Minimum Standards for Medical Diagnostic Laboratories (or Pathological Laboratories) in India

UNDER: Clinical Establishments (Central Government) Rules, 2012 

MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th May, 2018

G.S.R. 468(E).—Whereas the draft of certain rules to amend the Clinical Establishments (Central Government) Rules, 2012 was published, as required under section 52 of the Clinical Establishments (Registration and Regulation) Act, 2010 (23 of 2010), in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide notification of the
Government of India in the Ministry of Health and Family Welfare, Department of Health and Family Welfare, number G.S.R. 441(E), dated the 5th May, 2017 inviting objections and suggestions from all persons likely to be affected thereby;

And whereas objections and suggestions received from the public have been duly considered by the Central Government;

Now, therefore, in exercise of the powers conferred by section 52 of the said Act, the Central Government hereby makes the following rules further to amend the Clinical Establishments (Central Government) Rules, 2012, namely:—

RULES
1. (1) These rules may be called the Clinical Establishments (Central Government) Amendment Rules, 2018.
(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Clinical Establishments (Central Government) Rules, 2012, (hereinafter referred to as the said rules),
in rule 2, after clause (b), the following clause shall be inserted, namely.—
‘(bb) “Schedule” means the Schedule appended to these rules’.

3. In the said rules, after rule 8, the following rule shall be inserted, namely:—
“8A. Minimum Standards for Medical Diagnostic Laboratories (or Pathological Laboratories) — 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 Schedule.”

4. In the said rules, after rule 9, the following Schedule shall be inserted, namely:-

SCHEDULE

READ THE FULL NOTIFICATIONS –Minimum Standards for Medical Diagnostic Laboratories (or Pathological Laboratories)