15 Drugs recalled in the last four years from different suppliers
The Drug Regulatory Authority (DRA) has suspended two major medicine suppliers to the Ministry of Health, KMT and Paras, after it was found that these two companies had forged DRA certificates issued for registered medicines while they were bidding for drug supply tenders with the Ministry of Health.
The issue first came to the notice of the DRA in June 2019 when they received a complaint from the Ministry of Agriculture and Forests where a tender committee for veterinary drugs first discovered the forged DRA certificates.
All drugs supplied in Bhutan have to be registered with DRA which has a due process to authenticate the drugs and the company manufacturing it. This is to avoid spurious drugs manufactured by unknown entities coming into Bhutan.
The certificate is supposed to be renewed every three years where the company is supposed to give its status and other information to the DRA.
This is usually done by local Bhutanese companies who act as representatives or suppliers of the drugs.
After the MoAF alerted the DRA, the Health Ministry which had an ongoing annual tender for drugs also came to know about the issue and they too checked and came across some forged DRA certificates from the same two suppliers.
The DRA then conducted an investigation into the issue of both the MoAF and MoH tender documents where it was confirmed that some of the certificates had been forged with false extension dates.
The DRA head, Drug Controller Kinga Jamphel said that the issue fell into two categories. He said in some cases the Drugs had been registered but they had not been renewed with the DRA and so the two companies forged the dates to show that the certificate for the drugs were renewed.
He said the other category was more technical in that some certificates while not manipulating any information did not show the signatures clearly.
The Drug Controller Kinga said that Paras had manipulated documents in the case of 19 products with MoAF of which eight were chemicals, five were antibiotics, two were anthelmintic (anti-parasite) drugs and one was a biotech product.
In the case of the Ministry of Health tender the manipulation was in six chemicals used by hospitals.
In the case of KMT it had manipulated one document for a chemical in MoAF and in the case of MoH the six documents manipulated were: 2 for antibiotics, 1 one for biotech and three for chemical products for hospitals.
The DRA then put the matter to the Office of the Attorney General and the Royal Bhutan Police (RBP) in early July 2019 and issued a suspension of the two companies pending legal action.
The RBP wrote back saying that it could no prosecute the case and so the DRA put up the matter to the Bhutan Medicines Board which decided to take administrative action by suspending the licenses of both KMT and Paras for a year. No penalty was imposed.
The Drug Controller said that the investigation found that the specialized people who had prepared the tender documents for KMT and Paras had done the forgery without the knowledge of the management which is why no penalty was imposed or even stronger action was not taken.
One of the people who is an Indian citizen has already absconded.
KMT and Paras are both major suppliers but KMT is an older and bigger supplier. The disqualification of the two companies has resulted in a shortage of morphine tablets.
The DRA on its part said that the suspension of the companies happened a while ago and the same products can be taken from other sources. The DRA said that the shortage in certain drugs is not only due to the suspension but it is a cyclical issue.
The Drug Controller said that DRA, when approached, is actually quite flexible and allows certain name patient and urgently required drugs to even come in without registration.
He said that the two companies should have renewed the documents as it is not a very lengthy or difficult process but requires the updating of information and that it is unfortunate that the certificates were instead forged.
The DRA has cautioned procurement agencies for drugs to be vigilant for such practices in the future.
15 Drugs recalled in four years
Though not directly related the above case has again brought into focus the quality of drugs being supplied to Bhutan’s medical system.
A total of 15 different types of drugs supplied to government hospitals had to be recalled in the four financial years.
In 2015-16 financial year three drugs were recalled of which two were supplements and one was a Gastrointestinal medicine.
In 2016-17 there were four products of which two were pain killers, one was a blood pressure medicine and one was an anti microbial medicine.
In 2017-18 two medicinal products were recalled and one of them was a pain killer while another was a supplement.
In the 2018-19 financial year six medicines were recalled of which two were blood pressure medicines, two were antimicrobial medicines and two were supplements.
The DRA Drug Controller said that drug testing did not start with DRA but it was there even several years before the formation of the DRA and is an ongoing thing.
He said that Bhutan has its Royal Center for Diseases Control (RCDC) in Serbithang as its national lab but due to limited capacity the drugs are sent for testing to Nepal. He said earlier it was sent to Thailand but it was too expensive.
The Drug Controller clarified that most failures were in terms of the percentage of chemicals inside and also the dissolution rate or the rate at which it can dissolve in the human body.
He said that there were also those that may have been affected due to storage and transportation issues.
The DRA said said it has control measures for both pre-market (before the drug enters Bhutan) and post market (after the drug enters Bhutan) cases. He said that DRA also takes the feedback from patients and medical professionals.
The DRA was not in a position to share the names of the drug manufacturers or suppliers as in some cases it could be due to storage issues and so it wants to avoid any legal ramifications.
Around ten years ago stories by this reporter in the media and subsequent checks by the RAA of the drugs found several issues from quality to overpricing which had resulted in various reforms in the Health Ministry at the time.
It may be time to ask if another re-haul of the entire system is needed to ensure quality drugs.