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Promises and challenges of the lab industry

Take an interest, I entreat you, in those sacred places that are significantly designated as laboratories. Ask that they be multiplied and adorned. They are the future temples of wealth and well-being. It is within them that humanity matures and grows stronger and better. A quote by Louis Pasteur in the eighteenth century.

When I joined medical school 59 years ago, lab medicine was a small part of pathology and IVD industry was literally non-existent. It was fascinating to witness the all-round massive and extremely useful development of laboratory medicine in these years. There was rapid and vast improvement in technology of testing, the number of new tests evolved, automation in all sections of lab, use of information technology, quality management systems, etc. The list is endless; the journey continues and so does the curiosity to learn. Today, laboratory medicine has grown far beyond pathology to practice of all specialties of medicine, to screening of population for disease and wellness. It is also used for prognosis and management of disease. Diagnosis goes beyond identifying virus by molecular techniques to identifying its genome by NGS, and finding variants in real time.

Along with it, the IVD industry has also seen fast growth catering to various subsections of the laboratory services.

CAGR of Indian IVD industry is being predicted to be 7 percent to 13 percent by various analysts in the next 5 years. The growth in India is expected to be faster than in the USA, where CAGR of IVD industry is stable at only 2.6 percent.

In comparison to IVD industry, the Indian diagnostic market is growing faster at nearly 15 percent to 20 percent.

Various countries just spend 1.4 percent to 2.6 percent of total healthcare expenditure in diagnostics and realize almost 70 percent of all decision-making based on lab results. So, it is value for money.

Lab industry is expected to be in the forefront of healthcare delivery of the world and of India.

There are many challenges in laboratory industry and need to be highlighted so that they can be analyzed, and corrective action be taken.

  • Unregulated sample collection centers (SCFs). There is no policy and minimum standards for sample collection centers, which cater to a huge population and anyone can open an SCF with untrained staff and no minimum qualifications. These SCFs are supported by the corporates as they form major feeder for samples.
  • Absence of sample transport policy, which needs to be formulated at the earliest as pre-analytical errors contribute to almost 80 percent of lab errors, affecting patient treatment. ISO TS 20658 2017 standards for medical laboratories — requirements for collection, transport, receipt, and handling of samples need to be implemented.
  • Lab instruments/IVDs can be purchased by any one. Medical device rules (MDR) 2017 classify IVDs as drugs and therefore these can only be sold/purchased as defined in the Drugs & Cosmetic Rules 1945. If this is implemented, it will curb illegal labs in India.
  • Unregulated training institutes. Most of the Institutes training lab technicians are not recognized. They should be affiliated to Para Medical Council of India.
  • Unregistered lab technicians. There is no accountability of the unregistered technicians for the patients wanting lab services. Lab technicians need to be registered with Para Medical Council of India.
  • Unregistered medical diagnostic labs. CEA Act 2010 was passed but not implemented by many states. There is no punishment for running illegal labs, which is evident during COVID-19 pandemic.
  • No minimum qualifications to authenticate the reports. The Supreme Court orders/IMC Act 1956/MCI rules exist but are not being implemented leading to misdiagnosis. Minimum qualifications to authorize reports are not in sync with Indian Laws.

Acknowledgement to Dr Rohit Jain, MD Path, Pathologist, SDMH Jaipur for valuable inputs.

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