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Cover Story

The Medical Device Regulation Bill, 2006

The Medical Device Regulation Bill, 2006, will
Create an autonomous regulator for medical devices
Provide for rules governing safety, efficacy, design and manufacturing
Create panels to classify devices, and for testing and evaluation
Classify devices by risk, and link regulation to the level of risk

Background :

In the early 1980s, the government sent a senior health ministry official to an international meeting on medical devices regulation in the US. He was shocked to find that of about 50 countries that were represented, India was the only country with no regulation. Thus began a long-winded process that has culminated in the Medical Devices Regulation Bill, 2006. The one institution that has been a constant in the process is Kerala’s Sri Chitra Tirunal Institute for Medical Sciences & Technology. The state-owned hospital has been pushing for regulation since 1980. The reason, says its now retired founder director Sankaran Valiathan, is simple. “At the time, Sri Chitra was on the cusp of developing a range of local alternatives to imported devices, but we had no clue whose approval to take to launch the product.” Sri Chitra chose to apply to the ministry. After much discussion, the drugs regulator approved Sri Chitra’s blood bags. Yet Sri Chitra kept pushing for regulation. “Until there’s a new law, all decisions are ad-hoc,” says Valiathan, who became the ‘go to’ person for any government that looked at medical devices regulation. In 2000, six years after he retired, he chaired a committee set up by the Indian Council of Medical Research. The latest Bill is based on its suggestions.

The Business World in its issue dated Nov. 19, 2007 carried an in depth analysis of the situation with respect to the Regulation for Medical Devices as it exists to-day which includes opinions from the leaders of the Indian Medical Device Industry.

We reproduce below the abstracts of the contents of the Report :

  • 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.

  • 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. “It’s almost like we don’t exist,” says Pitre , Managing Director of Pune based Sushrut-Adler Group manufacturing orthopaedic implants.

  • 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. “We have to compete on price with those who cut corners,” says Pitre.

  • 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. “Quality has always been a concern with Indian players in the past,” says Vaibhavi Ananthanarayanan, programme manager of healthcare practice at Frost & Sullivan. “But it is more of a perception issue.”

  • 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.

  • “With more stringent regulations, Indian products will fare better than some foreign brands as they are less expensive and are made for the Indian consumer,” says Ananthanarayanan.

  • Confusing Regulatory Status: Another regulation is threatening to undo this promise. Since 2005, 10 categories of products are subject to the Drugs & Cosmetics (D&C) Act of 1940. An October 2005 notification requires importers and local manufacturers in these categories to be licensed by the Indian drugs regulator, the Drugs Controller General of India (DCGI). It gave existing players a grace period, now lapsed, to obtain licences. Companies allege the Act was not written for the devices industry and that it is endangering their survival.

  • The cause lies in the Act itself, say players, some of whom spoke under condition of anonymity. In Europe and the US, separate laws govern medical devices and implants. The pre-independence D&C Act was meant for drugs and cosmetics. Some of its requirements add to cost but not necessarily to quality, they add.

  • 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 minimize impurities. Importantly, a sterile drug is tested in-house for impurities.

    A sterile medical device can even be one that is sterilized at the point of use. For instance, a doctor orders different sizes of an orthopaedic implant from a company and, at the time of surgery, sterilizes only that which fits the patient. “You need a dust-controlled environment for processing plastic components since dust particles could get permanently embedded in it,” says K. Sunil, vice-president of TTK Healthcare, the country’s sole maker of heart valves. “But this is not so for metal components such as bone plates, which can be cleaned.” An in-house sterility testing laboratory will be expensive but hardly utilized.

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