Lok Sabha Question No. 3844 (UNSTARRED), answered on 2020-03-17
Subject: Import of Bulk Drugs/APIs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Ravi Kishan Shukla, Ravindra Kushawaha, Rajiv Ranjan (Lalan) Singh, Achyutananda Samanta, Andimuthu Raja

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

LOK SABHA UNSTARRED QUESTION No. †3844

TO BE ANSWERED ON THE 17 th  March, 2020

## Import of Bulk Drugs/APIs

†3844.SHRI RAVI KISHAN:

SHRI RAVINDRA KUSHWAHA:

SHRI RAJIV RANJAN SINGH ALIAS LALAN SINGH:

SHRI ACHYUTANANDA SAMANTA:

SHRI A. RAJA:

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

- (a)  whether  India  imports  around  70  per  cent  of  its  total  bulk  drugs  or  Active Pharmaceutical Ingredients (APIs) from China;
- (b) if so, the details thereof along with the percentage of raw material imported for the manufacture of antibiotics;
- (c) whether the current coronavirus outbreak has limited such import, if so, the steps being taken by the Government to ensure that stocks last for the foreseeable future;
- (d)  whether  the  Government  is  considering  restrictions  on  export  of  paracetamols, other key drug ingredients and their formulations and if so, the details thereof; and
- (e)  whether  the  Government  has  any  proposal  to  develop  bulk  drug  parks  in  the country to reduce dependence on imports, if so, the details thereof and the progress and timeframe for completion of the bulk drug parks?

## ANSWER

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

(a) & (b): The Indian Pharmaceutical industry is 3 rd largest in the world in terms of  volume  and  14 th largest  in  terms  of  value.  India  exported  medicines  worth  US $14389  mn  in  Financial Year 2018-19. India also exported Bulk  Drug/Drug Intermediates worth US $ 3911mn in Financial Year 2018-19. However, the country also imports various  Bulk  Drugs/Active Pharmaceutical  Ingredients  (APIs)  for producing medicines. Two-thirds of the total imports of Bulk Drugs/ Drug Intermediates  is  from  China.  The  imports  from  China  are  mainly  due  to  economic considerations.  The  details  of  India's  imports  of  Bulk  Drugs/  Drug  Intermediates (including from China) are as under:

| Year    |   Total imports (US $ mn) |   Imports from China (US$ mn) | Percent of Imports from China   |
|---------|---------------------------|-------------------------------|---------------------------------|
| 2018-19 |                   3560.35 |                       2405.42 | 67.56%                          |

As per the information received from the port offices of CDSCO, the quantity of raw materials imported for the formulation of antibiotic medicines in the country during each of the last three years is as follows:

|   Year |   Quantity of raw materials imported for the formulation of antibiotic medicines in the country (in MTs) |
|--------|----------------------------------------------------------------------------------------------------------|
|   2019 |                                                                                                 11230.5  |
|   2018 |                                                                                                 12006.1  |
|   2017 |                                                                                                  5591.44 |

- (c)  &  (d):  Department  of  Pharmaceuticals  has  constituted  a  Committee  under  the chairmanship of Dr. Eshwara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organization (CDSCO) to address the issue of drug security in the country in the context of novel coronavirus outbreak in China. Based on the recommendations of  the  Committee,  the  department  has  issued  necessary  instructions  to  National Pharmaceutical Pricing Authority (NPPA), Drugs Controller General of India (DCGI) and  State  Governments  to  ensure  adequate  supply  of  APIs  and  formulations  at affordable  prices  in  the  market  and  to  prevent  black-marketing,  illegal  hoarding, creating artificial shortages in the country. In this regard, Department of Pharmaceuticals has written to DGFT to restrict exports of 13 API and formulations made out of these APIs which includes paracetamol. NPPA has also written to Chief Secretaries  of  States  with  copies  to  Principal  Secretaries  Health  and  State  Drug Controllers requesting them to closely monitor the production and availability of APIs and formulations  to  prevent  the  black  marketing  and  hoarding  in  their  States  and UTs as well  as  to  ensure  that  there  is  no  violation  of  provisions  of  Drugs  (Prices Control)  Order,  2013  with  regard  to  compliance  of  ceiling  prices/  permissible increase in prices of scheduled/ non-scheduled formulations respectively.
- (e): The Department of Pharmaceuticals has formulated  a  Scheme  namely 'Assistance to Bulk  Drug  Industry for Common  Facility  Centre'  for  providing assistance of upto Rs. 100 crore for creation of Common Facility Centre (CFC) in any upcoming bulk drug park promoted by State Governments/State Corporations. The department has given 'In-principle' approval to the following proposals under this scheme:
1.  Govt. of Andhra Pradesh (AP Economic Cities Promotional Corporation Ltd.)
2.  Govt.  of  Telangana  (Telangana  State  Industrial  Infrastructure  Corporation Ltd.)
3.  Govt.  of  Himachal  Pradesh  (HP  State  Industrial  Development  Corporation Ltd.)

As per the said scheme the time frame for development of a CFC is 2 years from the date of final approval.

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