**Executive Summary**
This document is the answer from the Minister of State in the Ministry of Health and Family Welfare to Unstarred Question No. 2360 in Lok Sabha, regarding the regulation of diagnostic centers in residential areas. The response clarifies the roles of the State and Central governments in regulating diagnostic centers and managing biomedical waste, referencing the Clinical Establishments Act (CE Act) and the Bio-Medical Waste Management Rules. The answer was provided on February 13th, 2026.
**Key Points / Main Content**
* **Regulatory Responsibility:**
* Health is primarily a state subject; therefore, states/UTs are responsible for regulating and registering diagnostic centers and addressing biomedical waste issues.
* **Clinical Establishments Act (CE Act):**
* The Government of India enacted the CE Act, 2010, and notified the CE Rules in 2012, amended in 2018 and 2020, for registering and regulating Government (except those of Armed Forces) and private clinical establishments belonging to recognized systems of medicine.
* Clinical establishments must meet minimum service standards as per the CE Act.
* The CE Act is applicable in 19 States/UTs.
* **Bio-Medical Waste Management:**
* The Bio-Medical Waste Management Rules, 2016, under the Environment (Protection) Act, 1986, govern the management of biomedical waste generated by diagnostic laboratories.
* These rules apply to anyone who generates, collects, stores, transports, treats, or disposes of biomedical waste.
* **Enforcement:**
* States/UTs that have adopted the CE Act are primarily responsible for enforcing its provisions.
* The CE Act empowers a registering authority (District Collector/Magistrate) to take action, including imposing penalties and canceling registration for violations.
* Clinical establishments in States/UTs that have not adopted the CE Act are registered and regulated by respective state acts.
**Impact Analysis**
**States/UTs**
* **Impact:** Primary responsibility to regulate and register diagnostic centers and ensure proper biomedical waste management within their jurisdiction. Enforce the CE Act provisions where applicable.
* **Action Required:** Ensure diagnostic centers comply with the CE Act (if adopted) and Bio-Medical Waste Management Rules, implement state-level regulations if the CE Act is not adopted, and take action against violations.
**Diagnostic Centers**
* **Impact:** Must comply with the CE Act (where applicable) and Bio-Medical Waste Management Rules to maintain registration and operation.
* **Action Required:** Meet minimum service standards as required by the CE Act, properly manage biomedical waste according to the rules, and comply with registration requirements.
**Central Government (Ministry of Health and Family Welfare)**
* **Impact:** Provides overarching legislation (CE Act) and guidelines (Bio-Medical Waste Management Rules) but relies on States/UTs for implementation and enforcement.
* **Action Required:** Continue to support States/UTs in implementing the CE Act and Bio-Medical Waste Management Rules and monitor compliance.
Key Entities Referenced
Clinical Establishments (Registration and Regulation) Act, 2010 (CE Act): A central act enacted by the Government of India to provide for the registration and regulation of clinical establishments.
Bio-Medical Waste Management Rules, 2016: Rules governing the management of biomedical waste generated by diagnostic laboratories, notified under the Environment (Protection) Act, 1986.
States/UTs: The primary responsibility for regulating and registering diagnostic centers and addressing biomedical waste lies with the respective States/UTs.
Ministry of Health and Family Welfare: The Union ministry responsible for matters related to health and family welfare.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2360
TO BE ANSWERED ON13THFEBRUARY, 2026
REGULATIONOFDIAGNOSTIC CENTRES IN RESIDENTIALAREAS
†2360.SHRIIMRAN MASOOD:
Will the Minister of HEALTHANDFAMILYWELFARE be pleased tostate:
(a) whether the Government has taken any steps to regulate diagnostic centres operating in
residential areaswhich generate hazardousbiomedicalwaste;
(b) if so, the details thereof including the action taken against laboratories operating without
validregistration certificates;
(c)whether there is anyplanto make primary treatmentfacilities mandatoryfor the treatment
of medicalwaste; and
(d) if so, the detailsthereofand if not,the reasons therefor?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT. ANUPRIYAPATEL)
(a) to (d) : ‘Health’ being a State subject, the primary responsibility to regulate and register
diagnostic centres and to address the issue of biomedical waste lies with the respective
States/UTs.
Nonetheless, the Government of India enacted the Clinical Establishments
(Registration and Regulation) Act, 2010 (CE Act) and notified the Clinical Establishments
(Central Government) Rules, 2012 amended in 2018 and 2020 (CE Rules) to provide for
registration and regulation of Government (except those of Armed Forces) as well as private
clinical establishments belonging to recognized systems of medicine. As per CE Act, the
clinical establishments are requiredto fulfill the conditions of minimum standards of services
provided for each type of service provided. The CE Act is applicable in 19 States/UTs (12
States of Arunachal Pradesh, Assam, Bihar, Jharkhand, Haryana, Himachal Pradesh,
Mizoram, Rajasthan, Sikkim, Telangana, Uttarakhand & Uttar Pradesh and 7 UTs of
Andaman & Nicobar Islands, Chandigarh, Dadra & Nagar Haveli and Daman & Diu, Jammu
& Kashmir, Ladakh,Lakshadweep & Puducherry).
Further, management of biomedical waste generated by diagnostic laboratories is
governed by the Bio-Medical Waste Management Rules, 2016, notified under the
Environment (Protection) Act, 1986 by the Ministry of Environment, Forest and Climate
Change. These rules apply toall persons who generate,collect, receive, store, transport, treat,
dispose, or handle bio medical waste in any form including hospitals, nursing homes, clinics,pathological laboratories and so on. Compliance with these provisions forms part of the
conditions for registration and continued operation of clinical establishments under the CE
Rules.
The States / UTs which have adopted the CE Act are primarily responsible for
enforcing/implementing the provisions of the CE Act for regulating their diagnostic
laboratories. The Act has empowered a registering authority at the district level under the
chairmanship of the District Collector / District Magistrate totake actionsincluding imposing
penalties in respect of violation of its provisions. The Act also provides for cancellation of
registration, if the provisions of the Act are not complied with. The clinical establishments in
the States/UTs, which have not adopted and implemented the CE Act, are registered and
regulatedbythe respective StateActs.
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