Lok Sabha Question No. 1142 (UNSTARRED), answered on 2023-12-08
Subject: Import of Bulk Drugs or APIs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Goddeti Madhavi, Margani Bharat, Reddeppa Nallakonda Gari, Pocha Brahmananda Reddy

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS

## DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO. 1142 TO BE ANSWERED ON THE 8 TH  DECEMBER 2023

## Import of Bulk Drugs or APIs

## 1142.   SHRIMATI GODDETI MADHAVI:

SHRI MARGANI BHARAT:

SHRI N. REDDEPPA:

SHRI POCHA BRAHMANANDA REDDY:

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

- (a) whether the Government has taken/proposes to take steps to tackle India's reliance on China for APIs and other pharma products in view of the recent Ministry data showing the import of bulk drugs or APIs and drug intermediates (materials produced during API synthesis) from China  which  has  increased  from  20  per  cent  from  FY  21  to  Rs.  23,273  crore  in  FY  22 constituting 66 per cent of India's total imports of medical products worth Rs. 35,249 crore in that fiscal;
- (b) if so, the details thereof;
- (c) whether the Government is aware that Andhra Pradesh, a hub for drug manufacturing, also produces innovator and biosimilar drugs for the US and EU with over 26 drugs for these foreign markets having their APIs manufactured in the State;
- (d) if so, the details thereof;
- (e) whether the Union Government has any plan on extending financial assistance to the State of Andhra  Pradesh  to  further  manufacture  these  APIs, to increase India's  domestic manufacturing; and
- (f) if so, the details thereof?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI BHAGWANTH KHUBA)

(a) & (b) Yes, Sir. Country imports various Bulk Drugs/ APIs for producing medicines from various countries including China. Most of the imports of the Bulk Drug/APIs being done in the  country  are  because  of  economic  considerations  and  also,  China  is  one  of  the  largest producers of KSMs and APIs in the world.  The quantity and the value of Bulk Drug and Drug Intermediates imported from other countries including China during the last two years is as under: -

|         | Imports from all countries   | Imports from all countries   | Imports from China   | Imports from China   |
|---------|------------------------------|------------------------------|----------------------|----------------------|
| Year    | Quantity (MT)                | Value (In Rs Cr)             | Quantity (MT)        | Value (In Rs Cr)     |
| 2021-22 | 400642                       | 35,249                       | 264582               | 23,273               |
| 2022-23 | 402111                       | 36,229                       | 300120               | 25,551               |

However, it is also needs to be mentioned that Indian has exported Bulk Drug and Drug Intermediates worth Rs 37,853 Cr. in FY 2022-23.

(I)        The Government strives to minimize country's dependence on imports and to give fillip to  indigenous  manufacturing.  In  order  to  make  the  country  self-reliant  in  APIs  and  drug intermediates,  the  Department  of  Pharmaceuticals  is  implementing  the  following  three schemes:

(i)   Under the Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) in India, with a financial outlay of Rs. 6,940 crores  and  the  tenure  from  FY  2020-2021  to  FY  2029-30,  under  which  financial incentive is given for manufacturing of 41 identified products. A total of 48 applications have  been  selected  under  the  scheme.  Out  of  these,  27  projects  have  already  been commissioned with the installed capacity of 41,881 MT.

(ii)    Production Linked Incentive Scheme for Pharmaceuticals, with a financial outlay Rs. 15,000 crores and the tenure from FY 2020- 2021 to FY 2028-29, provides for financial incentive to 55 selected applicants for manufacturing of identified products under three categories for a period of six years. The eligible products under the scheme cover APIs/KSMs/Dis, except for the 41 eligible products already covered under the 'Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of  critical  Key  Starting  Materials  (KSMs)  /  Drug  Intermediates  (DIs)  /  Active Pharmaceutical Ingredients (APIs) in India'.

(iii)   The Scheme for Promotion of Bulk Drug Parks, with a financial outlay of Rs. 3,000 crores and the tenure from FY 2020-2021 to FY 2024-25, provides for financial assistance  to  three  States  for  establishing  Bulk  Drug  Parks.  The  Department  had received proposals from 13 States. After evaluation of the proposals as per prescribed criteria, the approval was accorded to the proposal of setting up Bulk Drug Parks in the states of Andhra Pradesh, Gujarat and Himachal Pradesh.

(II) So far as regulatory measures are concerned, as informed by the Ministry of Health and Family Welfare and CDSCO, the following steps have been taken to encourage indigenous manufacturing of drugs: The Drugs Rules,1945 was amended vide G.S.R. 1337 (E), Dated 27 October, 2017 providing that drugs 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. The Drugs Rules, 1945 were amended vide  Notification  No.  G.S.R.  1193  (E)  dated  12.12.2018  wherein  application  fees  were increased for grant of import Registration Certificate as well as fees for Overseas inspection.

(c)  &  (d):  As  per  the  information  provided  by  CDSCO  under  the  M/o  Health  and  Family Welfare,  there  is  no  unit  in  Andhra  Pradesh  manufacturing  and  marketing  innovator  and biosimilar drugs.

(e)  &  (f):  Under  the  Scheme  for  Promotion  of  Bulk  Drug  Parks,  Rs.  1000  Cr  have  been sanctioned for Government of Andhra Pradesh, out of which first instalment of Rs. 225 Cr has been released.