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A culture of quality excipients has ushered in: Experts at IPEC India Annual Conference
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Shardul Nautiyal, Mumbai
July 30 , 2025
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A culture of quality excipients has ushered in as the pharmaceutical industry advances towards manufacturing super and complex generics which requires high precision levels of process controls, Good Manufacturing Standards (GMPs) and regulatory compliance, experts deliberated on the occasion of IPEC India Annual Conference 2025 themed “Quality Excipients: The Foundation For Formulation Excellence” recently in Mumbai.
Excipients, traditionally considered inactive substances within pharmaceutical formulations, are now recognized as critical components that significantly influence drug product quality, efficacy, and safety.
Excipients strategic selection and application are paramount in addressing challenges such as solubility enhancement, stability improvement, and patient adherence. As the pharmaceutical industry evolves, the role of excipients has expanded, necessitating a comprehensive understanding of their impact on drug development and regulatory compliance. Traditionally viewed as inactive components, excipients are now recognized as strategic elements essential for ensuring product quality and regulatory compliance, it was emphasized.
Conference sessions included a CEO Panel on “Quality Excipients: Foundation for Formulation Excellence” moderated by Ajit Singh, chairman, ACG and International Pharmaceutical Excipients’ Council of India (IPEC India). It deliberated on patient centricity, ESG compliance and expertise in nitrosamine analysis to maintain excipient quality.
“In order to achieve patient centricity through high quality excipients, there is a need to focus on bringing low levels of nitrides or nitrosamine impurities. To address water contamination with very high levels of nitrides there is a lot of major required in terms of process controls, temperature controls and developing the analytical development methods and sites,” said Dr Ravleen Singh Khurana, managing director, Nitika Pharmaceuticals and secretary, IPEC India during the panel discussion.
While talking about achieving quality excipients on the panel, Geena Malhotra, managing director, Signet Excipients said that ESG compliance requires training, green sourcing policy, ethical purchasing policy, environmental risk management and focus on capacity building of resources like labour.
Aditi Kare Panandikar, managing director, Indoco Remedies spoke about the collaborative approach of excipient manufacturers and drug formulators to get the best excipient and drug quality.
Dr Pavan Bhat, CEO, Inventia spoke about good engineering practices (GEP) audit to address environmental contamination and quality issues.
Dr Sunil Bambarkar, managing director, Gattefosse India spoke about the company’s adherence to quality, regulatory compliance, certifications and transparency is paramount to their customers globally and in India.
“Maintaining excipient quality is paramount. According to the International Pharmaceutical Excipients Council (IPEC), adherence to their guidelines assists manufacturers in navigating regulations by providing frameworks for supplier qualification, risk assessment, and compliance for GMPs. These guidelines promote harmonization of excipient standards across different regions, aligning regulatory expectations globally. Proactive quality risk management, companies can achieve robust product design and drive continuous improvement—both of which are critical to maintaining an effective quality system,” stated Ajit Singh, chairman, IPEC India.
By focusing on excipients as strategic enablers, this conference sought to advance the discourse on their pivotal role in pharmaceutical development. Attendees were equipped with the knowledge and tools necessary to leverage excipients effectively, driving innovation, quality, and compliance in the ever-evolving pharmaceutical landscape.
“The conference delved into the multifaceted role of excipients as strategic enablers in the pharmaceutical industry. Discussions happened on innovative applications of excipients, strategies for ensuring their quality, navigating regulatory landscapes, and their impact on patient-centric product development. By bringing together industry experts, regulators, and researchers, the event aimed to foster a comprehensive understanding of how excipients drive quality and compliance in pharma,” said Kaushik Desai, secretary general, IPEC India.
The conference was attended from various sectors of the pharmaceutical industry, including formulation scientists, researchers, regulatory affairs specialists, quality assurance and control professionals, supply chain managers, procurement managers, excipient manufacturers and suppliers.
Participants gained insights into cutting-edge excipient technologies and their practical applications. The conference offered a deeper understanding of regulatory expectations and strategies for compliance, strategies for ensuring excipient quality and mitigating supply chain risks.
It also offered an opportunity for networking and knowledge sharing with thought leaders, professional excipients and pharma industry.
Other conference sessions were ‘Excipients In Focus: Challenges posed by New Regulations’, ‘Quality Expectations and Social Movements’, ‘Importance of quality of excipients through global certifications’, ‘Strategic Excipient Selection and Evolving Characterization Tools: Enabling Quality by Design in Inhalation Product Development’, ‘Invisible Architects: The Critical Role of Excipients in Stabilizing Biologicals and Peptides’, ‘Excipient End User : An interactive session, Panel discussion on “Quality and Compliance”, ‘Digitalization in excipient selection for the formulation development’, ‘Designing Stable Formulations with Predictive Modelling and Simulation’, ‘Unlocking the potential of Lipid Excipients for enhancing oral bioavailability’ and ‘Co-processed Excipients’.
Speakers included Kaushik Desai, secretary general, IPEC India, Kevin Hughes, president, IPEC Federation, D R Gahane, joint commissioner, FDA Maharashtra, Dr Iain Moore, senior advisor, EXCiPACT asbl, Dr Ulrich Reichert, head, CDMO and Bioprocess Materials, Regulatory Management, Merck LifeScience, Germany, Dr Rajesh Parab, Hon. treasurer, IPEC India, Vishakha Metkar, regional regulatory director, Colorcon Asia, Aditi Telang, senior manager regulatory affairs, Rouquette, Dr Gaurav Pratap Singh Jadaun, senior principal scientific officer, Indian Pharmacopoeia Commission, Jayakumar AV, president, quality, Ajanta Pharma, Dr Ketkee Deshmukh, head technical, Gattefosse Indias, Dr Nitesh Shah, business director, Asia South, Evonik Dr Parva Purohit, senior vice president R&D, Amneal Pharmaceuticals, Dr Heeshma Shah, director, technical services, Signet Excipients, Dr Rajiv Desai, Sr technical advisor, IPA, Dr Rajkiran Narkhede, senior manager, technical services and applications, BASF, Ravi Kumar, president, formulation R&D, MSN, Dr Shantanu Damle, technical director, Colorcon Asia, Dr. Sudipta Ganguly, vice president & head regulatory affairs global respiratory, EU, Cipla and Wilbur Vaz, manager, regulatory affairs, Colorcon Asia.
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