Lok Sabha Question No. 3680 (UNSTARRED), answered on 2019-12-10
Subject: Bulk Drug Manufacturer
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Chandra Sekhar Sahu, Chirag Paswan, Pritam Gopinath Munde

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

LOK SABHA UNSTARRED QUESTION No.3680 TO BE ANSWERED ON THE 10 th  December, 2019

## Bulk Drug Manufacturer

## 3680.  SHRI CHANDRA SEKHAR SAHU: SHRI CHIRAG KUMAR PASWAN: DR. PRITAM GOPINATHRAO MUNDE:

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  presently  a  very  large  percentage  of bulk  drug  requirements 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 years, year-wise;
- (d) whether the experts has 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  drug  sector  and  introduce  a  bulk drug policy in the country;
- (g) if so, the details thereof along with the proposals for setting up of Bulk Drug Units across the country including Jamui in Bihar; and
- (h) the time by which a final decision is likely to be taken in this regard along with the present status thereof?

## ANSWER

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

(a)  to  (c): India  has  been  importing  Bulk  Drugs/Active  Pharmaceutical  Ingredients (APIs) which are required for the manufacture of certain drugs in the country. Many bulk drugs are imported from China, for manufacturing of medicine. As per available data 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.

|   Year | Percentage (in terms of value)   |
|--------|----------------------------------|
|   2016 | 56.62%                           |
|   2017 | 68.62%                           |
|   2018 | 66.53%                           |

(d) to (h): 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  was 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. Department of Pharmaceuticals approved the 'Scheme for Development of Pharmaceutical Industry' in May 2018 which has 'Assistance to Bulk Drug Industry for Common Facility Centre' as one of its sub-schemes. No separate bulk drug policy is proposed.

Under  the  scheme  'Assistance  to  Bulk  Drug  Industry  for  Common  Facility  Centre', financial assistance would be provided for creation of common facilities in any upcoming Bulk  Drug  Park  promoted  by  State  Governments/State  Corporations.  The  Scheme would  be  implemented  through  a  one-time  grant-in-aid  to  be  released  to  a  State Implementing  Agency  (SIA)  set  up  for  the  purpose.  Some  of  the  indicative  activities under the Common facilities include Effluent Treatment Plants, Captive Power Plants, Steam and Cooling systems, Incubation facilities, Common logistic facilities, Advance common  testing  Centre,  Regulatory  awareness  facilitation  Centre  and  Emergency Response Centre. The maximum limit for the grant-in-aid under this category would be Rs. 100 Crore per Bulk Drug Park CFC or 70% of the project cost of CFC whichever is less. So far, the following proposals have been received under this scheme:

- a)    Andhra  Pradesh  Economic  Cities  Promotional  Corporation  Limited,  Andhra Pradesh for financial assistance to common facilities an Integrated Pharma Cluster to cater the needs of especially MSME segment at Orvakal of Kurnool District of Andhra Pradesh in 1000 acres.
- b)   AIDC  Ltd.,  Assam for  creation  of  Common  Facilities  at  proposed  bulk  drug  park in Sipajhar, Darrang district nearby Guwahati. The project will be implemented by the AIDC Ltd., a Government of Assam Undertaking Organization
- c)    Telangana State industrial Infrastructure Corporation Ltd. (TSIIC), Telangana for  development  of  Zero  Liquid  Discharge  (ZLD)  based  common effluent treatment plant in Hyderabad Pharma City.
- d)   Himachal  Pradesh  State  Industrial  Development  Corporation  Limited,  Solan,
5. Himachal Pradesh for setting up of Bulk Drug/API park in Baddi/Nalagarh, area. In-principle approval has been accorded to all the four proposals.

No proposal has been received from Jamui in Bihar.

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