Department of Pharmaceuticals along with Ministry of Chemicals and Fertilizers has launched the scheme “Strengthening of Pharmaceutical Industry (SPI)" to address demands of support required to existing Pharma clusters and MSMEs, to improve their productivity, quality and sustainability. The objective of the scheme is to foster resilience and future-readiness in the existing infrastructure facilities in order to make India a global leader in the Pharma Sector.

With a total financial outlay of INR 500 Cr across 5 years, i.e., the period from FY 21-22 to FY 25-26, the Scheme will also provide interest subvention or capital subsidy on their capital loans to MSMEs, which will further facilitate the growth in volumes as well as in quality, so as to meet national and international regulatory standards (WHO-GMP or Schedule-M).

The Scheme has 3 components which were devised after extensive stakeholder consultations to meet the expectations of the SME Pharma and MedTech Industry to upgrade their facilities on the fronts of Quality and Technology. These sub-schemes are

Assistance to Pharmaceutical Industry for Common Facilities (APICF), to strengthen the existing pharmaceutical clusters’ capacity for their sustained growth by creating common facilities. Under the sub-scheme, an outlay of 178 Cr for the scheme period of five years is proposed to support clusters for creation of common facilities with the focus on R&D Labs, Testing Laboratories, Effluent Treatment Plants, Logistic Centers and Training Centers in this order of priority. The limit of incentive will be 70 per cent of the approved project cost or INR 20 cr., whichever is less, as per approval of SSC. In case of Himalayan and north-east region, the grant-in-aid would be INR 20 crore per cluster or 90 per cent of the project cost, whichever is less. 

Intended beneficiaries of the scheme include (a) 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, and (b) Pharma clusters promoted by the State Governments. Expected benefits of the sub scheme include standardization of manufactured APIs/formulations, improvement in quality standards and environmental regulatory compliance, reduction in wastage of manufactured pharma products, increased availability of trained personnel for pharma clusters and competitiveness of Pharma units in cluster. 

Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) has earmarked INR 300 Cr to facilitate Micro, Small and Medium Pharma Enterprises (MSMEs) of proven track record to meet national and international regulatory standards. Incentive includes up to maximum of 5 per cent  per annum of interest subvention or through Credit linked Capital subsidy of 10 per cent. In both the cases, the loan supported is to a limit of 10 Crores and the eligible components of the loan have been listed out in the scheme guidelines. 

The sub-scheme covers upgradation of HVAC (Heating, Ventilation, and Air Conditioning) system to WHO norms i.e., HEPA (High-Efficiency Particulate Air filters); stability testing chambers; all equipment & instruments for operating a Microbiology laboratory including autoclaves, incubators, biosafety cabinets, HVAC systems; All lab scale and pilot scale manufacturing equipment required for R&D development – formulation/bulk.; State-of- art lab equipment for testing as per Pharmacopeia other than IP not limiting to NMR, HPLC, HPTLC, IR Spectrophotometer, Atomic Absorption Photometers, GC, Electrophoresis and Dissolution apparatus; Water management and purification systems including Steam systems; Automatic particle counters for sterile areas; and Laboratory information management system. Micro, Small and Medium Enterprises of pharma sector are expected to benefit through improvement in quality of manufactured pharma products and adherence to global quality standards.  

Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS) to facilitate growth and development of Pharmaceutical and Medical Devices Sectors through study/survey reports, awareness programs, creation of database, and promotion of industry. Outlay of INR 21.5 Cr will be leveraged across the period of five years to promote knowledge and awareness about the Pharmaceutical and MedTech. This will be done by undertaking studies, building databases and bringing industry leaders, academia and policy makers together to share their knowledge and experience for overall development of the Pharma and Medical Devices sector. 

With the pharmaceutical and medical devices industry in India as the beneficiary, the sub-scheme provisions grants to (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, and (c) Government/quasi-government agencies with relevant experience. The objective is to bring awareness about the policies of the Government and identifying problems/issues faced by the industry. Providing financial assistance to agencies will provide support/facilities for promotion of investment & growth of pharma sector and will benefit the pharma industry. 

This has been co-authored by Ishita Sirsikar and Cherishi Maheshwari.