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CE Act should be adopted on priority basis to effectively regulate path labs in the country: Dr. Arvind Lal

Shardul Nautiyal, Mumbai
Tuesday, January 10, 2023, 08:00 Hrs  [IST]

Clinical Establishment (CE) Regulation should be adopted on priority basis because it stipulates eligibility and qualification of personnel running a lab, standards or guidelines on the infrastructure and testing facilities. This is taking a long time to progress, according to Dr. Arvind Lal, chairman, Dr. Lal PathLabs while revealing the fact that the country has only 2000 National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited labs as of today.

A sizeable number of around 3 lakh path labs can qualify the accreditation criteria of NABL once the awareness about quality testing, regulatory oversight and compliance is adopted in a scientific way, Dr Lal explains. The accreditation of labs improves facilitation of accurate and rapid diagnostics, efficiency of treatment and reduction of errors in the laboratory process. Accreditation ensures a system of standard procedures with the aim to improve the quality of tests and hence patient safety.

NABL under the Quality Council of India (QCI) is mandated to implement an accreditation system for testing, calibration, medical and other laboratories based on national and international standards. Therefore, it is important for all laboratories to obtain NABL accreditation.

“The unaccredited labs which do not comply with the NABL criteria would face closure once the regulatory oversight gets streamlined. To cite an example, the Government of India (GoI) today exercises a very strong vigil or oversight on running of radiology centres in the country. If anyone tries to buy an ultrasound machine and places an order, the vendor is supposed to inform the Government immediately as a part of the compliance and norms. The Government has a clear cut protocol and guidelines on the same. There are Supreme Court (SC) rulings which say that the lab report cannot be released without the approval of a registered medical practitioner,” Dr Lal adds.

The Clinical Establishments (Registration and Regulation) Act, 2010 has been enacted by the Central Government to provide for registration and regulation of all clinical establishments in the country with a view to prescribing the minimum standards of facilities and services provided by them.

The Act makes it mandatory for registration of all clinical establishments, including diagnostic centres and single-doctor clinics across all recognized systems of medicine both in the public and private sector except those run by the defence forces.

The registering authority facilitates policy formulation, resource allocation and determines standards of treatment. It can impose fines for non-compliance of the provision of the Act. The Act lays down Standard Treatment Guidelines for common disease conditions, for which a core committee of experts has been formed. Further, the Act makes all clinical establishments to provide medical care and treatment necessary to stabilize any individual who comes or is brought to the clinical establishment in an emergency medical condition, particularly women who come for deliveries and accident cases.

Dr Lal PathLabs is a provider of diagnostic and related healthcare tests and services in India.

As on March 31, 2022, the company has 277 clinical laboratories (including national reference lab in Delhi, regional reference labs at Kolkata and Bengaluru), 4,731 patient service centres (PSCs), and 10,599 pick-up points (PUPs). Its customers include individual patients, hospitals, other labs, healthcare providers, and corporate customers.


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