The Drug Controller General of India (DCGI) has authorised zonal officers to sign test licenses in Form 11 of the Drugs and Cosmetics Rules, 1945 for import of small quantities of drugs to conduct bioavailability/bioequivaience (BA/BE) study for export.

“In continuation to this Office Order issued on 30.9.2014, 16.10.2014 and 06.1.2015 on the subject matter, it has been decided to modify the delegation of power to sign test license in Form 11 already granted to the zonal offices of Central Drugs Standard Control Organisation (CDSCO) under their jurisdiction under Rule 22 of the Drugs and Cosmetics Rules, 1945.

“The zonal officer are hereby authorised/delegated to sign test licenses in Form 11 of the Drugs and Cosmetics Rules, 1945 for import of small quantities of drugs which are approved for more than four years in the country intended for conducting BA/BE study for the purpose of export in healthy human volunteers,” the DCGI in his order said.

The DCGI has delegated this powers to the zonal offices of CDSCO under Rule 22 of the Drugs and Cosmetics Rules, 1945 under the conditions that the dosage form must be approved by CDSCO and must be more than four years old; the strength must be same as approved. In case the strength is not mentioned in the new drug data base, the study of lower strength be only considered; and the study must be conducted in healthy and adult human volunteers only. The application for study in patients must not be accepted.

In order to have uniformity in disposal, the application of BA/BE centre located under your jurisdiction will only be accepted for pre-screening. The following procedure is to be followed:  The applications are to be scrutinized as per checklist no. 5 published in the CDSCO website (copy enclosed as FIA). Any other categories of applications are not to be accepted. The review of application to be carried out as per enclosed format (F/B). The test license is to be issued with conditions as per attached format (F/C). The applications are to be disposed of in 10 working days (two weeks), the DCGI in his order said.

The records of such applications received, reviewed and disposed are to be maintained by each zone. All zonal heads are required to submit monthly status report of such applications to this office for information and records, the DCGI order further said.