Revamped PTUAS: Enhanced Subsidies for MSME Pharmaceutical Upgrades

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The Department of Pharmaceuticals (DoP) has revamped the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) sub-scheme with significant changes, including reimbursement subsidies of around 10-20 percent for upgrading quality standards and obtaining certificates for Micro, Small and Medium (MSME) manufacturers, enabling them to obtain revised Schedule M and World Health Organisation's (WHO) Good Manufacturing Practice (GMP) certifications.

The approval of the revised Scheme follows a comprehensive review by the Scheme Steering Committee in light of the requirements of the revised Schedule-M of the Drugs and Cosmetics Rule, 1945, as issued by the Department of Health and Family Welfare on December 28, 2023. The revised guideline also deletes the penalty clause, including the requirement of a bank guarantee, which was present in the guidelines previously.

The Department said that through the revision, it has broadened the eligibility criteria, flexible financing options emphasizing subsidies on a reimbursement basis over traditional credit-linked approach envisaging widespread adoption of the Scheme and comprehensive support for compliance with new standards. 

It also offers a dynamic incentive structure and integration with state government schemes, enabling units to benefit from additional top-up assistance. The Project Management Agency (PMA) has also enhanced the verification mechanism.

"The Department of Pharmaceuticals is confident that reform in the PTUAS Scheme will contribute to the pharmaceutical industry’s growth and compliance with global manufacturing standards.

 The revamped Scheme underscores the government's commitment to supporting the pharmaceutical industry, which is critical to the nation’s health and well-being," said the Department in an announcement.

The Scheme, in its revamped state, is expected to support 300 units (150 units each in 2024-25 and 2025-26), with a total outlay of Rs. 300 crore, as against the previous plan of supporting 420 new projects with the same financial outlay. 

The Pharmaceutical Industries Strengthening Program (SPI) sub-project notified the guidelines on March 11, 2022, but the project failed to attract many participants due to various reasons.