The Indian Pharmaceutical Alliance (IPA) hosted the first day of its seventh Global Pharmaceutical Quality Summit yesterday. The event brought together leaders from the industry, regulatory agencies, academia and subject experts from India and across the globe to facilitate discussions on “Making quality pharmaceuticals in India, sustainably, for the World.” The day highlighted the importance of sustainable operations in pursuit of quality excellence and strategies that will enable the Indian pharma industry onto the pedestal of a global leader.
In her keynote address, S Aparna, Secretary, Department of Pharmaceuticals (DoP), said, “It is imperative that we maintain the trust and credibility the pharma industry enjoys today. Quality and affordability need to be complemented by innovation and modernity. It is important regulators and stakeholders are aligned to improve access to quality healthcare.”
In his special address, Dr V G Somani, Drugs Controller General of India (DCGI), said, “COVID-19 has been challenging and India has demonstrated its commitment in drug delivery and vaccine supplies by collaborating with relevant stakeholders. Sustainability is the buzzword in the industry and IPA is taking the right efforts in this direction.”
While setting the context of the summit, Sudarshan Jain, Secretary-General, IPA, said, “IPA has been organising the Quality Summit since the year 2016 and has consistently been working towards pursuing quality excellence. This year’s focus is on sustainability as it is the key to a better future.”
Samir Mehta, President, IPA, said, “Achieving quality excellence and improving patient centricity in pharmaceutical operations has always been a priority for the Indian pharmaceutical industry. The industry should evolve from ‘Make in India’ to ‘Make and Discover in India’ and making quality pharmaceuticals in India, sustainably, for the world. We are entering a new paradigm in quality management and this summit aims to cover some important topics in quality with a focus on sustainability.”
Samina Hamied, Vice President, IPA, and Executive Vice Chairperson, Cipla, said, “I strongly believe that quality is a culture, not just a function, and needs to be embedded across fundamental pillars of the industry like operation, our workforce and management systems. A collaborative effort among industry, regulatory bodies, policymakers and healthcare drivers is the key. The seventh edition of GPQS is a step forward in this regard by enabling a knowledge-sharing networking platform on pivotal themes.”
The session on “Future of Pharmaceutical Operations and Quality” was deliberated by Dr Douglas Throckmorton, Deputy Director, Regulatory Platforms, US FDA and Joseph Hughes, Senior Partner, McKinsey and Company.
Dr Sotirios Paraschos, Inspector, Certification of Substance Department, EDQM, delivered a session on “CEP Holder Responsibilities towards EDQM and their Customers.”
Dr Atul Dubey, Director, Pharmaceutical Continuous Manufacturing, USP, spoke on USP’s initiatives for capability building and advancing continuous manufacturing, while Geena Malhotra, Global Chief Technology Officer, Cipla, spoke on Quality by Design – Design to Delivery.
A panel discussion on “How can we achieve Quality Excellence in Pharmaceutical Operations?” saw participation by Kristan Callahan, International Relations Specialist, US FDA India Office; Dr Paraschos, Dr Manisha Shridhar, Regional Adviser, WHO – SEARO and Dr Rubina Bose, Deputy Drugs Controller India, CDSCO. This was moderated by Dr Rajiv Desai, Executive Vice President, Global Quality Head, Lupin.