Islamabad-Drug Regularity Authority Pakistan (DRAP) has launched an online system for registration of cardiac stents to control movement of fake cardiac products in the market, said an official on Tuesday.

As per new registration process, the importer company of cardiac stents will register the company and product with DRAP, which will be available on the website.

Spokesperson Ministry of National Health & Regulation Services (NHS), Sajid Shah said, “Only authorised stents will be made accessible for patients through this system.”

Official describing the function of system also said that medical facility carrying the responsibility of treatment will also provide the record of patient and the stent with DRAP.

“The provided data will be matched with the registration form to ensure the transparency,” he said.

He said this step has been taken following the directives of ministry to control availability of illegal stents in the market.

This online national registry is unique in a way that for the first time a medical device national registry provides registration for Importer/manufacturer and cath lab/ medical institution.

This registry provides a restricted access which is password protected; therefore, only users registered with DRAP can access their data on the national registry for cardiac stent.

According to new regulatory framework for medical devices, under the directive of federal government about 38 importers have been registered.

The registered importers received establishment certificates mostly within three days after completing the simplified requirements.

Currently, more than 40 new stent products have been registered by now, while ensuring the life saving devices only from high quality assured manufacturers licensed from the stringent authorities of reference countries and certified Conformity Assessment Bodies (CAB), accredited with European Union authority.

Importer and manufacturer of cardiac stent will provide their cardiac stent import data including reference of importation, source (manufacturer), spec, lot no, expiry, quantity, rate and amount, thus will bring a complete transparency.

In addition the importer at the time of sale and supply will provide its sale Invoice information with its product details and institution to which these are sold.

Whereas, on the ‘usage or utilisation side’ the cath labs/ medical institution will provide its purchase data and its patient usage details along with utilised stent data so as to provide a complete track and trace system.

This initiative has been developed and successfully launched by the new dedicated MIS team of DRAP, timely fulfilling their commitment, in the larger interest of patients.

DRAP had faced severe criticism on import of unregistered stents in the country due to which people had to lose their lives.

Supreme Court (SC) had also taken the notice of the issue and directed the government to take preventive measures regarding provision of quality stents with controlled price.