Aiming to make the activities of the subordinate offices working under DCGI uniform, transparent and also to be implemented in rational ways, the Central Drugs Standard Control Organization (CDSCO) has issued guidelines for zonal, sub-zonal and port offices in the country.

These guidelines are intended for the guidance of departmental offices only. It sets out the nature of work that the zonal, sub-zonal and port offices of the CDSCO generally carry out and the guidelines about the policy that should be followed in disposing of the work and duties.

As per the 483-pages long guidelines, the broad functions, activities and duties of the zonal and sub-zonal offices include: to participate in the joint inspection for issuance/revalidation of CoPPs as per WHO certification scheme after receiving the application from the manufacturing firm; to participate in the joint inspection for grant/renewal of blood bank license; to participate in the joint inspection for grant/renewal of license for vaccine/ Sera manufacturing units for both human as well as veterinary; and also to participate in the joint inspection for grant/renewal of license for LVP manufacturing units.

Their functions also include: to participate in the joint inspection for grant/renewal of license for notified Medical Devices and Critical Diagnostics manufacturing units; to participate in the joint inspection for grant/renewal of license for bio-tech and bio-similar products manufacturing units; to participate in the inspection of clinical trial facilities and BA/BE centres as directed by the DCGI from time to time; and to carry out surprise check/raid jointly/independently on the basis of complaint received under whistle blower scheme and also from other sources.

As the zonal/sub-zonal offices deal with various applications, the DCGI has specified the targeted time lines and subsequent actions for disposal of the applications received in the office of zonal/sub-zonal offices.

For grant or renewal of blood bank license, targeted time line should be 21 working days from the date of submission of the application for scrutiny of the documents. In case some deficiencies are observed in the documents, notice of compliance should be forwarded to the applicants within this time frame otherwise tentative inspection date should be proposed to the State Licensing Authority with a copy endorsed to the applicant. On conformation of the date, inspection to be carried out and the application shall be disposed of. For grant or renewal of vaccine manufacturing licenses, targeted time line should be 30 working days, and for grant or renewal of medical devices manufacturing licenses, targeted time line should be 21 working days.

Likewise, for approval of institution for carrying out test on drugs, cosmetics and raw materials as prescribed under Rule 150F of Drugs and also for grant or renewal of LVP manufacturing licenses, targeted time line should be 21 working days.

For grant or renewal of bio-tech/bio-similar products manufacturing licenses and for approval BA/BE studies and clinical trial site, targeted time line should be 30 working days. For grant or revalidation of CoPPs, the  targeted time line should be 28 working days and for the issuance of CoPPs for additional products, the targeted time line should be 21 working days.