KARACHI: Federal Investigation Agency (FIA) has approached Ministry of Health seeking guidance in the case of pharmaceutical raw material import without the certificate of Drug Regulatory Authority of Pakistan (DRAP), sources told Customnews.pk on Sunday.
Sources said that the FIA had engineered this case against the Customs without any concrete grounds and the agency was now contacting different ministries to be able to create something against Customs.
It may be mentioned here that earlier, FIA approached Ministry of Commerce but the Ministry’s clarification could not prove Customs at fault.
The FIA has recorded statement of the Customs officers who are accused of clearing pharmaceutical raw material without fulfilling the mandatory requirements.
However, Customs is of the view that pharmaceutical (allopathic) raw material of pharmaceutical grade was cleared by strictly adhering to the provisions of relevant import policy order.
All imports and exports are governed by the import and export Control Act, 1950, and Order made there under called Import Policy Order.
As per the Import Policy Orders from 2005 to date the import of pharmaceutical (allopathic) raw material of pharmaceutical grade is subjected to procedural requirement as mentioned that ‘Import shall be allowed to pharmaceutical industries holding valid pharmaceutical manufacturing license in accordance with the provisions of Drugs (Imports and Exports) Rules, 1976 subjected to the condition that pharmaceutical (allopathic) raw material are of pharmaceutical grade and shall have at least 75 percent of the shelf life calculated from the date of filing of Import General Manifest (IGM) as per provision of Customs Act 1969, excepting those pharmaceutical raw materials specifically allowed by the Director General, Ministry of Health’.
As regards the position taken by investigating staff of the FIA that prior permission from the officer of the Federal Drug Department for each consignment was required, is not supported by law mentioned above.
Further the Federal Board of Revenue’s (FBR) clarification is self-explanatory that ‘It is clarified that since the new Sales Tax Notification SRO 673(1)/2005 does not prescribe any such condition to produce certificate from the Ministry of Health for granting sales tax exemption on pharmaceutical raw material, it is desired that the concerned appraiser staff may be directed to allow release of Imported raw materials for the basic manufacture of pharmaceutical active ingredients and for manufacture of pharmaceutical products, without payments of sales tax and without requiring any certification from the Ministry of Health’.
The FBR’s above mentioned orders were followed in letter and spirit by the field formations. Accordingly for the release of pharmaceutical raw material certificate from Drug regulatory Authority (DRAP) was not demanded by the’ customs if not submitted by the importer cum manufacturers themselves.