In a step that could significantly improve the diagnostic accuracy and safety of patients, the High Court in Delhi ordered the Union Government to announce the long -waiting minimum standards in the collection of medical samples or samples by laboratories and collection centers and instructions for their transport in the next three months.
The order, if implemented, could help reduce the inaccuracy in the test messages, especially if the samples are collected from the patient’s home, the experts said. This could also reduce dangerous treatment of biological samples and treatment errors caused by degraded samples, potentially save lives, they added.
Currently, India lacks specific regulations that regulate, as medical samples, such as blood, urine or swabs, collect, store and transport in diagnostic laboratories. This regulatory gap has led to extensive discrepancies, especially with private laboratories and collection of houses that operate without strict supervision.
Bad results
“Patients often assume that their test results are scientifically reliable. But when the samples are exposed to extreme heat or delayed when the laboratory is reached, the whole result can be invalid – without anyone realizing it,” Rohit Jain, who filed in 2019 in this matter.
“Incorrect results lead to incorrect treatment. It’s not just unethical – it’s dangerous,” Dr. Jain.
High Court while heard the action of Dr. Jaine 18th July, recorded the assurance of the Ministry of Health of the Union that the proposal of the minimum standards that the ministry stated that it was already approved by the General Directorate of the Health Services (DGHS) was at the advanced stage of the announcement.
The application submitted via the defense attorney Mrinmoi Chatterjee said that, despite the Delhi’s Delhi instructions in January 2023, the center had not been created by any instructions on the minimum sampling standards.
The Ministry of Health stated in its last report on the state of the court that the proposal of minimum standards is currently undergoing legal examination by legislative Ministry of the Legal Ministry and Justice.
The Ministry said four expert subcommitations with experts in pathology, biochemistry, hematology and microbiology were created to formulate “minimum standards for sampling and sampling policy”.
After the approval of the National Council for Clinical Facilities, after public consultation, the process of publishing instructions in the Indian Journal would begin.
In addition, the Ministry stated that two instructions issued by the Indian Medical Research Council-The National Institute of Virology (NIV) during the COVID-19 pandemics have currently been introduced, which, when reading in conjunction with minimal standards, offer comprehensive laboratory instructions in maintaining biological security and ensuring quality manipulation.
But Dr. Jain remains skeptical. “These design standards have been stuck for two years. Meanwhile, nothing has changed on Earth,” he said.
“There are aggregators and collection agents who do not have medical training, collect samples from people’s homes. They do not raise them, do not process them in time and no one follows how long it takes to get into the laboratory,” Dr. Jain, when he asked why private laboratories should be self -regulated.
According to him, there are well-established scientific windows in which samples must be analyzed-somewhere within 30 to 60 minutes of collection. “In the heat of 45 ° C in Delhi, the delay can completely disrupt the test results for several hours. However, the government has no binding standard. Why would private laboratories be regulated?” said.
ICMR has issued specific instructions for transporting samples related to high-risk pathogens and samples for COVID-19, but they said were limited and unlocked in all clinical facilities.
“The results of laboratory tests affect globally to 70% of the treatment decision. When they are wrong, they damage patients and erode confidence in the medical system,” Dr. Jain.
“Specifically, there is no law (for collecting and transporting samples), and therefore this petition has been filed. We want the government to release instructions,” said Ahuja, a former professor of pathology, the National Accreditation Board for Testing and Calibration Laboratory and the National Accreditation Council for Hospitals and Hindu providers.
“The quality of the samples must be maintained and instructions must be introduced. To have the law needed for an hour,” he added.
“I am very happy that the court was very positive to the pathologist’s requirements that the law must be introduced,” said Dr. Ahuja.
Published – July 26, 2025 9:17
