Local Face Mask Manufacturers a Disillusioned Lot
By Sulochana RamiahMohan
Several disappointed local face mask manufactures, who have been supplying face masks to local consumers since the COVID-19 pandemic-hit our land from early last year, have although contributing to the reduction of the shortage, allege the National Medicines Regulatory Authority (NMRA) has been ‘selective’ in approving the local manufactures of face masks, lethargy in certification of the device and what’s more, offers no guidelines on production requirements, in contradiction of the Government’s stance promoting local production as the way forward for Sri Lanka given the current status quo. Step-motherly treatment Moreover, they allege NMRA has been too stern and rigid in granting approvals for local face mask manufacturers attempt to export their face masks to foreign countries while they assert their product is one of high quality.
Their face masks are made to meet good standards and practices. Over 25 of the local manufacturers from the Western Province who spoke to Ceylon Today did not want to be identified as they fear their factories would also be raided hitting on their income when the country’s economy is spiralling downwards. NMRA has issued approval for very few mask manufacturers in the country, they claimed.
They alleged NMRA has rejected approval for some 20 local mask manufactures citing it’s not up to the standards while most of their masks are 3-ply-face masks and made with meltblown fabric (filter) in the middle layered by non-woven material on both sides. Some of the local face mask brands such as Allen, Supply Aid, Hontex, Shield, Gamma, Cmaster and Trust mentioned that they are disposable face mask manufacturers producing over 1 million masks per day that cater to the public.
However, some of them do not have NMRA approval nor device certifications despite being made with adequate care and guidelines. “There are 20 manufactures of face masks whom the NMRA has not granted approval for their product,” one of them told Ceylon Today.
But they also showed an example how the NMRA and other authorities support high-end factories particularly quickly issued approvals and support to Chinese Sensetronics Pvt. Ltd., within a short time to run a face mask factory built at an estimated USD 830,000, which was ceremoniously opened by State Minister of Production, Supply, and Regulation of Pharmaceuticals, Prof. Channa Jayasumana where the Minister emphasised that the factory was established in an attempt to boost local manufacturing.
The face mask producers also said the Government went about telling the masses that Senstetronics is the first local face mask manufacturers in the country when there are over 25 others who have face mask factories who have eased the plights of the people in getting face masks to all shops.
Braving all odds
One of the face mask manufactures speaking to Ceylon Today, questioned: “Do these authorities know the amount of face masks that we find in every nook and corner of the country and where it is coming from,” and said it’s the local manufactures who are braving all odds to supply face masks to towns. Last week, owner of one such factory had come under the hammer when the factory was raided by the Consumer Affairs Authority of Sri Lanka (CAASL). The factory supplies over 600,000 face masks on a daily basis and they are of high quality, the manufacturer told Ceylon Today.
His face masks are sold to top hotels and offices brought by his agents and suppliers. However, he had printed ‘Made in China’ on the box containing the masks, as NMRA had not issued him an approval certification. The manufacturer said despite making several attempts to get the approval from the NMRA, he was sidelined so he went ahead manufacturing masks. It’s of high quality and unmatched by many of those face masks already in town,” he claims.
“I have been asking NMRA officers to visit my factory for several months, and one fine day they visited my factory only to find fault with the procedures we follow and failed to see the quality of the face masks we make.” Some of his suppliers said this particular brand is in many of the hotels in the coastal areas of the country and they fear their supply of face masks to these star hotels will run out very soon.
Buying a face mask during the coronavirus (COVID-19) pandemic is not a hassle anymore because around 30 local face mask manufacturers have upped the supply roll of face masks competing with foreign made face masks in the market. However, in the recent past the CAASL has been raiding many of the small mask factories, filing legal actions stating they are operating without following the guidelines of the NMRA. So far, the Consumer Affairs Authority has raided two mask factories.
Handpicked for preferential treatment?
The local mask producers, many of whom had not obtained NMRA approval of class certification, blame NMRA officials for side-lining them while giving fullest support to others. One brand manufacturer added that some of the local face mask manufacturers also print ‘Made in China’ on their mask boxes for ‘obvious reasons’. “This is because people in the country also think that foreign brands are of highest quality, hence, some of them print such terms just to sell their product.
He says it is ‘understandable’ when the authorities don’t support these small-scale mask manufacturers they tend to avoid being ‘caught’ for not following Government policies but they are not willing to give a hand in supporting those striving to do something for the country. The local manufacturers also point out that the Chinese factory that is operating here mentions on their face mask box as ‘medical’ face mask when their NMRA certification says they are using ‘Non-Sterile’ material.
They question how can non-sterile material be a medical face mask. The manufacturer who spoke to us also claimed his face masks are approved by the Bureau Veritas, the lab that tests melt-blown fabric that is imported from China to Sri Lanka. Nadun T., one of the small-scale face mask manufacturers, says he noticed that the Sensetronics in their website quotes that they are manufacturing device 3 (class 3) masks when their NMRA certification says they are using device 1, which is 99 per cent filtering material that is used which is contradictory. These manufactures have already sought the attention of Minister of Energy Udaya Gammanpila, State Minister – Rattan, Brass, Pottery, Furniture and Rural Industrial Promotion Prasanna Ranaweera and Prof. Channa Jayasumana, to intervene and help boost their face mask produced locally and to support them to rectify problems without shutting them out from the business.
Repacking low-quality masks
These face mask manufacturers also say, there are so many vendors who are purchasing masks of low quality with no filter material used but repacking and selling in many places in the country including in Pettah. All these happen when Sri Lankans are left in the lurch never given a hand to prosper. “Even if there are faults in the procedures of making masks and qualities are not up to the standards of the authority, it’s the Government’s duty to give a hand to improve such local businesses and lift the standards of living of the people but what is happening is that many talented small-scale businessmen who are hiding from the authorities unable to cope with their stern actions and strict compliance procedures and sadly end up in Courts when they break rules.
If one would see the number of face masks sale taking place on the social media platform it’s a huge market. Can the CAASL and the NMRA stop such business people engaging seated in their cosy rooms? They can’t but these authorities all what they can do is to chase those who are doing business having employed people from their localities to earn a living.
Sri Lanka has been one of the countries that do not offer a friendly business environment for foreign investors and everything has been relaxed on certain foreign investors’ projects but that does not happen to Sri Lankans. Due to pandemic many have lost their jobs and return home from overseas. They are unable to find jobs or invest in a business mainly because the authorities have been working for those who have political influence or someone is already rolling in money. – [email protected]
No local mask manufacturer has been rejected – NMRA
Ceylon Today posed several questions to Regulatory Pharmacist, National Medicines Regulatory Authority (NMRA), Ministry of Health, Nutrition and Indigenous Medicine, Wasana Welipitiya. However, many of the questions we posed, such as ‘How many registered mask-making factories are there in Sri Lanka currently? Many local manufactures are saying that you are looking only for mask making procedures but not looking at the quality. Is there an issue? Many of the Mask manufacturers in Sri Lanka complain that you are more on rejecting than giving approval for them to export locally made masks. Anything to say? What are the criteria they should meet for exporting masks? How many are exporting masks overseas with your approval?’ were not answered: Below are the questions to which NMRA responded:
In mask manufacturing, what exactly does the NMRA look for?
A: Before March 2020, only four mask manufacturers were registered as local manufacturers, with NMRA and when the first COVID-19 wave hit the country, the supply from these manufacturers also was very little and could not fulfil the national need at that time. Therefore, NMRA allowed the importation of three-ply medical face masks to the country. At that time, most of the apparel industries that were converted to manufacturing three-ply, disposable medical face masks, but most of them did not have much of an idea on maintaining Good Manufacturing Practices, including Good Documenting.
At that time, I was personally advising some manufacturers on their practice. And, the NMRA team, without considering the risk, are still conducting site inspections for COVID-19 related items. NMRA is an institute which ensures quality, safety of efficacious medicines, Medical Devices and Borderline products available in Sri Lanka. The disposable three-ply medical face mask is the class 11a Medical Device, which the NMRA is keen on regulating.
If a person who is willing to manufacture the above product he has to submit a site master file, including information of his site and other related documents. Then, NMRA appoints a team for site inspection. After the inspection, if the team is satisfied the manufacturer has the following minimum GMP requirement they have to give a detailed inspection report which includes all the advice to improve their shortcomings found during the inspection.
If the team is not satisfied with the findings, they would advise to improve the shortcomings and would visit from time to time until they improve and are ready for approval. NMRA is not allowed to manufacture any medicines, medical devices or borderline products in unhygienic conditions. Also, the NMRA medical device regulatory team has been always helping in their practice and I also practically know about it.
At that time 15 three-ply medical face mask manufacturers were registered with NMRA and the Health Minister instructed to restrict the import of threeply medical face mask because now, in Sri Lanka, there were enough three-ply medical face masks to manage COVID19 situation and also, there were two KN95 manufactures registered with NMRA.
How many manufacturers were rejected or cancelled from making face masks?
A: There were no rejected applications at any stage. When someone applies for the site inspections, the NMRA team properly guides the manufacturers regarding their process and quality certificates. So far, not one of the many applications or Product registration applications has been rejected and but we gave advice to improve the quality of their products.
Why do we need to wear masks?
A: In general, the mask gives protection against airborne diseases. If someone wears a mask he has a protection against airborne pathogens. In a COVID-19 situation the virus spreads from one person to another by air. Therefore, a mask is the most powerful device we can use for the protection against the disease. Hence, we are very concerned about the quality of the masks. There are several categories of masks available globally as well as in Sri Lanka. I will explain about the quality of threeply medical face masks.
It should have proper bacterial filtration capacity of more than 95 per cent, proper breathability, splash resistance, microbial cleanliness. So the product should have to comply with global standards as EN 14683. NMRA registered manufactures and registered products already comply with those standards. If someone who is wearing a mask does not have such qualities in this kind of pandemic situation he is not having proper protection against the Covid-19 virus. That’s why NMRA strictly regulates manufacturing sites of the face masks as well as products.
Do you have a set of guidelines for local mask manufacturers and do you visit their factories?
A: Yes, and when the inspection is done all the instructions have been given based on their practices. Common guidelines are available on the website. But the NMRA inspection team guides them on a case by case basis.
What do you look for in the mask factory?
A: As I mentioned previously the NMRA team is fully focused on the Good Manufacturing Practices of the premises, including good Documentation practice, Hygienic conditions of the premises and workers, What measures are taken to reduce contamination of the product, Good Storage practices, and Complaint handling and Recall plan. The NMRA medical device team is always helping them to follow this process.
They provide their expert knowledge during office time and otherwise. And, I have also personally catered to their queries. If anyone complains about the process, I like to ask those who have followed our process to contact the NMRA Medical device regulatory team when they face any difficulties with NMRA criteria. We will help them. The NMRA also gives priority to local manufacturers.