Form 10 Waiver Procedures Dual use Drugs for Non Medicinal use only After 15 April 2011

The following Public Notice was issued by the Commissioner of Customs (Import), Jawaharlal Nehru Custom House, Nhava Sheva on 11 March 2011.

[Ref: Public Notice No.26/2011 dated 11 March 2011]

Attention of all Importers, Exporters, Custom House Agents, and the Trade is invited to the Circular No.6-2/2004-DC dated 13.12.2005 issued by the Drug Controller General (I) regarding the procedure to the followed in respect of import of Drugs having dual usage and Drugs which are used as a raw material for the manufacture of other Drugs by the actual users.

The above Circular states that a blanket exemption from registration and from provisions contained in Chapter III of the Drugs and Cosmetics Act as given in Schedule D to the Drugs and Cosmetics Rules cannot be given for import of such categories of Drugs which are not intended for medicinal use or Drugs which may themselves be used as Drugs but are used for manufacture of other Drugs. 

The Circular also states that to waive registration of import Licence in Form 10 for import of Drugs not intended for medicinal purpose, the importer will have to make an application to the CDSEO, HQ, where it will be examined on a case to case basis and necessary waiver from registration and import Licence will be granted accordingly.

However, as the procedures laid down by the Drug Control authorities have been challenged and the matter is now pending before the Hon’ble High Court of Delhi, the clearance of the subject goods has been held up. 

Representations have now been received from the Trade stating that there is loss of production due to non-availability of materials such as Citric Acid and there are no manufacturers of the subject goods in India, and they are totally dependent on the import channels. 

This issue has been examined in consultation with the Drug Control authorities and it has been decided that as a Trade Facilitation measure, the procedures laid down by the Drug Control authorities should be strictly followed after 15.4.2011.

F.No.S/26-Misc-5832/2011 Gr.IIC&D