New Delhi| The conference witnessed the presence of representatives of the European and Indian pharmaceutical & medical device authorities, CRO and industry to discuss unclear areas and uncover practical implementation solutions that address the implications of the new regulatory requirements.

Speaking on the occasion of the inaugural session of the conference, the Chief Guest, Gopal Krishna Aggarwal, National Spokesperson BJP for Economic Affairs said that government under the leadership of Prime Minister Narendra Modi Ji is always open to getting new ideas to further enhance overall all welfare and healthcare system of our country. He added that Indian pharmaceutical industry plays a key role in driving better health outcomes across the nation through its affordable and high-quality generics drugs, and that such Regulatory and Quality submit with objective to bring collaboration between Indian regulators and pharmaceutical industry and other countries especially regulated countries like Europe would really help to further enhance the mechanism of regulation to ensure high quality of healthcare product and medicine .

Dr. VG Somani, Drug Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), in his keynote address remarked that India is trying to be member of ICH ( International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), India is in process to sign MoUs USFDA, Japanese and African Regulatory Authorities also. The PM’s policies of Make in India, Skill India, Startup India and Ease of Doing Business have been incorporated in framing new regulations.

The online portal developed by CDSCO for filing and submission of applications has sped up the regulation process and it needs awareness and cooperation from other stakeholders. New Drug and Clinical Trial Rules have been framed and has been in place from 19th March 2019. It is a very good step in simplifying rules for new drugs and Clinical Trial. A new Public Relations Office (PRO) has been set up in the CDSCO for solving the problems faced by the industry. He also welcomed startups and innovation in the medical sector and stressed the need for developing the category of ‘Phytopharmaceuticals’ so as to create data for traditional Indian medicines. IAS Mr. Sudhanshu Pant. Joint Secretary, Ministry of Health and Family Welfare was also present and he appreciated efforts to carve out through such knowledge sharing sessions to work out a novel approach towards the sensations of a sustainable future in regulatory affairs.