Parliament Question: Unregulated Single Use Medical Devices

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 1086 TO BE ANSWERED ON24THJULY, 2026 UNREGULATED SINGLE USEMEDICALDEVICES 1086.SHRIAZAD KIRTI JHA: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) whether the Government is aware of the instances of unregulated reuse of Single-Use Medical Devices (SUDs) in public and private healthcare centres across the country, despite labelling regulations under the Medical Devices Rules, 2017, if so, the details of such cases reportedduring the last five years, State/UT-wise anddistrict-wise; (b) whether there are any health and financial impacts on patients from such reuse, if so, the detailsthereof; (c) the details of policies formulated by the Government to prevent unsafe SUD reuse and ensure ethicalandsafe practices; (d) whether there are any existing procedures for obtaining informed consent regarding SUD reuse andwhether patientsare adequatelyinformedof risks, if so, the detailsthereof; (e) whether any complaints or representations have been received from patients, healthcare professionals or civil society regarding this practice and calls for guidelines, if so, the details thereof; (f) the details of action taken/proposed to be taken by the Government against entities involvedinsuch unregulatedreuse; (g) the steps contemplated bythe Government toaddress patientsafety, informed consent and care qualityimplications; and (h) whether the Government has any plans to frame national guidelines or amend laws like the Drugs and Cosmetics Act or Clinical Establishments Act for clearer regulation in this regard,if so, the detailsthereof? ANSWER THE MINISTER OFHEALTH AND FAMILYWELFARE (SHRIJAGATPRAKASH NADDA)(a)to(h): Manufacture andimport of Medical Devicesare regulatedunderthe provisions of the Medical Devices Rules, 2017. As per Rule 44 of the said Rules, manufacturers and importers are required to appropriately label a medical device, including where the device is intended for single use. Non-compliance with such labelling requirements constitutes an offence under the provisions of the Medical Devices Rules, 2017 and the Drugs and Cosmetics Act, 1940. Central Drugs Standard Control Organisation (CDSCO) has not received any complaints or reported cases regarding unregulated reuse of Single-Use Medical Devices during the last five years. The Government of India has enacted the Clinical Establishments (Registration and Regulation) Act, 2010 and notified Clinical Establishments (Central Government) Rules, 2012 for registration of Clinical Establishments with a view to prescribing the Minimum Standards of facilities and services provided by them. Under the said Act, the National Council for clinical establishments has approved Minimum Standards for different levels of Hospitals. As per these standards, the hospitals are also required to follow standard precautions like practicing hand hygiene, use of personal infection equipment etc. and infection control practices including compliance to Bio-Medical Waste Management Rules to reduce highrisk of healthcare associated infection. ‘Health’ being a State subject, the States / UTs which have adopted the CE Act are primarily responsible for enforcing/implementing the provisions of the CE Act in the respective States/UTs. The Act also provides for cancellation of registration, if the provisions of the Act are not complied with. *******