Govt Sets Accuracy Norms For Diagnostic Kits For Diseases Such As TB, Dengue

(MENAFN- Live Mint)

New Delhi: The government has for the first time introduced India-specific performance standards for diagnostic laboratories in order to improve the accuracy, consistency, and reliability of test results and bolster patient confidence in the healthcare system, according to officials familiar with the matter and documents reviewed by Mint.

Developed jointly by the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO), the uniform standards apply to in-vitro diagnostic (IVD) kits that are used to test 39 critical diseases such as dengue, tuberculosis, malaria, chikungunya, Zika virus, Nipah virus, and several respiratory infections.

“These protocols will bring uniformity to the IVD sector in India, ensuring that the test kits used are of the highest quality and safety. The new guidelines will also provide a transparent process for manufacturers, clearly outlining specific requirements for testing sensitivity, specificity, and cross-reactivity," said one of the officials cited earlier.

In-vitro diagnostics are examinations conducted on samples such as blood or tissue taken from human body to detect a disease.

The framework marks the beginning of a uniform national approach to evaluating diagnostic products, and sets clear minimum standards and acceptance criteria for various critical disease markers. The decision comes at a time when India's diagnostic industry has expanded rapidly after Covid, reaching a market size of $1.72 billion in fiscal year 2023 (FY23).

Queries sent to the health ministry remained unanswered till press time.

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New rules and patient assurance

Under the new rules, all diagnostic kits must meet minimum thresholds for diagnostic accuracy. For instance, a dengue kit will now be required to show at least 80% sensitivity and 95% specificity. Sensitivity is a measure of how well a test can correctly identify people who have a disease. An 80% sensitivity indicates that out of 100 people who have a particular disease, the test correctly identifies 80 of them. Similarly, specificity measures how accurately a test correctly identifies those who don't have the disease.

Until now, in the absence of standardized testing panels, companies often relied on their own methods or imported protocols and kits, leading to inconsistencies. The new framework aims to ensure that every manufacturer's kit guarantees accuracy and reliability for patients nationwide.

“We received the notification only on Friday evening, so my team at J Mitra & Co. and I are still going through the finer details. It will require additional time, effort, and cost-whether in retraining people, upgrading processes, or strengthening documentation," said Jatin Mahajan, managing director at J Mitra & Co. "Yet, I view this as a meaningful step towards patient safety and achieving global credibility through adherence to the defined IVD standards. While backend costs will increase, we are committed to absorbing most of them through efficiency and local sourcing, so patients aren't impacted. For me, this is an opportunity to strengthen trust and demonstrate leadership in diagnostics."

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Impact on Industry and Public Health

The new framework is a game-changer for India's diagnostic industry, experts said.

Dr. Rajiv Bahl, director general of the ICMR, in a communication, said that this initiative was prompted by the post-pandemic expansion of the industry. He expressed confidence that the new protocols will not only enhance the quality of IVDs in India but also empower domestic manufacturers to compete successfully for global licensure.

“This landmark collaboration marks a significant step, as it is the first such initiative globally where a national regulatory body and a national research institute have worked together to create standardized evaluation protocols for high-risk diseases," Bahl said.

“By guaranteeing the quality of IVDs, the government aims to ensure accurate diagnoses and effective patient care, in line with its national vision of providing accessible, affordable, and high-quality healthcare for all," a second official said.

This is a crucial development for public health in India. Dr. Mahadev Swamy B, a consultant in interventional cardiology at SPARSH Hospital, Bengaluru, said that inaccurate test results can lead to delayed treatment, patient stress, and unnecessary medical interventions.

“Both situations can affect the safety of patients, increase the expenses and erode the trust as well. At the larger scale, unreliable diagnostics weaken the disease control programs and compromise the public health outcomes as well," he said. When test results do not align with a patient's symptoms, a repeat or confirmatory test is often recommended, especially for conditions like dengue or tuberculosis, to ensure accuracy and prevent inappropriate or delayed treatment, Dr Swamy B. added.

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Pricing and Outlook

The new guidelines are expected to improve public health outcomes by guaranteeing the quality of IVDs, which, in turn, support the national vision of providing "accessible, affordable, and quality healthcare for all".

Dr. Sunita Kapoor, director and laboratory head at City X-ray & Scan Clinic in Delhi-NCR, said that any increase in test prices would depend on whether kit suppliers raise procurement costs.

She added that quality-conscious labs might absorb minor price hikes to avoid affecting patients.“This new environment will require both domestic and international kit manufacturers to ensure their products comply with the new standards, bringing the "best to the shelves".

The ICMR has confirmed that this is an ongoing effort, with plans to expand the scope to cover other diseases and diagnostic formats in the future.

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