National Workshop on Regulatory Compliance for Accelerating Innovations
DATE OF POST: May 16, 2019
The Department of Biotechnology (DBT) and Central Drugs Standard Control Organisation (CDSCO) along with Biotechnology Industry Research Assistance Council (BIRAC) and Clinical Development Services Agency (CDSA) had organised an one-day interactive program, “National workshop on regulatory compliance for accelerating innovations” on February 08, 2019 with Venture Center, Pune. This was one of the 6 national programs being planned across the nation. DBT (which includes BIRAC and CDSA) works closely with the Indian drug regulators (CDSCO) and innovators to facilitate the journey from ‘bench to bed side’ faster. Venture Center is based at Pune is working with various innovators, start-ups by providing all assistance like incubator facility, mentorship, funding support etc.
Our Hon’ble. Prime Minister had launched the Make in India initiative on September 25, 2014, with the primary goal of making India a global manufacturing hub. There are 25 sectors assigned in ‘Make in India’, biotechnology being one of them. This workshop was aimed to facilitate “Make in India” drive by helping the innovators by offering them with an opportunity to interact with the regulators. The main theme was to resolve regulatory issues thereby facilitating market authorization wherever applicable. This series was planned as per the one of the recommendations of the inter-ministerial meeting at the NITI Aayog. First workshop of this series was organized on December 10, 2018 at ICGEB, New Delhi. The next workshop is scheduled on April 09, 2019 at C-CAMP, Bengaluru.
The workshop was attended by senior representatives from Government organisations, academia, medical device industry, in vitro diagnostics, new drugs, biopharma, phytopharma representing various start-ups, hospitals, institutes etc. There were total 96 participants representing 67 institutes who attended this interactive meet. There were 9 faculties including senior experts, present and former regulators from CDSCO (Central Drugs Standard Control Organisation); BIS (Bureau of Indian Standards); CDSA, THSTI (Translational Health Science & Technology Institute); NABCB, QCI (National Accreditation Board for Certification Bodies, Quality Council of India) and NIB (National Institute of Biologicals). There were 3 major themes (medical devices; new drugs & phytopharma and biopharma) and all questions were addressed by the regulators.