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. Atmanirbhar Bharat envisages self-reliance in terms of healthcare products, among other things, for people of India. In this context, the Department of Pharmaceuticals is supporting the pharma industry to enhance manufacturing capabilities by increased investment in green field projects through Production Linked Incentive (PLI) schemes.

FEATURES:

    • Tenure: FY 21-22 to FY 25-26
    • Approval of projects by Scheme Steering Committee (SSC) chaired by Secretary, DoP

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; and

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/SUB-SCHEMES OF THE SCHEME:

Components/Sub-schemes

About the sub-scheme

Assistance to Pharmaceutical Industry for Common Facilities (APICF)

Objective:  To strengthen the existing pharmaceutical clusters’ capacity for their sustained growth by creating tangible assets as “Common Facilities”.

Intended Beneficiaries:

      • 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.
      • Pharma clusters promoted by the State Governments: Such a Project Implementing agency shall be legal entity under Indian law with oversight of state government. Such a cluster may be exempted from requirement of formation of SPV & will be deemed to be an SPV for the purpose of this scheme.

Incentives: 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.

Benefits:

      • Standardization of manufactured APIs/formulations
      • Improvement in quality standards
      • Improvement in environmental regulatory compliance
      • Reduction in wastage of manufactured pharma products
      • Increased availability of trained personnel for pharma clusters
      • Increased competitiveness of Pharma units in cluster
Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)  

Objectives: 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.

Intended Beneficiaries:  Micro, Small and Medium Enterprises of pharma sector.

Incentives:

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.

Eligible activities:

      • Only machinery and electronic Management Information System (MIS) required for technological up gradation of the plant, i.e., machinery to meet the gap are considered.
      • Machinery bought after the date of sanction of loan that is approved for benefit under the scheme is considered for incentive.
      • In case of imported machinery import duty, shipping charges, customs clearance charges and GST are included in the cost of machinery.

Penalty clause: Pharma MSMEs which availed of the benefit under the scheme for interest subvention must achieve technological up gradation within 18 months of receiving the first disbursement of loan, failing which loan will be converted into a normal loan by the Lending Institution.

Benefits:

Improvement in quality of manufactured pharma products and adherence to global quality standards

Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS)

Objectives:

      • 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.
      • To facilitate growth and development of the sectors through conducting studies, organizing awareness programs, creation of databases and promotion of industry.

Intended Beneficiaries: The pharmaceutical and medical devices industry in India will be the beneficiary of this scheme.

Benefits:

The objective of the scheme is to bring awareness about the policies of the Government and identifying problems/issues faced by the industry however, the impact of this awareness or consultation cannot be directly linked to any physical output in terms of sales. For this The NITI Aayog has developed an Output Outcome Monitoring Framework, which will be the basis on which Project Management Consultant (PMC) will develop a monitoring system for DoP to capture data and monitor the scheme on a regular basis as per Output – Outcome framework.

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