TMI BlogRequirement of registration of manufacturing premises of foreign drugs manufacturer prior to their import in the country under Drugs and Cosmetics Rules – regX X X X Extracts X X X X X X X X Extracts X X X X ..... ugs 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 formulations. A provision has also been introduced for obtaining import permission from the Drug Controller of In ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 certificates have been clearly specified in the amendments. The validity of registration certificates will be 3 years from the date on which these are issued. A fee of 150 USD is to be charged for the registration of overseas manufacturer’s premises and fee of 1000 USD will be charged for every individual drug. The rules provide now for inspecti ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... additional drug. The exemption from import licences for the import of bulk drugs by the formulations for actual use under Schedule D has been deleted. A provision has been made that only drugs with minimum 60% of retained shelf life shall be allowed to be imported in the country. 4 A separate provision has been made to enable the Govt. hospitals to import small quantities of essential new drugs for the treatment of their own patients. The fee for such import licences has been kept Rs. 100/- for a single drug and the rate of Rs. 50/- for each additional drug. - Circular - Trade Notice - Public Notice - Instructions - Office orders Tax Management India - taxmanagementindia - taxmanagement - taxmanagementindia.com - TMI - TaxT ..... X X X X Extracts X X X X X X X X Extracts X X X X
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