Government of Pakistan
Directorate General of Intelligence & Investigation-FBR
1-Mauve area, G-10/4 Islamabad
C.No.3(16)DGCI/TDC/2010/3502 Dated: 09.06.2011
The Collector of Customs
Model Customs Collectorate (Appraisement)/
PaCCS/Port Qasim/Preventive), Karachi/Hyderabad/Quetta/
Multan/Lahore/Sambrial/Faisalabad/Rawalpindi/Peshawar.
ALERT NO. 31 OF 2011
SUB: REGULATION OF IMPORT OF DISPOSABLE SYRINGES, DISPOSABLE INFUSION SETS, CANNULA,S CATHETERS, AUTO DISABLE SYRINGES AND BUTTERFLY NEEDLESS AND DETERMINATION OF THEIR DUTY/TAXES
Reportedly un-registered, sub-standard and in un-approved packing disposable syringes, auto-disable, syringes, cannula etc. are being imported into Pakistan. Use of such Syringes etc. has exposed the masses to multiple health hazards. Besides the exemption from customs duty available to hospitals, medical and diagnostic institutes under SRO 575(I)/2006 dated 5th June, 2006 is being misused by commercial importers of the items.
2. Ministry of Health has declared subject item as ‘Drug’ vide SROs 324(I)/94 dated 19-4-1994, 958(I)/2009 dated 5-11-2009 and 349(I)/2010 dated 18-5-2010. As a result of this decision of Ministry of Health, import, export, sales and manufacturer of in this regard, the last deadline given to the manufacturers and importers vide SRO 350(I)/2010 dated 19-5-2010 to get their products registered has expired on 31st October, 2010, unregistered disposable syringes, disposable sets for collection or transfusion of blood or giving any infusion, cannula, catheters, stents, auto-disable syringes and butterfly needless shall not be allowed.
3. Due to non-regulation of syringe industry, importers and unlicensed syringe manufactures have allegedly remained involved in a number of malpractice like:-
(i) mis-declaration of quantity, value and tariff headings at the time of clearance by customs stations;
(ii) Heavily under invoiced import of syringes, sets, needles etc.;
(iii) most of the times, the commercial importers of subject items obtain customs clearance under SRO 575(I)/2006 dated 5th June, 2006 to enjoy concessionary customs duty @ 5% (instead of 20%). However, the said SRO is meant for direct imports by hospitals, medical and diagnostic institutes having relaxation in customs duty from 20% to 5%;
(i) import of syringes in polyethylene packing exposing the masses to infections diseases because syringes packed in polyethylene packing cannot be sterilized.
4. Recently, Ministry of Health has framed certain rules to regulate licensing registering and advertising, specifications, labeling & packing and import/export of subject items vide SROs 916 to 919 (I)2010 dated 30-09-2010. According to SRO:-
(i) The starting materials used in the manufacturing of the medical device shall be of a grade and quality acceptable for manufacturing of medical devices by the regulatory of Canada or Australia or UK or Japan or as may be specified by the Central Licensing Board.
(ii) The disposable syringes shall be packed only in blister packing and not in polyethylene packing. The packing materials used will be such that, if gas sterilization method is applied, it permits easy permeation of gases across it and does not affect sterility throughout its shelf life.
ii. A medical devise shall be imported only in finished from ready for use. The import of components of a medical device shall not be allowed except in accordance with the conditions specified by the Federal Government.
iii. The medical device so imported shall be available in the country of origin and at least two countries from amongst the USA, Japan, European Union, Australia and Canada and
5. Keeping in view the above, it is requested that all the AFU’s and Ports may please be fully appraised/briefed about the regulation status of syringes and other subject items and advised to ensure clearance of the same strictly according to afore stated rules and procedures.
Signed by
Syed Hamid Ali
Additional Director
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