PPE Suppliers Providing Unauthentic Certificates To Buyers Including Govt Procurement Agencies

Mumbai, 6 May 2020:

With increased demand for personal protective equipment (PPEs) in the country due to COVID-19 pandemic, unauthentic and fraudulent certificates are being provided by PPE suppliers to purchasers including government procurement agencies, putting the frontline healthcare workers’ life at risk, according to accrediting agencies and market sources.

Indian market is full of private certification bodies issuing certificates to industry and it is important to distinguish an authentic certificate from many unauthentic, fake or fraudulent certificates going around.

“The quality of PPEs is at centrestage now. Union health ministry has also specified standards and reports acceptable from national, international organizations and labs which has led to all kinds of certificates in the market, most of them unauthentic and some may even be fraudulent,” informs Anil Jauhri, former CEO, National Accreditation Board for Certification Bodies (NABCB).

In India, certification bodies should be accredited by NABCB for undertaking certification as per ISO 13485 which is an international standard for quality management systems (QMS) in medical devices and accepted by many regulators around the world.

In India, NABCB under Quality Council of India (QCI) is the national accreditation body for certification bodies (CBs) and any certificate bearing NABCB logo should be acceptable because NABCB makes sure the certificate is issued against a recognized standard following an acceptable process by a competent body.

There are certificates for CE mark as well as ISO standards. CE certificates can only be issued by notified bodies (NB) of European Commission (EC) whereas authentic ISO certificates would be those which come from duly accredited CBs and carrying logo of the accreditation body (AB) under the prevailing international system.

Jauhri explained that ISO is only a standards setting body and does not undertake any certification. Hence, use of ISO logo in any form on a certificate is misuse of its logo and you can assume that the certificate is not authentic.

“It may also be noted that CE mark is Europe’s regulatory mark and in case of PPEs, EC has a separate regulation under which NB are designated only in Europe. The list is available at the hyper link –https://ec.europa.eu/growth/tools databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501. There may be some branches or associates of NBs in India but any certificate must be from the NB listed in EC database,” he further informed.

The total projected demand of PPE kits till June, 2020 is estimated to be Rs. 2.01 crore. Around 107 PPE manufacturers have been identified who have raised their daily production to about 1.87 lakh PPE kits.

An authentic certificate should contain the name and address of the organization certified, scope of certification describing its activities under certification like production, packing and sale of PPEs like coveralls, shoe covers among others, standard (or sometimes scheme or regulation) against which certification is granted like ISO 9001 or ISO 13485 (standard) or AS 9100 or FSSC 22000 (scheme), date of issue and expiry of certificate, unique identification number of the certificate, name and address of the CB, logo of the CB, accreditation symbol indicating the name of the accreditation body (AB) which has accredited the certification body.

In most countries, in the absence of any law requiring CBs to register, accreditation is the only way of recognise a competent, authentic CB.

An International Accreditation Forum (IAF) Mark is an optional standard indicating that the certificate is covered under the Multilateral Mutual Recognition Arrangement (MLA) of the IAF and hence is internationally equivalent and acceptable in the market.

In order to judge the authenticity, the names of member ABs of IAF can be seen on its website-www.iaf.nu-which also gives information on which accreditation bodies are signatories to IAF MLAs for specific schemes – QMS or EMS or FSMS.

Once the user locates the AB in a country, he can go to its website from the link given on IAF website and then on AB’s website to verify if the CB is accredited. Then from the CB, one can verify the certificate because under international norms, CBs are obliged to help verify certificates issued by them. Pharmabiz