Zonal Officers gets authorization from the Drug Controller General of India (DCGI) to sign test licenses in Form 11 of the Drugs and Cosmetic Rules, 1945 which is used for importing small quantities of drugs for the purpose of conducting bioavailability/bioequivaience (BA/BE) study. On the subject, in the continuation of orders from office on 30.09.2014, 16.10.2014 and 06.01.2015, the decision is made to change the delegation of power as the signing authority in test licenses in Form 11 is granted to zonal offices of Central Drugs Standard Control Organisation (CDSCO). CDSCO is the Indian regulatory body under which medical devices are regulated in India. Learn more about registration of medical devices in South East Asia markets.

The order from DCGI read “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 zonal offices received this power under Rule 22 of Drug and Cosmetics Rules, 1945. READ ALSO: CDSCO India Authorized Agents for medical device registration.