This document provides guidance for the grant of permission for Drugs imported in Bulk for Non-Medicinal Use as per Rule 43 of Drugs and Cosmetics Rules 1945. The purpose of this guidance document is to ensure uniform implementation of Rule 43 of Drugs and Cosmetics Rule 1945 by CDSCO. It also specifies requirements to be fulfilled by the Importer for grant of such permissions. Efforts are also made to identify the list of drugs intended for non-medicinal use with the help of stakeholders which can be amended from time to time.

The dual use permissions are usually requested by the manufacturer of bulk drug using one of the bulk drugs as starting material based on the approval of State Licensing Authorities. The dual use permission may also be sought by the other industries like food industries etc. which uses raw bulk substance in lower strength than approved as drug by this organization. Similarly, the Animal feed Industry makes application for the import of raw materials for the exclusive use as animal feed.

The importers of dual use have a responsibility to undertake due diligence before making application for import of material for which following points may be important for consideration:

The drugs already registered for import,

• Approval status of usages of imported item in the country (alone or in combination with other drugs),
• International status (e.g. in most of the countries multivitamins are not considered as drugs hence regulated differently),
• Technical survey through Martindale extra pharmacopeia etc.

The application for dual use import may be made well in advance before the actual import to facilitate technical review for consideration. The permission for dual use items will be granted by Dy. Drugs Controller (India) of the respective Zones.

Based on the intended use of the product, the drugs that are falling under Schedule-D of Drugs and Cosmetic Rules have been categorised into:

1. 1 )Drugs meant for Non- medicinal use.
2. 2 )Drugs meant for Animal feed supplement, Feed premix.

3 ) Drugs meant for further processing / conversion to other drug.

Important Points for consideration

• 1 )The application should be complete before submission to the authorities.
• 2 )Application for dual use clearance is advised to be made by the manufactures or its authorised agent or importer to the authorities well in time for technical review for consideration preferably before the actual import to avoid demurrages. It may be advised that a period of two months before the actual import will be effective for smooth clearance of consignment.
• 3 )The consignment label, bills, invoices etc. in respect of imported items should clearly have indelible marking for its intended use.
• 4 )The applicant for manufacture of a drug using imported drug must have Master Formula Record duly attested by the Licensing authority for import application.
• 5 )The import of drug under dual use for purification or rendering it sterile will not be considered under dual use.
• 6 )The import permission for dual use item can be considered to actual users for the period of one year.
• 7 )If application is made to the Port officer, it will be forwarded with remarks to the Zonal head of CDSCO for review and consideration preferably by e mail / fax. The NOC from Zonal Head via e mail / fax will be sufficient for release.

The Zonal office will maintain data for such releases