Locally, Bangladesh is ready to manufacture standard KN95 masks to meet the strong demand for high-specific respirators in Covid-19. JMI Hospital Necessary Manufacturing Ltd, a manufacturer of medical equipment, has successfully completed tests on its recently built lines, which can produce 40,000 KN95 standard masks a day. The company is now awaiting the local drug administrator’s approval.
A few months ago, most people around the world did not know the KN 95 mask fairly well. But now because of the outbreak of Covid-19, it became an important part of life.
The Drug Administration Directorate-General (DGDA) would approve the company’s product standard based on reports from third party lab. On April 29, the authorities enlisted five ISO-17025 certified private sector laboratories to test local-made graded personal protective equipment (PPE)-gowns and masks. The list was drawn up by SGS Bangladesh, ITS Labtest Bangladesh, Dysin International, ULVS Bangladesh and TUV SUD Bangladesh Private Ltd.
“When approval is given, we will begin the commercial production of the KN95 standard masks under the Chinese standard guideline known as GB 2626-2006,” stated Dr Zakir Hossain, JMI Hospital Requisite’s deputy head of quality assurance.
DGDA Director Md Ruhul Amin told reporters that the authority will inspect the manufacturing facility after the proper test reports from accredited laboratories. “The company will have to wait for marketing approval if anything is considered acceptable. A firm will wait to announce its breathers grade,” he added. JMI imported masks and gloves for the local market, surgical and others. Nevertheless, they set up mask production lines in partnership with Chinese Liz fashion after the outbreak of Covid‐19 – at the beginning of this year. There they create masks for surgery.
Representative Charlie Yuan of Liz, quality insurances manager, said that in order to satisfy strict specifications in any industry, the jointly produced KN95 mask named JMI Respirator was added to the required four an additional special sheet. Even with costs that are a little higher than typically imported finished goods, the materials supplied are also the best in class, she said.
“However, it is just a matter of test reports and approval,” said Zakir Hossain, at the production floor in Munshiganj area. 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, after providing standard masks packed in N95 labelled paper boxes, JMI was recently controversially involved. The Bangladesh Health Department ‘s procurement office and the company also confirmed that the incident was incorrect. But the public considers this to be an investigative case of corruption. At the end of last month, the study committee had already provided the health department with a survey. Interestingly, however, the results must also be made public to transparency advocates.
The government of Bangladesh recently announced a 5-15 percent waiver of value added tax on EFPs and masks by 30 June. This was done to raise investment in the manufacture and selling of emergency goods as the world’s demand for products is strong.