**Summary:**
The Ministry of Health and Family Welfare addressed concerns regarding the operation of illegal and unauthorized pathology laboratories across the country in response to Lok Sabha Unstarred Question No. 2246 on August 1, 2025. The Ministry clarified that health is a state subject, and thus, the primary responsibility for regulating pathology laboratories lies with State/UT Governments. Data regarding the number of illegal laboratories is not centrally maintained.
The Government of India enacted the Clinical Establishments (Registration and Regulation) Act, 2010, to regulate both government and private clinical establishments, including pathology laboratories (excluding those of the Armed Forces). The Act mandates that pathology laboratories meet minimum standards for facilities, services, personnel, record keeping, and reporting. The Act empowers registering authorities at the district level, under the chairmanship of the District Collector/District Magistrate, to take actions and impose penalties for violations of the Act's provisions. States/UTs that have adopted the CE Act are responsible for regulating pathology laboratories within their jurisdiction according to the Act and its associated rules. The response was provided by the Minister of State in the Ministry of Health and Family Welfare, Smt. Anupriya Patel.
Key Entities Referenced
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
Lok Sabha: The lower house of the Parliament of India.
Manju Sharma: Member of Parliament who raised the unstarred question.
Anupriya Patel: The Minister of State in the Ministry of Health and Family Welfare who answered the question in Lok Sabha.
State Governments: Refers to the governments of the individual states within India, which have primary responsibility for health as a State subject.
Clinical Establishments Registration and Regulation Act, 2010: An act enacted by the Government of India to provide for the registration and regulation of clinical establishments, including pathology laboratories.
District Collector District Magistrate: The administrative head of a district who chairs the registering authority for clinical establishments.
States UTs: Refers to States and Union Territories of India.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2246
TOBE ANSWERED ON01STAUGUST, 2025
PATHOLOGYLABORATORIES
†2246.SMT.MANJU SHARMA:
Will the Ministerof HEALTHANDFAMILYWELFAREbe pleasedtostate:
(a)whether a large numberof illegal/unauthorisedPathology Laboratoriesare beingrun inan
uncontrolledmanneracross the country;
(b) if so, the detailsthereof;
(c)whether the Government proposes toset up any regulatorybody inthisregard;
(d) if so, the detailsthereof; and
(e) the other steps being taken by the Government as per the directions of the Apex Court
against these unauthorised, Pathology Laboratories?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a) to (e): ‘Health’ being a State subject, it is the primary responsibility of State/UT
Governments totake note of illegal/unauthorised pathology laboratoriesbeing operational. The
data anddetails, inthis regard,are not maintainedcentrally.
Furthermore, the Government of India enacted the Clinical Establishments
(Registration and Regulation) Act, 2010 to provide for registration and regulation of
Government as well as private clinical establishments (except those of Armed Forces),
including pathologylaboratories, belongingtorecognized systems of medicine. As perthe Act,
the pathology laboratories are required to fulfil the conditions of minimum standards of
facilities and services, minimum requirement of personnel, maintenance of records and reports
and other conditions. This Act empowers registering authority at District level under the
chairmanship of District Collector / District Magistrate to take actions including imposing
penalties in respect of violation of its provisions. The States / UTs which have adopted the CE
Act are primarily responsible for regulating their pathology laboratories as per provisions of
the Act andRulesthereunder.
*****