The Indian Rubber Gloves Manufacturers Association (IRGMA) in its latest bid to mitigate safety and health risks of medicos has sought directives through communications to the Ministry of Environment, Forests and Climate Change to ban the import of chlorinated gloves and has also notified the Customs (Imports) Department of the violation of bio-waste disposal rules by importers especially of the phased out chlorinated gloves, and non-compliance of gloves manufacturers sending chlorinated gloves to India, some making way into India spuriously. IRGMA is seeking the use of only BIS Approved Gloves, through GEM, for Government Hospitals, conforming to the consideration and implementation of QCO (Quality Control Order) aligned with MDR 2017 Compliance of CDSCO Gazette Notification which was to come into effect from 1st Oct 2022.
In their communications to the aforesaid authorities, IRGMA has brought to notice that the Central Pollution Control Board had issued a letter to phase out the use of chlorinated gloves by 27th March 2019; that West Bengal State Pollution Control Board has issued directives to ban the use of chlorinated gloves and that CPCB has issued directive not to allow imports in violation of guidelines that ban chlorinated gloves.
In yet another communication to the Malaysian Rubber Council, IRGMA has specified that chlorinated gloves of all kinds are not allowed by the Indian authorities owing to violation of the guidelines, and that they do not require test to be validated in the view of Ministry of Health and Family Welfare of India, and Biomedical Waste Rules 2016.
In their communication to AIIMS, IRGMA has issued a disclaimer to ensure that the healthcare industry procures the right quality of Disposal, Latex and Nitrile gloves to comply with the expected standards and rules prevalent.
The continuation of spurious import of examination gloves has serious safety and health risks. Many countries (US and Europe) have already banned the use of powdered, coated Nitrile Gloves, in their respective countries. The procurement of BIS Approved Gloves is very convenient because there are already many BIS certified companies manufacturing the gloves, and these companies are capable of supplying the quality product to the Hospital Staff.
Speaking about the directives on chlorinated gloves, Mr Sunil Patwari (President – IRGMA) said, “It is time that these spurious imports and usage of chlorinated gloves be curbed as it is detrimental to the health of both the healthcare providers and the patients, and for their safety the Government and the authorities must make firm implementations that impede the spurious circulation and import of chlorinated gloves.”
Mr Konda Anindith Reddy (Managing Director – Wadi Surgicals Enliva Gloves) added, “We need to ensure that we are providing the right quality gloves to the medical practitioners for the safety of them and the patients as well. This kind of trust will come only if there is a stringent regulation on the spurious circulation and import of chlorinated gloves.”
Medicos working in acute medical care units are at maximum risk of contracting infection with defective gloves. Even patients are equally at risk of contracting cross-infections if exposed to any open areas from a torn surgical glove worn by medical staff.
In order to implement the ban on noncompliant gloves and their spurious circulation, IRGMA has identified the urgent need and therefore requesting the for the FINALISATION OF QCO, through Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers; DIRECTING CDSCO to IMPLEMENTATIN of RULE 2 of CHAPTER 7; DIRECTING CDSCO, to ban the import of spurious/ loose gloves AND import of Chlorinated Gloves; DIRECTING the Govt Hospitals to procure only BIS approved Nitrile Gloves. IRGMA has urged the Govt to immediately consider that poor quality surgical gloves in hospitals need a check which is possible through FINALISATION OF QCO in compliance to CDSCO Gazette Notification (Rule 7 of Chapter 2).
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