In an effort to support pharma companies aligned with global quality standards, the Department of Pharmaceuticals (DoP) has announced a revamped Pharmaceuticals Technology Upgradation Assistance (RPTUAS) Scheme, expanding the scope of eligibility, among other things.

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“The revised guideline aims to support the pharmaceutical industry’s upgrade to the Revised Schedule-M & WHO-GMP standards, enhancing the quality and safety of pharmaceutical products manufactured in our country,” said the DoP, which is under the Ministry of Chemicals and Fertilisers.

The Centre has been tightening regulatory and manufacturing norms for the pharmaceutical industry ever since it has come under some intense global scrutiny following reports of contaminated cough syrups involving companies based in India, among other things.

The latest approval of the revised scheme comes after a review by the Scheme Steering Committee, against the backdrop of the revised Schedule-M of the Drugs and Cosmetics Rule, 1945, issued by the Department of Health and Family Welfare last December.

Key features of the scheme include broadened eligibility criteria and an “inclusive approach” by expanding its scope beyond micro, small, and medium enterprises (MSMEs) to include “any pharmaceutical manufacturing unit with a turnover of less than 500 crores that requires technology and quality upgradation.” However, the note added that there would be a preference for MSMEs and smaller players in achieving high-quality manufacturing standards.

The scheme also introduces more flexible financing options, as the note said, “emphasising subsidies on a reimbursement basis over the traditional credit-linked approach,” thereby facilitating better adoption of the scheme.

Further, the scheme supports a broader range of technological upgrades, the DoP said, outlining eligible activities to include testing laboratories, stability chambers, clean room facilities, effluent treatment, and waste management, to name a few.

The DoP also outlined a dynamic incentive structure for pharmaceutical units. Those with the following average turnover for the last three years would be eligible for incentives up to a maximum of ₹1 crore per unit, it said.

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Turnover Incentives

(i) Turnover less than ₹50.00 crore: 20% of investment under eligible activities

(ii) Turnover from ₹50.00 crore to less than ₹250.00 crore: 15% of investment under eligible activities

(iii) Turnover from ₹250.00 crore to less than ₹500.00 crore: 10% of investment under eligible activities.

The revised scheme also allowed integration with State government schemes, enabling units to benefit from additional top-up assistance. And it introduces a verification mechanism through a project management agency, it said, to ensure transparency, accountability, and the efficient allocation of resources.

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