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Category :
industry
Headline :
Department of Pharmaceuticals announces the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme
Date:
12/03/2024 10:45
According to an official release on Monday, the Department of Pharmaceuticals has revamped a scheme aimed at providing financial assistance to pharmaceutical companies for upgrading their facilities to meet global standards.
Under the revamped Pharmaceuticals Technology Upgradation Assistance Scheme (PTUAS), the government has broadened its scope to include pharmaceutical manufacturing units with a turnover of less than Rs 500 crore, beyond just MSMEs, if they require technology and quality upgrades, stated the Chemicals and Fertilisers ministry.
While MSMEs will still receive preference, the scheme now offers more flexible financing options, focusing on subsidies on a reimbursement basis rather than the traditional credit-linked approach. This flexibility is intended to widen the financing options for participating units, promoting wider adoption of the scheme.
Furthermore, in alignment with revised Schedule-M and WHO-GMP standards, the scheme now supports a wider range of technological upgrades, such as HVAC systems, water and steam utilities, testing laboratories, stability chambers, clean room facilities, effluent treatment, and waste management, ensuring comprehensive support for participating units.
The revised scheme also allows integration with state government schemes, enabling units to receive additional top-up assistance. This collaborative approach aims to maximize support for the pharmaceutical industry in their technology upgradation efforts.
Additionally, the scheme introduces a robust verification mechanism through a project management agency, ensuring transparency, accountability, and efficient resource allocation.
The revised guidelines aim to support the pharmaceutical industry's upgradation to the Revised Schedule-M & WHO-GMP standards, enhancing the quality and safety of pharmaceutical products manufactured in the country, as per the ministry's statement.
In January of this year, the Union Health Ministry notified the Revised Schedule M guidelines, which require pharmaceutical companies to inform the licensing authority about drug recalls and report product defects, deterioration, or faulty production.
These guidelines are introduced in response to complaints about sub-standard Indian drugs and reports of deaths abroad reportedly due to them since 2022. Schedule M, part of the Drugs and Cosmetics Act 1940, deals with 'Good Manufacturing Practices' to be followed by pharmaceutical manufacturing units in the country. Out of approximately 10,500 manufacturing units in the country, around 8,500 fall under the MSME category.
India is a major exporter of medicines to low/middle-income countries (LMICs) that require WHO GMP certification.
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