KARACHI: The clearance of pharmaceutical raw material allegedly by the customs officials without getting prior permission from the Federal Drug Department (FDD) has become a bone of contention between the Pakistan Customs and the Federal Drug Regulatory Authority.
The Federal Investigation Agency (FIA) has already issued notices to 76 customs officials for clearing the raw material.
According to details, the Drug Regulatory Authority was of the view that the customs officials were involved in illegal clearance of pharmaceutical raw material, as the importer Intervac (Private) Limited, Lahore, did not have the clearance certificate, which is mandatory under Rule 15 of the Drug (Import & Export) Rules, 1976.
Confronting the allegations leveled by the authority, the Pakistan Customs was of the view that in terms of Serial No 7, Part-II (Procedural Requirements) to Appendix-B read with paragraph 5(B)(i) of the Import Policy Order (IPO), 2013, the import of pharmaceutical (allopathic) raw material of pharmaceutical grade in the form of unprocessed ingredients is allowed, inter-alia, to pharmaceutical industries holding valid pharmaceutical manufacturing license in accordance with the provisions of the Drug (Import and Export) Rules, 1976.
The Import Policy Order, 2013 stated that the import shall be allowed to pharmaceutical industries holding valid pharmaceutical manufacturing license in accordance with the provision of Drug (Imports & Exports) Rules, 1976.
It may be mentioned here that the similar situation was witnessed during the regime of SRO673(I)/2005 in 2005 which later on was rescinded by SRO 552(I)/2008 and the matter was referred to the Federal Board of Revenue for the clarification and the Board vide its letter No. 1/51-STT/06 dated 16-07-2005 categorically instructed the field formations to allow release of imported raw material for the basic manufacture of pharmaceutical active ingredients and for the manufacture of the pharmaceutical products without payment of sales tax and without requiring any certificate from the Ministry of Health in terms of SRO 673(I)/2005, dated 02-07-2005.
In this regard, the authorities concerned of MCC-Appraisement (East) have already written a letter to the Joint Secretary (Imports), Ministry of Commerce in order to clear the entire scenario as per the law and procedure.
The sources informed Customs Today that the Chief Collector-Appraisement (South) Nasir Masroor has also written a letter to the FIA Director Lahore in which he adopted a viewpoint that the clearance of pharmaceutical raw material was allowed subject to the production of valid pharmaceutical manufacturing license in accordance with the provision of Drugs (Import & Export) Rules, 1976. Needless to mention that the Ministry of Health being the Regulatory Ministry has never objected to the said procedure adopted for the clearance of pharmaceutical raw material.
Mir Mansoor, Principal Appraiser while sharing his views with Customs Today said that he had presented before the authorities concerned of FIA in Lahore and kept a strong point of view according with the procedural requirement of the IPO, 2013 on the behalf of 76 Customs officials, who were allegedly involved in the said case.
“The Drug Regulatory Authority is manoeuvering the said case despite the fact that the procedures are clear in the Import Policy Order, 2013 for clearance of pharmaceutical raw material, adding that the clearance had been done on the authentic manufacturing license of the importer”, he added.
Muhammad Arshad, clearing agent of Intervac, while talking to this scribe by telephone, said that the Drug Act, 1976 has clear instructions for clearance of pharmaceutical raw material that the importer does not need clearance certificate from the Ministry of Health.
He alleged that the officials in the Ministry of Health were asking for speed money in order to issue clearance certificate, due to this the cost of doing business was increased.
