MINISTRY OF HEALTH AND FAMILY WELFARE RELEASES DRAFT GUIDELINES FOR MEDICAL DIAGNOSTIC LABORATORIES IN THE COUNTRY

May 9, 2017 by
Filed under: Uncategorized 

MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION – New Delhi, the 5th May, 2017

Central Govt proposes to introduce new rules called the Clinical Establishments (Central Government) Amendment Rules, 2017 by defining Minimum Standards for diagnosis or treatment of diseases. These rules are drafted by the Govt after consultation with the National Council for Clinical Establishments in the country.

Every clinical establishment relating to diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, are usually carried on with the aid of laboratory or other medical equipment, shall comply with the minimum standards of facilities and services as specified in the Rules.

Draft rules clearly defined the following :

- classification of laboratories based on their size;

- infrastructure specification for these labs;

- Scope of services that can be offered by these labs;

- mandatory human resource requirements for these labs,

- Minimum requirements on usage of equipments, instruments, consumables in labs

- Legal and Statutory compliances

- Record Keeping Guidelines

- basic systems and processes that should be followed by these labs in the country to be eligible    for licensing and registration of the labs.

Above guidelines are released by MoH as draft guidelines on May 5, 2017 and same are open for public comments.

Objections and suggestions, if any, on the above guidelines may be addressed to

The Under Secretary (Medical Services),

Ministry of Health and Family Welfare,

Government of India,

Room No. 508, D Wing, Nirman Bhavan, New Delhi – 110011

or send email to sunil.kumar20@gov.in

Draft guidelines are published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules will be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made available to the public.

Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government.

Click here for the full announcement :

Minimum Standards for Medical Labs – Clinical Establishments Act

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