Fake certifications, bogus products: How Indian market is flooded with substandard N95 masks
The COVID-19 pandemic has led to Indian market getting flooded with fake and uncertified N95 masks. Asiaville investigates.
Buying an N95 mask? Consider yourself lucky if you are able to buy an authentic one.
An investigation by Asiaville has found that the majority of the respirators available in the Indian offline and online markets falsely claim to have the N95 certification.
Because of poor understanding of this standard by sellers and consumers, and lack of proper regulatory oversight, unscrupulous manufacturers are taking advantage of the pandemic by flooding the market with bogus N95 masks, we found.
But before we go into details, let’s understand what an N95 mask is.
The N95 is a respirator standard set by the US National Institute for Occupational Safety and Health (NOSH), which tests masks based on its resistance to oil and particle filtering ability. So, in ‘N95’, the letter ’N’ signifies that the respirator is not resistant to oil, and ‘95’ implies that it filters 95% of airborne particles.
Only those facemasks that meet the US NIOSH, N95 classification for filtering airborne particulate contaminants are certified to be an N95 respirator. An equivalent standard in India is BIS FFP2.
N95 Equivalent standards in other countries:
FFP2 (Europe EN 149-2001)
KN95 (China GB2626-2006)
P2 (Australia/New Zealand AS/NZA 1716:2012)
Korea 1st class (Korea KMOEL - 2017-64)
DS2 (Japan JMHLW-Notification 214, 2018)
The N95 masks became popular when they were recommended by the World Health Organisation (WHO) during the SARS outbreak in 2002. Although the agency later recommended equivalent European standards like FFP2 & FFP3, N95 never lost its popularity.
"Although N95 and similar masks are efficient in protecting the wearer against viruses, they are not easy to breathe in and often get moist and hot after wearing it for more than 30 minutes,” says Sundeep S Salvi, Director, Pulmocare Research and education (PURe) Foundation, Pune.
“They are therefore not meant for routine household use or while travelling outside, they are mainly meant for health care providers who come in close contact with the COVID19 patients.”
The demand for N95 masks shot up during the COVID-19 pandemic, giving rise to a sudden spurt of counterfeit and spurious products.
“A respirator that has N95 written on it is not enough to certify its validity. It is often made with cheap fabric and duplicate parts to dupe the consumer. The situation is similar across the world and fraud alerts have been issued by several Governments,” says Salvi.
NIOSH has listed all the certified license holders to manufacture the N95 mask across the globe on their website. You can verify whether a manufacturer is certified or not by checking the website; pay special attention to the TC number on the particular mask.
While all medical devices are regulated in India under the Drugs Act since April 1, 2020, masks are not covered by these regulations.
Asiaville visited several shops and conducted an extensive verification of N95 claims by mask manufacturers. We found that none of them had a NIOSH certification, even though they had ‘N95’ printed on them. Most masks printed the logos of confirmation to European Standards or Indian standards to trick customers into buying them. These shops included an Apollo pharmacy outlet and a Jan Aushadhi store.
“This is what we have. We are told that this is N95. And people are buying these,” said a shop owner in Delhi’s Mayur Vihar, when asked about the authenticity of the masks he was selling.
The same was the case with such masks listed in online marketplaces like Amazon and Flipkart.
Several of the masks listed with the logo and certification of certified N95 manufacturers such as 3M were also fake, an investigation by Brand Protectors India, which works closely with brands to identify counterfeit products, had found.
“I'd say about 60% these masks are fake.... We got some 15 sellers blacklisted on these online platforms,” the founder-director Dhirendra Singh told Asiaville.
“Manufacturers of respirators have given in to the demand and have started printing ‘N95 mask’ on the respirator packs to authenticate their products. This is wrong and these fraud products are cheating their customers (sic),” says the website of Venus Safety and Health Pvt Ltd, a leading manufacturer of N95 masks in India.
Such companies don’t just try to cheat people, but government officials too. For instance, the following fake NIOSH compliance certificates were submitted in a recent tender of a state government.
“We insisted on NIOSH certification and ignored other standards that were easy to fake because they don’t provide a centralised database of approved manufacturers,” said an official who did not want to be named.
Even at the All India Institute of Medical Sciences (AIIMS), Delhi, nurses and doctors in several departments were provided with cheap N95 masks, Asiaville found out.
“Many of the masks we were provided were really substandard..They had really poor fit and finish, air was leaking. We were also told to re-use each of these masks,” says Dr. Srinivas Rajkumar T, General Secretary, RDA, AIIMS New Delhi.
At least 600 cases of COVID-19 infections have been reported from the medical staff of Delhi AIIMS. When Asiaville reached out to an official who is in charge of procurement, he refused to comment.
Asiaville spoke to several mask manufacturers by pretending that we were buyers. We found that the masks were sold at a Rs 30 to Rs 50 price range to the sellers, who in turn sold these for anywhere between Rs 100 and Rs 350. Several of them did not have any idea about NIOSH certification. Many of them said they would be able to supply masks with any kind of certification.
Police have taken action in some cases against mask manufacturers selling fake N95 masks. For instance in Bangalore, the police seized 12,300 masks, worth Rs 20 lakh in a raid in a godown. But the accused person had already sold about 70,000 masks worth Rs 1.05 crore.
But such actions have been rare.
Getting the certification
An estimate by the Association of Indian Medical Device Industry (AIMED) says that the demand for N95 masks in India was about 1.38 crores per year before the pandemic. But by the end of June, this rose to 25.8 crore. Simultaneously the prices too rose. In four months ending May 2020, the prices rose by at least 250%, according to a report.
Even though major suppliers such as 3M were able to raise their capacity, this was not adequate to meet the demand.
“Since the initial COVID-19 outbreak, we’ve ramped up to maximum production levels of N95 respirators and doubled our global output to a rate of more than 1.1 billion per year, or nearly 100 million per month. Even in India, we have increased the production of respirators, surgical masks and hand sanitisers in the range of 35% to 40%,” says Sandhya Ganapathy, General Manager, Communications, Security & Corporate Services at 3M, the largest global producer of N95 masks.
The country has only a handful of NIOSH approved manufacturers.
“Getting a NIOSH certificate is nearly impossible right now, because there is a lack of clarity about the procedures, and they are giving priority to US-based companies,” a Delhi based manufacturer told Asiaville.
“Getting certified by European Standard is costly. One has to spend around Rs 15 lakh for that,” the person said, adding that they print N95 on their masks, despite not having the NIOSH certification.
“There is a major issue of clarity, even in the government circle as well. They themselves don’t know what these standards are when they call for tenders,” the person added.
The Bureau of Indian Standards (BIS) has come up with the IS 9473 FFP2 standard to certify a mask as N95 equivalent in India. But the organisation has a limited capacity to test samples. Manufacturers complain that getting certification takes a long time, and that they are forced to get the products certified from labs of larger companies who have these facilities.
“Our application with BIS has been under processing for several weeks now. We get really nervous when we are told to test from a lab like that of Venus or 3M. They can fail us as we are their competitors,” said the mask manufacturer Asiaville spoke to.
In the first week of July, about 147 applications were pending before BIS.
Regional Offices of BIS have no inclination of sending samples to DRDe.. they refuse straightaway! Is this FAIR to country:Industry:citizens? Only 8-10 mnf get licence whereas there can be over 100 and help in increasing supply and reduce price!!— careline (@carelin79695380) July 10, 2020
A BIS official Asiaville spoke to said that the labs of private companies are used to address the issue of dearth of testing facilities, given the urgency of the situation.
“The samples are tested in front of our officers to ensure impartiality. And these are automatic machines, you cannot manipulate,” he said.
“Ideally these companies should be having their own labs. But we gave an exception in the case of FFP2 masks considering the urgency of the situation.”
So, what should consumers do to ensure that the masks they are buying are genuine and conform to N95 or equivalent standards?
“Buyers need to accept only ISO 13485 Certification from the International Accreditation Forum (IAF) or National Accreditation Board for Certification Bodies (NABCB) accredited certification bodies,” says Rajiv Nath, forum coordinator of Indian Medical Device Industry (AIMED).
He adds that you can verify CE certification by checking the listing of notified EU Certification bodies on the NANDO website, and NIOSH certification on its website.
“[Buy] from authorized sources. Safety is compromised and the health of the user is put at risk by counterfeits and fake products, besides economic loss in such a purchase,” says Ganeshan of 3M.