Central Government issues Guidelines for Scheme to Strengthen Pharmaceuticals Industry (SPI); aims to strengthen existing infrastructure facilities to improve productivity, quality and sustainability
The Ministry of Chemicals & Fertilizers has issued “Guidelines for the Scheme for Strengthening of Pharmaceuticals Industry (SPI)”.
Background:
The Pharmaceuticals industry a key sector for achieving wellness for all Indians. It is also an important sector in terms of providing employment to trained personnel. This scheme addresses the demand and requirement for support to already existing pharma clusters and MSMEs to improve productivity, quality and sustainability.
The following three sub-schemes are already approved in the Department of Pharmaceuticals as part of scheme for ‘Development of Pharmaceutical Industries’ (DPI):
1. Assistance to Pharmaceutical Industry for Common Facilities (APICF)
2. Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)
3. Pharmaceutical Promotion and Development Scheme (PPDS).
Now, the Department has decided to combine the above schemes into a single scheme with modification in the scheme guidelines, after stakeholder consultations for effective intervention.
Objective of the Scheme-
1. 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
2. To upgrade the production facilities of SMEs and MSMEs, to meet national and international regulatory standards, by providing interest subvention or capital subsidy on their capital loans, which will facilitate the growth in volumes as well as in quality;
3. 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
Components-
The Scheme will have 3 components / sub-schemes:
1. Assistance to Pharmaceutical Industry for Common Facilities (APICF)- This will help to strengthen the existing pharmaceutical clusters’ capacity for their sustained growth by creating common facilities
2. Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)- This will help facilitate Micro, Small and Medium Pharma Enterprises (MSMEs) of proven track record to meet national and international regulatory standards.
3. Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS): This will help facilitate growth and development of Pharmaceutical and Medical Devices Sectors through study/survey reports, awareness programs, creation of database, and promotion of industry
Key Takeaways:
1. The Guidelines provide for the financial outlay under each of the sub schemes mentioned above.
2. The Department of Pharmaceuticals (DoP) will provide overall policy, coordination and management support for the implementation of the Scheme.
3. Please refer to the table below for some key takeaways under the sub schemes-
| Sub- scheme | Objective | Key Takeaways | Incentive | Eligible activities |
| Assistance to Pharmaceutical Industry for Cluster Facility (APICF) | To strengthen the existing pharmaceutical clusters’ capacity for their sustained growth by creating tangible assets as “Common Facilities | 1.Pharmaceutical manufacturing units in a cluster who have come together to form a Special Purpose Vehicle (SPV) to execute the project of developing common facility
2. Pharma clusters promoted by the State Governments: Such a Project Implementing agency shall be legal entity under Indian law with oversight of state government.
3. Pharma enterprises shall hold at least 51% equity of the SPV.
4. The combined net worth of members of SPV shall be equivalent to total grant amount applied for and each SPV member must have a net worth of at least 1.5 times of their proposed equity contribution.
5. The project proposal must have technical recommendation from competent technical body (e.g. for CETP the State Pollution Control Board may be the competent body and in case of Research Labs and Testing centers, NIPERs/CDL may be the competent authority to grant technical recommendations).
6. The Guidelines also provide for specific details that have to be included in the project proposal |
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 | i. Research and Development Labs
ii. Testing Laboratory for Pharma Products iii. Effluent Treatment Plants iv. Logistic Centres v. Training Centres |
| Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) | To facilitate Micro, Small and Medium Pharma Enterprises (MSME) of proven track record to upgrade their technology to meet WHO-GMP or Schedule M standards | 1. Small and Medium Enterprises of pharma sector are the intended beneficiaries under the scheme
2. Eligible Applicants will apply in the prescribed format through the online portal to be set up by the PMC
3. Applications to be received by PMC on a rolling basis till 29th February 2024 from applicants subject to availability of budget.
4. The Guidelines also provide for physical and financial outlay |
1. Up to maximum of 5% per annum (6% in case of units owned and managed by SC/STs) of interest subvention for loan component eligible under the scheme taken to the upper limit of Rs. 10 cr. For a maximum period of 3 years on reducing balance for sanctioned loans by any scheduled commercial banks/financial institutions, both in the Public and the Private Sector or Credit linked Capital subsidy of 10% on loan component eligible under the scheme. Maximum limit of loan will be Rs. 10.00 crore
2. At least 50% of total sanctioned loan amount has to be on components eligible under the scheme for either interest subvention or capital subsidy, for approval of SSC
3. Minimum repayment period of the loan sanctioned for availing of the benefit under the scheme shall not be less than 3 years. |
1. Only machinery and electronic Management Information System (MIS) required for technological up gradation of the plant. Only procurement of new machineries will be permitted.
2. In case of imported machinery import duty, shipping charges, customs clearance charges and GST will be included in the cost of machinery. For machinery purchased domestically GST will be included in the cost of machinery.
3. An indicative list of such equipment categories, as provided by the Office of the DCGI is as under |
| Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS) | The scheme has two main objectives. The first objective is to promote Pharmaceutical and Medical Device Industry by bringing industry leaders, academia and policy makers together to share their knowledge and experience for overall development of the sectors. The other objective of the scheme is to facilitate growth and development of the sectors through conducting studies, organizing awareness programs, creation of databases and promotion of industry. | The pharmaceutical and medical devices industry in India will be the beneficiary of this scheme. Grants will be provided to any of the followings:
a. Recognized Industry associations that are significantly representative
b. Organizations/Firms with track record in conducting studies/survey etc. in Pharmaceuticals, medical devices and related sectors
c. Government/ quasi-government agencies with relevant experience.
The Grant-in-Aid will be released on submission of the following information/documents to PMC.
I. Confirmed date of the event/programme.
II. Disclosure of sources of funding.
III. Confirmation from the organizers that no Utilization Certificate is pending in respect of previous grant(s), if any, availed from this Department.
IV. Organizations receiving Grant for this component will be required to submit a report within two months after organization of the event on following lines: |
Organizations eligible for Grant:
1. Government agencies such as Academic institutions and autonomous bodies/ PSUs under the Department.
2. National/ State level Industries Associations in Pharmaceuticals, Medical Device and related sector.
3. A specialized organization having demonstrated expertise in the field in which proposed event is to be organized. |
1. Preparation of study reports on topics of importance for Indian Pharmaceutical and Medical Device industry
2. Support to Pharma and Medical Devices organizations to organize seminars, conferences, conventions, workshop & exhibitions (all such sessions individually referred to herein as the “Event”)
3. Non-financial Logo support for Pharma and Medical Devices events.
4. Creation of Database of pharmaceutical and medical device sector.
5. Organizing Mega events like annual India Pharma and Medical Devices meet and participating in other national or international events. |
- Scheme Outcomes:
- The NITI Aayog has developed an Output Outcome Monitoring Framework, which will be the basis on which PMC will develop a monitoring system for DoP to capture data and monitor the scheme on a regular basis as per Output – Outcome framework
- A mid-term review of the scheme would be conducted, for which the Department of Pharmaceuticals will engage the services of an approved independent agency. The review report would be submitted to the Scheme Steering Committee (SSC) for taking course correction / modification to the scheme /projects.
- Stake holder consultations will be organized by DoP through PMC from time to time to obtain feedback on the effective implementation and need for modifications in the Scheme.
Please refer to the link below for a detailed read of the Guidelines
