Implant Files: India fares poorly in probe into medical devices industry with low recall rate, non-existent regulations

The International Consortium of International Journalists (ICIJ) — the group that worked on investigations such as the Panama Papers and Paradise Papers leaks — on Monday published a report titled "Implant Files" on the medical device industry. Along with a network of 250 reporters and experts from 58 news organisations in 36 countries, ICIJ examined scores of documents to investigate various aspects of the field of implant devices. It includes findings on regulation, a look into corruption in the industry as well as reports on faulty devices and their recall.

"Patients around the world have become unwitting test subjects for new medical technology," ICIJ said. "Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants."

While the consortium's report is elaborate and goes into deep detail about the lack of regulation in several countries, manipulation and lobbying by manufacturers to boost revenue, track records of recalls of faulty devices and reports of patients being duped, among other aspects of the industry, there are three key findings:

File image of an X-ray picture showing the world's first cardiac re-synchronisation therapy defibrillator device. Reuters

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- The reports says several governments in Asia, Africa and South America choose to trust the US Food and Drug Administration (USFDA) and European authorities instead of regulating medical devices themselves.

- In the past decade, nearly 83,000 people died and 1.7 million were injured after their supportive sevices "broke, misfired, corroded, ruptured or malfunctioned" after being  implanted, despite regulators, doctors and manufacturers assuring patients that they were safe. Similarly, explant surgeries — operations to remove medical devices — caused nearly 5 lakh "adverse events".

- Doctors and manufacturers of medical devices often don't report untoward incidents caused by faulty implants, and when they do, the information is frequently unverifiable and incomplete.

In India, regulation 'effectively, doesn't exist'

In India, ICIJ teamed up with The Indian Express to investigate various aspects of the medical devices industry. The newspaper reported a number of its "startling" findings on Monday that reflect the sorry state of how the industry is monitored in India. Besides noting that India's regulatory system "effectively doesn’t exist", the report highlights that there are "no specific rules or a law" that gives the government the authority to direct a manufacturer to compensate a victim of a faulty device.

"It has been found that from coronary stents and pacemakers to breast and knee implants, from pelvic meshes to intrauterine devices — almost every medical device is advertised, sold, surgically implanted in a regulatory system that, effectively, doesn’t exist."

India's Central Drugs Standard Control Organisation earlier notified only 10 medical devices for regulation, but the list has expanded to 23 categories of devices now. While there is no comprehensive law to regulate the medical devices industry in India — a bill for this purpose was first drafted 12 years ago but has yet to be enacted — the current government introduced rules. However, these medical devices are still regulated as "drugs" under the Drugs and Cosmetics Act, 1940, and the Medical Device Rules, 2017, which came into effect in January 2018.

The National Pharmaceutical Pricing Authority of India (NPPA) monitors the prices of medical devices in India, but it's the NPPA's Drug Price Control Orders 2013 that applies only to medical devices. Of these 23 implants listed as "drugs", cardiac stents, drug eluting stents, condoms and intra-uterine devices are considered "essential" and have their ceiling prices fixed.

While India currently lacks a system to ensure compensation for a victim of faulty implants, the Ministry of Health and Family Welfare has been working to draft a formula since the emergence of faulty hip implants from Johnson & Johnson. "There are proposals that the government might include a special clause under the Medical Device Rules to include compensation for patients," The Indian Express reported. "But the patient can always approach a consumer court to seek damages from the device company."

The newspaper carried out the investigation over 10 months, examining medical devices such as stents, pacemakers, hip implants, knee implants, breast implants, pelvic meshes and intrauterine devices. Global companies such as Johnson and Johnson, Medtronic, Abbott, Bayer and Stryker were examined.

While the medical device industry in India is estimated to be worth $5.2 billion  and the fourth-largest in Asia, there are an alarmingly low number of reports on faulty implants. To put things in context: "In the last decade, the US had more than 26,700 recalls; Canada had more than 8,300, while India — with more than 1 billion people — had only 14 from the beginning of 2013 through 2017, the only years for which data was available."

The Indian Express also found that 40 cases of "medical device adverse events" were reported in India in 2014,— according to date from the Indian Pharmacopoeia Commission — but the figure spiked to  556 in 2018 alone. The coronary stents manufactured by Abbott accounted for 50 of these 556 cases.