Lok Sabha Question No. 5871 (UNSTARRED), answered on 2018-04-03
Subject: Bulk Drug
Ministry: CHEMICALS AND FERTILIZERS
Asked by: ANANDRAO  ADSUL, SHRIKANT EKNATH SHINDE, PRITAM GOPINATH MUNDE, Shrirang Appa Barne, DHARMENDRA YADAV

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

LOK SABHA UNSTARRED QUESTION No. 5871 TO BE ANSWERED ON THE 3 rd  April, 2018

## Bulk Drug

5871.

SHRI ANANDRAO ADSUL:

DR. SHRIKANT EKNATH SHINDE:

DR. PRITAM GOPINATH MUNDE:

SHRI SHRIRANG APPA BARNE:

SHRI DHARMENDRA YADAV:

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

- (a)  whether  India  was  the  world's  leading  bulk  drug  manufacturer  till  about  10  years back and if so, the details thereof;
- (b) whether overwhelming dependence on drug imports and related raw materials from China could prove harmful for the health sector in India in the long run;
- (c) if so, the facts thereof and the percentage of the total requirement of drugs imported from China during the last three years, year-wise;
- (d)  whether  the  experts  have  expressed  concern  over  the  security  risk  and  financial stress  of  the  drug  manufacturers  of  the  country,  if  so,  the  details  thereof  and  the reaction of the Government thereto;
- (e)  whether the Government proposes to revive the drug sector and introduce a bulk drug policy in the country;
- (f) if so, the details and status thereof; and
- (g) the time by which a final decision is likely to be taken 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):  India  has  been  importing  Bulk  Drugs/Active  Pharmaceutical  Ingredients  (APIs) which  are  required  for  the  manufacture  of  certain  drugs  including  some  essential medicines in the country.
- (b)  &(c):  This  occasion  may  not  arise  as  most  of  the  imports  are  done  on  economic considerations and there are other substitute suppliers for these APIs.

The details of India's imports of Active Pharmaceutical Ingredients is as under:

| Years   |   Total import (Rs. cr) |   Imports from China (Rs. cr) |
|---------|-------------------------|-------------------------------|
| 2014-15 |                 19833.2 |                         12758 |
| 2015-16 |                 21226   |                         13853 |
| 2016-17 |                 18372.5 |                         12255 |

(Source: DGCIS Kolkata)

As  per  the  data  of  Directorate  General  of  Commercial  Intelligence  and  Statistics, (DGCIS) Kolkata, during the year 2016-17, the share of China in the total bulk drugs imported into the country was approximately 66 per cent. (d) to (g): The Government, taking into account the drug security of the country, had set up a high level Committee on 8 th October, 2013 headed by Dr. V. M. Katoch, the then Secretary, Department of Health Research, which had the mandate to carefully study the  whole  issue  of  APIs  of  critical  importance  by  identifying  important  APIs  and  then working out a package  of interventions/concessions required to build domestic production  capabilities  and  examine  the  cost  implications.  The  Committee  has  since submitted its recommendations. The recommendations were examined and it has been decided to finance common facilities in bulk drug parks which would reduce the cost of production and in turn it would reduce the cost of medicines which would be available to the patients. In this connection, the Standing Finance Committee (SFC) of Department of  Pharmaceuticals  had  in  its  meeting  held  on  07.02.2018  approved  the  Scheme  for Development of Pharmaceutical Industry which has 'Assistance to Bulk Drug Industry for Common Facility Centre' as one of its components. No separate bulk drug policy is proposed.

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