News
Yaden International says its principal supplier Indar has impeccable track record
In response to our news story of last week (July 9) headlined; “Dangerous trend in health sector”, Yaden International (Pvt) Ltd states that its supplier/principal, Indar– which is the Ukraine company from which it will procure insulin for Sri Lanka’s State Pharmaceutical Corporation (SPC)–is a registered entity with the National Medicines Regulatory Authority (NMRA).
This means Indar has met the necessary requirements and standards set by the NMRA and that its facilities are capable of producing pharmaceuticals in accordance with prescribed standards, it says. Additionally, Indar is approved by the Pharmaceutical Inspection Cooperation Scheme (PICS), which also assures the standard of the production facility.
Yaden states that Indar has a “WHO GMP (Good Manufacturing Practices) certified facility” and distributes pharmaceuticals to numerous other countries globally, “with an impeccable track record”. Yaden has obtained sample licences from the NMRA and commenced the process of securing NMRA registration for the individual pharmaceuticals, it adds.
Yaden says they are reliably aware that the local agent who was awarded the 2023 tenders in question “was unable to deliver on time” and that, as a result, the Health Ministry “has called for tenders for emergency procurement”. Had this not been done, “there would have been a shortage of essential pharmaceuticals, resulting in the likely death of many patients”.
Yaden claims that, with its extensive experience and global reach, they are confident Indar will be able to deliver the necessary products on time and without any concerns as to quality. They say it is clear that obtaining pharmaceuticals from their supplier could not be said to cause any concern of “flooding the public health sector with unregistered drugs”. Yaden also clarifies that the “allegedly substandard pharmaceuticals” mentioned in our article have no relationship to them or their supplier and that “the newspaper should not have confused the issue of (allegedly) substandard pharmaceuticals (examples of which the newspaper has cited), and the high-quality products being supplied by our supplier on emergency procurement due to shortages”.
Reporter’s note: Yaden says that its supplier, Indar, is registered with the NMRA. Part IV of the NMRA Act, which governs the registration and licensing of medicines, states that “No person shall manufacture or import any medicine without registering such medicine with the Authority and obtaining a licence from the Authority thereafter”.
Neither the insulin isophane nor insulin soluble manufactured by Indar is registered with the NMRA. Approval of the manufacturing plant is only a partial requirement among a number of others which should have been completed prior to obtaining registration.
Sample import licences are issues for obtaining the samples that must be submitted to the NMRA with the registration dossier to be evaluated by the NMRA. Therefore, having obtained a sample import licence does not give any assurance about the safety, efficacy and affordability of the product.
Approval of the biological product is a stringent process where external experts (in the case of insulin, endocrinologists) are involved, in addition to NMRA pharmacists and the Medicines Evaluation Committee.
If a plant has PICS approval, the NMRA can consider waiving the requirement for inspecting the plant, which is needed to approve the plant. But this is not a qualification to bypass conditions for registration.
It is evident that the insulin products under consideration are non-registered products under Sri Lankan laws.
Yaden also says the local agent who was awarded the 2023 tenders “was unable to deliver on time”, causing the Health Ministry to call for emergency procurement. This is a matter of serious concern. Is Yaden saying that the relevant Government procurement agency granted a tender for urgent medication without getting assurance about the supplier’s capacity for supplying in time?
If so, this would validate the argument of multiple health sector sources that wrong procedures are creating endless problems and merits deeper inquiry. We hope an independent investigation is initiated.
Yaden says the Health Ministry called an emergency tender for insulin isophane and insulin soluble after the selected supplier failed to deliver. But documents seen by us say this is for “buffer stock” which is antithetical to “emergency supplies”.
If Yaden is able to provide the medication at short notice, does it mean the supplier had the Health Ministry’s order already manufactured for quick shipping–given that insulin purchases require a lead time of two-and-a-half to three months?
Did the Health Ministry give an undertaking to pay the full amounts due to Yaden/Indar when it has been delaying payments to other suppliers, thereby repeatedly holding up deliveries, including of insulin?
Further, if the selected supplier had failed to deliver the drugs, did the procurement agency inquire from the other short-listed suppliers–who still offered a vastly cheaper price per vial than Yaden/Indar–whether they could fulfill the order, as is usual procurement practice?
Inquiries from registered pharmaceutical companies who hold valid NMRA registration for insulin isophane and insulin soluble revealed that these “tenders for emergency procurement” were not seen by them. How, therefore, did the Health Ministry publicise these tenders?
We appreciate that Yaden International considers itself reliable. But given that several of the drugs it imported into Sri Lanka last year alone were ordered to be withdrawn from the market, there is great merit in mandating the full scope of registration for the medications it brings.
The withdrawn batches of drugs were levothyroxine sodium tablets–owing to “failure to comply with USP specifications with respect to the identification test”–while batches of ceftriaxone for injection, dobutamine injection, and gastro-resistant sodium valproate tablets were also taken off the market over other failures.
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