FOPE & PharmaState Academy advance MSME excellence with PULSE session 24 on contract management

On August 24, 2025, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy successfully hosted Session 24 of the PULSE (Pharma Upgradation & Learning Series for Excellence) Program, marking one of the final chapters in this year-long knowledge-sharing journey. This session built upon the foundation laid in Session 23 and explored the Management of Essential Contracts under the Revised Schedule M Guidelines.

The session featured Dr Sanjit Singh Lamba, Managing Partner at Trillyum Consulting, and a globally respected pharma leader with 35+ years of experience in Global Manufacturing, business operations, and regulatory compliance. Dr Sanjit shared insights on how the Revised Schedule M redefines contract obligations, stressing that contracts must be living documents, reviewed, implemented, and aligned with compliance and operational excellence.
Dr Sanjit emphasised the importance of standardised templates, responsibility matrices, and centralised repositories to ensure clarity and avoid outdated agreements. He recommended automated workflows, regular audits, and the appointment of a dedicated contract manager to strengthen compliance. On supply agreements, he outlined their role in ensuring reliable supply, legal protection, and cost optimisation. He differentiated supply agreements from quality agreements, the latter being crucial for GMP, regulatory compliance, and clear role definitions. Dr Sanjit also highlighted the importance of distribution, validation service, and technology transfer agreements, with proper documentation and vendor qualification. He stressed the significance of Integrated Pest Management (IPM) and cleaning validation in contracts to prevent compliance risks.

To support participants, 14 guidance documents, templates, and formats were shared as practical tools for MSMEs.

The panel was moderated by Harish Jain, President, FOPE & Director, Embiotic Labs, and featured distinguished panelists:

• Venkata Subbarao Chinni, Founder & Managing Director, Crius Group, a dynamic leader whose company has won multiple awards for innovation and excellence in nutraceutical manufacturing.

• Dr Jegan Jayabalan, Senior Director, Analytical Development at Recipharm, Bengaluru, a renowned expert in analytical development, validation, and pharmaceutical quality systems.

• Dr Sanjit Singh Lamba, bringing regulatory, strategic, and global GMP perspectives to the discussion.

The panel examined how essential contracts are central to compliance and business sustainability. The panel guided the participants on the importance of having separate supply and quality agreements, as revising a combined agreement can be cumbersome. Dr Sanjit emphasised that the contract giver initiates agreements and is responsible for monitoring and auditing them. Dr Jegan Jayabalan and Subbarao discussed how to safeguard quality when working with contract manufacturers, including the need for detailed change control processes and regular audits. They also highlighted the growing importance of agreements for services like data archiving and vendor audits. The discussion concluded with insights on preventing counterfeit products and the necessity of technology transfer agreements when shifting manufacturing sites.

The session also highlighted the launch of WELZO – a new state-of-the-art testing lab and training centre in Baddi. The centre is set to offer specialised training modules to strengthen industry skills and compliance readiness.

The PULSE series continues to empower MSMEs with practical knowledge, regulatory clarity, and actionable solutions. The program has become a trusted platform for collaboration between industry leaders, SMEs, and regulators.

The journey of PULSE moves forward with a stronger commitment to building a robust and globally competitive Indian pharma ecosystem.