Guidelines for availment of input combination for pharmaceutical products manufactured through Non Infringing (NI) process.

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..... Dated: 14 th February, 2011. To All Regional Authorities (RAs); All Commissioners of Customs; All Commissioners of Excise; Trade I .....

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..... also been brought to notice that the product patent for a number of pharmaceutical products patented in the country of import, particularly in the developed markets, have expired or are in the verge of expiry. However the process patent still exists for such products. India has great potential to get a major share of production of such products adopting a different manufacturing process (without .....

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..... as per SION or adhoc norms only and no additional quantity of input (irrespective of actual consumption) is allowed. Hence the manufacturer of pharmaceutical products through NI process, are not entitled for actual wastage than that of all Industry average of wastage norms (SION) or adhoc norm, irrespective of the country of export. 4. In view of above and various in-house deliberations, it .....

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..... specific and exporter specific. 6. Trade Industry is requested to see the details of the provision carefully in the aforesaid Notification and Public Notice on the subject. Any difficulty in implementation of the aforesaid guidelines shall be brought to the notice of this Directorate immediately. This issues with the approval of DGFT. Sd/- (Tapan Mazumder) Joint Dir .....

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