Laboratory business is increasing due to screening and follows up for lipid profile, blood glucose levels and speciality tests for thyroid hormone levels.
In India, diagnostic and pathology labs have just to register under the Shop and Establishment Act. This has given rise to an unorganized market. These centres located at the regional or city level are not necessarily owned by a pathologist or doctoral laboratory scientist. The organized segment is smaller with a handful of top laboratories. With most of the treatment decisions in the country based on lab results the market is highly competitive and price-driven with business referral payments. There is no regulatory body.
There is immense potential in this market for competent players who can take advantage of the increasing demand driven by rising disposable income and an increase in lifestyle diseases. A survey in the report “Understanding Healthcare Access in India” by the IMS Institute for Healthcare Informatics reveals that 90% of people were able to access diagnostic facilities and medicines within 5km of point of treatment. Additionally, 30% and 60% of people were able to access medicines and diagnostic facilities respectively at the point of treatment.
Technological advancements and higher efficiency systems can help private diagnostics players to enter urban and rural markets and expand at a larger scale. Information and communication technology (ICT) can help automate the entire process of testing and improve the sensitivity and specificity of the test. Automation will improve efficiency in laboratory work and improve quality and lead to error-free services. Operational and storage costs will be at a minimum.
Though there is no clarity on the requirements for approval of diagnostics products and medical devices in India independent laboratories and diagnostic centres should ensure:
· The diagnostics products and medical devices in their laboratories are validated and approved by globally accepted regulatory standards
· Assure accuracy, reliability, and conformity of the test results by adhering to national and international measurements
Though accreditation of laboratories is not necessary in India work within a structured framework and ensure quality compliance at every step.