Government Empowering Pharma Excellence by RPTUAS Scheme

Introduction

Recently for pharmaceutical companies, adhering to WHO GMP is essential to meet regulatory requirements and ensure the quality and safety of their products. Compliance with WHO GMP involves establishing and maintaining a quality management system, implementing proper manufacturing processes, ensuring the cleanliness and hygiene of facilities, conducting thorough quality control testing of raw materials and finished products, and maintaining comprehensive documentation of all processes.

Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)

The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has announced the Revamped Pharmaceuticals Technology Up-gradation Assistance (RPTUAS) Scheme, representing a significant step in the government's efforts to augment the technological capabilities via quality and safety of pharmaceutical products and align it with global standards.

Under the RPTUAS Scheme, the government provides ‘Subsidy’ i.e. ‘assistance or incentives’ to pharmaceutical companies to upgrade their technological infrastructure and processes to comply with the latest regulatory standards, including the Revised Schedule-M and WHO-GMP requirements. This initiative aims to enhance the overall quality and safety of pharmaceutical products produced in India, ensuring they meet international benchmarks and boosting the competitiveness of the Indian pharmaceutical industry on the global stage.

Key points

• The revamped scheme, derived from the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS), now extends eligibility to pharmaceutical units with an average turnover under Rs 500 crore over the past three years.

• Companies stand to receive a maximum incentive of Rs 1 crore, based on anticipated expenditures of Rs 150 crore each in 2024-25 and 2025-26, benefiting 150 companies annually. Previously, the scheme was confined to MSME pharma manufacturing units.

• The Schedule M of the Drugs and Cosmetics Act 1940 focuses on enforcing "Good Manufacturing Practices" within pharmaceutical units across the country.

• WHO Good Manufacturing Practice (GMP) standards ensure consistent production and control of pharmaceutical products, aligning with their intended use and marketing authorization.

• Introduced in 2022, the "Strengthening of Pharmaceutical Industry (SPI)" scheme, with a budget of Rs 500 crore spanning FY 21-22 to FY 25-26, includes PTUAS as a credit-linked scheme.
• Investments made for machinery and premises upgrades post-January 1, 2024, are factored into subsidy calculations, covering both domestic and imported machinery, along with eligible expenses on clean room facilities, testing labs, and waste management.
• The new benefit limit is pegged to the turnover of the company. Units with turnovers below Rs 5 crore receive a 20 per cent incentive, while those with turnovers ranging from Rs 50 crore to less than Rs 250 crore receive 15 per cent, and units with turnovers from Rs 250 crore to less than Rs 500 crore receive 10 per cent.

• The revised scheme eliminates the penalty clause, previously imposing penalties on pharma MSMEs for non-compliance with technological upgrades within 18 months of loan disbursement.

Conclusion

Department of Pharmaceuticals took a significant step towards reform in the PTUAS Scheme resulting in technological prowess and global competitiveness of India's pharmaceutical industry via compliance with global manufacturing standards. The revamped Scheme underscores the government’s commitment to support the pharmaceutical industry through alignment with international standards such as WHO-GMP and the Revised Schedule-M. This initiative not only ensures the quality and safety of pharmaceutical products but also fosters innovation and elevates India's stature as a hub for high-quality pharmaceutical manufacturing. With the elimination of penalties and a focus on tailored incentives based on turnover, the revised scheme is poised to catalyze transformative growth and propel the Indian pharmaceutical sector towards excellence on the global stage.