With a view to streamline the regulatory submission procedure, the veterinary division of the Central Drugs Standard Control Organization (“CDSCO”) has mandated the online submission of applications in Form-44 for issuance of New Drug permissions of Vaccines / Drugs for Bulk Drugs (API) in Forms 45-A/ 46A, finished formulations in Forms-45 /46, and Field Trial Permissions through the online SUGAM portal (www.cdscoonline.gov.in). Further, it has been clarified that the facility of offline submission of applications in Form-44 in hard copy/ through e-office may not be available for processing.
A Copy of the Circular is linked below for your ease of reference.
Source: Central Drugs Control Standards Organization
