Rohit Jain

About Rohit Jain

I am a pathologist practicing in India for the past 17 years, and for the last 13 years I have been actively involved in policy development for medical laboratories. In recognition of this work, I was included in The Pathologist Power List in 2018. One of the greatest challenges facing pathology in India is widespread quackery in medical diagnostics, which contributes to inaccurate lab reports at every stage – from pre-analytical to post-analytical – affecting a population of 1.4 billion people.

Unregulated and illegal sample collection centers, as well as online health service aggregators (including large e-commerce companies), operate freely in the absence of a national sample transport policy. Most diagnostic labs in India are not registered and are often run by unqualified individuals, despite the government issuing minimum standards for medical diagnostic laboratories in 2018. Implementation has been weak, leaving the sector largely unregulated.

Although the Supreme Court of India ruled on December 12, 2017, that only registered medical practitioners with postgraduate qualifications in pathology may countersign lab reports, enforcement has been poor. Reports are still being authorized by unqualified personnel, often using scanned (rather than legal digital) signatures, enabling fraud and jeopardizing patient care. Internal quality control checks are not mandatory, and laboratory instruments – classified as “drugs” under the 2017 Medical Device Rules – can still be purchased without restriction, allowing anyone to set up a laboratory and issue reports.

To address these issues, I have pursued legal action for over a decade with the support of attorneys Shashank Deo Sudhi and Mrinmoi Chatterjee, as well as colleagues from the Practicing Pathologists Society, Rajasthan.

Key developments include:

Delhi High Court (Contempt Case 739/2020): Directed the Government of India and Delhi Government to ensure no illegal or unauthorized labs operate within Delhi.

Delhi High Court (Contempt Case 450/2022): Acknowledged the importance of addressing illegal sample collection during COVID-19 by unregulated online health service aggregators.

Delhi High Court (Contempt Case 824/2024): Ordered the Government of India to urgently submit standards of procedure for sample collection, sample centers, and a national sample transport policy, with a deadline of July 18, 2025.

Delhi High Court (Writ Petition 16233/2024): Issued notice to the Government of India to frame guidelines preventing misuse of scanned or fake signatures being misrepresented as digital signatures in medical documents.

Rajasthan High Court (Writ Petition 22724/2017, January 8, 2025): Reiterated the Supreme Court ruling that only qualified pathologists may countersign laboratory reports.

These ongoing court orders offer hope that pathology practice in India is on the path to meaningful reform. With evolving policies and stronger enforcement, I believe the practice of pathology in India can be safeguarded and improved in the best interests of patient care.