ABSTRACT:
Pharmaceutical Industry is having tremendous growth in India. Central Drug Standard Control Organization (CDSCO) is the National Drug Regulatory Authority under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India and is responsible for put down the standards and assuring safety, efficacy and quality for Drugs, Approval for Clinical Trials. SUGAM is the online portal for submission of the various applications related to drugs, ethics committee, clinical trial, medical device, vaccines and cosmetics to CDSCO in India. The objective of the SUGAM is to adopt 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 and Family Welfare. The intentions of current study is to apprehend the software and 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.