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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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....registration of manufacturing premises of foreign drugs manufacturer prior to their import in the country under Drugs and Cosmetics Rules – reg. I am directed to invite your attention to the above mentioned subject and state 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....

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....fare (copy enclosed) . In case of doubt the local Assistant/Deputy Drug Controller may be consulted. 3. The new provisions will apply to all consignments of drugs & formulation imported from 1.4.2003 onwards (The provisions were to come into effect initially from 1.1.2003, but were subsequently extended by 3 months). 4. You are, therefore, requested to bring to the notice of all concerned by iss....

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....0% 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....

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....istration certificate shall be insisted in respect of an inactive bulk substance to be used as pharmaceutical aid for manufacture of drug formulation. The registration may be suspended or cancelled in the event any violation of the conditions for registration comes to notice. The new registration and import licence scheme shall also cover diagnostic kits viz. HIV I & II, HbsAg and blood group reag....