Thursday, November 15, 2007


Medical devices in the human body

Gauri Kamath

India’s medical implants and devices industry is a poor cousin of the country’s biopharmaceuticals and technology sectors. According to Frost & Sullivan, the global medical devices industry, at $196 billion, is dwarfed by its $500-billion-plus pharmaceuticals counterpart. In India too, at $1.8 billion, the market is just about as large as Ranbaxy or Dr. Reddy’s Labs, the country’s largest drug makers. And while India’s pet sunrise industries have been richly rewarded with tax breaks and other incentives for putting the nation on the global map, makers of bone plates, pacemakers, intra-ocular lenses, heart valves and stents do not even have a law to govern them.

Without effective regulation, bonafide producers compete with barnyard operators and local traders who use scrap metal as raw material, and import goods of unproven quality. Also, Indian companies often fare poorly against premium global brands such as America’s Medtronic or Boston Scientific, which are approved by stringent western regulators and backed by huge amounts of clinical trials data. Imports account for most of the Indian market.

Intensive Care

But things are changing. The Ministry of Science and Technology is readying to table a breakthrough Bill in the Parliament’s winter session. The Medical Devices Regulation Bill, 2006 proposes to set up an autonomous regulator for the sector. Its primary aim will be to set standards on a par with the rest of the world. “Once a device is tested and approved in India, there should be no testing needed in any importing country,” says B. Hari Gopal, adviser to the ministry. The Bill will also regulate imports into the country.

However, another regulation is threatening to undo this promise. Since 2005, 10 categories of medical devices are subject to the Drugs & Cosmetics (D&C) Act of 1940. Companies allege the Act was not written for the devices industry and that it is endangering their survival. In Europe and the US, separate laws govern medical devices and implants.

The Trouble With The Law

Take the concept of sterility. A sterile drug, like an intravenous fluid, has to be manufactured in ‘clean room’ conditions. This requires a certain type of flooring, furniture, air flow and energy requirement to minimise impurities. But
a sterile medical device can even be one that is sterilised at the point of use

The Doctor Can’t Carry On

At the busy basement workshop of Pune’s Sancheti Hospital, artificial ‘Indus knees’ are being made, an innovation that took founder orthopaedic surgeon K.H. Sancheti and his team seven years to design. Indus knee allows patients with debilitating knee pain to not just walk but even squat. So far, the hospital says, more than 400 patients, including poor villagers from the states of Maharashtra, West Bengal and Madhya Pradesh, have received the Indus knee. At Rs 25,000-30,000, it costs a lot less than the Rs 60,000-1 lakh for an imported device.

But work will soon stop here. Dr Sancheti says he is unable to meet the requirements of the D&C Act. “Why, for instance, do I need an in-house biological testing laboratory?” he asks. The end-product is irradiated at the state-owned Bhabha Atomic Research Centre in Mumbai, after which the package is opened only in the operating theatre. Dr Sancheti, a 2003 Padma Bhushan awardee, says if he were to meet all the Act’s requirements, the cost of manufacturing would quintuple.

Serious Side-Effects

Ironically, imports are being approved on the basis of documentation, minus factory inspections. “We are getting implants even from China but there is no rule to inspect their factories,” says Dr Sancheti.

Exports may be hit too. Importing countries need evidence — called a free sale certificate — that a device is approved for use in the exporting country. Until the DCGI licenses a unit, a free sale certificate is out of the question.

Compounding matters is the fact that the industry has not banded together to influence policy. “They could achieve a lot more if they joined hands,” says Dilip Shah, secretary general of the Mumbai-based Indian Pharmaceutical Alliance, a grouping of top drug makers that has been successful in shaping policy. The way the medical devices industry is structured, that’s next to impossible. Products range from CT scanning machines, ECG and MRI apparatus on the one hand, to knee and heart implants on the other. Even sutures are medical devices.

Each market segment has addressed its own issues so far. Drug-coated stent producers are one example. It was illegal trials of an imported stent in a government hospital in Mumbai that led to a High Court order for regulation of medical devices in 2005.

Since then, stent producers such as Bangalore’s Vascular Concepts (which went to court), and Ahmedabad’s Sahajanand Medical Technologies (SMT), have got their licences. Dhirajlal Kotadia, SMT’s chairman, says the process took almost a year. “There may be some negative impact in the short term, but the move is positive.” Companies that make hydrocephalus shunts and pacemakers are not included in the regulated categories as yet. Indeed, they may prefer to work quietly.

Sustained Release

Everyone agrees that there is a need for a new law. “It will clear some of the backlog in the current system,” says Swaminathan Jayaraman, CEO of Vascular Concepts. Adds Atul Sethi, MD of Indore-based pacemaker Shri Pacetronix, “A device cannot be regulated as a drug.”

According to some, the only solution is to allow existing devices to continue in the market unequivocally, by government fiat, till the new Bill comes into force.

And in a related story on the testing and safety of drug-coated sttents:

Drug-coated stents - tiny wire-mesh tubes used to prop open clogged heart arteries - may not be as dangerous as earlier thought, Swedish researchers who had raised concerns over the devices said on Sunday.

Fears that patients might do worse on so-called drug-eluting stents than on older bare metal ones have led to a $1-billion (around R8-billion) slump in sales in the past year.

But according to new four-year data from a 35,000-patient Swedish database of stent procedures, the largest in the world, patients receiving drug-coated stents are not at higher risk of dying or having a heart attack.

While drug-coated stents do carry a small increased risk of blood clots after the first year - something known as late stent thrombosis - this was offset by better outcomes in the early months following implantation.

"The slightly increased risk of late events with DES (drug-eluting stents) seems counterbalanced by an early gain," James told reporters.

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