Lok Sabha Question No. 577 (UNSTARRED), answered on 2018-02-06
Subject: Import of Raw Material
Ministry: CHEMICALS AND FERTILIZERS
Asked by: PARBHUBHAI NAGARBHAI VASAVA, Richard Hay

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

LOK SABHA UNSTARRED QUESTION No. 577 TO BE ANSWERED ON THE 6 th  February, 2018

## Import of Raw Material

†577. SHRI PARBHUBHAI NAGARBHAI VASAVA: PROF. RICHARD HAY:

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

- (a) the details of the percentage of raw material imported for allopathic medicines in the country, country-wise;
- (b)  the  details  of  the  amount  incurred  for  import  during  the  last  three  years  and  the current year along with the steps taken by the Government to minimize the import;
- (c) whether any pharmaceutical company/companies have been found to be supplying poor quality raw material to drug manufacturers in the country; and
- (d)  if  so,  the  details  thereof,  company  and  country-wise  and  the  action  taken/  being taken by the Government in this regard?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY  OF  SHIPPING  AND  MINISTRY  OF  CHEMICALS  AND  FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (a):  As  per  the  available  data  received  from  the  various  port  offices  of  Central  Drugs Standard Control Organization, hundreds of raw materials for manufacturing allopathic medicines have been imported from various countries. The percentage of import of raw materials from major countries for allopathic medicines is at Annexure 'A'.
- (b):  As  per  the  available  data  received  from  various  port  offices  of  Central  Drugs Standard Control Organization, details of value of raw materials imported from various countries during last three years and current year is as follows:

| Year                   |   Value (in Cr.) |
|------------------------|------------------|
| 2018 (till 28.01.2018) |              574 |
| 2017                   |             5097 |
| 2016                   |             6495 |
| 2015                   |             6477 |

The policies formulated by the government from time to time are made so that the country's dependence on imports are minimised. In this direction, the Government had on 29.01.2016 notified the withdrawal of exemption in customs duties which were earlier  given  to  certain  categories  of  drugs  and  bulk  drugs  to  provide  a  boost  to  the domestic manufacturers. Further, the government has removed bottlenecks in environment  clearance  etc.  which  the  manufacturers  were  facing,  in  order  to  give  a boost to domestic manufacturing of bulk drugs.

(c) & (d): The drugs imported from some of the companies in China were found 'Not of Standard Quality'.  The details of these companies and action taken by the Government is placed at Annexure-B. Further, The Central Drugs Standard Control Organization has directed  Customs  Collector  to  take  necessary  action  as  per  Rule  41(1)  of  Drugs  and Cosmetics Rules, 1945.

| The Details of the percentage of raw material imported country-wise in 2015   | The Details of the percentage of raw material imported country-wise in 2015   | The Details of the percentage of raw material imported country-wise in 2015   |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| S. No.                                                                        | Country Name                                                                  | Percentage (in terms of Value)                                                |
| 1                                                                             | CHINA                                                                         | 66.14                                                                         |
| 2                                                                             | ITALY                                                                         | 4.79                                                                          |
| 3                                                                             | SINGAPORE                                                                     | 4.05                                                                          |
| 4                                                                             | FINLAND                                                                       | 3.81                                                                          |
| 5                                                                             | DENMARK                                                                       | 3.33                                                                          |
| 6                                                                             | SWITZERLAND                                                                   | 2.43                                                                          |
| 7                                                                             | GERMANY                                                                       | 2.08                                                                          |
| 8                                                                             | SPAIN                                                                         | 1.87                                                                          |
| 9                                                                             | USA                                                                           | 1.82                                                                          |
| 10                                                                            | KOREA                                                                         | 1.49                                                                          |
| 11                                                                            | Others                                                                        | 8.19                                                                          |

| The Details of the percentage of raw material imported country-wise in 2016   | The Details of the percentage of raw material imported country-wise in 2016   | The Details of the percentage of raw material imported country-wise in 2016   |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| S. No.                                                                        | Country Name                                                                  | Percentage (in terms of Value)                                                |
| 1                                                                             | CHINA                                                                         | 56.62                                                                         |
| 2                                                                             | DENMARK                                                                       | 5.81                                                                          |
| 3                                                                             | ITALY                                                                         | 5.08                                                                          |
| 4                                                                             | FRANCE                                                                        | 3.95                                                                          |
| 5                                                                             | USA                                                                           | 3.75                                                                          |
| 6                                                                             | GERMANY                                                                       | 3.56                                                                          |
| 7                                                                             | SPAIN                                                                         | 2.28                                                                          |
| 8                                                                             | UNITED KINGDOM                                                                | 1.84                                                                          |
| 9                                                                             | KOREA                                                                         | 1.83                                                                          |
| 10                                                                            | NETHERLAND                                                                    | 1.77                                                                          |
| 11                                                                            | Others                                                                        | 13.53                                                                         |

| The Details of the percentage of raw material imported country-wise in 2017   | The Details of the percentage of raw material imported country-wise in 2017   | The Details of the percentage of raw material imported country-wise in 2017   |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| S. No.                                                                        | Country Name                                                                  | Percentage (in terms of Value)                                                |
| 1                                                                             | CHINA                                                                         | 68.62                                                                         |
| 2                                                                             | GERMANY                                                                       | 4.61                                                                          |
| 3                                                                             | USA                                                                           | 3.03                                                                          |
| 4                                                                             | KOREA                                                                         | 2.48                                                                          |
| 5                                                                             | NETHERLAND                                                                    | 2.23                                                                          |
| 6                                                                             | DENMARK                                                                       | 2.20                                                                          |
| 7                                                                             | MEXICO                                                                        | 2.05                                                                          |
| 8                                                                             | SPAIN                                                                         | 2.01                                                                          |
| 9                                                                             | UNITED KINGDOM                                                                | 1.55                                                                          |
| 10                                                                            | HUNGARY                                                                       | 1.50                                                                          |
| 11                                                                            | Others                                                                        | 9.73                                                                          |

| Year           | Details of drug                                          | Name of manufacturer and Country name                    | Action Taken                                                                                                              |
|----------------|----------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 2015           | Bacitracin                                               | M/s. North China Pharmaceutical Huashong Co. Ltd., China | CDSCO has communicated to Customs Collector to take necessary action as per Rule 41(1) of Drugs and Cosmetics Rules, 1945 |
| 2015           | Gelatin (Capsule Grade)                                  | Xiamen Gelkem, China                                     | CDSCO has communicated to Customs Collector to take necessary action as per Rule 41(1) of Drugs and Cosmetics Rules, 1945 |
| 2015           | Oxytetracycline Hydrochloride                            | M/S. Dafeng Tainsheng Pharmaceutical Co. Ltd., China.    | CDSCO has communicated to Customs Collector to take necessary action as per Rule 41(1) of Drugs and Cosmetics Rules, 1945 |
| 2016           | 4-amino benzoyl-l- glutamic acid                         | M/s Hanzhou Think Chemical Co. Ltd, China                | CDSCO has communicated to Customs Collector to take necessary action as per Rule 41(1) of Drugs and Cosmetics Rules, 1945 |
| 2016           | Enoxparin Sodium                                         | Shenzehnen Technology Co. Ltd.,China                     | Re sample sent To CDL, Kolkata                                                                                            |
| 2017           | 11-Beta, 17 Alpha, 21- Trihydroxypregn-4-Ene- 3,20-Dione | M/S Zhejiang Pure Pharmaceuticals Co Ltd., China.        | CDSCO has communicated to Customs Collector to take necessary action as per Rule 41(1) of Drugs and Cosmetics Rules, 1945 |
| 2018 till date | Metamizole Sodium Monohydrate EP/BP                      | Zhejiang Haisen Pharmaceutical Co Ltd, China             | Under Process (Importer requested for Re-export of the Consignments)                                                      |

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