure from FY 2020-2021 to FY 2024-25, provides for financial assistance for creation of common infrastructure facilities to three States which have been selected under the scheme viz Gujarat, Himachal Pradesh and Andhra Pradesh. The industrial units setting up plants for APIs in these Parks will get benefitted from the common infrastructure developed under the scheme, which will decrease the manufacturing cost and increase their competitiveness.

1. Details of APIs (Bulk Drug and Drug Intermediates) imported from China & from other countries from 2019-20 to 2022-23 (upto November, 2022)

|                               | Total Import            | Total Import               | Import from China                  | Import from China                     |
|-------------------------------|-------------------------|----------------------------|------------------------------------|---------------------------------------|
| Year                          | Quantity of Import (MT) | Value of Import (In Rs Cr) | Quantity of import from China (MT) | Value of import from China (In Rs Cr) |
| 2019-20                       | 3,64,433                | 24,172                     | 2,20,875                           | 16,443                                |
| 2020-21                       | 3,90,476                | 28,529                     | 2,56,609                           | 19,403                                |
| 2021-22                       | 4,00,642                | 35,249                     | 2,64,582                           | 23,273                                |
| 2022-23 (upto November, 2022) | 2,91,782                | 27,209                     | 1,92,808                           | 18,973                                |

Source: DGCIS, Ministry of Commerce and Industry

.

2. Details of Imports (by value) of APIs (Bulk Drug and Drug Intermediates) from top 25 countries in FY 21-22

|   S. No | COUNTRIES      |   2021-22 (Rs. in crore) |
|---------|----------------|--------------------------|
|       1 | CHINA PRP      |                 23273    |
|       2 | USA            |                  3096.81 |
|       3 | SINGAPORE      |                   964.28 |
|       4 | ITALY          |                   830.04 |
|       5 | SPAIN          |                   618.46 |
|       6 | KOREA RP       |                   560.33 |
|       7 | JAPAN          |                   555.42 |
|       8 | GERMANY        |                   549.71 |
|       9 | HONG KONG      |                   492.87 |
|      10 | SLOVENIA       |                   388.99 |
|      11 | AUSTRIA        |                   374.64 |
|      12 | FRANCE         |                   351.15 |
|      13 | DENMARK        |                   345.11 |
|      14 | SWITZERLAND    |                   272.85 |
|      15 | NETHERLAND     |                   268.91 |
|      16 | BELGIUM        |                   266.23 |
|      17 | INDONESIA      |                   235.29 |
|      18 | TAIWAN         |                   227.77 |
|      19 | UK             |                   212.91 |
|      20 | HUNGARY        |                   212.22 |
|      21 | MALAYSIA       |                   200.84 |
|      22 | MEXICO         |                   177.59 |
|      23 | CZECH REPUBLIC |                   120.09 |
|      24 | UAE            |                    68.14 |
|      25 | CANADA         |                    50.63 |

Source:

DGCIS, Ministry of Commerce and Industry