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The PHD Chamber of Commerce and Industry (PHDCCI), in association with the Department of Pharmaceuticals and the Kerala Branch of The Indian Pharmaceutical Association (IPA), is set to host a pivotal national conference on ‘GMP and RPTUAS’ in Kochi in Kerala on October 31, 2025.
Titled "Enhancing Pharmaceutical Quality Assurance through Good Manufacturing Practices (GMP) & Session on Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS)," the conference marks a significant step toward aligning the Indian pharmaceutical industry with the highest global standards.
The primary focus of the conference is to strengthen pharmaceutical quality assurance via the rigorous implementation of Good Manufacturing Practices (GMP). GMP is deemed the cornerstone of manufacturing, demanding vital measures in validation, review, and documentation to guarantee the consistent safety, efficacy, and quality of medicinal products, including vaccines. Key sessions will cover the overview of GMP principles, legal components, annexes for specific product classes, and understanding the WHO Certification Scheme.
A major highlight of the day will be the dedicated session on the recently launched RPTUAS. This initiative is spearheaded by the Department of Pharmaceuticals and represents a substantial effort by the government to bolster the technological capabilities of the domestic pharmaceutical sector, ensuring its global competitiveness and adherence to international benchmarks.
The revision of the scheme was necessitated by a comprehensive review following the issuance of the revised Schedule-M of the Drugs and Cosmetics Rule, 1945, by the Department of Health and Family Welfare on December 28, 2023. The RPTUAS guidelines are specifically designed to support the pharmaceutical industry in undertaking necessary technological upgrades to meet both the stringent revised Schedule-M and WHO-GMP standards, thereby boosting the quality and safety profile of Indian-manufactured drugs.
In a move demonstrating a more inclusive approach, the RPTUAS has broadened its eligibility criteria. The assistance is no longer restricted solely to Micro, Small, and Medium Enterprises (MSMEs). Any pharmaceutical manufacturing unit with an average turnover of less than Rs. 500 crore over the last three years, requiring technology and quality upgrades, is now eligible. This expansion ensures that a wider base of manufacturers can participate in the drive toward quality excellence, though preference is still retained for MSMEs.
The scheme offers robust and flexible financial support, shifting the focus from the traditional credit-linked approach to subsidies provided on a reimbursement basis. This enhanced flexibility is intended to facilitate more widespread adoption across participating units. Eligible activities for support are comprehensive, including upgrades to crucial infrastructure like HVAC systems, water and steam utilities, testing laboratories, stability chambers, clean room facilities, and effluent treatment. Incentives range from 10 per cent to 20 per cent of the investment, capped at Rs. 1 crore, depending on the unit's turnover slab.
Expected outcomes of the conference include increased industry-wide awareness and understanding of GMP principles, enhanced compliance for improved patient safety, and the strengthening of regulatory frameworks through the incorporation of GMP requirements. By facilitating the exchange of best practices and fostering a collaborative network, the conference aims to secure the Indian pharmaceutical industry’s commitment to quality assurance on a global scale.
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