ISLAMABAD: Though the Supreme Court has taken notice of the sale of unregistered, overpriced and substandard stents, the issue can only be addressed if regulations are put in place and all stakeholders are made bound to implement them.

Drug Regulatory Authority of Pakistan (Drap) Chief Executive Officer (CEO) Dr Mohammad Aslam claims that not only a committee has been set up to regulate the sale of stents but a decision has also been taken to involve Pakistan Medical and Dental Council (PMDC) to stop malpractices by the doctors.

Stents are small, expandable tubes that are used to treat narrowed arteries in the body. In people with coronary heart diseases caused by the built-up of plaques, stents can open narrowed arteries, reduce symptoms such as chest pain and help avoid a heart attack.

A doctor of Pakistan Institute of Medical Sciences (Pims) requesting not to be quoted said it was unfortunate that stunts were not sold through medical stores.

“Hospitals have allowed three or four representatives of companies of their choice to sit outside their cardiac centres and sell stents to the patients. As there are many types and sizes of stents ranging from 2mm to 3.8mm, patients can never get an idea about the exact price of a stent.”

He said stents were available from Rs35,000 to Rs150,000 while absorbable stunts (made of tissues) were sold for up to Rs350,000. On some stents, a special medicine is applied to make them resistant against blood clotting. These medicated stents also remain functional for a long time. As stents are made in China, Germany, Hong Kong, USA and other countries, their prices are also different, he said.

“Besides, whenever doctors participate in international conferences, they get free stents for experimental purposes to give reports about their performances. But in the end, some of these stents are sold or at least the patient remains unaware of an experiment being made on them. Only a strict regulation can stop such a heinous business of stents,” he said.

Pakistan Drug Lawyers Forum (PDLF) president Dr Noor Mohammad Mahar said Drap had registered stents without fixing their prices which was a clear violation of Section 12 of Drugs Act 1976.

“Stents are being imported at the rate of Rs2,500 to Rs8,000 each and sold for Rs100,000 to Rs250,000 per stent in connivance with Drap and health officials. Even an influential official of Drap got two stents registered for his own company on September 8, 2016,” he alleged.

“Stents are even registered for the company of a federal minister. There is no laboratory to check the quality of stents, medical devices, diagnostics and implants. Moreover, Drap uses a pick and choose police for registration of medical devices and thousands of applications are pending with it,” he said.

Dr Aslam, the CEO of Drap, agreed that it was a big issue and needed an extraordinary attention.

“In Pakistan, stents have been regulated since 2010 and there are 55 products each of which has 25 to 35 variants.” He said currently stents approved by authorities in the US, European countries and Japan are registered in Pakistan. For the absorbable stents, Drap demands a free sale certificate which means that the stent is also sold in the country where it is manufactured. This condition has been included to stop experiments on the patients in Pakistan.

“Unfortunately, people bring bags full of unregistered stents from UAE and sell them in hospitals. A stent of Rs20,000 is sold for Rs125,000.

“We have established a team and are coordinating with the PMDC to ensure the usage of only registered devices and avoid complaints that sometimes doctors claimed to have fixed a stent on the patient without implanting it,” he said.

In reply to a question, Dr Aslam said the names of the registered stents had been put on the website of Drap to facilitate the buyers. Meanwhile, in a statement on Sunday, Drap expressed concerns over malpractices by cardiac consultants and specialists who used unregistered, smuggled and low quality stents.

The import, export, distribution, sale, prescription and use of unregistered stents on patients is a cognizable offence and can lead to the registration of an FIR against the violators.“It has been noticed that some hospitals have given rooms to private firms in Punjab. Drap raided the sale office of a multinational company and recovered 40 unregistered stents and seized expired infusions in Lahore.”

Published in Dawn January 23rd, 2017