**Summary:**
In response to Lok Sabha Unstarred Question No. 3338, addressed on August 8, 2025, regarding a Quality Control Order (QCO) for medical and surgical gloves, the Ministry of Health and Family Welfare provides the following information:
A draft QCO for medical and surgical gloves was notified to the World Trade Organization (WTO) in February 2025. However, no specific timeline has been set for the final notification or implementation of the QCO.
The response acknowledges that other essential products, such as toys, steel, and footwear, are already covered under mandatory QCOs and BIS certification, while medical and surgical gloves are not.
The Ministry clarifies that medical and surgical gloves are currently regulated under the Medical Devices Rules, 2017, as per the Drugs and Cosmetics Act, 1940. These rules mandate adherence to specific standards to ensure the quality, safety, and performance of these medical devices.
The government is taking steps to ensure that medical and surgical gloves used in infection control meet uniform safety and quality standards through ISI marking
Key Entities Referenced
Ministry of Health and Family Welfare: The Union Ministry responsible for health policies in India.
Lok Sabha: The Lower House of the Parliament of India, where the question was raised.
Quality Control Order (QCO): A mandatory order to ensure the quality of specific products, in this case, medical and surgical gloves.
World Trade Organization (WTO): An intergovernmental organization that regulates international trade.
BIS certification: Certification from the Bureau of Indian Standards, indicating adherence to quality standards.
Smt. Anupriya Patel: The Minister of State in the Ministry of Health and Family Welfare who provided the answer to the question.
Department of Pharmaceuticals: The department, which is part of the Ministry of Chemicals and Fertilizers, responsible for pharmaceuticals related policies.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 3338
TO BE ANSWERED ON 08THAUGUST, 2025
QUALITYCONTROLORDER (QCO) FORMEDICALAND SURGICALGLOVES
3338.DR. BYREDDYSHABARI:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the Government intends to issue a Quality Control Order (QCO) for medical and
surgical gloves, considering that a draft QCO was notified to the World Trade Organization
(WTO)inFebruary 2025;
(b) if so, the details thereof alongwith the timeline by which the final notification is expected
tobe issued andimplemented;
(c) whether the Government is aware that several essential products such as toys, steel and
footwear are already covered under mandatory QCOs and BIS certification, while critical
healthcareprotective itemssuch asmedicalandsurgical glovesremainexcluded;
(d) if so, the detailsthereof;
(e) the reasons for the delay in bringing such essential healthcare items under mandatory BIS
certification; and
(f) the steps being taken by the Government to ensure that medical and surgical gloves used
ininfectioncontrol meet uniform safety andqualitystandards through ISImarking?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)to(f): As informed by the Department of Pharmaceuticals, it has published a draft
Quality Control Order (QCO) for medical and surgical gloves on website of World Trade
Organisation (WTO)inFebruary2025.No timelineisset for notification of the same.
Medical and Surgical gloves are regulated in the country under Medical Devices
Rules, 2017 under the Drugs and Cosmetics Act, 1940 and the said devices are required to
meet the standards as per the said rule to ensure quality, safety and performance of the
Medical Devices.
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