Guidance Document for Functions and Responsibilities of Zonal, Sub-Zonal and Port offices of CDSCO

The Central Drugs Standard Control Organization (CDSCO) has published a guidance document for the functions and responsibilities of Zonal, Sub-zonal, and Port offices. The document aims to provide uniformity, transparency, predictability, and accountability in the execution of CDSCO's activities and functions. It outlines the broad functions and activities of Zonal and Sub-zonal Offices, including the scrutiny of applications and participation in joint inspections for issuance/revalidation of Certificate of Pharmaceutical Products (COPPs), grant/retention of licenses for manufacturing or risk-based inspection, and other technical functions.

The document also lists administrative functions, such as maintenance of service records, leave records, and handling of cash and accounts. The targeted time lines for disposal of applications received in the office of Zonal/Sub-zonal offices are specified, including 21 working days for grant/renewal of Blood Centre license, 30 working days for grant/retention of Vaccine manufacturing licenses, and 45/60 days for grant of Medical Devices Manufacturing licenses.

The document includes annexures listing procedures to be followed during on-site evaluation (OSE) by Drugs Inspectors, screening of applications for COPPs, CLAA items & Approved Testing Laboratories, and other checklists for various activities. The document also outlines the responsibilities of Port offices, including processing of import/export applications, conducting inspections, and issuing licenses.

Overall, the guidance document aims to ensure that all CDSCO offices follow uniform procedures and guidelines in carrying out their functions and activities, ensuring transparency, predictability, and accountability.