Health Ministry Dismisses ISO Certification
By Camelia Nathaniel
A Chinese company that had been supplying medical equipment to the Health Ministry is today in a dilemma having been let down by the Health Ministry after having imported a huge consignment of intravenous (IV) sets used for saline transfusion. Shandong Protos Medical Products Co. Ltd has been importing disposable IV sets for the Health Ministry for the past thirteen years and this product and manufacturer have been registered with the Cosmetics, Devices & Drugs Regulatory Authority Sri Lanka (CDDA) since 2000.
Explaining the incidents that led to the crisis the local agent for Shandong medical products China Afeel Kaiyoom told The Sunday Leader that local tender was called by the State Pharmaceuticals Corporation (SPC) and M/s Dowel International the local agent had bid for this tender on behalf of the manufacturer and has been supplying the SPC periodically.
“In 2004 we received the tender for this product to supply three million IV sets for saline and we supplied the SPC.
When we supplied there was a concern by the end users namely the Medical Supplies Division of SPC and doctors that there was a sticker on the outer pouch which they thought had been placed there to cover some damage in the packaging. Then it was clarified that it was not a sticker used to cover any damage in the packaging but was instead a dialetic sterilization sticker which is an ISO standard method of Ethylene Oxide (EtO) sterilization. We explained this to the SPC and they accepted our explanation in 2004 and that was the end of that issue.
Thereafter the entire three million IVs that we supplied were used, and we have continuously been awarded the tenders for the supply of IV sets as our prices were the lowest in the market, which was around US $ 10 to 11 cents per set. All other bidders were between US $ 13 to 20 cents,” he said
However, he said that in one instance although they had quoted the usual US $ 10 to 11 cents per set, another party who had quoted US $ 18 cents had been awarded the tender, which is almost double the price. “We then inquired as to why we had not been awarded the tender having quoted the lowest prices while a higher bidder had been given the tender. This issue went on for about a year without the tenders being finalised. Finally the Medical Supplies Division (MSD) which deals with medical supplies when hospitals run out of stock, called for urgent tenders locally for 500,000 IV sets.
We quoted for that and as we were the lowest bidders they awarded us the tender to supply 160,000 IV sets. When we imported that stock and supplied it, they said that the sticker was on the pack, adding that later it was highlighted even in the news that inferior quality IV sets were imported from China, and claiming that it was not safe, etc. Once again this issue regarding the sticker was brought up by the MSD in spite of us having explained the process and the MSD having accepted our explanation, he said.
While that explanation was going on, the end users had said that they did not want the sticker. “We then told them that if they did not want the sticker they should have told us that prior to us importing the consignment of IV sets and not wait until we had imported it.
Even after that this hassle about the sticker was going on and in the meantime we were also trying to renew our registration which takes place every two years. Our registration was valid when we quoted for the three million sets in 2011 but it was being delayed and they kept it for over a year without processing it. In 2012 they again sent us a letter asking us to forward a sample without the dialetic sterilization sticker,” he said.
He said that the Health Ministry had sent the local agent a letter stating that they needed a sample from the manufacturer without the sticker, and wanted to know if they could supply the IV sets without the dialetic sterilization sticker, and the manufacturer told them that they certainly could.
“We then gave a fresh sample without the dialetic sterilization sticker to the tender board which was evaluated and approved, and we received a letter from the Health Ministry confirming that the tender has been awarded to us. In return the SPC also informed us that we had won the tender and that they were awaiting confirmation from the Cosmetics, Devices & Drugs Regulatory Authority Sri Lanka regarding the new packaging.
They also wanted a no objection letter (NOL) from the Drugs Authority for the purpose of clearance, stating that they had no objection to us importing the IV sets without the sticker. This was a standard procedure and this NOL was also supplied by the SPC to them, as we had no issues with the Drugs Authority over the years,” added Kaiyoom.
Thereafter he said that the Drugs Authority said that they will grant the manufacturer 90 days payment, but our principals said that they needed 100% LC at sight. According to Kaiyoom they said that the tender board will make payment of 75% and 25% and not 100%. They had then said that if the manufacturer wanted 100% at sight then they had to give a 25% total guarantee which was an additional guarantee.
“We had given them 100,000 dollars (Rs. 10 million) guarantee which we also provided. After doing all that the LC was then opened in February 2013. When the LC was opened they sent us a letter stating that they wanted this product air lifted as there was an acute shortage of IV sets at the hospitals,” he said.
However airlifting of this product would cost double that of sea freight, and the importer had said that it would be a total waste of money and we had a consignment already prepared for shipment and it was shipped immediately from China.
“That was around 850,000 out of the three million sets – the first batch. But we were worried that although we attempted to help them out they would finally raise some issue and we would be at the receiving end. We then made a request to the National Drug Quality Assurance (NDQA) to check the samples of the stock just to make sure that they were satisfied with the quality of the product. This is something that no other drug manufacturer or importer has ever done,” said Kaiyoom.
However ironically by this time there was a change of Secretaries at the Health Ministry and at this time the manufacturer’s registration was pending. Then the Drug Authority had asked the manufacturer to submit a new sample without the sticker to consider the registration, while on the other hand the no objection was granted to them by the Health Ministry.
Every product usually has a batch number, date of manufacture and date of expiry. So since the manufacturer felt that the packing was the only issue they changed the packaging and continued with the same batch number, as the batch which had the sample sticker. When they did that the Drug Authority then questioned as to how the different types of packing can have the same batch number.
“So then we explained to them that this was a misunderstanding where the manufacturer had only changed the packaging and continued with the same batch number. Then the Recall Committee of the Drugs Authority by another letter informed us that they were not accepting the explanation letter from the manufacturer and had decided to discontinue the registration for that product file and requested the manufacturer to submit a new file for registration,” he added.
Subsequent to the Drugs Authority requesting for a new file to be submitted and the old file being closed, in March 2013, in May the same year the local agent submitted a new file, registration and file number. Anyway while this issue was pending the contracted order had already arrived at the port. By then the Drugs Authority had informed the tender board not to allow this consignment to be cleared as there was an issue with the batch numbers.
Now that was misleading information because the consignment that had arrived did not have the same batch numbers and what the Drugs Authority was referring to was the registration samples, which issue had already been settled as they had requested for a new file.
“The tender board however has the right to import any product even without registration, but this was a registered product that we have been supplying for the past 13 years. Therefore we were appealing to them to look into this issue carefully and resolve it in a fair manner as we have been long time suppliers.
Since there was no issue with the product we could have taken it back, but the only issue was that we had manufactured this product for the Sri Lanka Health Ministry and there was a Sri Lanka government logo on the packaging. Hence this product could not be sold to any other party.
We then appealed to the Chairman of the SPC he was really helpful and said that they could not take a decision as it was up to the Health Ministry, but offered to make a new file and appeal. Then when that appeal was made the tender board had accepted it,” said Kaiyoom.
However even with the batch number issue of the registration sample sorted out with the new file submission, why does the CDDA still raise the same issue of batch numbers for the new consignment cargo which has no quality issues, sticker problem or batch number problems?
The consignment which the Ministry of Health claimed was urgently required and had wanted airlifted, has still not been cleared and has been lying in the port since March 2013.
The problem now facing the manufacturer is that the whole consignment cannot be used by any third party in Sri Lanka or abroad as the Sri Lanka government logo is printed not only on the individual packaging but also on the cartons.
The Sunday Leader’s attempts to contact the Health Minister and Dr. Hemantha Benaragama of the CDDA in this regard failed and even the Deputy Minister was not available for comment at the time of this article going to press.
However the Health Ministry spokesman W.A.D. Wanninayake responding to our inquiry said that he was not aware of this particular issue but said that the reason for the rejection could have been the concern over the sticker issue.
“We are very concerned about the quality of the products we use at the hospitals as even the slightest issue could be disastrous. Sometimes the sterilisation procedures used in the Western countries may not suite our climatic conditions, as our storage facilities are different. From what I understand what has happened is that the goods imported are not the same as the sample that may have been provided.
The members of the tender board comprise experts and in addition the technical evaluation committee too is made up of professionals in the field and they will not reject this product without valid reasons. Hence it is simply not from the point of view of the importer or the manufacturer, but we have to see that the product is of the highest standard,” said Wanninayake.
The question that remains to be answered is that if the dialetic sticker paper is part of the ISO standard why would the CDDA reject that packaging, and if this dialetic sticker paper packaging is not acceptable to the Sri Lankan market, why didn’t the CDDA still give those instructions in guidelines to the manufacturers of products which can use EtO gas sterilisation with dialetic sticker paper?
It is ironic that while the Health Ministry talks about the standard of these products, they seem to be ignoring the fact that this particular sterilisation process is ISO certified. Hence is the Health Ministry implying that they have no regard for ISO certification?
As for the manufacturer, who is making every attempt to resolve this matter amicably, they warn that if this issue is not amicably resolved within a reasonable time frame, they will be compelled to claim damages and losses from the SPC through legal means.