Global experts highlight tech and quality at IPA’s Pharma Summit 2024

New Delhi: The Indian Pharmaceutical Alliance (IPA) successfully concluded the 9th Global Pharmaceutical Quality Summit 2024, themed “Advances in Manufacturing and Quality – Patient Centricity.”

The two-day event brought together industry leaders, global regulators, quality experts, and stakeholders to discuss critical topics shaping the pharmaceutical landscape in India.

With 16 sessions and 45 speakers, the summit saw participation from senior officials from the Government of India, USFDA, MHRA, and IGBA. Sudarshan Jain, Secretary General of IPA, delivered the welcome address, followed by opening remarks from Nilesh Gupta, Chair of the Quality Committee at IPA and MD of Lupin, and Patrizia Cavazzoni, Director of CDER at USFDA. Special remarks were given by Rajeev Raghuvanshi, Drug Controller General of India, and Arunish Chawla, Secretary of the Department of Pharmaceuticals.

The first day focused on strategic priorities, quality management, and technological advancements in the pharmaceutical industry. The release of the IPA Best Practices Guideline on Good Engineering Practices and Process Analytical Tools was a key feature. Sessions explored AI’s role in enhancing pharmaceutical quality, the importance of cybersecurity, and strategies to minimize cross-contamination. The day concluded with discussions on future data and documentation imperatives for compliance and quality.

Sarah McMullen, Country Director of USFDA, opened the second day, followed by sessions on regulatory reforms led by Chandrasekhar Ranga, Joint Drugs Controller of India, and Susana Almeida, Secretary General of IGBA. Discussions also covered talent acquisition and skilling institutes for quality manufacturing. Panel discussions on the future of pharma quality and operations, and the biopharma opportunity, featured leaders from top pharmaceutical companies. The summit concluded with Nilesh Gupta emphasizing continuous improvement and a strong quality culture.

Sudarshan Jain Secretary General, Indian Pharmaceutical Alliance, highlighted “This year’s theme, ‘Advances in Manufacturing and Quality with focus on Patient Centricity,’ highlighted the unwavering commitment of the industry to enhance the culture of quality in the pharmaceutical sector, always prioritizing patient welfare. Our focus is on reimagining the future of manufacturing and quality through leveraging technological advancements, seizing the digital future of pharma quality operations, and adopting a shift in mindset. The insights and collaborations will significantly advance quality in the pharmaceutical industry.”

Rajeev Raghuvanshi, Drug Controller General of India, Government of India, said, “Changing the culture is a slow process, but the journey has started well, and we are moving in the right direction. One of the most impactful initiatives is the risk-based inspections, where we inspected about 400 manufacturing units, closing more than 36% for non-compliance. This has significantly improved perceptions and realities on the ground. The first group of industries with more than 250 crores of turnover will soon come under the compliance purview of the revised Schedule M, ensuring higher standards and better quality. Additionally, we are enhancing internal processes, including the transfer of 207 officers to raise a culture of quality and integrity. Our ongoing efforts aim to bring consistency and efficiency to the regulatory framework.”

Arunish Chawla, Secretary, Department of Pharmaceuticals, Government of India, said, “Quality is of paramount focus – standing on three essential pillars: market, patient, and neighbour. Market quality commands a premium and builds reputation, which is our best defence against malpractices. Patient quality is driven by robust regulatory systems, and India is progressing rapidly on this front. Our mission going forward is to make quality the center of policy framework. We’ve upgraded Schedule M of the Drug and Cosmetic Rules, surpassing WHO GMP standards in some areas. With the audits starting in July 2024, we aim to produce world-class products, as emphasized by the Prime Minister’s vision of ‘Zero defect and Zero effect.’ Quality requires investment, and we support medium and small plants through reform initiatives.”