- NMRA has issued 1,601 waivers of registration from 2018 till June 2023
- Concerns over pharmaceutical quality, safety, and fairness of prices
- NAO report notes NMRA had issued waivers to same applicants for same meds
The National Medicines Regulatory Authority (NMRA) is at the centre of a growing controversy after it was revealed that the authority had issued over 1,000 Waiver of Registration (WOR) letters over the past six years. This revelation has caused widespread concern about the quality, safety, and fairness of the price of medicines being imported to Sri Lanka.
From 2018 to June 2023, the NMRA has issued a total of 1,601 WOR letters. Accordingly, the authority has issued 141 WOR letters in 2018, 217 in 2019, 200 in 2020, 126 in 2021, 656 in 2022, and 261 in 2023 up to June, the National Audit Office (NAO) revealed in its recently published special audit report on the requirement, procurement, supply, distribution, and regulation of medicines in the years 2022 and 2023.
As outlined in Section 109 of the National Medicines Regulatory Authority Act No.5 of 2015, the authority is empowered to grant permission under specific circumstances – such as to address life-saving situations, control infectious outbreaks or epidemics, respond to national emergencies, or uphold national security – to import and distribute specific medicines in designated quantities.
However, as revealed in the NAO report, it has been observed that the authority has issued WOR letters for the importation of medicines without adhering to these provisions.
Accordingly, it is further revealed that over the years, such letters had been issued to entities including the State Pharmaceuticals Corporation (SPC), Medical Supplies Division (MSD), and private institutions for reasons not stipulated in the act, such as the expiration of previous registrations, unavailability of registered suppliers, and delays in the registration process.
A concerning trend
According to the findings of the NAO, the NMRA has repeatedly issued WOR letters to the same applicants for the same medicines. This practice has had adverse effects, including the decline of interest from 80 local agents in registering medicines. Moreover, it has created a concerning trend where importers may be tempted to bypass registration requirements, which could have detrimental effects on the health system.
In a sample examination of 30 medicine importers who received WOR letters from January 2022 to June 2023, a total of 306 WOR letters were issued during the audited period. Some importers received between two and 54 WOR letters each, with instances of multiple letters being issued for the same medicine to the same importer. Specifically, 29 medicines received between two and four WOR letters each, with 17 importers involved in this sample.
According to the NAO report, the highest number of WOR letters, 54, was issued to one Yaden International, followed by 28 to one Pharma Associates, and 27 to one Sisili Projects Consortium Ltd.
According to Subsection 58(1) of the act, only medicines registered under the authority should be imported into the country. However, despite the authority’s obligation to refrain from issuing WOR letters or to minimise their issuance, instances have occurred where such letters were issued even for medicines registered under different brand names.
In a sample analysis of seven selected medicines, it was found that WOR letters had been issued to other importers, despite the existence of between two and 57 registered medicines for each of these products.
A fast-tracked deviation
The NAO has further uncovered significant irregularities in the issuance and ratification of WOR letters, particularly concerning approvals granted to the MSD and the SPC through the Special Pathway system.
A fast-track method for issuing WOR letters had been implemented based on the approval of the Chief Executive Officer, bypassing the Waiver of Registration Subcommittee (WORSC). This decision, made by the Board of Directors on 16 September 2022, had allowed for the issuance of WOR letters by verifying only basic documents such as purchase orders, indents, and sales invoices.
However, the NAO has revealed that in approving WORs under the Special Pathway system, crucial factors such as price fairness, expert opinions, essentiality of the medicine, availability of registered alternatives, registration status of the medicine and supplier, and prior quality issues had been overlooked. Additionally, recommendations for an independent, unbiased committee to handle the issuance process, as suggested in a special audit on 14 March 2018, had been ignored.
From 2022 to June 2023, a total of 287 WOR letters had been issued under the Special Pathway: 57 to the MSD and 176 to the SPC in 2022, and three to the MSD and 51 to the SPC in 2023 up to June. According to the NAO report, in 2022 alone, 233 WOR approvals had been granted to the MSD and SPC.
However, 89 letters to the MSD and 58 to the SPC had not received ratification from the Medicines Evaluation Committee (MEC). The lack of ratification was due to various reasons, including the non-essential nature of the medicines, inconsistencies in dosage, higher pricing, availability of registered alternatives, local production options, and non-registration of manufacturers or local agents.
For the WOR letters that did receive ratification, it had often come with conditions such as the requirement for manufacturers to be registered and for prices to be below the Maximum Retail Price (MRP).
The NAO’s investigation has further revealed that between 2022 and June 2023, a total of 917 WOR letters had been issued to the MSD and SPC. This practice has raised concerns, as Subsection 58(1) of the NMRA Act No.5 of 2015 strictly prohibits the importation of medicines without proper registration and licensing from the authority.
The MEC primarily considers the presence of registered alternatives when granting approval for WORs. In 166 cases provided through the Special Pathway system, ratification was denied due to the availability of between one and 21 registered medicines in each case.
Approval for the WOR had been sanctioned via the Special Pathway system for the importation of 400,000 units of meropenem injection USP 500 mg, a widely prescribed antibiotic for infected patients. However, the MEC had not ratified this approval due to prior reports of quality failures associated with the medication.
The audit has further revealed reports of quality issues with medicines from manufacturers of 15 other approved medications.
Furthermore, ratification from the MEC was withheld for 29 medicines, including ofloxacin vial eye/ear drops 5 ml, cinnarizine tablets BP 25mg, rifaximin tablets 550 mg, and mosapride citrate tablets 5 mg, which are utilised for ear infections, haematological conditions, and digestive system disorders.
These medications were excluded from the list of essential medicines, leading to the denial of ratification for their WOR through the Special Pathway method.
Quality failures
Despite comprehensive document review requirements outlined in the Guidelines on Registration of Medicines, medicines without validated quality assurances have been imported due to limited evaluation by the WORSC without sample testing.
Over the years, instances of problems with the quality of imported medicines have been reported, leading to removal from use, temporary suspension, and voluntary removal by importers. A total of 26 incidents were reported between 2018 and June 2023, indicating a concerning trend.
Between 2019 and 31 October 2023, there have been significant instances of medicines being taken out of circulation due to quality concerns. Specifically, one medicine had been removed from use in 2019 and another had been temporarily suspended in 2020, followed by eight medicines being removed from use in 2021 and five in 2022. As of 31 October 2023, three medicines had been removed from use, while six have been suspended from use. Additionally, one medicine had been voluntarily removed by the importer, reflecting ongoing challenges in ensuring the quality and safety of imported medicines.
For example, defective furosemide syrup, used for various illnesses, was distributed to public hospitals despite quality issues. Additionally, two fatalities were reported at the Peradeniya Teaching Hospital due to adverse reactions from bupivacaine purchased under a WOR letter in 2022, prompting a recommendation for its complete removal from use.
Oversight neglected
The NAO audit has further revealed that the subcommittee tasked with this process should have met biweekly, but only 15 out of the required 36 meetings had been held from January 2022 to June 2023. Notably, no meetings had occurred in September 2022 when the fast-track mechanism had been approved by the Board of Directors.
The audit has found that WOR letters had been issued without proper consideration of factors such as price reasonableness, expert opinion, essentiality, the number of similar registered medicines, and the registration status of medicines, suppliers, and manufacturers. This oversight has led to a risk of importing medicines without confirmed quality, safety, efficacy, and price fairness.
Additionally, importers had failed to submit routine reports as required by Section 109(4) of the act and the NMRA had not established a system to collect and track these reports, resulting in the lack of follow-up on whether imported medicines complied with regulations.
Official responses
In response to a question by The Sunday Morning regarding the number of WOR letters issued to the SPC, its General Manager Dinusha Dasanayake said: “There are some items with the MSD for which we don’t have any registered suppliers in Sri Lanka. In such cases, we procure these items from unregistered suppliers and we are compelled to request the NMRA to issue WORs. This is the normal procedure.”
He continued: “Apart from that, we have only one or two suppliers for some items. Sometimes, these suppliers do not quote for our tenders. In cases where no registered suppliers quote for tenders, procurement committees are compelled to award them to unregistered parties, subject to WOR.
“In these circumstances, we are compelled to request the NMRA to issue WORs. However, the NMRA has a standard set of documents. What we are doing is requesting suppliers to provide these documents to the NMRA to obtain WORs. However, issuing WORs is at the discretion of the NMRA. We just request to see the possibility.”
Meanwhile, when contacted by The Sunday Morning, NMRA Chairman Dr. Ananda Wijewickrama said: “We received the NAO report last week. We haven’t appointed any committee yet; we will need to discuss that with the Secretary to the Health Ministry and the NMRA Board. We haven’t done that yet. However, we have already changed the mechanism of issuing the WOR.”
All attempts to contact MSD Deputy Director General Dr. G. Wijesuriya, Ministry of Health Secretary Dr. Palitha Mahipala, and Health Minister Dr. Ramesh Pathirana were futile.