Experts gathered at the 73rd IPC in Hyderabad emphasized the evolving landscape of excipient quality and regulatory standards, attributing this shift to technological advancements, global alignment efforts, and a strong commitment to patient safety and product efficacy.
During discussions themed around “Excipients-Pharma Partner in Delivering Quality Medicines,” panelists highlighted the critical role of excipients in pharmaceutical manufacturing worldwide. They underscored the need for stringent regulatory frameworks in India to meet international standards, noting the absence of specific regulations for excipients despite their integral role in formulations.
Ajit Singh, Chairman of ACG, pointed out the significance of India’s production-linked incentive (PLI) scheme in supporting the excipient sector, emphasizing its pivotal role in pharmaceutical formulations.
Kaushik Desai, Secretary-General of IPEC India, reinforced the importance of excipient quality, noting their presence in numerous formulations and the crucial role they play in ensuring product stability.
Ravleen Singh Khurana, Managing Director of Nitika Pharmaceuticals, stressed adherence to global regulatory guidelines such as GMP, IPEC, FDA, WHO, and EXCiPACT. He emphasized that regulatory compliance is fundamental in maintaining a resilient and trustworthy pharmaceutical supply chain, critical for ensuring excipient quality and safety.
Khurana also highlighted past incidents where excipients were implicated in fatal outcomes, prompting regulatory bodies to scrutinize dissolution and disintegration processes. He emphasized the need for excipients to meet rigorous standards of quality and purity to mitigate risks of adverse effects.
The discussion also shed light on India’s dependency on imported excipients, which accounts for 70% of the market, predominantly sourced from the US and Europe to meet regulatory requirements for finished pharmaceutical products. Khurana noted that while India excels in APIs, the excipient sector is predominantly comprised of MSMEs with limited investments, lacking participation from Indian MNCs.
The panel sessions covered diverse topics including lipid excipients’ role in drug delivery, modern continuous manufacturing techniques, and the challenges and best practices in regulatory compliance for excipients. Experts unanimously agreed on the importance of identifying and mitigating risks associated with excipient sourcing, manufacturing, and distribution to prevent contamination or adulteration of medicines, safeguarding public health.
In conclusion, the deliberations at the IPC underscored the critical need for India to strengthen its regulatory framework for excipients, aligning with global standards to ensure safe and effective pharmaceutical products.