On May 25, 2025, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 22 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on the Manufacture of Oral Solid Dosage Forms (OSD). The session attracted over 130 attendees, reinforcing the PULSE series’ role as a key learning platform for industry professionals.
Session Highlights:
Chief Guest: The event began with a keynote address by Milan Patel, Joint Managing Director, Troikaa Pharmaceuticals
Milan Patel delivered an inspiring keynote emphasising that Revised Schedule M is not a short-term fix but a long-term transformational journey—a mindset change that must begin with the top leadership. Mr. Patel outlined three pillars of implementation:
- People – Recruit the right professionals and train them continuously with robust internal programs.
- Equipment – Prioritise automation and system upgrades for quality and efficiency.
- Documentation – Ensure thorough, process-aligned SOPs and real-time CAPA management.
He reinforced that compliance and profitability are not opposites, but in fact complementary drivers of sustainable growth. He encouraged MSMEs to break the journey into achievable milestones, start small, and stay committed. While acknowledging the challenges, he assured that patient-centric compliance ultimately leads to greater business opportunities, fewer rejections, increased productivity, and long-term reputation gains.
Expert Educator: The session was led by Abhay Kumar Srivastava, Senior President – Operations, Mankind Pharma
Presentation Highlights: Srivastava underlined the deeper meaning behind each regulatory clause—beyond compliance, it’s about ensuring patient safety and business viability. According to him, the revised Schedule M expectations are not new; inspectors have been indirectly preparing the industry through CGMP queries and observations for a long time.
Highlighting five key elements of Revised Schedule M, he explained how they align with both quality and business sense. For instance, equipment qualification ensures value for money, and automated data systems enhance integrity. He stressed that quality culture cannot be created overnight—it must be cultivated through solving problems, improving processes, and adopting structured programs like Lean Six Sigma. Srivastava urged companies, especially MSMEs and heritage facilities, to view quality as a competitive advantage. He advised starting with a QRM (Quality Risk Management) SOP, forming a cross-functional risk committee, and creating a risk register focusing on people, processes, premises, and policies.
In conclusion, he called on the industry to embrace Revised Schedule M not as a challenge, but as a long-term investment in operational excellence and global competitiveness.
Panel Discussion: The session’s panel discussion, moderated by Harish Jain, President, FOPE, Director, Embiotic Laboratories, featured the following industry experts:
- Digambar Nigade, Vice President – Quality, Injectables, Amneal Pharmaceuticals
- Rajesh Kapoor, 28+ Yrs in cGMP & Compliance, Pharma Compliance Expert, Regulatory Trainer
- Abhay Kumar Srivastava, Senior President – Operations, Mankind Pharma
Engaging Q&A Session with Panellists: During the Q&A session, panellists addressed several practical concerns related to implementing Revised Schedule M in Oral Solid Dosage (OSD) manufacturing. On process validation for legacy products, Digambar Nigade recommended using concurrent validation with ongoing batches instead of relying on retrospective data. Kapoor emphasised that legacy equipment must be evaluated against current GMP standards—minor upgrades can be considered, but if they fail to meet requirements, replacement is necessary, with qualification conducted using current controls. Srivastava outlined key components for AHUs in OSD facilities, stressing the importance of temperature and RH control, terminal filtration, and integrated design for pressure differentials. For multi-product facilities with space limitations, Nigade suggested administrative controls and process segregation through strategic facility zoning, while Srivastava recommended secondary change rooms or strategic alliances with other manufacturers to manage compliance. The panel concluded that a phased, risk-based approach with clear documentation and management commitment is essential for successful compliance, particularly for MSMEs.
Supporting Associations: The PULSE series continues to receive strong support from key industry associations and pharmaceutical professionals, with ongoing engagement from SMEs and real-time resolution of their queries.
Stay tuned for updates on the PULSE initiative and upcoming sessions. For inquiries or to pre-book participation, visit PharmaState Academy’s official website