Pharmacy of the World: Addressing Challenges in Excipient Quality

Dr. Devendra Chavan, senior scientist-II at USP, will shed light on the importance of excipient quality and development for use in medicines.

The Health Master

December 13, 2023

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Last Updated on October 2, 2024 by The Health Master

Excipient Quality

Excipient Quality: In the pursuit of maintaining its image as the Pharmacy of the World, Pharmexcil, the Pharmaceuticals Export Promotion Council of India (Pharmexcil), is set to host a capacity building programme in Bengaluru on December 15, 2023.

This article explores the key highlights of the event, focusing on the prickly challenges surrounding excipient quality in medicines and the crucial role played by the Indian Pharmacopoeia Commission (IPC) in setting pharmacopoeial standards for ensuring the quality of medicines.

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The Theme: Quality Compliance & Patient Safety

1. Importance of Quality Compliance

The overarching theme of the Bengaluru chapter is the “Capacity Building Programme on Importance of Quality Compliance & Patient Safety – Industry Practices & Regulatory Expectations.”

Delving into the intricate aspects of quality compliance becomes pivotal in the pharmaceutical industry, and this event aims to shed light on its significance.

2. Distinguished Dignitaries

The event boasts the presence of esteemed dignitaries, including Guest of Honour Indu Nair, joint secretary, Department of Commerce, Government of India, and Chief Guest T K Anil Kumar, principal secretary, health & family welfare, Government of Karnataka.

Their insights are expected to enrich the discourse on the pharmaceutical landscape.

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3. Panel Session on Access to Affordable Biopharmaceuticals

An intriguing aspect of the event is the panel session on access to affordable biopharmaceuticals.

Experts from the Department of Biotechnology, United States Pharmacopoeia, Biocon Ltd, and the University of Hyderabad will share their perspectives on building a resilient value chain in biopharma to address non-communicable diseases.

4. Pharmexcil’s Ongoing Initiatives

Highlighting Pharmexcil’s commitment to knowledge dissemination, the article touches upon the organization’s recent capacity building programs in Mumbai, Chennai, Hyderabad, and Chandigarh.

These programs, initiated since September 15, 2023, have focused on equipping the industry with good manufacturing practices (GMPs), quality, and safety norms.

Insights from Experts: Navigating Quality and Compliance

5. Resource Persons and Industry Experts

The programme will feature resource persons from the Central Drugs Standard Control Organisation (CDSCO), industry experts, and consultants experienced in highly regulated and semi-regulated markets.

This diverse array of perspectives aims to provide a comprehensive understanding of the challenges and best practices in the pharmaceutical industry.

Click for more articles on CDSCO

6. Chairing the Biopharmaceuticals Session

Dr. SR Rao, former secretary, Review Committee on Genetic Manipulation, will chair the session on access to affordable biopharmaceuticals.

The panelists, including senior figures from USP, Kemwell Biopharma, Biocon Limited, and the University of Hyderabad, promise an engaging discussion on building a resilient biopharma value chain.

7. Role of IPC in Setting Standards

Dr. Gaurav Pratap Singh, principal scientific officer at IPC, will elaborate on the pivotal role IPC plays in setting pharmacopoeial standards for ensuring the quality of medicines.

This session is expected to provide insights into the regulatory framework that governs pharmaceutical quality.

8. Excipient Quality and Development

Dr. Devendra Chavan, senior scientist-II at USP, will shed light on the importance of excipient quality and development for use in medicines.

The discussion will include insights from the USP DEG toolkit and DEG/EG Identification (ID) test in Excipient Monographs.

Panel Session: Regulatory Expectations

9. Panelists and Moderators

The article explores the panel session on “Quality Compliance & Patient Safety- Regulatory Expectations.”

With panelists including Rajshekhar from CDSCO, Dinesh Mahandale from Relicare Tech Services Pvt. Ltd., and representatives from Biocon Limited and IPEC India, the session aims to decode regulatory expectations in the pharmaceutical domain.

Harish Jain, a member of Pharmexcil, will moderate the session.

Conclusion: Fostering a Robust Pharmaceutical Ecosystem

In conclusion, the Pharmexcil’s capacity building programme in Bengaluru is poised to address critical challenges in maintaining excipient quality in medicines.

The event’s emphasis on quality compliance, patient safety, and regulatory expectations reflects a collective effort to foster a resilient and robust pharmaceutical ecosystem.

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.

FAQs

Q: Why is excipient quality crucial in medicines?
- A: Excipient quality is crucial as it directly impacts the overall quality and effectiveness of medicines. It plays a vital role in drug formulation and delivery.
Q: How does the IPC contribute to pharmaceutical standards?
- A: The Indian Pharmacopoeia Commission (IPC) plays a pivotal role in setting pharmacopoeial standards, ensuring the quality and safety of medicines in India.
Q: What are the key challenges in ensuring patient safety in the pharmaceutical industry?
- A: Ensuring patient safety involves addressing challenges such as quality compliance, regulatory expectations, and access to affordable pharmaceuticals.
Q: How does the pharmaceutical industry address non-communicable diseases through biopharmaceuticals?
- A: The pharmaceutical industry addresses non-communicable diseases through the development and accessibility of biopharmaceuticals, as discussed in the panel session.
Q: How can companies adhere to regulatory expectations in the pharmaceutical domain?
- A: Adhering to regulatory expectations involves implementing robust quality compliance measures, which will be discussed in the panel session on regulatory expectations.