LAHORE - The Punjab government has banned the use, storage and procurement of unregistered stents, a practice already prohibited as per rules of Drug Regulatory Authority of Pakistan (DRAP).
The move comes after fleecing of heart patients by the medical mafia and flooding of the market with unreliable coronary stents hit the headlines, prompting the apex court to take notice of the issue.
The imposition of this ban now is a testimony to the murky state of affair in the health sector and it has left many heart patients wondering about the quality of the stents they have already got implanted. Interestingly, the decision is only for public sector cardiac institutions as those in the private sector fall in preview of Punjab Healthcare Commission (PHC) and not Secretary Specialised Healthcare and Medical Education. The SH&ME Department has directed heads of specialized healthcare institutions and tertiary care hospitals in the province to stop use of unregistered stents both for private and general patients. They have also been stopped from storing or procuring such items in bulk or through local purchase. Unregistered stents should also not be procured for model pharmacies of the institutions.
The heads of Cardiology Department have been directed to ensure that no outsider vendor is found selling these stents in the premises of hospitals. The Department has warned that strict legal action would be taken against those using unregistered stents or violating instructions. As the PHC has not come into picture as yet, it seems that either the government is not interested in stopping use of unregistered stents at private cardiac institutions or there is no such issue in the private sector.
Medical community believe that there was no need of issuing fresh instructions as unregistered implants could not be used both in the public and private sector as per the DRAP rules. The only thing needed to be done, doctors say, was to enforce DRAP rules and check illegal practice in public and private sector.
Despite prohibition as per DRAP rules, consultants at public sector cardiac institutions were implanting these unregistered stents for monetary benefits. Vendors of importers were freely roaming inside the premises of Cardiac Departments of tertiary care hospitals and specialized cardiac institutions including Punjab Institute of Cardiology. This practice is more common in the private sector where there is no need of inviting tenders for procurement of implants. Increasing complaints of using unregistered stents in Angiography despite availability of more than 55 registered brands caused Federal Investigation Agency (FIA) to conduct a raid at Mayo Hospital in mid January, confiscating illegal implants. On the recommendation of consultants at Mayo Hospital, patients were purchasing unregistered stents from agents of importers roaming inside the health facility.
Recovery of unregistered implants and fear of same practice at other institutions created unrest among patients, causing the government to take steps that could be seen.
The biggest specialized cardiac institution in the province, the PIC had gone one step ahead of Mayo Hospital by placing order of supplying 100 resolute onyx stents of different sizes manufactured by Meditronics USA to the importer, ACP System. PIC purchased 100 stents costing Rs12.5 million, each Rs125,000, from ACP System.
The purchase order clearly showed that the said device was approved by the Food and Drug Administration (FDA) of the US for patients’ use. But consumer access to FDA website showed that the device was not approved for patients use. Actually, resolute onyx stent is still in trial and not approved by FDA for implantation to patients in the US.
Interestingly, PIC Chief Executive Prof Nadeem Hayat Malik purchased unregistered stents knowingly that it was against law. As a member of committee probing case of procurement of unregistered suture for PIC in April 2015, he recommended action under PEDA rules against 11 consultants and administrative doctors including ex CEOs of PIC Prof Jawad Sajid and Prof Azhar.
The committee also recommended recovery of Rs66.8 3 million from these consultants and administrative doctors.
Chatters’ consignment
confiscated
FIA yesterday claimed to have seized 20,000 unregistered catheters (a drug supposed to be used in cardiac treatment with stents) from Allama Iqbal International Airport (AIIAP).
An FIA officer said that above said drug was being imported by the company whose stents were already seized in Lahore a few weeks ago. The spokesman for FIA said that on information a consignment of illegal catheters/stents at Lahore Airport was examined and it appeared that these drugs were imported illegally with fake stamps.
Consignment has been seized at Airport and necessary legal action is being initiated along with DRAP and Health department.