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Experts stress on need to enforce stringent regulatory standards for excipients

Nandita Vijayasimha, Bengaluru
Wednesday, July 10, 2024, 08:00 Hrs  [IST]

The landscape of quality and regulatory standards for excipients is evolving. This is driven by advancements in technology, global harmonization, and a steadfast commitment to patient safety and product efficacy, said a panel of experts.

At the recently concluded 73rd IPC at Hyderabad, an expert panel deliberated on Excipients-Pharma partner in delivering quality medicines. They stated that as pharmaceutical manufacturing expands globally, there is a need to enforce stringent regulatory standards for excipients to align with international expectations.

Currently, in India excipients are sans regulations but the Union government’s production linked incentive (PLI) scheme extends financial support to this sector, underscoring its importance, stated Ajit Singh, chairman ACG.

Kaushik Desai, secretary-general, International Pharmaceutical Excipients Council (IPEC) India said one excipient gets into 100 of formulations reinstating its quality importance in a medicine.

Noting that the shifting dynamics in quality and regulatory standards for excipients are pivotal in pharmaceutical manufacturing and formulation processes, Ravleen Singh Khurana, managing director, Nitika Pharmaceuticals said, excipients play a crucial role in ensuring product stability. Therefore adherence to regulatory guidelines: GMP, IPEC, FDA, WHO, and EXCiPACT is essential.

By prioritizing excipient quality, we safeguard the future of pharmaceuticals, ensuring they are safe and effective for all. It is here regulatory compliance is the cornerstone of a resilient and trustworthy supply chain, ensuring that the quality and safety of excipients remain unwavering, said Khurana.

The major cause of the fatality incidents that happened in the past are because of excipients. Now these incidences took attention of regulatory bodies and the industry realised the failure was in dissolution and disintegration process due to excipients. We need to ensure that excipients meet high standards of quality and purity to reduce the risk of adverse effects, he said.

Even as India is progressing rapidly in APIs the same is not for excipients. The reality is that India’s dependency on imported excipients stands at 70% of which 95% is sourced from US and Europe to serve regulatory market with finished products. Moreover, India’s excipient manufacturers are mostly MSMEs with limited investments. No Indian MNC is engaged in manufacturing excipients, said Khurana.

Ketekee Deshmukh representing Gattefosee India spoke on ‘Lipid excipients: Carving out a niche pharma drug delivery’. She highlighted on the absorption ability of the formulation to maintain the drug in solubilized state throughout the digestion test.

Dr Hemgir, Gosavi, head, global formulation application lab, Merck Life Science delved on ‘Continuous manufacturing: A modern way to scaling up operations’. Pushpavalli Krishnamurthy, global regulatory & QMS manager, Ingredion, USA presented on the topic ‘Navigating the regulatory compliance in qualification of safe excipients: Challenges, Trends and Best Practices’. Karthik Iyer, director, strategic customer development, South Asia USP focused on ‘Role of US Pharmacopeia in driving medicine quality.

On a concluded note, the experts concurred that identifying and mitigating potential risks associated with excipient sourcing, manufacturing, and distribution will only prevent contamination or adulteration of medicines.


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