There have been instances in the past in Hyderabad when cardiologists from top corporate hospitals have brazenly implanted stents on patients without taking import licence or approval from the local regulator body like Central Drug Standard Control Organisation (CDSCO) and Drug Control Administration (DCA).
Highly experienced and quiet well ‘connected’ cardiologists in the capital also indulge in directly importing stents through their agents and bypassing the local regulatory authorities.
Authorities said that this practice of importing stents directly will end up risking the lives of patients.
Such facts came out in the open when, a couple of years ago, a series of raids based on complaints of malpractices were conducted at all the top corporate hospitals by officials of CDSCO, DCA and CBI. During the raids, the investigating teams, who were also assisted by a few government doctors, also found out that corporate hospitals do not maintain records or purchase bills of stents.
The hospitals do not have bill receipts to indicate the name of the distributors and other financial records of the number of stents that were being used by the hospital. “The stent manufacturing company representatives bring five to six different variety of stents and hand them over to the doctors. No questions are asked and no records are kept,” sources said.
Officials familiar to the medical devices’ industry point out that all the major corporate hospitals in Hyderabad did not have proper records of the sale and distribution of stents.
“Similar raids were not conducted again. So, we don’t know whether the situation has now improved,” officials said.
What happens when MNC manufacturers recall stents?
Multinational stent manufacturers routinely recall medical devices, especially stents, whenever manufacturing defects are detected during their routine quality inspection drives. The recalls occur because such defects potentially can cause serious health problems for patients and sometimes even prove to be fatal.
With 90 per cent of the stents in Hyderabad and elsewhere being imported, such product recalls have serious implications here because there is no regulatory body in place to ensure that the recalled stents are not in active use. If a particular batch of the imported stents is recalled, there is no other option, except for depending on the manufacturer to pull out the defective stock.
“What if a defective stent has already been implanted? What will be the situation of the patient? Who will compensate the patient? Who will ensure that the patient is properly compensated? These are the questions that can only be answered if we have a regulatory body like USFDA,” experts suggested.