Guidelines for availment of input combination for pharmaceutical products manufactured through Non Infringing (NI) process - DGFT Clarifies
TRADE and Industry belonging to Pharmaceutical sector and the Pharmaceutical Export Promotion Council have been representing before Department of Commerce that neither the Standard Input Output Norm (SION) notified for the pharmaceutical products nor the ad hoc norms ratified for such products by DGFT, allow them the actual requirement of inputs for manufacture of drugs (particularly the APIs) through Non Infringing (NI) process. So they have been requesting for inputs combinations based on actual consumption for such products.
DGFT clarifies that “Once a SION has been notified for a product based on all Industry average or the ad hoc norm for the product is ratified, inputs and the corresponding quantities are allowed as per SION or ad hoc 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 ad hoc norm, irrespective of the country of export.”
However DGFT has decided to incorporate a new provision to allow this facility to pharmaceutical sector subject to fulfillment of certain specified condition and documentation. Accordingly Notification No. 22 dated 14.02.2011 and Public Notice No.29 dated 14.02.2011 have been issued, detailing the new provision. (Please see – 15 02 2011)
DGFT Policy Circular No. 19/(RE-2010)/2009-14 Dated: February 14, 2011