Indian market deluged by discarded medical devices from ‘developed’ world

MUMBAI: Poor regulation and lack of indigenisation in India’s multibillion dollar healthcare sector, has set off a rampant trend of ‘dumping’ of medical equipment by first-world nations, say reports. In their quest to meet the massive demand for ‘certified’ medical equipment especially in the cardiac and orthopaedic sectors, markets like India, and even China, Uganda and Nigeria have turned into destinations for “diversion of unwanted stocks” from the first world. Patients in these countries end up being fleeced unwittingly by companies looking for fatter margins, and are also delivered either unnecessary products or pre-used and substandard hand-me-downs.   

While complaints have started to flood in from across the developing world, China led the pack, instituting a probe last year, against western and Japanese medical device makers for selling dialysis kits at exorbitant prices in comparison to indigenous versions. Recently, Uganda and Nigeria complained about poorly-calibrated, old machines being dumped in their hospitals in the name of donations.

TOI reports that domestic manufacturers in India, have also repeatedly petitioned government officials about the need to indigenise this sector quickly for similar reasons. Indian manufacturers blame poorly-controlled Chinese companies for exporting low-priced equipment of questionable quality to this country.

The problem is complex with a range of stakeholders calling the shots in an environment open to exploitation in the absence of requisite legal frameworks or checks and balances. 

The main charge against the ‘dumpers’ is that, not only are they imposing medical devices on developing nations, the gadgets are being ‘sold at inflated prices’ by first-world countries and trading companies.

In terms of sheer numbers, the stakes are high in a market like India. Contributing about 6% of India’s $40 billion healthcare sector (Ficci estimate), the medical equipment sector is small but vital to the healthcare industry. Consider cardiac and orthopaedic- the sector’s biggest revenue-earners. About 3 lakh Indians undergo heart procedures and around 1 lakh knee-replacement surgeries. These cost a patient between Rs 1.5 lakh and Rs 5 lakh. Each involves use of medical devices. From the high end stent or a ball-and-socket knee joint to the humble clip or blood pressure-monitoring cuff, devices play a crucial role. The US Food & Drug Administration lists 150 types of medical devices used during angioplasties and cardiac bypass surgeries and over 120 types for orthopaedic operations. The medical devices list is long. Ficci estimates about 14,000 product types. Yet few Indians ask doctors about the make of stents or intra-ocular lenses.

The medical devices segment in India is worth over Rs 35,000 crore. “Imports account for Rs 27,000 crore and could balloon to Rs 85,000 crore soon,” said a healthcare expert. TOI reports that unfortunately for Indians, the Drug Controller General of India’s office has regulations for only 20 devices. A new legislation widening the scope of regulation is expected this year.

According to Rajiv Nath of Hindustan Syringes and Medical Devices (HSMD), which makes single-use injections, there’s little awareness among Indian lawmakers that medical devices are classified into seven fields (disposables, consumable, electronics, equipment, implants, diagnostic and surgical instruments). “They club these with medicines without realising that electronic medical devices are different from, say, consumables used in operations. Just as you wouldn’t want one doctor performing your heart surgery and knee replacement, you cannot have one set of regulations for the pharmaceutical industry covering all medical devices.” 

There’s another problem: Pricing. According to Dr G S K Velu of Trivitron Healthcare, a Chennai medical devices company, “Many companies sell drug-eluting stents at heavy premiums. They possibly get it at Rs 5,000 to 10,000 but charge patients Rs 75,000.” Nath said: “The government reduced duty on imported medical devices. Was this benefit passed on to patients? Did government check if the MRP of imported implants or stents has come down? 

Worse, retailers and hospitals blackmail Indian manufacturers to maintain the same MRP as importers so they get their margins.” A doctor who didn’t want to be named pointed to `indirect dumping’: Diversion of unwanted stocks to the third world. He said a landmark clinical trial on drug-eluting stents, COURAGE, in 2009 proved angioplasties don’t necessarily help more than aggressive medical management in patients with stable coronary artery disease. “After the trial, there was drop in stent use across the US. Foreign manufacturers flocked to countries such as India to promote stent use,” he said.

Dr Velu says, “CT and MRI scanners and ventilators can be imported with zero regulation. Patient monitors and dialysis machines are brought in without regulation.” Many of these machines-some refurbished after a year’s use and resold cheaper – are dumped in India, where the regulatory framework is feeble, he says.

Yet, Dr Nath of HSMD says, ironically, doctors prefer a refurbished imported machine over a new India-made one as the latter isn’t certified by the government. “Who do we go to for certification? Government regulates a handful of medical devices, the rest are in the unregulated sector. A known, imported brand is thus preferred,” he said.

A Mumbai medical equipment vendor conceded dumping was rampant. “Do Indian consumers know if the dialysis machine they’re strapped to or oximeters checking their oxygen levels aren’t new? Or whether they’re calibrated to function in Indian settings?” he wondered.

A 2012 report in The Lancet showed that about 40% of healthcare equipment in poor countries is out of service mainly because of ill-conceived donations-for instance, oxygen concentrators donated to a Gambian hospital worked on a voltage incompatible with the country’s power supply.

But the Advanced Medical Technology Association (AdvaMed), which represents most American manufacturers, denies that foreign makers don’t care about their end users. Vibhav Garg, co-chair AdvaMed-India Working Group said, in the context of Indian consumers, “AdvaMed’s member companies try to make appropriate technologies available to the Indian market to help India address its non-communicable disease burden,” adding that his company actually focuses on adapting devices to customised settings.

A collaboration between The Lancet and Imperial College London, UK, in 2012 which examined how medical technology should best be used to improve health in low- and middle-income countries found that instead of relying on hand-me-down technologies from wealthier countries, which can be costly, inappropriate for local conditions, and even dangerous, there should be an effort towards developing what they call “frugal technologies”. These are cost-effective technologies that are developed specifically to cope in local conditions. Examples include: the Jaipur foot, a rubber prosthetic for people who have lost their leg and foot below the knee; PATH’s Uniject injection system, which allows once-only use of needles for injectable contraceptives; and the eRanger, a durable rural ambulance, based around a motorbike and stretcher sidecar (which can be modified to carry one or two people).

The report also advocated a wider understanding of what is meant by medical technologies, pointing out that technological improvement to sanitation and road conditions could also have a far-reaching impact on public health in many low- and middle-income countries. The authors of the report said advances in technology need to be accompanied by innovation to have a significant effect on health, which includes the development of effective delivery mechanisms and novel approaches to financing. –EJ

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