• NMRA probe underway; hospitals directed not to use questionable meds
• 50 batches of meds, 29 products withdrawn from usage as of Dec. 
• Injectable medications most affected; 18 batches withdrawn, 7 batches withheld
• Highest withdrawal of meds manufactured in India; rest from Pakistan, Bangladesh

Serious concerns regarding the quality of medicines in the local market have resurfaced, with the National Medicines Regulatory Authority (NMRA) recently making the decision to withhold 13 batches of different types of medicines and withdraw these batches from use in local hospitals, as learnt by The Sunday Morning.

NMRA Chairman Dr. Ananda Wijewickrama told The Sunday Morning that investigations were currently underway and that the authority had informed all hospitals to withhold the questionable medicines until investigations were complete.

Confirming this, Medical Supplies Division (MSD) Deputy Director General Dr. Garusinghe Wijesuriya said: “The NMRA meets once a month and during its evaluations, the latest decision was made to withhold 13 batches of different types of medicines. Penalties will be applicable to those who have imported questionable medicines.”

Medicines being withdrawn or withheld 

According to the latest statistics available from the MSD of the Ministry of Health, 2024 has seen a significant number of product withdrawals and instances of products being withheld in the pharmaceutical and medical device sectors, reflecting growing concerns over product safety and quality. 

With multiple batches and products affected by various issues, this year has highlighted the critical importance of maintaining rigorous quality control and regulatory compliance to protect consumer health. A total of 79 circulars have been issued by regulatory bodies, primarily addressing products manufactured in India, Sri Lanka, Pakistan, and other countries.

As of December, 50 batch withdrawals have been initiated, primarily targeting pharmaceuticals and medical devices such as injections, tablets, and syringes. These withdrawals were prompted by manufacturing defects, contamination, and labelling discrepancies, which caused the products to fail to meet required safety and quality standards. 

Additionally, 29 products, including syringes, gloves, and intravenous medications, have been withheld from the market due to potential safety risks, including improper storage conditions and manufacturing defects. 

Injectable medications have been among the most affected, with 18 batches withdrawn and seven batches withheld. Popular medications like co-amoxiclav, meropenem, and cefotaxime were impacted by contamination or incorrect labelling. Similarly, lorazepam and sulfasalazine tablets had three batches withdrawn due to labelling and packaging issues. 

Surgical and medical devices, particularly examination gloves and biopsy needles, were also subject to withdrawals and being withheld due to contamination risks or failure to meet international standards. Additionally, five batches of auto-disable syringes and hypodermic syringes were withdrawn, further highlighting concerns regarding product quality and safety, according to the MSD.

When analysing the MSD statistics geographically, India was the largest source of affected products, with 33 withdrawals and 15 products being withheld. These included products such as clindamycin injections, lorazepam tablets, and calcium gluconate. 

Sri Lanka also saw significant product actions, particularly with co-amoxiclav products, leading to 12 withdrawals and six instances of products being withheld from manufacturers such as Navesta Pharmaceuticals. Product actions for medicines originating from Pakistan and Bangladesh were largely focused on meropenem injections and lactulose syrups, with three batches of meropenem from Pakistan withdrawn along with two batches from Bangladesh.

The reasons for these product actions varied but were primarily driven by contamination, labelling and packaging errors, manufacturing defects, and short expiry dates. Contamination concerns, particularly in injectable medications and medical devices, posed direct risks to patient safety. 

Labelling and packaging issues, including incorrect dosage instructions and missing information, were also significant contributors to the recalls. Manufacturing defects, such as faulty syringes or gloves, were another common reason for product withdrawals. In some cases, products with near-expiry dates were recalled to ensure that consumers did not use medications past their efficacy period.

NMRA under scrutiny 

Meanwhile, as per the latest audit report issued by the National Audit Office (NAO), the NMRA has come under scrutiny following a series of operational issues outlined in the report, raising concerns about delays in medicine and medical device registrations, quality assurance testing, and adherence to legal provisions.

The National Medicines Quality Assurance Laboratory (NMQAL) has faced delays in issuing test reports for medical drug samples submitted between 2019 and 2021. Out of 216 medical drug samples received in 2019 and 2020, only 157 test certificates had been issued, and of the 477 samples received in the year under review, only 299 had received certificates. 

By 31 July 2022, 91 samples had not received test reports, including 42 samples submitted by the court. The delay could potentially affect court proceedings, with experts emphasising the need for timely quality testing and better data management.

The NMRA has also been criticised for deviating from the proper procedures for re-registering medicines. Instead of issuing new registration certificates, the authority had extended the existing registrations for 2,904 out of 3,892 applications received in the year under review. This practice had been conducted without formal approval and violates provisions of the NMRA Act, raising concerns over compliance with legal standards.

A significant gap in the evaluation process has been identified, as the Medicines Evaluation Committee (MEC) and the Medical Devices Evaluation Committee (MDEC) had failed to submit required technical evaluation reports for many medicines and medical devices. 

The evaluation reports, which should include assessments of benefits, risks, quality, safety, and pricing, had not been provided as mandated by the act. The issue is compounded by the limited frequency of the MDEC meetings, which only meets once a month, leading to a backlog of evaluations.

The NMQAL also lacks the necessary facilities to perform quality checks on medical devices and borderline products, as stipulated by the act. The NMRA Chairman acknowledged the lab’s limitations, noting that while third-party test reports could be used for clinical evaluation, the laboratory was still not equipped to handle such tests, especially for products that fell under the Borderline Products category.

There have also been significant delays in the registration of medical devices. Although the evaluation of dossiers is supposed to be completed within 300 days, 146 dossiers submitted in 2020 had not been processed by 25 June 2022. Delays had occurred at various stages, including transfers to pharmacists and submission for performance evaluation. 

Experts argue that the authority has not taken sufficient measures to speed up the registration process, which has become increasingly inefficient.

In several cases, dossiers had been submitted to incorrect professional bodies for performance evaluation, resulting in lengthy delays. One medical device dossier, meant for the College of Dentistry and Stomatology, had first been sent to the Apeksha Hospital in Maharagama and then to a chemical pathologist before being properly directed to the college, leading to a delay of over three years in issuing a registration certificate. 

Similar misallocations of dossiers have been observed for other devices, highlighting the lack of formal guidance for the MDEC on the appropriate professional bodies to consult.

The audit has also revealed that many dossiers submitted for registration contained inaccurate or incomplete information. Key details, such as dates of submission, technical evaluation, and pharmacists’ recommendations, had often been missing or incorrectly recorded. This lack of proper documentation has raised concerns about the integrity and efficiency of the registration process.

The MDEC has struggled with low participation, with only 35% attendance in the 10 meetings held during the year. Seven members had not attended a single meeting, affecting the decision-making process. Experts are calling for better management to ensure that members actively contribute their expertise to the evaluation of medical devices.

Finally, the NMRA faced a technical failure in its online system in August 2021, leading to delays in issuing pharmacy licenses. Instead of issuing new licenses, existing licenses from 2019 and 2020 had been rubber-stamped with extended dates. In some cases, the date extensions had not been documented, with signatures being missing. The NMRA has been urged to improve its online system to prevent further disruptions.

The audit findings have highlighted critical gaps in the NMRA’s operations, particularly in its handling of medical drug sample testing, medicine and medical device evaluations, and the registration process. The authority has been urged to take immediate corrective actions to ensure compliance with the law, improve efficiency, and minimise delays in the registration and evaluation of medicines and medical devices. 

When contacted, Health Ministry Secretary Dr. Anil Jasinghe said that efforts would be accelerated to complete the long-delayed laboratory for medicine quality checks in Sri Lanka.

However, he said that they were still in the process of gathering relevant data, including statistics and information on medicine shortages, quality issues, and other related areas.

Dr. Jasinghe stated that once the evaluation of these persistent issues was complete, appropriate actions would be taken promptly.