Vol. 8, Issue 5 (2019)

Author(s):
Sidharth Malhotra, Raghotham S, Urooj Ahmed Khan, Gaurav Kumar Jain and Balamuralidhara V

Abstract:
Medical Devices Industry is having tremendous growth in India. Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India and is responsible for laying down the standards and ensuring safety, efficacy & quality for Medical Devices, Approval for Clinical Investigation. SUGAM is the online portal for submission of the various applications related to manufacturing and import of medical devices and their clinical investigation to CDSCO in India. The objective of the SUGAM is to enable paperless grant of various clearances by CDSCO, consolidate the Indian Drug Regulatory Framework by streamlining the CDSCO processes, permit higher level of transparency in drug regulatory processes. SUGAM is launched by the Ministry of Health & Family Welfare. The intentions of current study are to apprehend the software & online portal requirements and registration process of Pharmaceutical Products in India. The various applications that are submitted through this portal are permission to import drugs, medical devices, cosmetics and biological Permission to conduct clinical trials and BA-BE studies etc. SUGAM plays a major role in Pharmaceutical regulatory sector by making submission more simple and easy. This portal has taken India, a step ahead in the approval of pharmaceutical products.