Directives in diagnostics: A pressing need

Setting up a diagnostic center in India is as simple as investing capital and obtaining a ‘Shops and Establishments’ license. No relevant qualification or certification required. There is no official checklist of basic requisites to set up a laboratory and standardisation to be followed. 

Unlike in the case of setting up, for example a restaurant, where every last detail and permit is combed through with a keen eye, there is no need to seek approval for location of a lab or space and safety measures on-site, there is no record of repair and maintenance of technical equipment, and basic hygiene and sanitation of the facility is left to the discretion of the business owners. Worse yet, there are no consequences for those who violate laws and global standard practices because there is no centralised governing body to overlook these important issues.

Cost of lack of regulation: Inaccurate diagnosis & poor health outcomes

One may argue the benefits of lack of regulations - less bureaucracy. This means less obstacles in setting up a business and more freedom to shape the business model any way the entrepreneur desires. Though if this liberty comes at the cost of unreliable test reports and health hazards, which could cost a person their life, they are not worth it.

Most of the regulation we see in the pathology industry comes from private players who have modeled their business and services on the international industry standards. These self-regulated businesses are competing in a saturated market to stand out and justify the premium they charge by providing top-quality services and technology. This helps improve accuracy of diagnosis and creates superior customer service benchmarks. The competition keeps the large diagnostic chains on their feet, alert, and pushes them to innovate thus ultimately upping the quality of diagnostic healthcare available to Indians. 

To compare our healthcare infrastructure and services with that of the developed countries, a lot of work enhancements need to come into force. A change in the regulatory scenario can transform the landscape of the pathology industry. These improvements ought to begin with the emergence of a set of practice standards along with making accreditations by NABL (National Accreditation Board for Laboratory) mandatory for any operator in the industry. This will ensure labs maintain basic protocol, at the very least. 

Monetary infrastructure, medical and corporate expertise, and a right team are the key components to set up a laboratory of international standards. And that’s the simpler part. Major work starts with operations - maintaining quality and highest level of accuracy for every patient report. This requires strict and sustainable processes, and solid business model that demands to be followed. All of this, without overlooking the fact that, in the end, it’s the fulfillment of every customer’s expectations and needs, which is a paramount factor in building strong customer relationships.  

Efficient blood collection for blood reports, same day report analysis depending on the test, online records, consultation of the results of the report with an expert, and guaranteed error free diagnosis are just some of the parameters of customer care management which need to be covered by a pathology laboratory successfully.

Win the trust of the people 

By being persistent with these quality practices, not only will the trust of the people in our medical system grow, but it will also help our country emerge as a global player in the diagnostic zone, thereby setting a gold standard for the other laboratories to enter the healthcare sector.

Recently, the government has shown positive support on overcoming the regulatory hurdles related to the medical devices used in the industry, and has set a new precedent. This has generated a hope that the authorities will also look into making the diagnostic space a sector with better regulations and monitoring in place. This step towards progress will be beneficial for all – the customers, the investors, and the country.

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Ameera Shah is the promoter and managing director of Metropolis Healthcare Ltd