KARACHI: Following the Supreme Court (SC)’s orders to devise a pricing policy for stents, the Drug Regulatory Authority of Pakistan (DRAP) has invited an expression of interest (EOI) for consultancy services to develop a pricing mechanism.
The DRAP is in the process of framing a mechanism for price fixation of cardiac stents, defibrillators, pacemakers, prosthetic heart valves, and cardiac balloon catheters. The EOI has been put out for consultants to carry out the activities including study and research to determine the landed cost of the aforementioned imported items.
The DRAP also intends to determine the components of operating expenses in marketing and sales of the cardiac stents, defibrillators, pacemakers, prosthetic heart valves and cardiac balloon catheters on the basis of prudent management practices.
“Expenses and margin/mark-up in percentage terms in the supply chain of these items will also be required”, the DRAP added.
It has sent the EOI to reputable firms who can suggest a reasonable rate of profit or rate of return on investment to importers and review internationally followed practices on a mechanism for the fixation of price.
The DRAP has sought suggestions to evolve cost-plus pricing mechanism or any alternative mechanism based on empirical evidence.
In this regard, the technical proposals will be opened on 24 April 2017 in the presence of consultants or their authorized representatives.
Earlier, the SC had directed the regulator that the prices of coronary stents should be regulated. The court also directed the chief executive officer of the DRAP to clear all applications pending for the registration of stents [suppliers]. Subsequently, the DRAP Registration Board held a meeting and constituted an Evaluation Cell for the scrutiny of registration applications of cardiac stents, catheters, and cannulas.
The Registration Board reviewed deferred applications of stents with each application thoroughly discussed by the Board along with experts in cardiology. In light of their clinical experience and recommendations regarding safety, efficacy, quality and use, decisions were taken by the Board.
It was also discussed with the cardiologists how many companies they referred to the DRAP for the completion of their registration application and for applying for new applications of products that were badly needed in institute. The registration board considered 32 applications to register medical devices for import and decided to approve 12 applications on the clinical experience and strong recommendations of cardiologists regarding safety, efficacy, quality and use for cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest.
Over 18 applications were rejected due to non-submission of relevant documents and 2 applications were deferred for provisions of further documents. Approved applications are subject to inspections by manufacturers abroad and the verification of storage facilities etc as per policies.
Additionally, the drug regulator has ordered stent manufacturers to put price tags on its products and local and private hospitals to display the price list of coronary stents in a drive to curb unethical profiteering.
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