Lok Sabha Question No. 2309 (UNSTARRED), answered on 2019-12-03
Subject: Active Pharmaceutical  Ingredients
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Devusinh Jesingbhai Chauhan

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

LOK SABHA UNSTARRED QUESTION No.2309 TO BE ANSWERED ON THE 3 rd  December, 2019

## Active Pharmaceutical Ingredients

## 2309. SHRI DEVUSINH JESINGHBHAI CHAUHAN:

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

- (a) whether it is a fact that India is very much dependent on China and European Union for Active Pharmaceutical Ingredients (APIs) and if so, the details thereof;
- (b) whether any meeting has been held recently with the officers of Ministry of Health, Commerce and Industry, Chemicals and Fertilizers to  draw  a  comprehensive  plan  to produce APIs in the country;
- (c) if so, the details thereof;
- (d) whether it is true that India does not have the latest sophisticated infrastructure and funds to ensure adequate quality control;
- (e)  whether  it  is  true  that  pricing  is  a  big  issue  for  manufacturing  APIs  in  India,  as Chinese APIs are low-priced;
- (f) if so, the details thereof; and
- (g) the steps being taken by the Government to manufacture APIs in the country and maintain the pricing at Chinese API level?

## ANSWER

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

(a): Many bulk drugs are imported from China and European Union, for manufacturing of medicine. As per available data from the various Port Offices of CDSCO, the details of the percentage of bulk drugs imported from China and European Union are as under:

|      | Percentage (in terms of value)   | Percentage (in terms of value)   |
|------|----------------------------------|----------------------------------|
| Year | API Import from China            | API Import from European Union   |
| 2016 | 56.62%                           | 16.78%                           |
| 2017 | 68.62%                           | 15.91%                           |
| 2018 | 66.53%                           | 11.76%                           |

(b)&(c): An Inter-Ministerial Task Force has been constituted under the Chairmanship of the  Hon'ble  Minister  of  State  (Chemicals  &  Fertilizers)  on  18.04.2018  to  formulate  a roadmap for the enhanced production of Active Pharmaceutical Ingredients (APIs) in the country.  The Task Force also includes the members from Ministry of Health & Family Welfare, Ministry of Commerce and Industry and members from Ministry of Chemicals and Fertilizers. Last meeting of the Task Force was held on 19.06.2019

(d): No,  Sir. The  fact is  India  pharma  industry  has  been  granted  the  highest accreditations  from  United  States  Food  and  Drug  Administration  (USFDA),  United Kingdom's Medicines and Healthcare products Regulatory Agency (UKMHRA), Therapeutic Goods  Administration (TGA), Pharmaceuticals  and Medical Devices Agency  (PMDA),  European  Medicines  Agency  (EMEA)  which  are  considered  as  the stringent  regulatory  authorities  globally.  As  regard  to  adequate  quality  control  of imported  drugs, it may  be  mentioned  that  for  import of any  drug  the foreign manufacturing site and the drug are required to be registered as well as import license is required to be obtained from Central Drugs Standard Control Organization (CDSCO) under the provisions of the Drugs and Cosmetics Act, 1940 and rules made there under. As per the requirements no drug shall be imported unless it complies with the standard of strength, quality and purity and the test prescribed under the provision of the Drugs and Cosmetics Act, 1940 and rules made there under. The port offices of CDSCO verify the  consignments  at  the  port  and  draw  samples  for  testing  of  drugs  from  imported consignments as per the defined criteria.

(e) & (f): The feedback from the Industry is that the cost involved in manufacturing the APIs in China and India are more or less the same these days and China could do it low-priced mainly due to its large volumes of production.

(g): With the objective to ensure drug security in the country by increasing availability and  affordability of the  bulk  drugs  in  the  domestic  market,  the  Department  of Pharmaceuticals has prepared a scheme namely 'Assistance to Bulk Drug Industry for Common Facility Centre'. Under this scheme, financial assistance would be provided for creation  of  common  facilities  in  any  upcoming  Bulk  Drug  Park  promoted  by  State Governments/State  Corporations.  Further,  Department  of  Commerce  has  convened series  of  meetings  with  stakeholders,  Pharma  Associations  and  Research  Institutions for  evolving  strategy  for  indigenous  development  of  manufacturing  of  APIs,  KSM  and Drug Intermediates. Department of Commerce has commissioned a study in this regard on 'Strategies to reduce import dependence of APIs, KSMs and Intermediates aimed at developing the Detailed Project Report (DPR)'. Also, the Ministry of Health and Family Welfare has  taken  various  measures  to  streamline  indigenous  manufacture  of  drugs. Details are as under:-

-  G.S.R.  1337  (E), Dated  27  October,  2017:  Drug  manufacturing  license,  sale license  and  approval  of  drug  testing  laboratory  shall  remain  valid,  if  licensee deposits  a  license  retention  fee  as  prescribed,  before  the  expiry  of  a  period  of every succeeding five years from the date of its issue, unless it is suspended or cancelled by the licensing authority. Also, it is mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by  the  Drugs  Inspectors  of  Central  Government  and  State  Government.  The licensed manufacturing premises shall be inspected jointly by the Drugs Inspectors of Central Government and State Government to verify the compliance with the conditions of license and the provisions of the Drugs & Cosmetics Act and Rules for not less than once in three years or as needed as per risk based approach.
-  The Ministry of Health and Family Welfare, Government of India has amended the  Drugs  and  Cosmetics  Rules,  1945  vide  Notification  No.  G.S.R.  1193  (E) dated  12/12/2018  wherein  application  fees  have  been  increased  for  grant  of various Import Registration certificate as well as Overseas Inspection.