DoP Revises PTUAS Guidelines to Support MSMEs

The Department of Pharmaceuticals has revamped PTUAS guidelines, offering reimbursement subsidies to MSMEs for upgrading quality standards and obtaining certifications.

The Department of Pharmaceuticals (DoP) has made substantial changes to the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) sub-scheme, with a focus on aiding MSMEs in the pharmaceutical sector. 

These alterations include offering reimbursement subsidies ranging from 10 to 20% to assist MSME manufacturers.

Specifically in enhancing quality standards and obtaining certifications, particularly the revised Schedule M and World Health Organisation's (WHO) Good Manufacturing Practice (GMP) certifications.

Key Changes 

The revamped scheme follows a comprehensive review conducted by the Scheme Steering Committee, considering the updated requirements outlined in the revised Schedule-M of the Drugs and Cosmetics Rule, 1945, issued by the Department of Health & Family Welfare on December 28, 2023. 

Notably, the revised guidelines eliminate the penalty clause, including the bank guarantee requirement, which was present in the previous version.

According to the department, the revision aims to broaden the eligibility criteria and provide flexible financing options. 

The focus has shifted towards subsidies provided on a reimbursement basis rather than the traditional credit-linked approach. It aims to encourage broader participation in the scheme and comprehensive support for compliance with new standards. 

Additionally, the revamped scheme integrates with state government schemes to assist units.

Financial Outlay & Expected Impact

The revised scheme is anticipated to support 300 units over the next two fiscal years, with a total outlay of INR 300 Cr. This marks a departure from the previous plan of supporting 420 new projects with the same financial allocation. 

Moreover, the revised guidelines specify the intended beneficiaries as existing pharmaceutical manufacturing units with an average turnover of less than INR 500 Cr over the last three years.

Additionally, under the revised incentive structure, eligible pharma units can receive a maximum subsidy of INR 1 Cr. The subsidy amount varies based on the turnover of the units, with percentages ranging from 10 to 20% of the investment made for upgrade activities. 

Importantly, the revised guidelines eliminate previous restrictions on the types of expenses eligible for subsidy, allowing a broader range of expenditures related to technological upgradation to be considered.

Streamlined Application Process

Pharmaceutical units seeking support under the scheme must apply online, providing a detailed gap analysis of their existing manufacturing facilities. 

Additionally, subsidies are disbursed in installments, with the first installment requiring the submission of requisite certificates and expenditure details. 

The verification mechanism has also been enhanced through the Project Management Agency (PMA), ensuring transparency and accountability.

By providing financial incentives and streamlining the application process, the revised scheme aims to facilitate the adoption of global manufacturing standards, thereby fostering the growth and competitiveness of the pharmaceutical industry in India.