Poor quality PPEs flood market due to lack of strict quality control; procedural loopholes lead to rise of pandemic profiteering

Yatish Yadav

New Delhi: With demands for Personal Protective Equipment (PPEs), masks and gloves mounting each day to protect frontline workers and others involved in the fight against highly contagious coronavirus, the unauthentic certification firms have popped across the country to make quick money.

According to the experts, many of these fly-by-night operators distributing certificates for meagre Rs 5, 000-10,000, are neither by National Accreditation Board for Certification Bodies (NABCB), an organisation working under the aegis of Quality Council of India nor registered with the drug controller under medical devices rules to carry out an audit of the manufacturing site.

NABCB provides accreditation to certification and inspection bodies based on the assessment of their competence and in accordance with international standards and guidelines and those seeking to register with drug controller needs to have prior accreditation from NABCB.

Sources said the government is looking at several complaints filed by the notified associates flagging the names of hundreds of such certification firms that are operating without experts, experienced auditors and office address.

Some suppliers are flaunting ISO number to claim certification from US and Europe based accreditation bodies, operating as non-governmental organisations. Significantly, only 11 firms are NABCB accredited bodies and eight companies registered with drug controller are authorised to carry out an audit of medical device manufacturers.

Anil Jauhri, former CEO of NABCB told Firstpost that these unauthentic PPE certification bodies are taking gullible buyers for a ride because these cannot be authenticated by a third party. Jauhri said those agencies directly buying from the manufacturer must examine if the certificate is issued by NABCB notified bodies because we are at least 18 months away from strict regulation for medical devices.

"We do not have regulation in force today to ensure standardization of medical devices. PPEs are also not regulated and for the next 18 months, we have to rely on the voluntary regime as far as quality is concerned. Now, in the absence of regulation, anything is selling in the market. A large number of certification bodies are distributing certificate, which is of no worth at all. That is why my suggestion is not to go for export of PPEs because we are not producing standard quality PPEs and we should not be branded with China for providing sub-standard PPEs," Jauhri said.

"Secondly, the buyers need to be educated about the difference between bogus and genuine accreditation and the must-have tools to check whether they have been certified by NABCB's notified bodies. Also, in the absence of regulation, genuine manufacturers should go for Bureau of Indian Standards (BIS) voluntary certification that would ensure quality PPEs and masks," he said.

The medical devices which were earlier not defined have now been notified effective from 1 April 2020 but manufacturers have been given 18 months breather to meet the rules.

Aradhana Mishra, senior general manager of MTIC INTERCERT, an European notified body for PPEs and medical devices, said many PPEs buyers purchasing directly from a small manufacturing unit doesn't even know if they have NABCB rating. She said Delhi has become a hub for phoney certification of PPEs and medical device and requires strict crackdown by the government.

"Some are even offering certification for Rs.5000. This is shocking because it simply means they are printing the name of suppliers on the certificate without actual audit etc. They will only be caught if exporting these materials on the basis of such a certificate because the lie will be called immediately by international accreditation bodies. We have been raising this issue and trying to create awareness in MSME meetings," Mishra said.

Jauhri said in order to ensure the quality of PPEs, the procuring agencies must purchase it from manufacturers tested and certified which also includes nine authorised labs as recommended by textiles ministry.

"Ministry of Textiles have done a commendable job in producing quality PPEs during the ongoing pandemic. The ministry not only eliminated our dependence on Chinese import but also put in place a mechanism to check the quality. Now, hospitals, government or private agencies must buy PPEs from manufacturers certified by these nine labs as suggested by the ministry," Jauhri said.

Dr BK Rana, founding CEO of Quality and Accreditation Institute said the government has started enforcement measures and they have formed a group of experts from textiles and quality consultancy domain to run an awareness campaign for the users to spot a sub-standard PPE coverall and unauthentic certification. Rana said plethora of suspicious certification firms is sprouting just to make quick money taking advantage of this distressful situation.

"Many of these certification bodies registered in India or abroad are not illegal but at the same time, they are not recognised by international standard organisations. We have struggled with this issue for the last two months and now putting a mechanism in place to check suspicious certificates and poor quality PPEs. Even for the gloves that doctors wear, we have noticed some manufacturers have used cheap material and after wearing it for an hour, the hand is turning white. So we have started an awareness campaign as well for the procurement agencies," Rana said.

Soumik Mondal of SGS India, a notified body of NABCB said they are having a series of webinar with the government as well as industry experts to educate more people about PPEs certification.

"The big issue is legal vacuum and lack of awareness among procuring agencies," Mondal said.

Jauhri also clarified that normally in no country there is a specific law to regulate the issue of certificates but in India, due to rampant abuse, there is need for a law to regulate both accreditation and conformity assessment bodies, which means labs, inspection bodies and certification bodies.

"Since there is no specific law, anyone can open a certification body or lab and issue certificate or report. We would not know if it's competent or follows right process or method," Jauhri said further adding that many certification firms today are taking advantage of lack of regulatory mechanism.

Steps to ensure standardisation

In the absence of strict regulation, the BIS has relaxed testing norms for critical components for safety wear and have also allowed third-party testing certification for manufacturers, who lacks the in-house facilities. BIS is the national standard body of the country for the harmonious development of the activities of standardisation, marking and quality certification of goods.

BIS has said that the latest move will boost the number of PPEs being manufactured every day in the country. It said the norms have been relaxed to enable more manufacturers to be brought in the ambit of BIS product certification scheme, which will, in turn, result in a greater quantity of BIS certified PPEs being made available to the users.

The details of new norms reviewed by Firstpost for three components €" filter half masks, surgical face masks and eye protectors €" reveals the testing procedures though relaxed will ensure that products are certified by a notified body and accredited lab, approved by the government. The experts believe this move will have twin advantage -- help small manufacturing sector and bring more manufacturers under the ambit of standard.

For face masks, BIS has approved sub-contracting for tests with enough safeguards. As per the new guidelines, the lab must be recognised by the BIS or it should be a government lab empanelled by the BIS.

"Conformity of the materials to the requirements of the standard may be established either through the supplier/manufacturer's test certificate or test report issued by BIS lab/BIS recognised Lab/BIS Empanelled Lab or through in-house testing," BIS guidelines for masks manufacturers said.

For the manufacturing of Eye Protectors, BIS said if the testing of sample is done at the factory of a BIS licensee, it will be conducted under supervision of a BIS certification officer.

Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry said this relaxation was sought for N95, three-layer surgical mask and eye protectors (goggles) to enable a larger pool of compliant manufacturers so that non-licensed manufacturers could use the facility of the licensed manufacturer as cost of test equipment like for three-layer surgical mask manufacturing is Rs 15-16 Lakh. The cost is quite prohibitive for an SME manufacturer and it takes time to set up.

He also said for users who are dependent on HLL the move by BIS means access to a larger pool of indigenous manufacturers with lower prices than imports currently and for new manufacturers, it will ensure flexibility and ease of doing business.

"There is an acute shortage of goggles and also of masks. So by sharing of limited testing equipment and resources, we are trying to have more suppliers added to pool," Nath said.

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