An Unregulated Mess: Inside India’s Medical Device Industry

Is the unregulated $5.8 billion medical device industry of India running at the cost of patient safety?

(Photo: iStock)

A 32-year-old unable to sit for more than a few minutes at a stretch. A metal pin poking the inside of a woman’s knee. A tumour near the hip of a 50-year-old.

A trip to the hospital should solve their problems? Well, here’s the irony. A trip to the hospital is what caused their problems.

Two words – medical technology, are at the centre of it all.

“Let's continue to improve lives by unleashing innovation.” That’s how medical technology manufacturers see the advancement they’re doing in the field. And unleash innovation, they did. Unbridled, unethical and unregulated. The suffering patients affected by faulty medical devices hold testimony to that.

One can argue the $400 billion global industry is making people live longer and better lives. But is it coming at a cost too big?

Vojhala is one of the patients affected by faulty hip implants. (Photo Courtesy: Vijay Vojhala)

“I had an active lifestyle, but due to unforeseen circumstances, had to get a hip replacement surgery done in 2008. Being a medical representative, I had access to a lot of doctors and information about what’s new and best in the field. I decided to go for the metal-on-metal hip implant because the docs told me I could do everything from run to play tennis once I get the replacement. But what followed was a nightmare with metal poisoning, foggy mind, partial loss of hearing and unending pain,” narrates 45-year-old Vijay Vojhala, one of the 4,451 patients affected by Johnson & Johnson’s faulty hip implants in India.

The implant made of cobalt and chromium was found to be leaking metals in the body of patients, leading to fluid accumulation and metal poisoning in some cases.

This happened globally, and the device was first recalled in 2009 in Australia. But a month later, the company applied for an import license to sell the same product in India, and the authorities readily complied without any due diligence. It was only three years later in 2013, that the device was officially recalled in the country.

India’s Medical Device Regulations

So, what makes it so easy for faulty devices and errant manufacturers to function with impunity?

India’s medical device regulations (or the lack of it), in short.

The medical device industry in the country is estimated at $5.8 billion and is pegged to increase to $9.6 billion by 2022.

Now, figure this. Till January 2018, there was no particular law to regulate medical devices in India. Business was going on as usual under the Drugs and Cosmetics Act, 1940. Devices were being regulated as drugs, if at all. Only 10 devices were declared as drugs by Central Drugs Standard Control Organization (CDSCO).

The Medical Device Regulation Bill to consolidate laws was rejected by the Rajya Sabha in 2006.

(Photo: iStock)

Then came the Medical Devices Rules (MDR), 2017. About time, right? Except, it’s still woefully inadequate.

Speaking to FIT, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), says:

It’s been far too long that the authorities have been inactive. After years of proposals given to Ministry of Health and them being rejected, they came up with half-baked regulations. Many suggestions by us and other involved parties have been ignored.

For starters, it still regulates only 23 devices, explains Nath. Rest can enter the market without going through these rules. The guidelines classify medical devices within 4 classes based on their risk profile – Class A and B for low risk, require limited checks and C and D for moderate and high risk require more extensive quality control under CDSCO.

But that would leave out many devices like X-Ray, ultrasound machines and even pacemakers.

There’s a need for sub-categorisation so that devices aren’t loosely defined and get away with lesser requirements of clinical and quality data. Orthopaedic implants, for example, are vaguely defined as drugs.

What About Imported Devices?

Experts say the quality controls now defined under MDR are almost at par with the US Food and Drug Administration’s (FDA) standards. But even FDA’s rules have many loopholes.

There are two ways a device can be approved by the FDA – either under the premarket approval (PMA) or the 510(k) process. The former is more strict than the latter, but is still not as robust as the process for drug approval. The latter, a huge loophole, is also one under which majority of devices are approved. It says that a device doesn’t even need to undergo the process of approval if it can be established that it is similar to a product already in the market.

The same applies to the new Indian rules. There’s no permission required for devices entering the market which already have a predicate device up for sale.

And this is easy for manufacturers to flout, they just have to show that their device is a minimal variation of a previous device. Be it a change in material, or design or usage, it can be directly sold without any check for the new changes.

As for devices which already have approval from FDA or adhere to European standards, there’s no extra screening while entering the Indian market.

(Photo: iStock)

Dr Sumit Ray, senior critical care specialist, feels that isn’t enough.

Even if they’re approved by foreign standards, there still has to be an Indian regulation specific to our population. Indian bodies and health are different than say US or UK. A regulatory body needs to assess that for which devices its needed and which can do without it.

Well, here’s the catch. There’s still no specific medical device regulatory body and the industry is being monitored by drug regulators.

And for context, 80-90 percent devices used in India are imported, whether they’re US/UK manufactured, or cheap Chinese alternatives. And for the latter, it’s more of a freeway to enter the Indian market.

Unlicensed Manufacturers Run Amok

The rules are also missing details behind the devices like that of the manufacturer, the subcontractor, how they are functioning, and the packaging.

This is letting unlicensed manufacturers sell and export devices without any consequence.

AiMeD had reported close to 50 such manufacturers operating right under the noses of the authorities in Delhi NCR. But the February 2017 complaint hasn’t been acted upon by CDSCO. These companies are selling unapproved devices in Indian as well as foreign markets.

“Why this disregard for patients’ lives at the benefit of companies’ profits?” asks Nath.

No Place for Patients’ Complaints

The J&J case is a perfect example of patients and their problems being ignored. First, the patients were never informed that the hip implants they had in their bodies were faulty. And how would they? There’s no patient registry being maintained by the regulatory authority, leaving it to the hospitals or the manufacturers to keep a record if they please.

Vojhala is one of the patients affected by faulty hip implants. (Photo Courtesy: Vijay Vojhala)

Second, there is no specific platform where they can report their grievances.

Another case highlights the problem. A patient had an imported knee implant fitted, which started causing her pain and gave bruises over the next two years. Turned out, a metal pain from the implant became loose and started poking the inside of her skin. She went back for her revision surgery to the same doctor, who had done her first surgery at Medanta and was now at Fortis. And they were charged all over again for the entire procedure done in July 2018 as well as the new implant.

Vinod Tejwani, the patient’s son, asked several questions as to why the fault happened and why they were being charged again with no fault of theirs. But he didn’t get any response from the either the hospital or the manufacturer. The latter responded after Tejwani raised the issue on social media but to no avail yet.

I had no idea where I was supposed to go with my problems, who do I report to? Who would hear my grievance?

Vinod Tejwani, Patient Family

Ideally, an adverse event reporting system set by the regulator should have come to their help, whether or not the complaint held ground.

When contacted, Fortis' official response said this:

“The patient had visited Fortis Bone & Joint Institute on 27th July 2018 with complaint of knee pain. A surgical procedure was done on 28th July 2018 by orthopaedic team. Medical treatment was administered to the Patient in accordance with standard medical protocols. This was a revision surgery and such surgeries are sometimes required due to various reasons, depending upon the condition of each patient. Attending family of the patient was explained in detail that the procedure conducted was medically required and the associated treatment cost was due to the fact that the earlier surgery was done two years back at a different hospital to which the family had consented. Queries of the patient’s family were responded appropriately and promptly to their satisfaction”.

But Tejwani says there has been no such communication from the hospital and this doesn’t really solve their concern. Thus, the need for an uncompromised third-party system to report adverse events.

Malini Aisola from the NGO All India Drug Action Network (AIDAN), which helps patients seek justice, told FIT:

There’s a newly launched medico-vigilance programme, but there’s no direct mechanism where the patients can feed in their issues. Even after the J&J fiasco, a lot of patients started contacting us regarding their adverse events with various medical devices.

The Nexus Between Hospitals, Doctors and Manufacturers

(Photo: iStock)

What makes it all the more difficult for patients is the nexus between hospitals, doctors and manufacturers.

Three industry insiders FIT spoke to all said that the way doctors and manufacturers benefit from each other is grossly unethical.

The network of dishonest is much stronger than the network of the honest. A large number of doctors take kickbacks on devices and drugs by manufacturers to use their products. If not direct monetary payment, then through trips abroad or financing their kids’ education etc.

Dr Sumit Ray

All patients admit that when they go to a doctor, they have no option but to trust them since they’re the most reliable authority they have access to. So, if a doctor tells them, device XYZ is the best and they should go for it, the patients more often than not don’t do any research of their own and question that decision.

So, who’s keeping a check on them?

FIT contacted Additional Secretary, Health Ministry RK Vats and Professor Balram Bhargava, Secretary, Department of Health Research and Director General, ICMR, to ask if anything is being done to strengthen the law, especially seeing the J&J case.

“Right now, there’s nothing going on about this issue. We have a meeting in a few weeks, let’s see,” responded Professor Bhargava.

RK Vats, however, didn’t respond to our queries.

Our question remains. The problems have been flagged off, the suggestions have been given, when will the authorities act?