Surge in fake certificates as new players flood market with Covid-19 med products | India News - whatsaup.in
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Surge in fake certificates as new players flood market with Covid-19 med products | India News

MUMBAI: The Covid-19 pandemic has led to a surge in fake and inauthentic certificates endorsing a host of key medical products –right from masks, PPE kits, oximeters, thermometers, sanitizers, diagnostic kits and, even ventilators. This has given rise to medical products of sub-standard or questionable quality being sold, and used by end-users like hospitals, jeopardizing the safety of healthcare workers and patients. Earlier the extent of the problem was limited to about 20% of manufacturers, which increased to over 80% recently with the entry of new players.
The rise of Covid-19 cases in March-April triggered a huge demand for these medical devices and equipment, leading to a mushrooming of cottage industries, some with poor quality control and inadequate knowledge of standards, industry experts told TOI. Worse, fly-by-night manufacturers surfaced, while there were also unauthorised imports from China, they added.
Typically, medical devices are approved by BIS with the stamping of ISI mark, which denotes compliance to Indian product standards. Further, there’s a quality management certification, ICMED (Indian Certification for Medical Devices) by Quality Council of India (QCI) which gives process certification by internationally reputed bodies (Intertek, SGS, TUV, UL) to medical devices manufacturers, which is voluntary at present. These certification bodies are accredited by NABCB, a constituent board of QCI, for the ICMED scheme as well as for Medical Devices Quality Management Systems (MDQMS) certification as per the international standard ISO 13485, a subset requirement of ICMED scheme.
If the company does not conduct proper due diligence and tests the product for its safety and efficacy, it may seek a fraudulent process and product certification, to mislead the end-user, patient and consumers.
Dr RP Singh secretary general QCI said “QCI is aware that many fake certifications are being issued by few certification bodies either accredited through foreign accreditation bodies without proper oversight in Indian market or not accredited at all. This is a serious issue which is being pursued by the government and we expect that a notification will be issued soon by the appropriate authority to curb such malpractices. It is closely working with relevant ministries and regulators to facilitate in providing accredited conformity assessment bodies (certification / inspection bodies and testing laboratories) for credible certification of such medical products, and thus to minimize fake/fraudulent certification”.
A uniform certification endorsing credible quality and processes should be made mandatory for all medical devices as it will inspire confidence and trust in end-users like hospitals and patients.
Says Rajiv Nath forum coordinator Association of Indian Manufacturers of Medical Devices “India needs to have a legislative authority to regulate certification and accreditation bodies. It’s also important to create a registry of certificates and authentic certification bodies from credible sources”.
Hospitals under Association of Healthcare Providers, doctors represented by Indian Medical Association, and consumer organisations have also sought clarity on credible certification.
Dr Ganesh Mani chairman Delhi-based Max Smart Super Speciality Hospital said: “ICMED certification should be made mandatory on all medical devices. This will inspire trust and confidence to the user that it is unlikely to fail”.
Hospitals should focus on strict verification protocols as part of their procurement practices, experts add. Says Rama Venugopal, executive director of Value Added Corporate Services, with experience in regulatory requirements: “The regulator should create a registry of certificates which are authentic, inauthentic and fake. This is the only way industry will develop confidence. Also, it has to call for a complete audit of procurement practices of accredited and certified hospitals to check certificates approved in-house as part of the vendor selection process. All agencies for accreditation, certification, inspections and testing should be registered. Now, global platforms have put up search registries asking user industries (healthcare organisations) to verify certificates online”.
Now with the surge in pandemic, the problem has multiplied as new manufacturers from garments, textile, auto industry diversified into medical devices to make PPE raw materials, coverall, masks, goggles, face shields etc to address the urgent demand. Many UK, European and US certificates from dubious bodies endorsing sub-standard and poor quality medical products like masks, PPE kits and oximeters are in circulation.

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