Government revamps pharma scheme
New Delhi: The Department of Pharmaceuticals has announced significant revisions to the Pharmaceuticals Technology Upgradation Assistance Scheme (PTUAS), aimed at enhancing the capabilities of drug companies to meet global standards, according to an official release on Monday.
Under the revamped scheme, which has been expanded and made more inclusive, financial aid will now be extended not only to Micro, Small, and Medium Enterprises (MSMEs) but also to pharmaceutical manufacturing units with a turnover of less than Rs 500 crore. The focus remains on supporting smaller players to achieve superior manufacturing standards.
One of the key changes introduced is a shift towards more flexible financing options, with subsidies provided on a reimbursement basis rather than the conventional credit-linked approach. This flexibility is intended to widen the accessibility of the scheme and encourage broader participation.
Additionally, the revised scheme aligns with the updated Schedule-M and WHO-GMP standards, supporting a wider array of technological upgrades. Eligible activities include enhancements to HVAC systems, water and steam utilities, testing laboratories, clean room facilities, and more, ensuring comprehensive support for participating units.
Furthermore, the scheme now allows for integration with state government schemes, providing units with additional top-up assistance. This collaborative approach aims to maximise support for the pharmaceutical industry in their technology upgradation endeavours.
To ensure transparency and accountability, a robust verification mechanism has been introduced through a project management agency. This mechanism is aimed at efficient resource allocation and ensuring the effectiveness of the scheme.
The overarching goal of these revisions is to facilitate the pharmaceutical industry’s transition to the Revised Schedule-M and WHO-GMP standards, thereby enhancing the quality and safety of pharmaceutical products manufactured in the country.
Earlier this year, the Union Health Ministry notified the Revised Schedule M guidelines, which mandate pharmaceutical companies to inform the licensing authority about drug recalls and report product defects or faulty production. These guidelines were introduced in response to complaints of sub-standard Indian drugs and reports of deaths abroad allegedly linked to them since 2022. Schedule M, part of the Drugs and Cosmetics Act 1940, outlines the ‘Good Manufacturing Practices’ to be adhered to by pharmaceutical manufacturing units in the country. With approximately 8,500 out of 10,500 manufacturing units falling under the MSME category, these revisions hold significance for the industry.
