The importer has to fulfill the conditions that are stipulated in the Rules and also comply with following conditions.
Conditions of Import Licence
The importer has to
fulfill the conditions that are stipulated in the Rules and also comply with
following conditions.
1. The manufacturer shall observe undertaking given in Form
9
2. The Licensee should maintain a proper record of imported
drug wherein the entries should be made serially for the stock of imported
material, its distribution, persons to whom the imported drug is issued, price
charged, remaining and quantity of imported drugs. The drug imported for the
purpose of test or analysis or the new drugs imported are not for general use.
3.
The importer should maintain all proper storage facilities for drugs imported
as required in accordance with the provisions of the Act.
4. The importer should permit the inspector or officer on
behalf of the State Government or Central Government without notice to inspect
the premises, stocking facilities, records, analytical details, and sale of
imported substance.
5. The licensee
should withdraw the substance from market if asked to do so by Authority,
iffound that the substance is substandard.
An import licence is
for one category of drug from single manufacturer abroad, or it could be for
more drugs from same manufacturer from one location. Separate licence is
required for import of drugs from different manufacturers or from the same
manufacturer located at different places.
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