Last year, 42-year old Shaista Jabeen (name changed), had a plate implanted to fix her broken wrist, at a hospital here. She, according to her family, had been charged for “high quality titanium plate”, for which they had to dole out extra money. However, a year later, due to complications, when the plate was removed, it was found to be of a “cheap and inferior quality”.
Since there is no mechanism to check quality of implants, Jabeen’s family was left helpless taking the “fraud” as destiny.
Jabeen’s is not the lone case. Many doctors working in hospitals across Kashmir express concern over lack of quality control in medical devices and implants.
If a patient buys a screw for fixing bone, there is no way he can find out whether the quality is worth the price he has paid, said a senior doctor at Bone and Joint Hospital.
He said there were “substandard and exorbitantly priced” medical devices and implants being sold in the market and there was no mechanism in place to address the issue.
“Lack of price and quality checks for medical devices and implants are subjecting patients in Kashmir to health risks in addition to burning a hole in their pockets,” he said.
Another doctor working in SKIMS Medical College Hospital said that quite often the implants were found to be faulty and many patients ended up with lifelong complications. “However, there is no mechanism in place to report such incidences,” he said.
While medicines, drugs and consumables, such as bandages and syringes come under purview of Drugs and Cosmetics Act 1940, there was no such regulation in place for implants and medical devices.
The government of India has been mulling to bring implantable medical devices under purview of Drugs and Cosmetics Act. However, the move is expected to take over a year.
A doctor in health department said patients were “fleeced” with exorbitantly priced medical implants, quality of which was also “questionable”.
Recently, a report, International Consortium of Investigative Journalists (ICIJ) highlighted that India’s medical device industry found the country’s regulatory system so poor that it “effectively, doesn’t exist.”
Commissioner/secretary health and medical education department, Atal Dulloo said that government had “plans to address this issue and a number of steps are being taken to bring about quality and price control in the medical device market”.
“We are opening AMRIT stores which will ensure that only best quality products are available to the patients at affordable prices,” he said. He said that efforts were on to open such stores in every big hospital immediately.