Indian Pharmaceutical sector, noting a significant increase in foreign sponsors' confidence in Indian testing facilities: Dr. Ekta Kapoor

Indian Pharmaceutical sector, noting a significant increase in foreign sponsors' confidence in Indian testing facilities: Dr. Ekta Kapoor
“Role of AI in Diagnostic Parasitology: Focus on Neglected Tropical Diseases” on 27/03/2024. Chief Guest for the CME would be Prof. C.M Singh, Director, Dr.RMLIMS, Lucknow
Lucknow। The Central Drug Research Institute (CDRI), Lucknow, recently hosted a one-day symposium shedding light on Good Laboratory Practice (GLP) studies and the essential requirements for Investigational New Drug (IND) submission.


The symposium, held at CSIR-CDRI, welcomed esteemed experts in the field of GLP studies, regulatory affairs, and pharmaceutical compliance. The symposium also served as a platform to honor the illustrious career of Dr. Sharad Sharma, Chief Scientist at CDRI, who is retiring this month. Dr. Radha Rangarajan, in her welcoming address, acknowledged Dr. Sharma's significant contributions to the Institute particularly for GLP facility. She also shed light on the importance of GLP certification for a research Institute like CDRI which has significant role in drug discovery and development.

The symposium featured distinguished speakers, each offering unique perspectives and insights into key aspects of GLP studies and IND submissions. Distinguished speakers included Dr. Sebastian Joseph, Senior Director at PharmaLex and a renowned toxicologist; Dr. Manthan D Janodia, Professor in the Department of Pharmaceutical Regulatory Affairs and Management at Manipal College of Pharmaceutical Sciences; and Dr. Ekta Kapoor, Head of the National GLP Compliance Monitoring Authority of Department of Science & Technology, Govt. of India.

Further in session Dr. Sebastian Joseph emphasized the importance of customization in IND-enabling preclinical studies. He said, to address regulatory inquiries effectively, meticulous data maintenance and systematic evaluation of it is a key component of GLP studies. Dr. Manthan D Janodia delved into the pivotal role of GLP studies in pharmaceutical regulatory compliance, highlighting their contribution to both scientific advancement and economic growth. He underscored the regulatory imperative to minimize risks associated with drug development and also emphasized the inherent uncertainty in drug safety. Dr. Ekta Kapoor's presentation was focused on India's journey towards full adherence to the Mutual Acceptance of Data principles. She highlighted India's achievements in the pharmaceutical sector, noting a significant increase in foreign sponsors' confidence in Indian testing facilities, with 40-45% now relying on data generated within the country.

At the end of symposium, all Scientist of CDRI expressed their profound gratitude for Dr. Sharma's unwavering dedication and significant contributions to the institute's success in establishing itself as a renowned GLP laboratory. Many of them shared their fond memories with him. The Director of CDRI, in a touching gesture, personally honored Dr. Sharma, acknowledging his invaluable role in shaping the institute's trajectory and fostering a culture of excellence.

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