Lok Sabha Question No. 4732 (UNSTARRED), answered on 2025-03-28
Subject: Scheme for Strengthening of Pharmaceutical Industry
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Malaiyarasan D

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

LOK SABHA UNSTARRED QUESTION No. 4732 TO BE ANSWERED ON  28 th  MARCH 2025

Scheme for Strengthening of Pharmaceutical Industry

## 4732. Shri Malaiyarasan D:

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

(a)  the  details  of  the  'Strengthening  of  Pharmaceutical  Industry'  Scheme  launched  by  the Government, including its objectives and key components;

(b) the funds allocated for the implementation of this scheme across the country and the amount disbursed so far to various pharmaceutical companies and institutions;

(c) the steps being taken to enhance the capacity of the pharmaceutical sector to meet domestic and global demand for medicines, including the promotion of generic drugs and affordable medicines;

- (d) the impact of this scheme on the growth of the pharmaceutical industry in the country and on the availability of quality medicines to the common people; and
- (e) the measures taken to encourage innovation, research and development and manufacturing of high-tech medicines, including vaccines and biologics, under the scheme?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY  OF  CHEMICALS  AND FERTILIZERS

(SMT. ANUPRIYA PATEL)

- (a): Details of the components of the Strengthening of Pharmaceutical Industry scheme, along with their objectives, are as follows:
- (i) Assistance  to  Pharmaceutical  Industry  for  Common  Facilities  (APICF): To strengthen the existing infrastructure facilities by providing financial assistance to pharmaceutical clusters for creation of common facilities;
- (ii) Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS): To support the upgrade of production facilities of small and medium pharmaceutical  companies  having  average  turnover  of  less  than  ₹  500  crore,  to attain the standards specified in the revised Schedule M to the Drugs Rules, 1945 and the World Health Organization - Good Manufacturing Practices (WHO-GMP); and
- (iii) Pharmaceutical  and  Medical  Devices  Promotion  and  Development  Scheme (PMPDS): To promote knowledge and awareness in and about the pharmaceutical industry  by  taking  up  studies,  building  databases  and  sponsoring  events  for knowledge and experience sharing within the pharmaceutical industry.

(b):  Details  of  the  fund  allocated  for  the  scheme  and  the  amount  disbursed  till  date  are  at Annexure.

(c)  to  (e):  Details  of  major  steps  and  measures  taken  to  enhance  the  capacity  of  the pharmaceutical sector to meet domestic and global demand for medicines, including promotion of  generic  drugs  and  affordable  medicines,  and  to  encourage  innovation,  research  and development  and  manufacturing  of  high-tech  medicines,  along  with  their  impact,  are  as follows:

- (i) The Strengthening of Pharmaceutical Industry scheme has been launched.  Under the scheme, seven projects have been approved for creation of common facilities with total  grant-in-aid  to  the  tune  of  ₹  121.47 crore  to  pharmaceutical  clusters, against  which  an  amount  of  ₹  94.91  crore  has  been  disbursed  till  25.3.2025. Further,  support  for  upgrade  to  attain  the  standards  specified  in  the  revised Schedule M to the Drugs Rules, 1945 and WHO-GMP has been approved for 103 small and medium pharmaceutical companies, with total sanctioned amount of ₹ 105.01 crore till 25.03.2025.
- (ii) The Production Link Incentive (PLI) scheme  for promotion of domestic manufacturing  of  critical  Key  Starting  Materials  (KSMs)  /  Drug  Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) in India ('PLI scheme for bulk drugs') has been launched. Under the scheme, 34 projects have been commissioned for 25 bulk drugs, including penicillin G, clavulanic acid, prednisolone, olmesartan,  sulfadiazine,  atorvastatin,  carbamazepine  etc.  Against  committed investment of ₹3,938.57 crore, investment worth ₹4,253.92 crore has been realised under the scheme. As of December 2024, applicants under the scheme have made cumulative sales worth ₹1,556.04 crore, including exports worth ₹412.42 crore.
- (iii) The  PLI  Scheme  for  Pharmaceuticals  has  been  launched  for  production  of formulations and bulk drugs other than those notified under the PLI scheme for bulk  drugs.  Under  the  scheme,  financial  incentive  is  provided  to  55  selected applicants for manufacturing identified products under three product categories. As of December 2024, cumulative sales worth ₹ 2,34,569.27 crore have been made under the scheme, including exports worth ₹ 1,49,420 crore.
- (iv) The Scheme for Promotion of Bulk Drug Parks has been launched for creation of common infrastructure facilities for production of bulk drugs at optimised cost. Under the scheme, three bulk drug parks have been approved for development, one each  in  Bharuch  (Gujarat),  Nakkapalli  (Andhra  Pradesh)  and  Una  (Himachal Pradesh) districts. Government of India has approved financial assistance to the tune of ₹1,000 crore for each of the said parks. The parks are at different stages of development.
- (v) Pradhan Mantri Bharatiya Jan Aushadi Pariyojana scheme has been launched for making quality  generic  medicines  widely  available.  Under  this,  quality  generic medicines  are  made  available  through  a  network  of  over  15,000  Jan  Aushadhi Kendras at maximum retail prices (MRPs) that are about 50% to 80% lower than MRPs of leading branded medicines in the market. In the last 10 years, medicines worth  ₹6,975  crore  in  MRP  terms  have  been  sold  through  JAKs,  resulting  in estimated savings of about ₹30,000 crore to citizens in comparison to the prices of branded medicines.
- (vi) The Promotion of Research and Innovation in Pharma and MedTech sector scheme has been launched with an outlay of ₹5,000 crore over a period of five years ending with the financial year 2027-28, to promote and incentivise research and innovation in  six  identified  areas,  which  include  development  of  new  drugs,  precision medicine,  complex  generics,  biosimilars,  anti-microbial  resistance  drugs,  etc. Centres of Excellence have been set up in NIPERs under the Scheme for Promotion of Research and Innovation in Pharma MedTech Sector to promote research and innovation in identified core areas of pharmaceutical research.  Further, the PLI Scheme  for Pharmaceuticals also incentivises investment in research and development and manufacturing and sales of high-tech medicines.

Annexure referred to in the reply to part (b) of the Lok Sabha Unstarred Q. No. 4732 for answer on 28.3.2025, raised by Shri Malaiyarasan D, regarding Scheme for Strengthening of Pharmaceutical Industry

## Details of the fund allocated for the scheme and the amount disbursed till date

| S. No.   | Sub-schemes                                                         |   Fund allocated (in crore ₹) | Amount disbursed (in crore ₹)   |
|----------|---------------------------------------------------------------------|-------------------------------|---------------------------------|
| 1        | Assistance to Pharmaceutical Industry for Common Facilities         |                         178.4 | 94.91                           |
| 2        | Revamped Pharmaceutical Technology Upgradation Assistance Scheme    |                         300.1 | -                               |
| 3        | Pharmaceutical and Medical Devices Promotion and Development Scheme |                          21.5 | 6.78                            |
| Total    | Total                                                               |                         500   | 101.69                          |

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