The authorities have enlisted five ISO-17025 accredited private labs to test locally-manufactured PPE
Bangladesh is ready to manufacture KN95 standard masks, locally, to cater for the spiked demand for high-specification respirators amid Covid-19.
JMI Hospital Requisite Manufacturing Ltd, a medical equipment maker, has completed successful test runs of its newly-installed lines that can manufacture 40,000 KN95 standard masks a day.
The company is awaiting the local drug administrator's approval.
The Directorate General of the Drug Administration (DGDA) would approve the company's product standard based on third party lab reports.
The authorities, on April 29, have enlisted five ISO-17025 accredited private sector labs to test locally-manufactured graded personal protective equipment (PPE) - gowns and masks.
SGS Bangladesh, ITS Labtest Bangladesh, Dysin International, ULVS Bangladesh, and TUV SUD Bangladesh Private Ltd made the list.
"After getting the approval we will begin commercial manufacturing of KN95 standard masks under the Chinese guideline on standards called GB 2626-2006," said Dr Md Zakir Hossain, deputy general manager for quality assurance at JMI Hospital Requisite.
DGDA Director Md Ruhul Amin told reporters, after proper test reports from certified labs the authority will inspect the manufacturing plant.
"If everything is found satisfactory the company will be accorded with marketing approval. A company must wait to proclaim the grade of its respirators," he added.
JMI had been importing surgical, and other, masks and gloves for the local market.
However, after the outbreak of Covid-19 - at the beginning of this year - they set up mask manufacturing lines in collaboration with Chinese Liz fashion. They are manufacturing surgical masks there.
Liz representative Charlie Yuan, a quality assurance manager, said that the jointly-developed KN95 mask named JMI Respirator has added an extra special layer to the mandatory four – so that the mask can satisfy stringent requirements in any markets.
The sourced materials are also the best in class despite costs being a bit higher than those of traditionally-imported finished products, she claimed.
"However, it is just a matter of test reports and approval," said Zakir Hossain, at the production floor in Munshiganj area.
The team was talking to some visiting reporters on Thursday.
Initially, each KN95 mask would cost around Tk150-160, which is 30-50 percent lower than the imported masks with the same certification, said Md Abdur Razzaq, the managing director of the JMI group.
"Scale and normalisation of the supply chain in the coming days should help the company to bring the cost down to as low as Tk130 per KN95 mask," he added.
While talking to The Business Standard, he also expressed an aspiration for locally- manufactured N95 standard masks in coming days, though that is costlier because of research and development efforts and international lab test reports.
N95 is the specialty mask originally designed and manufactured by American company 3M.
It prevents the entrance of extremely small airborne particles, bacteria and viruses to human lungs.
The National Institute for Occupational Safety and Health (NIOSH) of the United States of America has its widely accepted guideline for the standard of N95 respirators that ensures at least 95 percent protection from unwanted micro particles and germs.
Other accreditation or standard agencies from different corners of the world have had their own guidelines for the specialty masks claimed and believed to be of similar effectiveness.
KN95 is one of those.
The JMI Group, in partnership with Japanese medical equipment multinational Nipro, pioneered the manufacturing of medical accessories in Bangladesh in the late 1990s.
The partnership already has extended in the area of drugs and dozens of types of medical equipment, and they are exporting some of those to over 30 countries – including Europe.
However, JMI recently was embroiled in controversy after supplying normal masks packed within paper boxes labeled as N95.
Both the procurement office of the Bangladesh health department and the company claimed the incident was a mistake. However, the public perceives this as a corruption case that should be investigated.
The health department already received a report from its investigation committee at the end of last month. However, surprisingly to the transparency advocates, the findings have yet to be made public.
The Bangladesh government recently declared a waiver from value added taxes – ranging from 5-15 percent – on PPE and masks, until June 30. This was done to spur investment in manufacturing and selling the emergency products while the world has high demand for the items.