Lok Sabha Question No. 329 (STARRED), answered on 2022-03-25
Subject: Illegal Pathological Laboratories
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Santosh Kumar

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO.329 TO BE ANSWERED ON THE 25 TH  MARCH, 2022

## ILLEGAL PATHOLOGICAL LABORATORIES

## †*329. SHRI SANTOSH KUMAR:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether the Government is aware that a large number of illegal and unauthorised pathological laboratories are operating unchecked throughout the country;
- (b) if so, the details thereof;
- (c) whether the Government proposes to set up a regulatory body in this regard and if so, the details thereof; and
- (d) the other steps taken by the Government in this regard as per the guidelines of the apex court?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (DR MANSUKH MANDAVIYA)

- (a) to (d) A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 329* FOR 25 TH  MARCH, 2022

(a)  to  (d)  'Health'  is  a  State  subject,  and  it  is  within  the  ambit  of  respective  State/ Union Territory (UT) Government's responsibility to regulate pathological laboratories in their territorial jurisdiction.

Government  of  India  on  its  part  has  enacted  the  Clinical  Establishments (Registration and Regulation) Act, 2010 (CEA) and notified Clinical Establishments (Central  Government)  Rules,  2012  to  register  and  regulate  clinical  establishments, including the pathological laboratories.

The Clinical Establishments Act, 2010 provides that in each District there shall be a District Registering Authority under the District Collector to be notified by the State Government, empowered to enforce all provisions of the Act including grant and cancellation  of  registration.  Further  every  State  shall  constitute  a  State  Council  for Clinical  Establishments  at  State  Level,  under  the  chairmanship  of  State  Health Secretary, by notification for hearing appeals against orders of the aforesaid authority.

As  per  the  provisions  of  the  aforesaid  Act,  no  one  can  run  a  pathological laboratory,  in  the  States/UTs,  where  the  said  Act  is  applicable,  unless  it  is  duly registered under  the Act. For registration and  continuation,  every pathological laboratory is required to fulfil, among others, the conditions of minimum standards of facilities and services and minimum requirement of personnel.

Following the Apex Court's Judgment dated 12.12.2017, and after consultations with  various  stakeholders,  the  Government  notified  Clinical  Establishments  (Central Government)  Amendment  Rules,  2018,  specifying  minimum  standards  of  medical diagnostic laboratories / pathological laboratories. These Rules were further amended in 2020 specifying the qualifications of Technical Head of laboratory/Specialist/Authorized Signatory of all three categories of laboratories, i.e., Basic,  Medium  and  Advanced,  which  clearly  demarcate  the  scope  of  work  of  the medical and non-medical laboratory professionals.

Further, the Ministry of Health and Family Welfare has issued  advisory to all States  and  UTs  to  regulate  online  health  service  aggregators  and  related  service providers  including  laboratory  services  as  per  the  applicable  laws.  The  States  /  UTs have been further advised that the Department of Home of the concerned State 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.

As  on  date,  the  Clinical  Establishments  Act,  2010  is  applicable  in  11  States namely  Arunachal  Pradesh,  Himachal  Pradesh,  Sikkim,  Mizoram,  Bihar,  Jharkhand, Rajasthan,  Uttar  Pradesh,  Uttarakhand,  Assam,  Haryana  and  7  Union  territories namely  Andaman  &  Nicobar  Islands,  Daman  &  Diu,  Dadra  &  Nagar  Haveli, Puducherry, Chandigarh, Lakshadweep, Jammu and Kashmir and Ladakh.

Other 17 states and 1 Union Territory have their own state specific Acts.