9th Annual Clinical Trial Summit – 2018

Dr Umakanta Sahoo, Managing Director GCT-India, participated in the 9^th Annual Clinical Trial Summit – 2018 held at Kohinoor Continental Hotel, Mumbai. Pharma companies, CROs, SMOs, Institutions and Regulators discussed the current trends in clinical research in India.

Some of the highlights of the meeting:

• Salient features of the New Drugs & Clinical Trials Rules, 2018:

o    Compensations formula and its implementation
o    Access to investigational drug – post trial and its mechanism
o    Timelines for CT approval
o    Clarification of processes for CT for new Drug, BA BE Trials, Biosimilars / Biologics etc.
o    Empowered EC committee – in approving and deciding on compensation

• Inspection and quality of clinical trials
• Risk-based Monitoring requirements for Indian Sponsors and Sites
• Clinical development of Biologics
• Evolving partnerships for clinical research

Overall, the regulator’s initiative to promulgate the comprehensive new rule for Clinical Trial was welcomed by one and all. It was perceived that global pharma and clinical research community will appreciate these positive trends and will place more trials in India. India is poised to come back soon and contribute significantly with cost competitiveness, fast enrollment, and thus helping global pharma to market their products in the shortest time possible. It was emphasized that all stakeholders should make efforts to promote the positive trends and get trained to understand the newer regulations for effective and meaningful implementation on the ground.