Dr Raman Sardana, Head, Infection Prevention and Control, Coordinator Laboratory Services, Senior Consultant Microbiology, Indraprastha Apollo Hospitals talks about the requirement of regulating the laboratories to Romiya Das of Elets News Network (ENN).

What is your overview of the IVD industry in India?

Dr Raman Sardana, Head, Infection Prevention and Control, Coordinator Laboratory Services, Senior Consultant Microbiology, Indraprastha Apollo Hospitals

Past one decade, people have turned more conscious about their well-being and awareness. Coupled to this, there is a general economic affordability which has escalated expenditure on their own healthcare. Even the corporate world desires their employees free of lifestyle diseases and more fit people in the work culture, laying more stress upon preventive health-checks and changes in the life-style pattern. The Indian IVD market is valued at more than US$ 500 million and is expected to surpass US$ 1.5 billion by 2018 growing at a CAGR of 20 per cent as mentioned by MarketReportsOnline.com. The growth in healthcare insurance sector is another aspect to the growth of the industry, along with home collection for tests. Looking at the overview there are hospital based labs and many corporate stand alone labs are growing with the outreach to the people. We are also looking at rapidity of response, which asks for more and more IVDs to be available. Also, the contribution of peoples willingness to spend has assisted to the growth of IVD sector. As insurance companies set in to cover healthcare, they desire to bring more and more people under this umbrella and are dependent upon IVDs for knowing the current health status and prognostic interpretation. The successful labs and diagnostics centres are getting the best technologies in India as fast as possible at the same level as the best centres in the world. Technicians working with IVDs in India are trained in-house by the people who have been trained elsewhere outside India or people who are providing IVD kits. But, there is a lag phase in acquiring a technology and putting it to great use. There is no formal education program in majority of the technical institutes in India which can cater to recent advances in equipment and technology.

What are latest technological advancements in this domain?

There is a thrust on more and more automation in the West. Whatever we are doing in IVDs on the clinical side should be standardised, uniform, the results should be reproducible and accurate (as near to the actual value). People in the west have moved from technician-based structure to automation and we see this trend coming to India as well. There is some amount of semi-automation that came up about two decades back, now we see more automated machines coming in. People want a single link or control over all the equipments. There is a surge in point of care testing though the equipments and reagents used require stringent quality control. Not many people are aware that they have to carry out quality checks. Also, faster and diagnostic tests are being sought to lessen the burden of prolonged stay.

What are your views on industry regulatory requirements?

There is the mushrooming of many laboratories at every nook and corner of a city and these labs do tests at a minimal cost. Majority of the cost is incurred on running IVD tests on strict protocols, though it wont come at lower price for the patients. The standardised labs cannot perform tests below a certain price which is their incurring cost. There is a large population which even if can afford, would opt for a lab with lower price. Here the regulatory can help in a way that every new lab which opens its operation should be registered. It should be told to follow a base minimum a quality programme. Labs should be encouraged to undergo National accreditation (NABL) that would improve quality tremendously. There are many public sector units which say that they would ask their employees to get themselves or their beneficiaries to get tested only by accredited labs. Such riders are important to encourage labs to undergo the accreditation process. Thus, accreditation should be a voluntary effort with some kind of incentivisation.

Where are we lacking?

The basic challenge is that we are not manufacturing our own kits. We are not customized to Indian healthcare, Indian genetic makeup and Indian biochemical parameters. Today, we use reference range which has been set by West. The country lacks trained manpower who can work on imported IVDs. Most of our distribution systems are not tuned to keeping the same parameters which are required for the storage or transportation of IVD kits.

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