Parliamentary Secretary for National Health Services Dr Darshan on Thursday said that the government under Drug Regulatory Authority of Pakistan issued Statutory Regulatory Order (SRO) for legalizing the import, sale and usage of medical device stent.
Speaking in the National Assembly during question hour, he said the stents would be imported if these were approved for use and sale by regulatory authorities of USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherland, Norway, Spain, Sweden, Switzerland, UK, WHO, prequalified by the CABs, notified by European Union Directive.
He said the government took steps to ensure availability of high standard stents for cardiac patients in the country in order to save them from spurious and sub-standard stents.
The government has issued a directive to the Policy Board and Drug Regulatory Authority of Pakistan (DRAP) to take measures to ensure that the prices of cardiac stents remain stable and within the reach of common man, he added.
The DRAP, he said had also issued an advisory to the provincial government and all concerned for taking measures to check the irrational, restrictive, exorbitant prices and huge unethical profiteering in cardiac stents during cardiac procedures including stenting in public and private sector.
A committee has also been constituted to review the existing Medical Devices Rules, 2015 in order to implement them with practical consideration and ground realities, he remarked.
Parliamentary Secretary said that application forms for grant of Provisional Establishment Certificate and for Provisional Registration of a medical device for import had been devised and uploaded on the official website of DRAP and widely publicized in the print media.—APP