ISLAMABAD: In light of severe criticism from certain quarters over the recent stent scam unearthed in Lahore, the chief of the premier drug body shot back on Sunday.
“It is unfortunate that some groups trading in medical devices are trying to defer and halt the regulation process from time-to-time so that they can continue enjoying an unregulated system at the risk and cost to patients,” Aslam Afghani, the chief executive officer of the Drug Regulatory Authority of Pakistan (DRAP), said in a statement on Sunday.
Pakistan Drug Lawyers Forum and Pakistan Young Pharmacist Association had in a press conference on Wednesday termed the alleged stent scam “a drama” and spoke against various anomalies at DRAP.
They alleged the stent scam making headlines in media had been crafted so that around 11 Chinese companies registered despite violating the rules, could turn a profit. They had also alleged that the DRAP chief was a partner at a medical supply company and helped register 11 Chinese stents.
Afghani rejected the allegations.
He said that some vested interests and lobbies were out to maximise profits at the cost of public interest and that no vilification campaigns would stop them. He claimed that sweeping reforms in drug regulations have unnerved the drug mafia and there will be no compromise.
The DRAP chief went on to say that the authority had registered 55 stents with 25-60 variants (sizes) of each stent since 2010 which had been approved mostly from medical authorities in the US, Japan, European Union. A few from countries such as Turkey and China too had been registered but after thorough evaluation and on-site inspection to check whether they complied with good manufacturing practices.
Cardiac stents approved by DRAP, Afghani said, cover most requirements such as old and new advanced types, bare metal and drug-eluting stents. For special requirements, applications can be processed as soon as the applicant completes the mandatory requirements for quality, safety and efficacy.
Regarding the recent episode of cardiac stents in Lahore, the initial report of the Federal Investigation Agency (FIA) cited three main aspects of the case including regulatory and legal issues, financial scam and unethical practices of using expired, fake, copy, falsely claimed approval of the European Union Regulatory Authority.
Moreover, to register stents, DRAP had recently promulgated the Medical Devices Rules 2015.
Regarding the prices of stents, a comprehensive regulation covering all types of medical devices is under phase-wise implementation.
The statement further denied allegations that one stent with different sizes was registered to a Karachi-based company.
Afghani said that some companies, whose cases for unauthorised manufacturing of unregistered drugs and violations of licensing conditions are being processed, were involved in the media campaign against DRAP.
Published in The Express Tribune, January 30th, 2017.
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