Lok Sabha Question No. 1892 (UNSTARRED), answered on 2024-12-06
Subject: Upgradation of Pharmaceutical Industry
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Navaskani K, Shri Selvam G, Shri C N Annadurai

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

LOK SABHA UNSTARRED QUESTION No. 1892 TO BE ANSWERED ON THE 06 th  DECEMBER, 2024

## Upgradation of Pharmaceutical Industry

1892.   Shri C N Annadurai:

Shri Navaskani K:

Shri Selvam G:

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

- (a) the primary objectives and implementation status of the Strengthening of Pharmaceutical Industry (SPI) scheme across the country;
- (b) the details of pharmaceutical companies, particularly MSMEs, that have benefited from the SPI scheme indicating the criteria for selecting beneficiaries;
- (c) whether the SPI scheme include provisions for upgrading pharmaceutical infrastructure, such as common facilities, if so, the details thereof;
- (d) whether a large number of pharmaceutical parks or clusters have been supported under the SPI scheme, if so, the details thereof;
- (e) the steps being taken under the SPI scheme to support the upgradation of technology in pharmaceutical units; and
- (f) the mechanisms that are in place to monitor the progress of the SPI scheme?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SMT. ANUPRIYA PATEL)

(a): The SPI scheme is a Central Sector Scheme (CSS) with an outlay of Rs.500 Cr with the scheme period from FY 2021-22 to FY 2025-26.

## Objectives of the SPI scheme are as follows:

- I. To strengthen the existing infrastructure facilities in order to make India a global leader  in  Pharma  Sector  by  providing  financial  assistance  to  pharma  clusters  for creation  of  Common Facilities to improve the quality and ensure the sustainable growth of cluster;
- II. To upgrade the production facilities of Pharma units to meet up to date regulatory standards, by providing subsidy on reimbursement basis, which will enable them to obtain revised Schedule M and WHO\_GMP certifications.
- III. To promote knowledge and awareness in and about the Pharmaceutical and Medical Devices  Industry  by  taking  up  studies,  building  databases  and  bringing  industry leaders,  academia  and  policy  makers  together  to  share  their  knowledge  and experience for overall development of Pharma and Medical Devices industry.

## The Scheme has 3 components / sub-schemes:

- I. Assistance to Pharmaceutical Industry for Common Facilities (APICF)
- II. Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS)
- III. Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS)

The implementation status of the three sub-schemes is as under :

- I.  Assistance to Pharmaceutical Industry for Common Facilities (APICF) :
- a) Outlay: Rs.178.40 Crore (out of which Rs. 20.15 Crore has already been utilised under old APICF)
- b) No. of projects which have been sanctioned assistance: 7
- c) Amount Sanctioned: Rs.121.46 Crore
- d) Amount Disbursed: Rs.62.47 Crore
- II.  Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS):
- a) Outlay: Rs.300.10 Crore
- b) No. of projects which have been sanctioned assistance: 62
- c) Amount Sanctioned: Rs. 59.55 Crore
- d) Amount Disbursed: Nil
- III. Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS):
- a) Outlay: Rs.21.50 Crore
- b) No. of studies which have been sanctioned assistance: 11
- c) Amount Sanctioned: Rs.1.16 Crore
- d) Amount Disbursed: Rs.0.88 Crore
- e) No. of reports finalised: 5
17. (b): The names of the beneficiaries which have been sanctioned assistance under RPTUAS scheme are given in the Annexure .

Criteria for selecting the beneficiaries are as under:

- i. Existing pharma units which require to upgrade to Revised Schedule M and WHOGMP standards.
- ii. Existing Pharmaceutical manufacturing units having average annual turnover of less than Rs. 500 crore over the last 3 years.
3. (c):  Under  the  sub-scheme  APICF,  the  support  is  provided  to  strengthen  the  existing pharmaceutical  clusters'  capacity  for  their  sustained  growth  by  creating  tangible  assets  as 'Common Facilities'.

Incentive under the scheme: The limit of incentive will be 70% of the approved project cost or Rs 20 cr., whichever is less, as per approval of SSC. In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 20 Crore per Cluster or 90% of the project cost of the Common Infrastructure Facilities (CIF), whichever is less.

The illustrative list of eligible activities under this sub-scheme in order of priority is as under:

- i Research and Development Labs
- ii Testing Laboratory for Pharma Products
- iii Effluent Treatment Plants
- iv Logistic Centers
- v Training Centers

Under  RPTUAS  sub-scheme,  the  support  is  provided  to  existing  Pharma  units  to upgrade the technological capabilities to Revised Schedule M/ WHO-GMP standards.

Incentive under the scheme : The rate of incentive under the scheme ranges from 10% to 20% (depending on the annual turnover of the Pharma unit) of the expenditure incurred on eligible activities subject to a maximum of Rs. 2 crores.

Expenditure incurred on below items would be considered for subsidy:

- a. Utilities (HV AC, Water, Steam)
- b. Clean Room Facility
- c. Testing Lab, Stability Chamber
- d. Effluent treatment/Waste Management
- e. Consultation/Certification Expenses
- f.  Production Equipment
- g. Any other item with the recommendation of the Technical Committee
8. (d): Under API-CF sub scheme of SPI scheme, 07 projects have been approved from F.Y. 202223 to till date with the total Grant-in-aid of Rs. 121.46 crores out of which Grant-in-aid of Rs. 62.47 crores has already been released under the scheme.
9. (e): The Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS) sub-scheme of Strengthening of Pharmaceutical Industry (SPI) encourages units to upgrade the production  facilities  of  existing  Pharma  & API  manufacturing  units  having  average  sales turnover up to Rs. 500 Crore so as to meet national and international regulatory standards.

The objective of the scheme is to facilitate existing pharma units to upgrade to Revised Schedule M and WHO-GMP standards.

Under RPTUAS, support for existing pharma units is proposed in the form of incentive ranging from 10% to 20% subject to a maximum of Rs. 2 Crore under eligible activities listed out in the scheme guidelines.  An outlay of 300.10 Cr has been earmarked under RPTUAS for the scheme period of five years.

- (f):  The  Scheme  is  implemented  through  a  Project  Management Agency  (PMA)  which  is responsible for providing secretarial, managerial and implementation support and carrying out other  responsibilities  as  assigned  by  the  Department  from  time  to  time.  The  scheme  is periodically reviewed and monitored by the Scheme Steering Committee [headed by Secretary (Pharmaceuticals)] which also provides timely directions for effective implementation of the scheme.

Physical visits are also being done by the officials of Department and PMA for review/ effective  monitoring  of  projects  under  the  scheme.  Periodic  interactions  are  done  with  the applicants by the officials of Department and PMA.

Statement referred to in reply to part (b) of the Lok Sabha Unstarred Question No. 1892 for answer on 06.12.2024

| Applicants approved under RPTUAS sub-scheme (as on 05.12.2024)   | Applicants approved under RPTUAS sub-scheme (as on 05.12.2024)   | Applicants approved under RPTUAS sub-scheme (as on 05.12.2024)   | Applicants approved under RPTUAS sub-scheme (as on 05.12.2024)   |
|------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|
| S. No.                                                           | Name of Applicant                                                | Amount (in Rs. Lakh)                                             | Nature of Entity (MSME/Non- MSME)                                |
| 1                                                                | Dinakara Life Science Private Limited                            | 200                                                              | MSME                                                             |
| 2                                                                | Anuja Healthcare Limited                                         | 188.7                                                            | MSME                                                             |
| 3                                                                | Ethix Health Care (HP)                                           | 97.46                                                            | MSME                                                             |
| 4                                                                | Bennet Pharmaceuticals Limited                                   | 112.8                                                            | MSME                                                             |
| 5                                                                | Maxwell Pharma (HP)                                              | 102.46                                                           | MSME                                                             |
| 6                                                                | Ce Chem Pharmaceuticals Private Limited                          | 120.75                                                           | MSME                                                             |
| 7                                                                | MSea Pharmaceuticals Private Limited (HP)                        | 82                                                               | MSME                                                             |
| 8                                                                | Park Pharmaceuticals (HP)                                        | 188.33                                                           | Non-MSME                                                         |
| 9                                                                | Alapati Pharma                                                   | 50.27                                                            | MSME                                                             |
| 10                                                               | Sreepathi Pharmaceuticals Limited                                | 105.84                                                           | MSME                                                             |
| 11                                                               | BDR Lifesciences Pvt. Ltd.                                       | 168.62                                                           | Non-MSME                                                         |
| 12                                                               | Sangharsh Lifecare Private Limited                               | 177.98                                                           | MSME                                                             |
| 13                                                               | Dano Vaccines &Biologicals Pvt Ltd                               | 56.2                                                             | MSME                                                             |
| 14                                                               | Pro-Pharma Care Pvt Ltd                                          | 114.68                                                           | MSME                                                             |
| 15                                                               | Three B Healthcare Limited (HP)                                  | 109.4                                                            | MSME                                                             |
| 16                                                               | Nandu Chemical Industries                                        | 60.93                                                            | MSME                                                             |
| 17                                                               | Denis Chem Lab Ltd                                               | 66.91                                                            | MSME                                                             |
| 18                                                               | Daffohils Laboratories Pvt Ltd                                   | 74.6                                                             | MSME                                                             |
| 19                                                               | Auraya Healthcare Unit-Ii                                        | 102.83                                                           | MSME                                                             |
| 20                                                               | Bakul Pharma Private Limited                                     | 111.45                                                           | MSME                                                             |
| 21                                                               | Medoz Pharmaceuticals Pvt Ltd (HP)                               | 90.39                                                            | MSME                                                             |
| 22                                                               | Navil Laboratories Pvt Ltd                                       | 126.51                                                           | MSME                                                             |
| 23                                                               | Unispeed Pharmaceuticals Private Limited (HP)                    | 55.7                                                             | MSME                                                             |
| 24                                                               | Pharma Force Lab (HP)                                            | 200                                                              | MSME                                                             |
| 25                                                               | Virdev Intermediates Pvt Ltd                                     | 200                                                              | MSME                                                             |
| 26                                                               | Magnum Chemi Gran Pvt Ltd                                        | 200                                                              | MSME                                                             |
| 27                                                               | Velite Pharmaceuticals                                           | 35.56                                                            | MSME                                                             |
| 28                                                               | Sirmour Remedies Pvt Ltd                                         | 167.21                                                           | MSME                                                             |
| 29                                                               | Sarv Pharmaceuticals                                             | 52.5                                                             | MSME                                                             |
| 30                                                               | Altis Finchem Private Limited                                    | 162.15                                                           | MSME                                                             |
| 31                                                               | Mediforce Healthcare Pvt Ltd                                     | 22.76                                                            | MSME                                                             |
| 32                                                               | Kentrech Laboratories Private Limited                            | 76.68                                                            | MSME                                                             |
| 33                                                               | Sanzyme Pvt Limited                                              | 69.53                                                            | MSME                                                             |
| 34                                                               | SciTech Specialities Pvt Ltd                                     | 39.33                                                            | MSME                                                             |
| 35                                                               | Talent Healthcare                                                | 126.35                                                           | MSME                                                             |
| 36                                                               | Neha Life Science Private Limited                                | 52.6                                                             | MSME                                                             |
| 37                                                               | Systacare Remedies                                               | 11.07                                                            | Non-MSME                                                         |
| 38                                                               | Prochem Pharmaceuticals Private Limited                          | 79.65                                                            | MSME                                                             |
| 39                                                               | Goish Remedies Limited                                           | 107.56                                                           | MSME                                                             |
| 40                                                               | Saimirra Innopharm Private Limited                               | 115.88                                                           | MSME                                                             |
| 41                                                               | Alexi Pharmicia Pvt Ltd                                          | 65.39                                                            | MSME                                                             |
| 42                                                               | Tosc International Private Limited                               | 31.55                                                            | MSME                                                             |
| 43                                                               | Vulcan Laboratories Private Limited                              | 191                                                              | MSME                                                             |
| 44                                                               | Vowcare Products                                                 | 11.39                                                            | Non-MSME                                                         |

| 45    | Saurav Chemicals Limited                   |   31.86 | MSME    |
|-------|--------------------------------------------|---------|---------|
| 46    | Vasa Pharmachem Private Limited            |   50.26 | MSME    |
| 47    | Arnav Research Laboratories                |   67.95 | MSME    |
| 48    | Murli Krishna Pharma pvt ltd               |   57.77 | MSME    |
| 49    | Biodeal Pharmaceuticals Limited            |  105.3  | MSME    |
| 50    | Zenith Drugs Limited                       |  113.5  | MSME    |
| 51    | Nucare Laboratories India                  |   82.37 | MSME    |
| 52    | Aqua Fine Injecta Pvt Ltd                  |   33.79 | MSME    |
| 53    | Adrhim Pharmaceuticals Llp                 |   75.71 | MSME    |
| 54    | Swati Chemicals                            |  145.24 | MSME    |
| 55    | B. Sharda Pharma Pellets Private Limited   |   45.04 | MSME    |
| 56    | Emil Pharmaceutical Industries Private Ltd |  200    | MSME    |
| 57    | Brit Lifescience                           |  128.4  | MSME    |
| 58    | Srikem Laboratories Pvt Ltd                |   24.2  | MSME    |
| 59    | Protech Biosystems Pvt Ltd                 |   85.97 | MSME    |
| 60    | Schon Pharmaceuticals Limited              |   97.4  | MSME    |
| 61    | Ornate Labs Pvt Ltd                        |    3.94 | MSME    |
| 62    | Mendine Pharmaceuticals Pvt Ltd            |   23.52 | MSME    |
| Total | Total                                      | 5955.19 | 5955.19 |

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