Lok Sabha Question No. 436 (UNSTARRED), answered on 2019-11-19
Subject: API from China
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Mala Roy

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

LOK SABHA UNSTARRED QUESTION No. 436

TO BE ANSWERED ON THE 19 th  November, 2019

## API from China

## 436. MS. MALA ROY:

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

- (a) whether it is true that the Government is dependent on China for the supply of Active Pharmaceuticals Ingredients (API) for drug manufacturing;
- (b) if so, the details of total percentage imported from China; and
- (c) the contingency plan of the Government in case of sudden dipping in the supply of APIs along with the quality check currently in place for API imported into the country?

## ANSWER

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

- (a) & (b): Yes, Sir. The country imports Bulk Drugs/Active Pharmaceutical Ingredients (APIs) for producing medicines including certain essential medicines.

The  details  of  India's  imports  of  Bulk  Drugs,  Drug  Intermediates  from  China  are  as under:

| Years   |   Total import (US $ mn) |   Imports from China (US$ mn) | Percent of Import from China   |
|---------|--------------------------|-------------------------------|--------------------------------|
| 2016-17 |                  2738.46 |                       1826.34 | 66.69%                         |
| 2017-18 |                  2993.25 |                       2055.94 | 68.36%                         |
| 2018-19 |                  3560.35 |                       2405.42 | 67.56%                         |

(Source: DGCIS Kolkata)

(c) : The imports from China are due to economic considerations, however, there are other  sources  like  United  States,  Italy,  Singapore,  Hong  Kong  etc.    from  which  Bulk drugs/APIs can be imported during contingencies. The policies formulated by Government  from  time  to  time  are  designed  to  minimize  country's  dependence  on imports and to give fillip to indigenous manufacturing. In this direction, the Department of Pharmaceuticals has formulated a Scheme namely 'Assistance to Bulk Drug Industry for Common Facility Centre' for providing assistance to Bulk Drug Industry for Common Facility Centre in any upcoming bulk drug park promoted by State Governments/State Corporations. An Inter-Ministerial Task Force was also constituted under the

Chairmanship  of  the  Minister  of  State  (Chemicals  &  Fertilizers)  on  18.04.2018  to formulate a roadmap for the enhanced production of Active Pharmaceutical Ingredients (APIs) in the country.

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  site  and  the  drug  are  required  to  be  registered  and  import license is required to be obtained in accordance with provisions of said Act and Rules. As  and  when  issue  regarding  quality  of  imported  drug  is  received,  action  is  taken  in accordance with the provisions of said Act and Rules.

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