L.B. Singhal
Director General

Sub: Exemption from the requirement of registration by the Drug Controller General of India, under the provisions of Drugs and Cosmetics Act, for 100% EOUs/SEZ Units.

As you are aware, for import of drugs, registration under Drugs and Cosmetics Act had been made mandatory with effect from 1.4.2003. The Council had received representations that this is causing problem for 100% EOUs/SEZ Units . Accordingly, we had taken up this issue with Drug Controller General of India and Ministry of Commerce. Ministry of Commerce had taken up this issue with Drug Controller General of India as well.

Now DGFT has issued a Policy Circular No.9(RE-2003)/2002-2007 dated 30.6.2003 which has provided exemption to 100% EOUs/SEZ Units from the condition of registration. However, if these units make supplies to the domestic markets, they will have to follow the formalities of registration under the Drugs and Cosmetics Act. The details may please be seen in the above stated Policy Circular. Policy Circular is available on the DGFT website www.nic.in/eximpol

This is for your information, please.

(L.B. Singhal)
Director General