The Ministry of Chemicals and Fertilizers in India recently released the guidelines for the “Strengthening of Pharmaceutical Industry (SPI)” scheme. This initiative has been allocated a financial outlay of Rs.500 Cr for the period from FY 21-22 to FY 25-26. The focus is on bolstering the pharmaceutical industry through financial assistance, contributing to infrastructure improvements and regulatory compliance among SMEs and MSMEs.
Key Features of the SPI Scheme
Under this scheme, pharma clusters will receive financial assistance for constructing Common Facilities. This support is aimed at enabling SMEs and MSMEs to upgrade their production capacities to meet national and international regulatory standards such as the World Health Organization-Good Manufacturing Practice (WHO-GMP) or Schedule-M. The beneficiaries of this financial assistance will be provided either interest subvention or capital subsidy on their capital loans, a move that would catalyze both volume and quality growth.
Understanding WHO-GMP and Schedule-M
WHO-GMP represents a vital element of quality assurance. It ensures that medicinal products are consistently produced and controlled in line with the quality standards pertinent to their intended use and product specifications. On the other hand, Schedule M of drugs and cosmetics rules encapsulates the GMP requirements for the pharmaceutical industry in India.
Components of the SPI Scheme
The SPI scheme has three main components: Assistance to Pharmaceutical Industry for Common Facilities (APICF), Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS), and Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS).
The APICF aims to reinforce the capacity of existing pharmaceutical clusters by creating common facilities. These include R&D Labs, Testing Laboratories, Effluent Treatment Plants, Logistic Centers and Training Centres. An outlay of 178 Cr has been proposed for its implementation.
The PTUAS is intended to assist Micro, Small and Medium Pharma Enterprises with an established track record to meet national and international regulatory standards. Under this sub-scheme, SME Industries will either receive up to a maximum of 5% per annum (6% for units owned and managed by SC/STs) of interest subvention or a Credit linked Capital subsidy of 10%. An outlay of 300 Cr has been earmarked for this sub-scheme over the schema period of five years.
The PMPDS is designed to facilitate the growth and development of the Pharmaceutical and Medical Devices Sectors through study/survey reports, awareness programs, creation of databases, and industry promotion.
Significance of the SPI Scheme
The SPI scheme is seen to bolster the existing infrastructure facilities, positioning India as a global leader in the Pharma Sector. It is expected to improve not only the quality but also trailblaze the sustainable growth of clusters. The scheme is attuned to cater to the burgeoning demand in terms of support required by existing Pharma clusters and MSMEs across the country, thereby improving their productivity, quality and sustainability.
Other Related Pharma Sector Schemes
Promotion of Bulk Drug Parks Scheme and Production Linked Incentive (PLI) Scheme are two other notable initiatives related to the Pharma sector. The former aims to develop three mega Bulk Drug parks in India in partnership with States to curb bulk drugs’ manufacturing cost in the country and reduce dependence on other nations for bulk drugs. The latter promotes domestic manufacturing of critical Key Starting Materials (KSMs)/Drug Intermediates and Active Pharmaceutical Ingredients (APIs) in the country. Both schemes together aim to ensure the continuous supply of drugs and delivery of affordable healthcare to citizens.