Lok Sabha Question No. 4510 (UNSTARRED), answered on 2019-01-08
Subject: Bulk Drug Manufacturers
Ministry: CHEMICALS AND FERTILIZERS
Asked by: PRITAM GOPINATH MUNDE, Shrirang Appa Barne, SHIVAJI ADHALRAO PATIL, ANANDRAO  ADSUL

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

LOK SABHA UNSTARRED QUESTION No. 4510 TO BE ANSWERED ON THE 8 th  January, 2019

## Bulk Drug Manufacturers

4510. DR. PRITAM GOPINATH MUNDE:

SHRI SHRIRANG APPA BARNE:

SHRI ADHALRAO PATIL SHIVAJIRAO:

SHRI ANANDRAO ADSUL:

## Will the Minister of CHEMICALS AND FERTILIZERS

- (a) whether India is the world's leading bulk drug manufacturer till about 10 years back and if so, the facts in this regard;
- (b)  whether  presently  a  very  large  percentage  of  bulk  drug  requirement  are  sourced from China;
- (c)  if  so,  the  details  thereof  and  the  percentage  of  drugs  out  of  the  total  requirement imported from China during the last three year, year-wise;
- (d)  whether  the  experts  have  expressed  their  concerns  over  the  security  risk  and financial stress of the manufacturers of the country;
- (e) if so, the details thereof and the action taken by the Government thereon;
- (f)  whether the Government proposes to revive the drugs sector and introduce a bulk drug policy in the country; and
- (g) if so, the details and the present status thereof along with 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.    The  country  is  dependent  on  imports  of  bulk  drugs/Active Pharmaceutical Ingredients (APIs) from China for producing certain essential medicines.
- (b) & (c): As per data available from the various Port Offices of Central Drugs Standard Control  Organization  (CDSCO),  the  details  of  the  percentage  of  bulk  drugs  imported from China are as under:
- (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. Based on the recommendations of the Committee 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 Department has prepared a scheme for providing Assistance to Bulk Drug Industry for Common Facilities. No separate bulk drug policy is proposed.

|   Year | Percentage (in terms of value)   |
|--------|----------------------------------|
|   2015 | 66.14%                           |
|   2016 | 56.62%                           |
|   2017 | 68.62%                           |

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