Keynote address: Indian Pharmacopoeia – The contextual relevance

The insightful keynote address by Dr Rajeev Singh Raghuvanshi, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, MoH&FW, Govt of India set the context for the sessions at Pharma LabNext Conclave 2021.

He gave an overview on the analytical value chain and explained how newer techniques were improving sensitivity and accuracy of data generation while digitalisation and modelling were making data analysis more efficient in pharma R&D. This, in turn, has led to better decision making at the quality and regulatory end.

He said that there are several developments in medicinal products, be it 3D structures, co-crystals, drug-device combinations, biologics, gene and cell therapies or digital therapies. But, this has also increased complexities in R&D, manufacturing and regulation. Therefore, pharma companies have to adapt to these changes, strategise to deal with new realities, plan for contingencies and build new capabilites to survive and thrive in a complex and volatile environment.

He said that India Pharma Inc is growing rapidly and is a major exporter of pharma products worldwide. However, he also highlighted that it has a thriving domestic market as well and there must not be any difference in the quality created for exports and domestic consumption. He emphasised that it is important for the quality of the pharma and medicinal products created for the domestic market to match global standards. He also urged manufacturers and regulators to join hands to rebuild our quality management systems for domestic production of pharma products.

Dr Raghuvanshi went on to give an overview about Indian Pharmacopoeia Commission and its initiatives. He informed that it is working for the benefit of the Indian pharma industry, he spoke on the five areas where IPC has initiated changes since he took charge, i.e. IP-online, impurity limits – harmonising with ICH, dissolution for SR Products, flexible monographs and increasing inventory of impurity standards.

He concluded the session by inviting the industry to partner and support IPC through various ways such as by raising issues and giving suggestions for improvement, joining IPC as advisors and consultants, promoting use of IPRS and IPIS and promoting use of IP.

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