A Crying need for Regulation

Though the medical equipment market is witnessing a steady growth, its time for regulation in this field say the equipment manufacturers and vendors. K Deepalakshmi finds out the need for an indigenous regulation

Growth has always been contagious. India is scaling new heights in the healthcare segment, with an increasing number of private players entering healthcare and government doing its part by promoting public health. Thanks to the reputation of Indian medical expertise, the flow of international patients has picked up over the years, contributing to the trend of medical tourism, now also called medical travel.

This boom in healthcare, driven by both domestic and external demand, has increased the demand for hospital equipment which has in turn triggered the growth of allied fields of healthcare, mainly medical equipments. Seeing the existing players flourishing, new players have forayed into the market with high hopes. On the other hand, a proper regulation in this field is yet to come. Are we compromising quality for the sake of growth?

Why regulate?

Healthcare is always seen as a service more than a business. While there are regulations prescribed for pharmaceuticals and organization like AGMARK (Agricultural Marketing) for checking the quality of food products, Hallmark to check the quality of gold, Silkmark to certify purity of silk, there is no certification needed for medical devices. Even the Bureau of Indian Standards (BIS) does not seem to take care of medical devices. This has allowed a free flow of medical devices in India and has pushed quality and safety to the background. The users have no clue about the equipments' effectiveness and are forced to go by the word of the manufacturer, since it is not possible to personally check every piece of equipment. "Benchmarking and certification enhance credibility of equipment. Hence they are a must," says V Sashi Kumar, Managing Director, Phoenix Medical Systems, Chennai

Existing Regulations

In the year 2006, the Union Government identified 10 life saving devices, namely, cardiac and drug eluting stents, catheters, bone cement, heart valves, scalp vein sets, orthopedic implants, internal prosthetic replacements, IV cannulae and intraocular lenses and laid guidelines and regulations for import, manufacture and selling of these products through the Drug Controller General of India (DCGI). Central Drugs Standard Control Organization (CDSCO) was given the authority to issue approval after duly testing these equipments. This is considered a remarkable step towards regulating the medical equipment market.

Two major certifications that are internationally acknowledged are US FDA (United States Food and Drug Administration) and CE ('Conformité Européenne'), the certifications from US and European Union respectively. The ISO 13485:2003 prescribes the standards for medical equipments. Some Indian hospitals too insist on these certifications before buying the equipments. "Even countries like Thailand have their own certification for medical devices but India is yet to have one," says G Muthukrishnan, Managing Director, Trans Healthcare, Chennai.

How to regulate?

It is clear that a regulation and certification is necessary for medical equipments, consumables and disposables, but what are the components of this regulation process? "The regulation should come under a single body for all kinds of medical devices," says Sashi Kumar. The regulation should include imported goods and a certification should be made mandatory for selling these products. "Benchmarks alone are not adequate. They must be efficiently executed," he adds.

Regulating Refurbished Goods

Sale of refurbished medical equipments is now an emerging market. There is a mixed response to these products as industry questions the quality of these products. "India is seen as a dump yard for these products," says Muthukrishnan. There are possibilities of breakdowns in such machines. There are even chances of spreading infection by using them, he adds. These chanrges are vehemently refuted by refurbished industry traders. "We sell these goods after thorough checking and guarantee for optimum efficiency," refutes Rajagopal Geethu, Director, Zigma.

Such arguments can come to an end with proper regulation. Both agree for a regulation. "A strict regulation can control the import of equipments that are mere scrap," says Geethu. He also suggests a separate certification for these products.

Testing

For an effective execution, proper testing facilities are a necessity. It is also necessary for these centres to be easily accessible. They must be spread across the country. The testing centres have to be set up before regulations are put in place. "The recent regulations on life saving products is yet to be implemented effectively since there are very less testing centres," says Muthukrishnan. "We are still waiting for the certification since there is a delay in testing," he adds. The government should increase the number of testing centres across the country to enable speedy certification.

Another possible solution is to outsource testing to private companies. The testing for CE marking and US FDA are carried out by accredited private companies. "We are accredited to carry out five different certification including ISO," says Paul Chan, General Manager - Medical, Asia Pacific, Underwriters Laboratories.

Accepting Existing Regulation?

An easier way to implement the regulation is to adopt any existing regulatory benchmarks. For instance the CE Marking is accepted by more than 30 countries. Similarly can we accept a guideline set by another country? "This could only be a temporary solution," says Chan.

To accept another certification is better than not having one. But let us not forget the first step has already been taken by setting up guidelines for life saving devices. "The requirement are different for each country, adopting another certification will not help on a long run," Chan adds. These guidelines can be used as a reference in setting up new ones.

Effect on pricing

Certifications come for a price. Insisting on a certification involves additional spending on various fees and these could account for an increase in the price of equipments. However Chan is of the opinion that "The certification cannot affect the prices as the quality always drives the price."

Implementing these guidelines is as much a task as creating them. Adequate awareness must be created among the manufacturers, traders and the users about these regulations. A separate body should constantly monitor the execution of these regulations. They must be periodically reviewed and updated to meet the current industrial scenario. Hence, the regulation to be completely enforced will require much more time than to draft them. But, better late than never.

k.deepalakshmi@expressindia.com