Context:
The Department of Pharmaceuticals (DoP) announced Revamped Pharmaceuticals Technology Upgradation Assistance (RPTUAS) scheme.
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• The DoP under the Ministry of Chemicals and fertilizer launched this Scheme.
• It aims to offer financial support to drug manufacturers for upgrading the technological capabilities and aligning with global standards.
• Scheme followed by a comprehensive review by the Steering Committee in light of the requirements of the revised Schedule-M of the Drugs and Cosmetics Rule, 1945.
- Schedule M prescribes requirements of facilities and their maintenance, personnel, manufacture, control and safety testing, storage and transport of material, written procedures and records, and traceability among others.
Pharmaceutical Technology Upgradation Assistance (PTUAS) Scheme
- Its objective is 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.
- Sub-scheme under- Strengthening of Pharmaceutical Industry (SPI),2022.
- It is credit linked scheme.
- Online portal has been developed by SIDBI
About RPTUAS
• Eligibility for the PTUAS has been expanded beyond MSME to include other manufacturing unit with a turnover of less than 500 crores that requires technology and quality upgradation.
• Scheme emphasize subsidies on reimbursement basis and over traditional credit-linked approach.
• The scheme aligns with revised Schedule-M and WHO-GMP standards, covering a broader range of technological upgrades. This includes improvements in:
- HVAC systems
- Water and steam utilities
- Testing laboratories
- Stability chambers
- Clean room facilities
- Effluent treatment
- Waste management
• Companies are eligible for incentives capped at ₹1 crore based on their average turnover for the past three years:
- Turnover < ₹50 crore: 20% of investment reimbursement
- Turnover ₹50 crore – ₹250 crore: 15% of investment reimbursement
- Turnover ₹250 crore – ₹500 crore: 10% of investment reimbursement
• It allows integration with state government schemes, enabling units to benefit from additional top-up assistance.
• It also introduces a verification mechanism through a Project Management Agency, ensuring transparency, accountability and the efficient allocation of resources.