Requirement of registration of manufacturing premises of foreign drugs manufacturer prior to their import in the country under Drugs and Cosmetics Rules – reg

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....tate that Ministry of Commerce is contemplating to remove certain drugs from the restricted list in the new Exim Policy. Notwithstanding this, certain conditions imposed by the Ministry of Health & Family welfare will continue to apply. 2.         Attention in this regard is also invited to the Notification GSR No. 604(E) , dated 24.8.2001 issued by the Ministry of Health and Family Welfare, amending various provisions of the Drugs and Cosmetics Rules, whereby a new provision for the registration, in India, of foreign manufacturers of bulk drugs and formulations, has been introduced. This condition has to be satisfied before imports are effected from any foreign manufacturer of bulk drugs or formul....

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....ry. The notification has also introduced few other provisions viz. enhanced import licence fees, increased validity period of licence, deletion of exemption from requirement of import licence for bulk drugs for actual users, requirement of minimum 60% of retained shelf life for imported drugs and provisions for import of small quantities of new drugs by Govt. hospitals for treatment of their own patients etc. 2         Under the new dispensation, foreign manufacturers have to apply for registration certificate for their manufacturing premises and the individual drugs to be imported. The applications can be made by authorized agents of foreign firms in India. The documents required for registration ....