India’s $9 billion diagnostic industry is witnessing a strong growth that is going to accelerate with the rise in awareness on preventive health, changing lifestyle and insurances fuelling the preventive healthcare segment. Currently, the diagnostic sector in India is highly fragmented with standalone centres accounting for 45-50% and the organised ones having less than 35% share while the rest are hospital-based diagnostic centres. While the diagnostic industry has always been dominated by the unorganised players, major diagnostic chains are slowly disrupting the market by acquiring smaller local labs.
Diagnostic services play a vital role in spotting the health problems and informing medical interventions that make the integrity of the test a crucial aspect as the doctor takes the decision based on the reports. Right from the time the blood sample is collected, the pre-test, and till the report reaches, the whole integrity of the system must not be breached as it could result in the whole detection and treatment process getting complicated.
The biggest challenge is the oversupply in the industry because anybody and everybody can start a pathology lab or an imaging centre without any consequences as the IVD products are sold to unauthorized/unqualified/unlicensed persons and this leads to a deficit of accountability towards the patients and the doctor.
Of late the Government of India has been working on the Rules & Regulations to regulate the In Vitro Diagnostics (IVD), Medical device Industry and the Medical Diagnostic Laboratories. The IVD Product manufacturers could play a Pivotal role in the society by regulated sale of the IVD products as per the Drug & Cosmetic Act 1940 and Medical Device Rules 2017 as per which the IVD products could only be sold only to a government authority, a hospital, medical, educational or research institution or to a Registered Medical Practitioner (registered with the Medical Council of India /state Medical council) for the purpose of supply to their/his patients as these IVD products are rampantly being used by quacks in India and dealers/distributors of these items in INDIA are openly selling and distributing these items without disclosing the legal identity of buyers.
The gap remains the ill representation of the major stakeholders working in sync for patient care. The Medical device manufacturers’ Association and the Laboratory Medicine Doctors’ Associations should join hands to achieve the regulated sale/purchase being the major stakeholders as the governments’ cannot police all the time. For the first time ever Practicing Pathologist Society, Rajasthan and AIMED have come together with the sole motive to understand the burning issues, feasible & amicable solutions and work in sync for the betterment of patient care. Moreover regular interactions would have symbiotic implications for the health sector to grow and innovate. This conjoint effort is yet to see the light of the day but surely would benefit the patients, all the stakeholders and an improvement in the health services across India.
It is the need of hour to formulate a comprehensive guideline by the major stakeholders to regulate the medical devices including in vitro diagnostic medical devices being used for generating a laboratory report to ascertain its authenticity for proper and accurate treatment. This could probably help in reinforcing the lost trust deficit in the medical Diagnostic ecosystem.
Dr ROHIT JAIN
Founder Secretary
