Medical Testing Labs

Regulations or Accreditations ??? – beginning of a new conundrum

Medical Labs are undoubtedly an important part of the health ecosystem in any country but in India, like many other sectors related to health and safety, they have remained largely unregulated and therefore lacking assurance of quality and reliability.

The Clinical Establishments Act, 2010 intended to fill this gap but unfortunately only 11 states and almost all union territories have adopted the Act till now and from all accounts none has enforced the minimum standards prescribed under it. Therefore, there is not even data on how many medical labs are operating in the country much less any measure of their quality. The role of medical labs came into sharper focus as covid pandemic set in and India scrambled to develop covid testing facilities.The question begs an answer not only in relation to covid testing but for the larger issue of assuring quality of medical labs in general in the country.

Read the informative post by Mr Anil Jauhri, International Conformity Assessment Expert about Medical Labs and whether they need Regulations or Accreditations in the country .

Source : Healthcare Quality News Letter from QAI – http://www.qai.org.in/

Regulate Online Health Aggregators

Health Ministry Advisory to States, UTs

The Union Health Ministry has asked all states and UTs to implement a time-bound action plan for regulating online health service aggregators who have neither provided any details of laboratories on behalf of which they are providing services, nor their registration status, including compliance to minimum standards.

The ministry has further advised that the Department of Home of the state concerned may also be requested to investigate such matters with an objective to prevent any kind of violation (civil or criminal/cyber or otherwise) of applicable laws.

In a letter written to all states and UTs on January 19, Health Ministry Secretary Shri Rajesh Bhushan referred to an August 2020 order by the Delhi High Court which directed the ‘concerned authorities’ to initiate action against any illegal online health service aggregators operating in Delhi in violation of the ‘applicable laws’, including the Clinical Establishments (Registration and Regulations) Act, 2010.

Health Secretary said the laboratories and other clinical establishments, providing any type of medical services, are required to be registered either under the Clinical Establishments (Registration and Regulations) Act, 2010 (in those states/UTs where it is applicable) or under the state laws, as applicable.

This ministry has also notified in gazette, the minimum standards for laboratory services vide notifications dated May 21, 2018, and the amendment notification dated February 14, 2020, the letter stated.

Certain online health service aggregators, operational in various parts of the country, may perhaps be neither providing any details of laboratories, on behalf of which, they are providing services, nor their registration status, including compliance to minimum standards, Secretary said in the letter addressed to chief secretaries and administrators of all states and UTs.

The details of qualified staff, as required for running the laboratory services, may also not be available on their online portals.

“Health being a state subject, and keeping in view the directions of the Hon’ble Court in the above said order, it is requested, that a time-bound action plan may be made and implemented, as per the applicable laws, for regulating such online health service aggregators, and the related service providers, operational in your state/UT.

“It is further advised that the Department of Home of the state concerned may also be requested to investigate such matters with an objective to prevent any kind of violation (civil or criminal/cyber or otherwise) of applicable laws. It is further requested that an Action Taken Report may be sent to this Department on a priority basis,” the letter said.

Download the advisory issued by Dept of Health, MoH&FW

Medical Devices Regulation

Announcement from CDSCO

CDSCO has released a notification about the regulation of certain medical devices like blood glucose monitors, BP monitors, Nebulisers and Thermometers , the same is shared here

Medical Device Industry and other stakeholders including Hospitals, Diagnostics Sector, other healthcare orgns and patient communities have to follow the med dev regulations that are being announced on regular basis .