On May 11, 2025, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 21 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on the Manufacture of Active Pharmaceutical Ingredients (APIs). The session attracted over 90 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 Namit Joshi, Commercial Director, Centrient Pharmaceuticals & Chairman, Pharmexcil. In his keynote. He emphasised that Revised Schedule M adoption is no longer optional—it’s essential for sustaining India’s position as the “pharmacy of the world.” Highlighting India’s export growth, he stressed the need to strengthen domestic manufacturing standards, especially among MSME pharma units, to ensure quality, compliance, and global competitiveness. He identified three key pillars for successful implementation: infrastructure upgrade, cost of compliance, and skilled workforce development, urging the industry to address all simultaneously. He concluded by encouraging the industry to act decisively, as the future of Indian pharma depends on proactive compliance and commitment to excellence.
Expert Educator: The session was led by Dr Jitender Khurana, International GMP Consultant: Quality System, Auditing, FDA Remediation and Training.
Presentation Highlights: Dr J.P. Khurana began by clarifying that Part I of the Revised Schedule M is applicable to all manufacturers, including API manufacturers, while Part XII specifically outlines requirements for APIs. He explained that the scope excludes products like vaccines, gene therapies, blood derivatives, and radiopharmaceuticals. Dr. Khurana underlined that quality responsibility lies across the value chain—from vendor qualification to final API use—and stressed the importance of a clearly defined, independent quality unit (QA/QC). He outlined critical compliance points across the API lifecycle—from vendor approval, material flow, and personnel hygiene, to facility design, labelling control, and computerised system validation.
He stressed the need for scientifically justified sampling, impurity profiling, and robust internal audit and deviation investigation systems. He reiterated the importance of contract manufacturing oversight, change communication to clients, and licensing authority notifications during recalls. The session concluded with a strong push for systematic documentation and continuous compliance vigilance in line with global GMP. He also elaborated on infrastructure expectations, such as ensuring unidirectional material flow, proper ventilation and drainage, and use of food-grade lubricants to minimise contamination risks. Additionally, Dr. Khurana addressed the validation of utility systems (water, steam, HVAC, compressed air) and the qualification of cleaning and maintenance processes. His session provided a practical interpretation of the revised requirements, making the implementation roadmap clearer for API manufacturers.
Panel Discussion: The session’s panel discussion, moderated by Mr. Arjun Kapoor, Additional General Secretary, FOPE, featured the following industry experts:
- Dr Jitender Khurana, International GMP Consultant: Quality System, Auditing, FDA Remediation and Training
- Dr Sanjit Singh Lamba, Managing Partner at Trillyum Consulting and a pharmaceutical veteran with over 35 years of experience
- Dr Ajay Shrivastava, Site Head – Global API Business SUN Pharma, Panoli
Engaging Q&A Session with Panellists: During the panel discussion, Dr. Sanjit Lamba addressed air classification for API manufacturing. Dr. J.P. Khurana emphasised that storage responsibilities extend beyond the manufacturing site—even dealers and transporters must comply with defined conditions, supported by written agreements and periodic checks. He explained that stability testing must simulate market packaging to justify shelf life or retest dates. On bacterial endotoxins, panellists, including Dr. Ajay Shrivastava and Dr. Lamba, explained that water quality, clean equipment, operator hygiene, and environmental controls are critical. They highlighted that aqua-based processes are more prone to endotoxin risk, requiring stepwise validation and process mapping. Equipment holding time and drying status were also cited as key contributors to endotoxin contamination, underscoring the need for robust cleaning and drying validation protocols. During the discussion, the panel clarified that “ambient temperature” is not a valid universal storage condition, as it varies widely across India. Stability studies must be performed under defined ICH conditions, and vendor recommendations alone are not sufficient for regulatory justification. The panel emphasised that storage conditions must be scientifically justified and validated through actual data, not assumed based on ambient claims. On the question of re-evaluating raw materials, the panel stressed that expiry dates cannot be extended post-expiry without formal stability data. However, retest dates may be extended based on risk assessments, trending data, and case-by-case evaluation by the user, provided there is no regulatory non-compliance.
Closing Remarks: The session concluded with a vote of thanks by Harish Jain, National President, FOPE, who expressed gratitude to the speakers, panellists, and participants for their active involvement.
Stay tuned for updates on the PULSE initiative and upcoming sessions. For inquiries or to pre-book participation, visit PharmaState Academy’s official website.