March 12, 2024
2 mins read

India to Enhance Pharma Standards

The new scheme covers all pharmaceutical manufacturing units with a turnover of less than Rs 500 crore…reports Asian Lite News

Department of Pharmaceuticals on Monday announced a wider Revamped Pharmaceuticals Technology Upgradation Assistance Scheme in a significant step to help upgrade the technological capabilities of the country’s pharmaceutical industry and ensure its alignment with global standards.

The new scheme covers all pharmaceutical manufacturing units with a turnover of less than Rs 500 crore.

The revised guideline aims to support the pharmaceutical industry’s up-gradation to the Revised Schedule-M & WHO-GMP standards, enhancing the quality and safety of pharmaceutical products manufactured in our country, according to an official statement.

Key features of the revised scheme are:

Broadened Eligibility Criteria: Reflecting a more inclusive approach, eligibility for the Pharmaceuticals Technology Upgradation Assistance Scheme (PTUAS) has been expanded beyond Micro, Small and Medium Enterprises to include any pharmaceutical manufacturing unit with a turnover of less than 500 crores that requires technology and quality upgradation. 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 a traditional credit-linked approach. This flexibility is designed to diversify the financing options of the participating units, facilitating a more widespread adoption of the scheme.

Comprehensive Support for Compliance with New Standards: In alignment with revised Schedule-M and WHO-GMP standards, the scheme now supports a broader range of technological upgrades. Eligible activities include improvements such as HVAC systems, water and steam utilities, testing laboratories, stability chambers, clean room facilities, effluent treatment, waste management etc. ensuring comprehensive support for participating units.

Dynamic Incentive Structure: Pharmaceutical units have been classified into three categories. Units with a turnover of less than Rs 50 crore will be eligible for an incentive of 20 per cent of investment, while those with a turnover from Rs 50 to 250 crore will get an incentive of 15 per cent of their investment. Units with a turnover of Rs 250 to 500 crore will be eligible for an incentive of 10 per cent.

State Government Scheme Integration: The revised scheme allows integration with state government schemes, enabling units to benefit from additional top-up assistance. This collaborative approach aims to maximize 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 the efficient allocation of resources.

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