Excipients: Need to enforce stringent Regulatory Standards for quality

Currently, India lacks specific regulations for excipients.

Regulation Law Act

Last Updated on July 12, 2024 by The Health Master


The world of pharmaceutical excipients, the inactive ingredients that make up a medication, is undergoing a significant transformation.

This shift is driven by three key factors: advancements in technology, a global push for harmonization, and an unwavering commitment to patient safety and drug effectiveness.

Global Harmonization and Stringent Standards

A recent panel of experts at the 73rd IPC in Hyderabad emphasized the need for stricter regulations on excipients, particularly as pharmaceutical manufacturing becomes increasingly global.

Aligning with international quality standards is crucial to ensure patient safety and drug efficacy.

Currently, India lacks specific regulations for excipients.

However, the government’s Production Linked Incentive (PLI) scheme acknowledges the importance of this sector by offering financial support to excipient manufacturers.

The Crucial Role of Excipients in Drug Quality

The importance of high-quality excipients cannot be overstated.

As Kaushik Desai, Secretary-General of the International Pharmaceutical Excipients Council (IPEC) India, pointed out, a single excipient can be present in up to 100 different drug formulations.

This highlights the critical role excipients play in a medication’s overall quality.

Regulatory Compliance

Ravleen Singh Khurana, Managing Director of Nitika Pharmaceuticals, stressed that the evolving landscape of excipient quality and regulations is essential for robust pharmaceutical manufacturing and formulation processes.

He emphasized the importance of adhering to established regulatory guidelines such as GMP, IPEC, FDA, WHO, and EXCiPACT.

Prioritizing excipient quality safeguards the future of pharmaceuticals by guaranteeing the safety and effectiveness of medications for all.

Regulatory compliance forms the bedrock of a strong and trustworthy supply chain, ensuring the unwavering quality and safety of excipients.

Learning from Past Incidents

Past incidents of medication-related fatalities have served as a wake-up call for regulatory bodies and the pharmaceutical industry.

The focus has shifted to ensuring excipients meet the highest quality and purity standards to minimize the risk of adverse effects.

This is particularly crucial during the crucial dissolution and disintegration stages of a drug’s action within the body.

India’s Excipient Landscape

While India is a frontrunner in Active Pharmaceutical Ingredients (APIs), the story is different for excipients.

A staggering 70% of India’s excipients are imported, with a whopping 95% coming from the US and Europe to cater to the production of finished drugs for regulated markets.

This highlights India’s significant dependence on external sources.

Additionally, most Indian excipient manufacturers are small and medium-sized enterprises (MSMEs) with limited investment.

The industry currently lacks a major Indian multinational corporation (MNC) player.

Panel Highlights

The conference featured presentations by leading figures in the pharmaceutical industry.

Ketekee Deshmukh of Gattefosee India discussed the niche role of lipid excipients in maintaining drug solubility throughout the digestion process.

Dr. Hemgir Gosavi, Head of the Global Formulation Application Lab at Merck Life Science, explored the concept of continuous manufacturing as a modern approach to scaling up production.

Regulatory compliance in excipient qualification was addressed by Pushpavalli Krishnamurthy, Global Regulatory & QMS Manager at Ingredion, USA.

Finally, Karthik Iyer, Director of Strategic Customer Development for South Asia at USP, shed light on the role of the US Pharmacopeia in driving the quality of medications.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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