The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, has announced the launch of the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS). This initiative seeks to upgrade the technological capabilities of the Indian pharmaceutical industry, aligning it with global standards. A press release on this launch was issued on March 11, 2024.
The approval of the revised Scheme follows a comprehensive review by the Scheme Steering Committee, taking into account the requirements of the revised Schedule-M of the Drugs and Cosmetics Rule, 1945, issued by the Department of Health & Family Welfare on 28/12/2023. The revised guidelines aim to support the pharmaceutical industry’s upgradation to the Revised Schedule-M & WHO-GMP standards, thereby enhancing the quality and safety of pharmaceutical products manufactured in the country.
Key Features of the Revised Scheme
Broadened Eligibility Criteria
The eligibility for the PTUAS has been expanded to include any pharmaceutical manufacturing unit with a turnover of less than 500 crores, beyond Micro, Small, and Medium Enterprises (MSMEs). Preference remains for MSMEs, supporting smaller players in achieving high-quality manufacturing standards.
Flexible Financing Options
The scheme introduces more flexible financing options, emphasizing subsidies on a reimbursement basis over the traditional credit-linked approach. This flexibility aims to diversify the financing options of the participating units, facilitating a more widespread adoption of the scheme.
Comprehensive Support for Compliance
The scheme supports a broader range of technological upgrades in alignment with revised Schedule-M and WHO-GMP standards. Eligible activities include improvements such as HVAC systems, water and steam utilities, testing laboratories, stability chambers, clean room facilities, effluent treatment, waste management, ensuring comprehensive support for participating units.
Dynamic Incentive Structure
Pharmaceutical units meeting specific turnover criteria will be eligible for incentives subject to a maximum of Rs. 1.00 crore per unit, based on their turnover in the last three years.
State Government Scheme Integration
The revised scheme allows integration with state government schemes, enabling units to benefit from additional top-up assistance, maximizing support for the pharmaceutical industry in their technology upgradation efforts.
Enhanced Verification Mechanism
The scheme introduces a robust verification mechanism through a Project Management Agency, ensuring transparency, accountability, and efficient resource allocation.
The Department of Pharmaceuticals is confident that the reform in the PTUAS Scheme will contribute to the growth of the pharmaceutical industry and compliance with global manufacturing standards. The revamped Scheme underscores the government’s commitment to supporting the pharmaceutical industry, critical to the nation’s health and well-being.
